[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Incyte Corporation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":638},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,38,0,25,[9,51,75,99,129,163,185,208,235,259,282,299,324,349,371,393,417,442,466,488,510,535,558,583,621],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100633083","phase-3-a-study-to-evaluate-chemotherapy-with-or-without-incb161734-in-previously-untreated-kras-g12d-mutated-metastatic-pancreatic-ductal-adenocarcinoma-100633083",false,"NCT07522073","A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma","A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)","DAWN-303","Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic PDAC with a KRAS G12D mutation\n* No prior systemic treatment in the metastatic setting\n* ECOG Performance status 0-1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior treatment with any KRAS inhibitor\n* Chronic or current active infection requiring systemic treatment within 1 week prior to the first dose of study drug\n* Known active CNS metastases\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.","ALL","18 Years",{"count":21,"type":22},588,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of standard chemotherapy with or without INCB161734 in participants with metastatic pancreatic ductal adenocarcinoma (PDAC).",[28],"Solid Tumors",[30,31,32,33,34,35,36,37],"INCB161734","KRASG12D Mutation","pancreatic ductal adenocarcinoma (PDAC)","KRAS G12D inhibitor","KRAS inhibitor","KRAS mutation","pancreatic cancer","metastatic pancreatic cancer","RECRUITING","2026-06-29",{"date":41,"type":42},"2026-06-30","ACTUAL",{"date":44,"type":42},"2026-04-09",{"date":46,"type":22},"2029-03-19",{"name":48,"class":49},"Incyte Corporation","INDUSTRY",217,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100614842","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-standard-of-care-chemotherapy-and-bevacizumab-with-or-without-inca33890-in-the-first-line-treatment-of-metastatic-microsatellite-stable-colorectal-cancer-100614842","NCT07284849","A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer","A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer","Inclusion Criteria:\n\n* Stage IV colorectal adenocarcinoma not amenable to curative resection.\n* No prior systemic treatment for unresectable or metastatic disease. Participants who received adjuvant or neoadjuvant therapy may enroll if there was no recurrence within 12 months of the end of treatment.\n* Measurable disease per RECIST v1.1.\n* ECOG performance status of 0 or 1.\n* Adequate organ function determined by laboratory results.\n\nExclusion Criteria:\n\n* MSI-H\u002FdMMR per historical data in the medical record.\n* BRAF V600E mutation per historical data in the medical record.\n* Untreated and\u002For progressing CNS metastases.\n* History of other malignancy within 2 years.\n* Treatment with an anti-PD-(L)1 or other immune checkpoint inhibitor for any indication within the last 3 years.\n* Active autoimmune disease that has required systemic treatment in the past 2 years.\n* Significant concurrent and\u002For uncontrolled medical condition.\n* History of organ transplant, including allogeneic stem cell transplantation.\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":59,"type":22},700,[25],"The purpose of this study is to evaluate the efficacy and safety of standard-of-care chemotherapy and bevacizumab with or without INCA33890 in the first-line treatment of metastatic microsatellite stable colorectal cancer.",[63],"CRC (Colorectal Cancer)",[65,66,67],"Metastatic Colorectal Cancer","Colon Cancer","INCA33890",{"date":41,"type":42},{"date":70,"type":42},"2026-03-05",{"date":72,"type":22},"2029-09-28",{"name":48,"class":49},275,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":83,"minAge":19,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100609453","phase-3-study-to-evaluate-incb123667-versus-investigators-choice-of-chemotherapy-in-participants-with-platinum-resistant-ovarian-cancer-with-cyclin-e1-overexpression-100609453","NCT07214779","Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression","A Phase 3, Randomized, Open-Label Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression","MAESTRA 2","Inclusion Criteria:\n\n* Histological diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.\n* Have platinum-resistant disease.\n\n  * Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum containing regimen.\n  * Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after the last dose of platinum.\n* Archival FFPE tumor tissue block or slides from a specimen no older than 5 years must be available. If not available, participant must be willing to undergo a pretreatment tumor biopsy.\n* Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent chemotherapy is considered an appropriate next therapeutic option.\n* Should have received prior treatment with bevacizumab unless there was a contraindication for its use.\n* Should have received prior treatment with mirvetuximab soravtansine if the tumor is positive for FRα, unless there is an exception for its use on medical grounds.\n* Measurable disease per RECIST v1.1.\n\nExclusion Criteria:\n\n* Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade\u002Fborderline ovarian cancer.\n* Have primary platinum-refractory disease, defined as progression on or within 3 months after the last dose of first line platinum-containing therapy.\n* Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study treatment.\n* Known active CNS metastases and\u002For carcinomatous meningitis.\n* Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years before the first dose of study treatment.\n* Clinically significant gastrointestinal abnormalities.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.","FEMALE",{"count":85,"type":22},466,[25],"The purpose of this study is to evaluate INCB123667 versus investigator's choice of chemotherapy in participants with platinum-resistant ovarian cancer with cyclin E1 overexpression.",[89],"Ovarian Cancer",[91],"INCB123667",{"date":41,"type":42},{"date":94,"type":42},"2025-12-09",{"date":96,"type":22},"2029-05-14",{"name":48,"class":49},172,{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":18,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":23,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100609391","phase-2-pharmacokinetics-safety-and-efficacy-of-povorcitinib-in-adolescent-participants-with-moderate-to-severe-hidradenitis-suppurativa-100609391","NCT07213973","Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa","A Phase 2, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Povorcitinib in Adolescents With Moderate to Severe Hidradenitis Suppurativa","Inclusion Criteria:\n\n* Aged ≥ 12 to \\\u003C 18 years at the time of informed consent\u002Fassent signing.\n* Body weight ≥ 30 kg at both screening and baseline visits.\n* Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit.\n* Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits.\n* HS lesions corresponding to refined Hurley Stage IB, IC, IIB, IIC, or III at both the screening and baseline visits.\n* Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for treatment of their HS).\n* Agreement to use contraception.\n* Willing and able to comply with the study protocol and procedures.\n* Further inclusion criteria apply.\n\nExclusion Criteria:\n\n* Presence of \\> 20 draining tunnels (fistulas) at either the screening or baseline visit.\n* Women who are pregnant (or who are considering pregnancy) or breastfeeding.\n* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.\n* Laboratory values outside of the protocol-defined ranges.\n* Further exclusion criteria apply.","12 Years","17 Years",{"count":109,"type":22},40,[111],"PHASE2","The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of povorcitinib in adolescent participants with moderate to severe hidradenitis suppurativa over a 54-week open-label treatment period.",[114],"Hidradenitis Suppurativa (HS)",[116,117,118,119,120,121],"Hidradenitis Suppurativa","HS","INCB054707","Povorcitinib","Acne inversa","Hidradenitis",{"date":41,"type":42},{"date":124,"type":42},"2026-02-02",{"date":126,"type":22},"2028-03-25",{"name":48,"class":49},30,{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},"100608004","phase-1-a-study-to-evaluate-inca036873-in-participants-with-advanced-solid-tumors-and-hematological-malignancies-100608004","NCT07195916","A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies","A Phase 1, Open-Label, Multicenter Study of INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies","Inclusion Criteria:\n\n* Age ≥18 years.\n* ECOG performance status of 0 or 1.\n* Histologically confirmed:\n\n  * Clear cell renal cell carcinoma (ccRCC).\n  * Diffuse large B-cell lymphoma (DLBCL, NOS).\n  * High-grade B-cell lymphoma (HGBCL).\n  * Peripheral T-cell lymphoma (PTCL, incl. NOS and ALCL).\n  * Cutaneous T-cell lymphoma (CTCL, incl. MF or SS ≥Stage IIB with B0\u002FB1 blood involvement).\n* Disease progression, relapse, or refractory to prior therapy:\n\n  * ccRCC: ≥1 prior line incl. ICI + TKI.\n  * DLBCL\u002FHGBCL: ≥2 prior lines incl. immunochemotherapy and salvage.\n  * PTCL\u002FCTCL: ≥1 prior systemic therapy.\n* Measurable disease by RECIST v1.1 (ccRCC), Lugano 2014 (lymphomas), or ISCL\u002FUSCLC\u002FEORTC (CTCL).\n* Tumor tissue available for central testing.\n\nExclusion Criteria:\n\n* Untreated or progressive CNS disease unless previously treated and stable.\n* Other active invasive malignancy within 2 years (except certain low-risk cancers).\n* Prior CD70-targeting therapy, including CAR T.\n* ASCT or CAR T ≤12 weeks before enrollment; prior organ or allogeneic transplant.\n* Unresolved ≥Grade 2 toxicity from prior therapy (with exceptions).\n* Primary immunodeficiency or active autoimmune disease requiring immunosuppression.\n* Active HBV, HCV, HIV, or other chronic infections requiring systemic therapy.\n* Pregnancy, breastfeeding, or unwillingness to use effective contraception.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",{"count":137,"type":22},280,[139],"PHASE1","A study to evaluate the safety and tolerability of INCA036873 in participants with advanced solid tumors and hematological malignancies.",[28,142],"Hematologic Malignancies",[144,145,146,147,148,149,150,151,152,153,154,155],"Advanced solid tumors","Metastatic solid tumors","Clear cell renal cell carcinoma (ccRCC)","Diffuse large B-cell lymphoma (DLBCL)","High-grade B-cell lymphoma (HGBCL)","Peripheral T-cell lymphoma (PTCL, incl. ALCL)","Cutaneous T-cell lymphoma (CTCL, incl. MF and SS)","Non-Hodgkin lymphoma (NHL)","CD70","Bispecific antibody","Immunotherapy","T-cell engager",{"date":41,"type":42},{"date":158,"type":42},"2026-01-08",{"date":160,"type":22},"2028-08-18",{"name":48,"class":49},22,{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":173,"briefSummary":174,"conditions":175,"keywords":176,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},"100581837","phase-3-rollover-study-for-participants-previously-enrolled-in-clinical-trials-of-povorcitinib-100581837","NCT06855498","Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib","A Phase 3b, Multicenter, Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib","STOP-LTR","Inclusion Criteria:\n\n* Ability to comprehend and willingness to sign a written ICF for the study.\n* Completed the treatment period of a predetermined, Incyte-sponsored, povorcitinib parent study without safety or tolerability concerns, per investigator's assessment.\n* Received clinical benefit from treatment with study drug during the parent study, as determined by the investigator.\n* Demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements.\n* Willingness to avoid pregnancy or fathering children as defined in the protocol.\n* Willingness and ability to comply with the study Protocol and procedures.\n\nExclusion Criteria:\n\n* Had been permanently discontinued from study treatment during the parent study.\n* Had temporary study drug interruption due to safety and\u002For efficacy reasons at or after the final visit of the parent study.\n* Received at least 1 dose of either of the following therapies within the 28 days prior to starting treatment in this rollover study:\n\n  * Biologic immunomodulator (examples include but are not limited to adalimumab, bimekizumab, dupilumab, infliximab, nemolizumab, secukinumab).\n  * Live, attenuated vaccine.\n* Plans for administration of a live, attenuated vaccine during this study or within 8 weeks after the last dose of study drug.\n* Women who are pregnant (or who are considering pregnancy) or breastfeeding.\n* Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib and\u002For other products in the same class.\n* Currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.\n* Any condition that would, in the investigator's and\u002For sponsor's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",{"count":172,"type":22},600,[25],"Rollover study for participants from predetermined, Incyte-sponsored parent clinical trials of povorcitinib.",[114],[118,177,116,121,117],"povorcitinib",{"date":41,"type":42},{"date":180,"type":42},"2025-02-28",{"date":182,"type":22},"2028-02-28",{"name":48,"class":49},316,{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":18,"minAge":106,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":23,"phases":195,"briefSummary":196,"conditions":197,"keywords":199,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":201,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},"100561101","phase-3-a-study-to-evaluate-axatilimab-and-corticosteroids-as-initial-treatment-for-chronic-graft-versus-host-disease-100561101","NCT06585774","A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (AXemplify-357)","AXemplify-357","Inclusion Criteria:\n\n* ≥ 12 years of age at the time of informed consent.\n* New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy.\n* History of allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative, nonmyeloablative, or reduced-intensity conditioning are eligible.\n* Adequate hematologic function with ANC ≥ 0.5 × 109\u002FL independent of growth factors for at least 7 days prior to study entry.\n* Willingness to avoid pregnancy or fathering children.\n\nExclusion Criteria:\n\n* Received more than 1 prior allo-HCT. Prior autologous HCT is allowed.\n* Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD.\n* Received more than 7 days of systemic corticosteroid treatment for cGVHD or unable to begin a prednisone dose ≥ 1.0 mg\u002Fkg per day (or methylprednisolone equivalent) for cGVHD.\n* Received previous systemic treatment for cGVHD, including extracorporeal photopheresis.\n* Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D1.\n* Prior treatment with CSF-1R targeted therapies.\n* Active, uncontrolled bacterial, fungal, parasitic, or viral infection.\n* Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-HCT was performed, including DLIs for the treatment of molecular relapse.\n* History of acute or chronic pancreatitis.\n* Active symptomatic myositis.\n* History or current diagnosis of cardiac disease indicating significant risk of safety for participation in the study, such as uncontrolled or significant cardiac disease.\n* Severe renal impairment, that is, estimated CrCl \\\u003C 30 mL\u002Fmin measured or calculated by Cockcroft-Gault equation in adults and Schwartz formula in pediatric participants, or endstage renal disease on dialysis.\n* Impaired liver function, defined as total bilirubin \\> 1.5 × ULN and\u002For ALT and AST \\> 3 × ULN in participants with no evidence of liver cGVHD.\n* Pregnant or breastfeeding.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",{"count":194,"type":22},240,[25],"This study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).",[198],"Chronic Graft-versus-host-disease",[200],"cGVHD",{"date":41,"type":42},{"date":203,"type":42},"2025-01-21",{"date":205,"type":22},"2030-03-31",{"name":48,"class":49},123,{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":23,"phases":218,"briefSummary":219,"conditions":220,"keywords":223,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},"100635960","phase-1-a-study-to-assess-the-safety-and-pharmacokinetics-of-incb123667-when-administered-orally-to-adult-participants-with-moderate-or-severe-hepatic-impairment-100635960","NCT07559474","A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment","A Phase 1, Open-Label Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment","Inclusion Criteria:\n\n* Ability to comprehend and willingness to sign a written ICF for the study.\n* Aged 18 to 80 years, inclusive, at the time of signing the ICF.\n* Moderate or severe hepatic impairment based on CP score.\n* Medical findings consistent with the degree of hepatic dysfunction, determined by medical history, physical examination, vital sign measurements, 12-lead ECGs, and clinical laboratory determinations at screening or check-in (as applicable). Participants with abnormal findings considered not clinically significant by the medical monitor or investigator are eligible.\n* Body mass index of 18.0 to 43.0 kg\u002Fm2 (inclusive).\n* Willingness to avoid pregnancy or fathering children.\n\nExclusion Criteria:\n\n* Participants who have a current, functioning organ transplant or are on the national transplant list and expected to receive a transplant within 3 months.\n* Tobacco or nicotine-containing product use of \\> 10 cigarettes per day within 1 month before screening.\n* Participants who had a change in disease status within 30 days before screening, as documented by the participant's medical history, that is deemed clinically significant by the investigator.\n* Participants who have a history of paracentesis within 2 months prior to check-in.\n* Participants who required new medication or an increase in dose for hepatic encephalopathy within 3 months prior to check-in.\n* Participants who have a history of unstable diabetes mellitus (as evidenced by hemoglobin A1c ≥ 10.0%). Medications for treatment of diabetes mellitus must be reviewed and approved by the investigator and medical monitor. Participants who have a portal systemic shunt. Up to 3 participants with transjugular intrahepatic portosystemic shunt may be included.\n* Participants who had esophageal banding within 3 months prior to check-in or required any other treatment for gastrointestinal bleeding within 6 months prior to check-in.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.","80 Years",{"count":217,"type":22},16,[139],"This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with moderate or severe hepatic impairment.",[221,222],"Hepatic Insufficiency","Liver Diseases",[224,225],"hepatic impairment","liver impairment (moderate and severe)","2026-06-12",{"date":228,"type":42},"2026-06-16",{"date":230,"type":42},"2026-05-27",{"date":232,"type":22},"2027-04-13",{"name":48,"class":49},4,{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":242,"enrollmentInfo":243,"targetDuration":4,"studyType":23,"phases":244,"briefSummary":245,"conditions":246,"keywords":248,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":252,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":258},"100635954","phase-1-a-study-to-assess-the-safety-and-pharmacokinetics-of-incb123667-when-administered-orally-to-adult-participants-with-severe-renal-impairment-or-end-stage-renal-disease-100635954","NCT07559396","A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease","A Phase 1, Open-Label Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease","Inclusion Criteria:\n\n* Aged 18 to 85 years, inclusive, at the time of signing the ICF.\n* Severe renal impairment or ESRD based on CKD-EPI.\n* Body mass index of 18.0 to 43.0 kg\u002Fm2 (inclusive).\n* Willingness to avoid pregnancy or fathering children.\n\nExclusion Criteria:\n\n* Participants who have a current, functioning organ transplant or are on the national transplant list and expected to receive a transplant within 3 months.\n* Participants with laboratory values outside the accepted range for participants with severe renal impairment or ESRD at screening. Participants with out-of-range values will be assessed by the investigator or designee for eligibility.\n* Tobacco or nicotine-containing product use of \\> 10 cigarettes per day within 1 month before screening.\n* Participants who had a change in disease status within 30 days before screening, as documented by the participant's medical history, that is deemed clinically significant by the investigator.\n* Participants who have a history of paracentesis within 3 months prior to check-in.\n* Participants who required new medication or an increase in dose for renal disease within 3 months prior to check-in.\n* Participants who have a history of unstable diabetes mellitus (as evidenced by hemoglobin A1c ≥ 10.0%). Medications for treatment of diabetes mellitus must be reviewed and approved by the investigator and medical monitor.\n* Participants who had esophageal banding within 3 months prior to check-in or required any other treatment for gastrointestinal bleeding within 6 months prior to check-in.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.","85 Years",{"count":217,"type":22},[139],"This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with severe renal impairment or end stage renal disease.",[247],"Renal Impairment",[249,250,251],"severe renal impairment","Kidney failure","end-stage renal disease",{"date":228,"type":42},{"date":254,"type":42},"2026-05-29",{"date":256,"type":22},"2027-01-04",{"name":48,"class":49},2,{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":23,"phases":268,"briefSummary":269,"conditions":270,"keywords":272,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":109},"100600982","phase-2-study-to-assess-the-safety-and-tolerability-of-tafasitamab-in-adult-participants-with-primary-autoimmune-blood-cell-disorders-100600982","NCT07104565","Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders","A Phase 2a, Open-Label, Multicenter Study of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders","Inclusion Criteria:\n\n\\- Ability to comprehend and willingness to sign a written ICF for the study.\n\n* Aged ≥ 18 years.\n* Confirmed historical diagnosis of one of the following autoimmune blood disorders:\n\n  * Primary ITP.\n  * Primary wAIHA.\n* No history of splenectomy.\n* Confirmed transient response to at least 1 prior early-line treatment (eg, corticosteroids, IVIG, rituximab):\n\n  * Primary ITP: Increase in platelet count to ≥ 30 × 109\u002FL with at least a 2-fold increase of baseline platelet count.\n  * Primary wAIHA: Increase in hemoglobin to ≥ 10 g\u002FdL with an increase of at least 2 g\u002FdL from baseline.\n* Received ≥ 1 standard course of rituximab (375 mg\u002Fkg × 4 weekly doses or 2 doses of 1000 mg flat dose every 2 weeks) with last dose given at least 6 months prior to initiation of study treatment. Note: If rituximab was the only prior therapy, individuals with NR to rituximab will not be eligible.\n\n  * Primary ITP: a PR (platelet count ≥ 30 × 109\u002FL with at least a 2-fold increase of baseline platelet count) within 6 months of the last administered dose followed by relapse OR a CR (platelet count \\> 100 × 109\u002FL) lasting \\\u003C 48 weeks OR NR (platelet count \\\u003C 30 × 109\u002FL or less than 2-fold increase of baseline platelet count or bleeding) within 6 months of the last administered dose.\n  * Primary wAIHA: a PR with hemoglobin ≥ 10 g\u002FdL and with an increase of at least 2 g\u002FdL from baseline OR a CR (hemoglobin ≥ 12 g\u002FdL and normalization of hemolytic markers) OR NR (hemoglobin \\\u003C 10 g\u002FdL or \\\u003C 2 g\u002FdL increase of baseline hemoglobin).\n* Persistent or chronic active primary ITP or active primary wAIHA with indication for treatment at the time of inclusion.\n\n  * Primary ITP: platelet count \\\u003C 30 × 109\u002FL within the 15 days before treatment is scheduled to begin (Day 1).\n\nNote: Participants treated with a rescue therapy during screening in response to a documented platelet count \\\u003C 30 × 109\u002FL are eligible, irrespective of platelet count within 15 days of Day 1.\n\n• Primary wAIHA: hemoglobin \\\u003C 10 g\u002FdL documented with DAT result positive for IgG, with or without C3d, and evidence of hemolysis based on low haptoglobin, elevated LDH, and\u002For indirect bilirubin.\n\n* ECOG performance status of 0 to 2.\n* Willingness to avoid pregnancy or fathering children.\n* Further inclusion criteria apply.\n\nExclusion Criteria:\n\n* Clinical manifestations typical for cold agglutinin disease.\n* Life-threatening bleeding or urgent need to elevate the platelet count for primary ITP or hemodynamic instability or hemoglobin \\\u003C 6 g\u002FdL with urgent need to elevate hemoglobin for primary wAIHA within 2 weeks prior to Day 1.\n* Prior treatment with anti-CD19 therapy (eg, mAb, bispecific T-cell engager, or CAR T cell) for any indication.\n* Previous severe allergic reaction to a mAb or known allergy to any component\u002Fexcipient of tafasitamab.\n* Changes in doses (\\> 10%) of permitted disease-related therapies, including oral corticosteroids and TPO-RA (primary ITP participants) within 2 weeks prior to Day 1, or change in ESA (primary wAIHA participants) dose within 2 weeks prior to Day 1.\n* Evidence of hypogammaglobulinemia during screening (IgA \\\u003C 70 mg\u002FdL, IgG \\\u003C 700 mg\u002FdL, and\u002For IgM \\\u003C 40 mg\u002FdL) and frequent and\u002For severe infections.\n* Women who are pregnant or breastfeeding.\n* History of malignancy except for the following:\n\n  * Malignancy treated with curative intent with no evidence of active disease for more than 2 years before screening.\n  * Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanoma skin cancer.\n  * Adequately treated carcinoma in situ without current evidence of disease.\n* Congestive heart failure (left ventricular ejection fraction of \\\u003C 50%, assessed by 2 dimensional echocardiography or a multigated acquisition scan).\n* Participants with:\n\n  * Known positive test result for HCV (with HCV antibody serology testing) and a positive test for HCV RNA.\n\nNote: Participants with positive serology must have been tested for HCV RNA and are eligible only in the case of negative HCV RNA test result.\n\n• Known positive test result for chronic HBV infection (defined by HBsAg positivity or positive HBV DNA test result).\n\nNote: Participants with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA was undetectable, provided that they are willing to undergo monthly ongoing DNA testing. Antiviral prophylaxis may be administered as per institutional guidelines.\n\nNote: Participants who have protective titers of HBsAb (HBsAb positive, HBcAb negative, and HBsAg negative) after vaccination or prior HBV infection are eligible.\n\n• Seropositivity for or history of active viral infection with HIV.\n\n* Active systemic infection (including infection with SARS-CoV-2).\n* Participants in a severely immunocompromised state, per investigator's clinical assessment.\n* Receipt of a live-attenuated vaccine within 4 weeks prior to the first infusion of tafasitamab (inactivated and killed vaccines are acceptable).\n* Coagulation or platelet function abnormality.\n* An active medical condition with a strong indication for treatment with anticoagulation agents (eg, intracoronary stent within 12 months).\n* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.\n* Toxicities related to prior therapies must be CTCAE (v5.0) ≤ Grade 1 at the time of study treatment\u002Fenrollment (except for chronic toxicities \\[≤ Grade 2\\] not expected to resolve).\n* Chronic infectious disease requiring systemic antibiotics or antifungal or antiviral medications.\n* Unwillingness to undergo transfusion with blood components.\n* Current use of prohibited medication as described in the protocol.\n* Inadequate recovery from toxicity and\u002For complications from a major surgery before starting therapy.\n* Further exclusion criteria apply.",{"count":267,"type":22},56,[111],"This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.",[271],"Immune Thrombocytopenia",[273,274,275],"primary warm autoimmune hemolytic anemia","primary immune thrombocytopenia","anti-CD19 monoclonal antibody",{"date":228,"type":42},{"date":278,"type":42},"2025-12-29",{"date":280,"type":22},"2028-03-09",{"name":48,"class":49},{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":4,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":12,"sex":4,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":288,"phases":4,"briefSummary":289,"conditions":290,"keywords":292,"overallStatus":294,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":298,"locationsCount":4},"100482434","expanded-access-use-of-itacitinib-to-treat-a-single-patient-with-stat1-gain-of-function-gof-disease-100482434","NCT05561985","Expanded Access Use of Itacitinib to Treat a Single Patient With STAT1 Gain of Function (GOF) Disease","Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-","EXPANDED_ACCESS","Expanded access use of Itacitinib to treat a single patient with aplastic anemia.",[291],"STAT1 Gain-of-Function Disease",[293],"STAT1 GOF disease","AVAILABLE","2026-06-09",{"date":297,"type":42},"2026-06-10",{"name":48,"class":49},{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":23,"phases":309,"briefSummary":310,"conditions":311,"keywords":313,"overallStatus":316,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":4},"100643299","phase-3-a-phase-3-study-of-inca033989-versus-best-available-therapy-in-participants-with-essential-thrombocythemia-100643299","NCT07623200","A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia","A Phase 3, Randomized, Open-Label Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia and a CALR Mutation Previously Treated With Cytoreductive Therapy (EXCALIBUR-ET2)","EXCALIBUR-ET2","Inclusion Criteria:\n\n* Confirmed diagnosis of high-risk ET.\n* Presence of mutCALR.\n* Prior treatment with at least 1 cytoreductive therapy.\n\nExclusion Criteria:\n\n* Presence of any hematologic malignancy other than ET.\n* Major bleeding or thrombosis within the last 3 months prior to study enrollment.\n* Any prior allogenic or autologous stem-cell transplantation.\n* Unresolved toxicity ≥ Grade 2 from previous therapy except for stable chronic toxicities (Grade 2) not expected to resolve, such as stable Grade 2 peripheral neuropathy.\n* Prior nonhematologic malignancy except for the following: Malignancy treated with curative intent and with no evidence of active disease for more than 2 years before screening. Adequately treated carcinoma in situ without current evidence of disease.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria apply.",{"count":308,"type":22},426,[25],"This study is being conducted to evaluate INCA033989 versus best available therapy in participants with essential thrombocythemia and a CALR mutation previously treated with cytoreductive therapy.",[312],"Essential Thrombocythemia",[314,315],"calreticulin (CALR)","mutCALR","NOT_YET_RECRUITING","2026-06-05",{"date":295,"type":42},{"date":320,"type":22},"2026-07-31",{"date":322,"type":22},"2030-11-01",{"name":48,"class":49},{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":331,"sex":18,"minAge":19,"maxAge":332,"enrollmentInfo":333,"targetDuration":4,"studyType":23,"phases":335,"briefSummary":336,"conditions":337,"keywords":339,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":348},"100638619","phase-1-a-study-to-evaluate-dermal-open-flow-microperfusion-and-plasma-pharmacokinetic-study-of-multiple-doses-of-oral-povorcitinib-or-topical-ruxolitinib-cream-in-healthy-adult-participants-100638619","NCT07588139","A Study to Evaluate Dermal Open-Flow Microperfusion and Plasma Pharmacokinetic Study of Multiple Doses of Oral Povorcitinib or Topical Ruxolitinib Cream in Healthy Adult Participants","An Open-Label, Dermal Open-Flow Microperfusion and Plasma Pharmacokinetic Study of Multiple Doses of Oral Povorcitinib or Topical Ruxolitinib Cream in Healthy Adult Participants","Inclusion Criteria:\n\n* Ability to comprehend and willingness to sign a written ICF for the study.\n* Aged 18 to 65 years, inclusive, at the time of signing the ICF.\n* Body mass index between 18.0 and 30.5 kg\u002Fm2, inclusive.\n* No clinically significant findings on screening evaluations (clinical, laboratory, and ECG).\n* Ability to swallow and retain oral medication.\n* Willingness to avoid pregnancy or fathering children.\n\nExclusion Criteria:\n\n* History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and\u002For neurological disease within 6 months of screening.\n* Participants with any history of an autoimmune disease diagnosis.\n* History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension.\n* History or presence of an abnormal ECG.\n* Presence or history of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn's disease or chronic pancreatitis).\n* Any malignancies or history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.\n* Current or recent (within 3 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy; excluding appendectomy and hernia repair) that could affect the absorption of study drug.\n* Any major surgery within 4 weeks of screening.\n* Donation of blood to a blood bank or participation in a clinical study (except a screening visit) within 4 weeks of screening (within 2 weeks for plasma-only donation).\n* Blood transfusion within 4 months of check-in (Day -1).\n* Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment (includes latent treated tuberculosis).\n* Known tuberculosis infection that is active or participant-reported history of tuberculosis or treatment thereof.\n* Positive test for HBV, HCV, or HIV. Participants whose results are compatible with prior immunization for or immunity due to infection with HBV may be included at the discretion of the investigator.\n* Has received a live vaccine (including attenuated) or anticipation of need for such a vaccine during the study within 3 months prior to the first dose of study drug. Note: Examples of live vaccines include but are not limited to the following: measles, mumps, rubella, chickenpox\u002Fzoster, yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid. Seasonal influenza vaccines for injection are generally killed-virus vaccines and are allowed; however, intranasal influenza vaccines are live, attenuated vaccines and are not allowed.\n* Medical or self-reported history of alcoholism within 3 months of screening.\n* History of significant alcohol use within 3 months of screening, defined as regular alcohol consumption \\> 21 units per week for males and \\> 14 units for females (1 unit = 8 oz of beer or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type).\n* Positive urine or breath test for ethanol or positive urine or serum screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.\n* Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study treatment with another investigational medication or current enrollment in another investigational drug study.\n* Current treatment or treatment within 15 days or 5 half-lives (whichever is longer) before the first dose\u002Fapplication of study treatment with strong inducers or strong and moderate inhibitors of CYP3A4, P-gp, or BCRP (refer to the Drug Interaction Database for prohibited drugs.\n* Consumption of red wine, Seville oranges, grapefruit or grapefruit juice, pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices within 72 hours before the first dose of study drug.\n* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.\n* Known hypersensitivity or severe reaction to povorcitinib or any excipients of povorcitinib, to ruxolitinib or any excipients of ruxolitinib or any JAK inhibitors.\n* Inability to undergo venipuncture or tolerate venous access.\n* History of tobacco or nicotine containing product use within 1 month of screening.\n* Use of prescription drugs (including hormonal contraceptives) within 14 days of study treatment administration\u002Fapplication or nonprescription medications\u002Fproducts (including vitamins, minerals, and phytotherapeutic\u002Fherbal\u002Fplant-derived preparations) within 7 days before study treatment administration\u002Fapplication. However, occasional and standard dose paracetamol, acetaminophen, ibuprofen, and standard dose vitamins are permitted. Mega dose vitamins or supplements are not permissible.\n* Women who are pregnant or breastfeeding.\n* Any condition that would interfere with full participation in the study, including administration\u002Fapplication of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.\n* Excessive exercise (ie Iron man®, triathlon, etc) within 7 days before check-in (Day -1).\n* Tattoo or scarring at skin sample sites.\n* Participants prone to keloid or hypertrophic scar formation or any known wound healing disorder.\n* Not willing to avoid excessive sun exposure, steam baths, sauna, swimming, and other strenuous activities for 14 days after Day 12 to ensure good tissue regeneration.\n* Pronounced hairiness on the planned application sites, dOFM probe insertion sites, and skin biopsy collection sites, that may negatively affect dose application, probe placement, and\u002For sample testing.\n* Not willing to refrain from shaving the planned application sites, dOFM probe insertion sites, and skin biopsy collection sites, or using skin care products on the planned application sites, dOFM probe insertion sites, and skin biopsy collection sites, for at least 5 days before Day 1.\n* Not willing to avoid sunbathing, using tanning salons, or using spray\u002Flotion tanning agents within 7 days prior to Day 1 dose administration\u002Fapplication.\n* Presence of needle phobia.\n* Increased risk of thrombosis (eg, personal or first-degree relative\\[s\\] history of deep vein thrombosis).\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",true,"65 Years",{"count":334,"type":22},24,[139],"The purpose of this study is to evaluate the interstitial concentrations using the open-flow microperfusion device and plasma pharmacokinetics following multiple doses of povorcitinib or topical ruxolitinib cream in healthy adult participants.",[338],"Healthy Participants",[118],"2026-06-01",{"date":342,"type":42},"2026-06-03",{"date":344,"type":42},"2026-05-18",{"date":346,"type":22},"2026-09-19",{"name":48,"class":49},1,{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":18,"minAge":356,"maxAge":107,"enrollmentInfo":357,"targetDuration":4,"studyType":23,"phases":359,"briefSummary":360,"conditions":361,"keywords":362,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":370},"100602482","phase-2-a-study-to-evaluate-axatilimab-versus-best-available-therapy-in-pediatric-participants-with-chronic-graft-versus-host-disease-after-at-least-2-prior-lines-of-systemic-therapy-agave-256-100602482","NCT07124078","A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)","A Phase 2, Randomized, Open-Label Study of Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)","Inclusion Criteria:\n\n* Aged ≥ 2 to \\\u003C 18 years at the time of signing the informed consent.\n* Active, moderate to severe cGVHD, requiring systemic immune suppression.\n* Participants with refractory or recurrent cGVHD who have received at least 2 lines of systemic therapy, including corticosteroids and ruxolitinib.\n* Concomitant use of systemic corticosteroids is allowed. Participants on systemic corticosteroids must be on a stable dose of corticosteroids for at least 2 weeks prior to C1D1. Topical and inhaled corticosteroid agents are allowed.\n* Participants must accept to be treated with one of the following BAT options on C1D1: CNI (cyclosporine or tacrolimus), ECP, MMF, an mTOR inhibitor (everolimus or sirolimus), rituximab, imatinib, methotrexate, or ibrutinib.\n* History of allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative, nonmyeloablative, or reduced-intensity conditioning are eligible.\n\nExclusion Criteria:\n\n* Receipt of more than 1 prior allo-HCT. Prior autologous HCT is allowed.\n* Evidence of relapse of hematologic disease or treatment for relapse after the allo-SCT was performed, including DLI for the treatment of molecular relapse. Note: Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible.\n* Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D1.\n* Severe renal impairment, that is, GFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2 as estimated using modified Schwartz formula, or end-stage renal disease on dialysis.\n* Impaired liver function, defined as total bilirubin \\> 1.5 × ULN and\u002For ALT and AST \\> 3 × ULN in participants with no evidence of liver cGVHD.\n* History of acute or chronic pancreatitis.\n* Active, symptomatic myositis.\n* Female adolescent participants who are pregnant or breastfeeding.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.","2 Years",{"count":358,"type":22},60,[111],"This study will be conducted to compare Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.",[198],[200],{"date":364,"type":42},"2026-06-02",{"date":366,"type":42},"2026-05-20",{"date":368,"type":22},"2029-07-31",{"name":48,"class":49},41,{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":83,"minAge":19,"maxAge":379,"enrollmentInfo":380,"targetDuration":4,"studyType":23,"phases":382,"briefSummary":383,"conditions":384,"keywords":385,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":386,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":392},"100594759","phase-2-a-study-of-incb123667-in-participants-with-platinum-resistant-ovarian-cancer-with-cyclin-e1-overexpression-100594759","NCT07023627","A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression","A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 1)","MAESTRA 1","Inclusion Criteria:\n\n* Histological diagnosis of a high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.\n* Have platinum-resistant disease:\n\n  * Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of a platinum-containing regimen.\n  * Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after the last dose of platinum.\n* Willingness to undergo a pretreatment biopsy. Note: Tissue from a fresh pretreatment biopsy is preferred, however an archival sample is acceptable as long as the sample is no older than 5 years.\n* Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent therapy is considered an appropriate next therapeutic option.\n* Must have received bevacizumab unless there was a contraindication for its use.\n* If the tumor tests positive for FRα, participants must have received mirvetuximab soravtansine unless there is an exception for its use on medical grounds.\n\nExclusion Criteria:\n\n* Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade\u002Fborderline ovarian cancer.\n* Have primary platinum-refractory disease: either did not respond (CR or PR) to first-line platinum-containing therapy or progressed on or within 3 months after the last dose of the first line platinum-containing therapy.\n* The tumor tests positive for FRα but the participant has not received mirvetuximab soravtansine for any reason other than medical contraindication.\n* Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study drug.\n* Known active CNS metastases and\u002For carcinomatous meningitis.\n* Known additional malignancy that is progressing or requires active treatment.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.","99 Years",{"count":381,"type":22},160,[111],"This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.",[89],[91],{"date":340,"type":42},{"date":388,"type":42},"2025-11-12",{"date":390,"type":22},"2027-10-24",{"name":48,"class":49},79,{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":23,"phases":402,"briefSummary":403,"conditions":404,"keywords":406,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":416},"100626904","phase-1-study-of-inca036978-in-participants-with-myeloproliferative-neoplasms-100626904","NCT07441694","Study of INCA036978 in Participants With Myeloproliferative Neoplasms","A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Life expectancy \\> 6 months.\n* Willingness to undergo a pretreatment and limited on-study BM biopsies and aspirates (as appropriate to disease).\n* Participants with MF, PV and ET as defined in the protocol.\n\nExclusion Criteria:\n\n* Presence of any hematological malignancy other than MF, PV, or ET.\n* Malignancy within the last 3 years prior to enrollment.\n* Acute or chronic HBV, Active HCV or known HIV or tuberculosis infection.\n* Clinically significant or uncontrolled cardiac disease.\n* Has undergone any prior allogeneic stem-cell transplantation or such transplantation is planned in the next 6 months.\n* Laboratory values outside the Protocol-defined ranges.\n* Prior history of major bleeding or thrombosis within the last 3 months prior to study enrollment.\n* Presence of chronic or current active infectious disease requiring systemic treatment.\n* Treatment with an MPN-directed therapy (approved or investigational) within the per protocol threshold before the administration of study drug.\n* Prior radiation therapy within 28 days before the first dose of study treatment.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",{"count":401,"type":22},218,[139],"This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and\u002For recommended dose for expansion (RDE)s of INCA036978 administered as monotherapy and in combination with a standard disease-directed therapy.",[405],"Myeloproliferative Neoplasms",[405,407,408,409],"Myelofibrosis","Essential thrombocythemia","Polycythemia Vera",{"date":254,"type":42},{"date":412,"type":42},"2026-05-11",{"date":414,"type":22},"2030-05-24",{"name":48,"class":49},49,{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":23,"phases":426,"briefSummary":427,"conditions":428,"keywords":430,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":128},"100563352","phase-3-a-study-of-tacrolimusmethotrexateruxolitinib-versus-post-transplant-cyclophosphamidetacrolimusmycophenolate-mofetil-in-non-myeloablativereduced-intensity-conditioning-allogeneic-peripheral-blood-stem-cell-transplantation-bmt-ctn-2203-100563352","NCT06615050","A Study of Tacrolimus\u002FMethotrexate\u002FRuxolitinib Versus Post-Transplant Cyclophosphamide\u002FTacrolimus\u002FMycophenolate Mofetil in Non-Myeloablative\u002FReduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)","A Randomized, Multicenter, Phase III Trial of Tacrolimus\u002FMethotrexate\u002FRuxolitinib Versus Post-Transplant Cyclophosphamide\u002FTacrolimus\u002FMycophenolate Mofetil in Non-Myeloablative\u002FReduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation","Inclusion Criteria:\n\n* Age 18.0 years or older at the time of enrollment.\n* Participants undergoing allogeneic HCT for one of the following indications:\n\n  * Acute leukemia or chronic myelogenous leukemia with no circulating blasts and with less than 5% blasts in the bone marrow. Therapy related myeloid neoplasms are allowed.\n  * Myelodysplasia\u002Fchronic myelomonocytic leukemia with no circulating blasts and with less than 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \\\u003C 5% versus 5-10% blasts in this disease). Therapy related myeloid neoplasms are allowed.\n  * Lymphoma \\[follicular lymphoma, Hodgkin lymphoma, diffuse large B cell lymphoma, mantle cell lymphoma, peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma and anaplastic large cell lymphoma\\].\n* Planned NMA\u002Freduced intensity conditioning regimen.\n* Participants must have a related or unrelated PBSC donor as follows:\n\n  * Sibling donor must be a 6\u002F6 match for HLA-A and -B at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation. HLA-matched parents and children may be used as donors.\n  * Unrelated donor must be a 7\u002F8 or 8\u002F8 match at HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing. Unrelated donor must be willing to donate peripheral blood stem cells and meet NMDP criteria for donation.\n  * Donor selection must comply with 21 CFR 1271.\n* Cardiac function: Left ventricular ejection fraction at least 45%.\n* Estimated glomerular filtration rate greater than 60 ml\u002Fmin\u002F1.73 m2 using the 2021 CKD-EPI formula Note: For eligibility, GFR by 2021 CKD-EPI is required. A baseline creatinine clearance by Cockcroft-Gault should be done to establish baseline CrCl for ruxolitinib dosing.\n* Pulmonary function: DLCO corrected for hemoglobin at least 40% and FEV1 predicted at least 50%.\n* Liver function: AST\u002FALT \\\u003C 3x ULN; Total bilirubin \\\u003C 2 mg\u002FdL excluding Gilbert's syndrome or hemolysis.\n* Karnofsky Performance Score of at least 60%.\n* Female participants (unless postmenopausal for at least one year before the screening visit, or surgically sterilized), agree to practice two effective methods of contraception at the same time, or agree to completely abstain from heterosexual intercourse, from the time of signing the informed consent through 15 months post-transplant. Fertility preservation methods will be left to institutional standards.\n* Male participants (even if surgically sterilized), of partners of women of childbearing potential must agree to one of the following: practice effective barrier contraception or abstain from heterosexual intercourse from the time of signing the informed consent through 15 months post-transplant.\n* Plans for the use of targeted small molecule inhibitor post-transplant maintenance therapy must be disclosed upon enrollment and must be used irrespective of the outcome of the randomization. Planned use of investigational maintenance agents is not permitted. Planned hypomethylating agents as maintenance therapy is not permitted.\n* Voluntary written consent obtained prior to the performance of any study-related procedure that is not a part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.\n\nExclusion Criteria:\n\n* Prior allogeneic transplant.\n* Active CNS involvement by malignant cells.\n* Participants with secondary AML arising from myeloproliferative neoplasms or secondary AML arising from overlap syndromes, including CMML and MDS\u002FMPN syndromes; participants with secondary AML arising from myelodysplastic neoplasm are eligible.\n* Participants with primary, post-Essential Thrombocythemia (post-ET) and post-Polycythemia Vera (post-PV) myelofibrosis.\n* Participants with uncontrolled bacterial, viral, or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment.\n* Active or inadequately treated latent infection with Mycobacterium tuberculosis (i.e., TB).\n* Presence of clinically significant fluid collection (ascites, pleural or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated.\n* Participants seropositive for human immunodeficiency virus (HIV) with detectable viral load. HIV+ participants with an undetectable viral load on antiviral therapy are eligible.\n* Evidence of uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV). The study allows:\n\n  * Positive HBV serology with undetectable viral load and ongoing antiviral prophylaxis to prevent potential HBV reactivation.\n  * Positive HCV serology with quantitative PCR for plasma HCV RNA below the lower limit of detection, with or without concurrent antiviral HCV treatment.\n* Arterial or venous thrombosis including DVT, PE, stroke, and myocardial infarction within six (6) months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia. Catheter-associated DVT is not exclusionary.\n* Female participants who are pregnant (as per institutional practice) or lactating.\n* Participants with a serious medical or psychiatric illness likely to interfere with participation in this clinical study.\n* Participants with prior malignancies except resected non-melanoma skin cancer or treated cervical carcinoma in situ. Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent \\\u003C 5 years previously must be reviewed and approved by the Protocol Officer or Chairs.\n* Planned use of ATG or alemtuzumab in conditioning regimen.\n* Planned use of prophylactic donor leukocyte infusions.\n* Prior use of ruxolitinib.\n* Prior use of immune checkpoint inhibitors (i.e., PD1, PDL1, CTLA4 modulators) within six (6) months prior to conditioning.\n* For participants with 7\u002F8 HLA-matched donors:\n\n  * Donor specific antibodies (DSAs) directed at the mismatched donor allele.\n  * Any use of desensitization protocols.\n* Treatment with any other Investigational Medicinal Product (IMP) is not allowed while on study treatment. An IMP is defined as medications without any known FDA or EMA approved indications.",{"count":425,"type":22},572,[25],"The purpose of this study is to assess Tacrolimus\u002FMethotrexate\u002FRuxolitinib versus Post-Transplant Cyclophosphamide\u002FTacrolimus\u002FMycophenolate Mofetil in Non-Myeloablative\u002FReduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation",[429],"Graft-versus-host Disease (GVHD)",[429,431,432,433,434],"Chronic GvHD (cGvHD)","steroid-refractory","ruxolitinib","Janus kinase inhibitor","2026-05-19",{"date":366,"type":42},{"date":438,"type":42},"2025-04-02",{"date":440,"type":22},"2031-01-17",{"name":48,"class":49},{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":18,"minAge":356,"maxAge":379,"enrollmentInfo":450,"targetDuration":4,"studyType":23,"phases":452,"briefSummary":453,"conditions":454,"keywords":456,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":459,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":334},"100446242","phase-2-to-assess-the-efficacy-safety-and-tolerability-of-incb000928-in-participants-with-fibrodysplasia-ossificans-progressiva-100446242","NCT05090891","To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva","Progress","Inclusion Criteria:\n\n* Female and male participants:\n\n  * Cohort 1: ≥ 12 years of age.\n  * Cohort 2: 6 to \\\u003C 12 years of age.\n  * Cohort 3: 2 to \\\u003C 12 years of age (after eDMC review of safety data from Cohort 2).\n* Clinical diagnosis of FOP.\n* Willingness to avoid pregnancy or fathering children based on the criteria below.\n* Willing and able to undergo low-dose WBCT (excluding the head) imaging without requiring intubation.\n* Further inclusion criteria apply.\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding.\n* CAJIS score ≥ 24.\n* FOP disease severity that in the investigator's opinion precludes participation.\n* Any clinically significant medical condition other than FOP that would, in the investigator's judgment, interfere with full participation in the study, pose a significant risk to the participant, or interfere with interpretation of study data.\n* Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.\n* HIV, HBV, or HCV infection. Note:\n* Further exclusion criteria apply.",{"count":451,"type":22},98,[111],"This Phase 2, Randomized, Double-Blind, Placebo-Controlled Study is intended to evaluate the Efficacy, Safety, and Tolerability and PK of INCB000928 administered to participants with a clinical diagnosis of fibrodysplasia ossificans progressiva (FOP).",[455],"Fibrodysplasia Ossificans Progressiva (FOP)",[457,458],"fibrodysplasia ossificans progressiva (FOP)","heterotopic ossification",{"date":460,"type":42},"2026-05-22",{"date":462,"type":42},"2022-05-05",{"date":464,"type":22},"2033-01-20",{"name":48,"class":49},{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":23,"phases":475,"briefSummary":476,"conditions":477,"keywords":478,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":128},"100540188","phase-1-a-study-to-evaluate-the-safety-tolerability-of-incb160058-in-participants-with-myeloproliferative-neoplasms-100540188","NCT06313593","A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms","A Phase 1, Open-Label, Multicenter Study of INCB160058 in Participants With Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Age ≥ 18 years\n* MF:\n\n  * Intermediate-1 or higher risk PMF, post-PV MF, or post-ET MF with evidence of minimum burden of disease based on splenomegaly, and for the monotherapy cohort, participants must have been previously treated with at least 1 JAK inhibitor for ≥ 12 weeks and resistant, refractory, intolerant to, or have lost response to JAK inhibitor treatment.\n  * For the MF SubOpt R cohort: Therapeutic regimen prior to enrollment as defined in the protocol and unlikely to benefit from further monotherapy in the opinion of the investigator.\n* PV: Confirmed diagnosis of PV and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment.\n* ET: Confirmed diagnosis of high-risk ET as defined in the protocol and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment.\n* Life expectancy \\> 6 months.\n* Willingness to undergo a pretreatment and regular on-study bone marrow biopsies and aspirations (as appropriate to disease).\n* Existing documentation of JAK2V617F mutation from a qualified local laboratory.\n\nExclusion Criteria:\n\n* Presence of a hematological malignancy requiring treatment, other than PMF, post-PV MF, post-ET MF, PV, or ET.\n* Prior history of major bleeding or thrombosis within the 3 months prior to study enrollment.\n* Participants with abnormal hematologic, hepatic, or renal function based on laboratory evaluation.\n* Has undergone prior allogenic or autologous stem-cell transplantation or allogenic stem-cell transplantation is planned\n* Active invasive malignancy.\n* Significant concurrent, uncontrolled medical condition.\n* Acute or chronic HBV, active HCV or known HIV.\n* Any prior MPN-directed therapy within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.\n* Participants undergoing treatment with G-CSF or GM-CSF, romiplostim, or eltrombopag at any time within 4 weeks before the first dose of study treatment.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",{"count":474,"type":22},186,[139],"This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.",[405],[405,479,407],"INCB160058","2026-04-30",{"date":482,"type":42},"2026-05-04",{"date":484,"type":42},"2024-08-08",{"date":486,"type":22},"2028-10-09",{"name":48,"class":49},{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":23,"phases":497,"briefSummary":498,"conditions":499,"keywords":500,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":509},"100529852","phase-1-a-study-to-evaluate-incb161734-in-participants-with-advanced-or-metastatic-solid-tumors-with-kras-g12d-mutation-100529852","NCT06179160","A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation","A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation","Inclusion Criteria:\n\n* ≥18 years old.\n* Locally advanced or metastatic solid tumor with KRAS G12D mutation.\n* For Part 1a and Part 2 Combination Groups 1, 2, and 7: Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, declined available therapies that are known to confer clinical benefit, or no standard available treatment to improve the disease outcome.\n* Cohort specific requirements aas defined in the protocol.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Prior treatment with any KRAS G12D inhibitor\n* Known additional invasive malignancy within 1 year of the first dose of study drug\n* History of organ transplant, including allogeneic stem cell transplantation\n* Significant, uncontrolled medical condition\n* History or presence of an ECG abnormality\n* Inadequate organ function\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply",{"count":496,"type":22},710,[139],"This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.",[28],[30,31,32,501,502],"colorectal cancer (CRC)","non-small cell lung cancer (NSCLC)",{"date":482,"type":42},{"date":505,"type":42},"2024-01-04",{"date":507,"type":22},"2027-01-01",{"name":48,"class":49},37,{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":18,"minAge":106,"maxAge":4,"enrollmentInfo":517,"targetDuration":4,"studyType":23,"phases":519,"briefSummary":520,"conditions":521,"keywords":522,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":534},"100589808","phase-3-study-to-evaluate-the-efficacy-and-safety-of-ruxolitinib-cream-in-participants-with-hidradenitis-suppurativa-true-hs1-100589808","NCT06959225","Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1)","A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa","Inclusion Criteria:\n\n* Diagnosis of HS for at least 6 months prior to screening visit.\n* Mild to moderate HS (Hurley I or II) with the following at both screening and baseline visits:\n\n  * A total AN count of at least 4, with no draining tunnels AND\n  * Affecting at least 2 distinct anatomical areas\n* Agreement to NOT use topical and systemic antibiotics for treatment of HS during the vehicle-controlled period.\n* Agreement to NOT use topical antiseptics, including washes and leave-on products on the areas affected by HS lesions during the vehicle-controlled period and Weeks 16 to 20 of the extension period.\n* Further inclusion criteria apply.\n\nExclusion Criteria:\n\n* Body surface areas to be treated exceed 20% BSA at screening or baseline\n* Presence of draining tunnels at screening or baseline.\n* Medical history including current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.\n* Laboratory values outside of the protocol-defined criteria.\n* Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.\n* Further exclusion criteria apply.",{"count":518,"type":22},550,[25],"The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.",[116],[523,524,525],"Hidradenitis suppurativa","skin disease","ruxolitinb cream","2026-04-15",{"date":528,"type":42},"2026-04-16",{"date":530,"type":42},"2025-06-23",{"date":532,"type":22},"2027-07-11",{"name":48,"class":49},101,{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":542,"targetDuration":4,"studyType":23,"phases":544,"briefSummary":545,"conditions":546,"keywords":547,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":557},"100518704","phase-1-a-study-to-evaluate-inca033989-administered-as-a-monotherapy-or-in-combination-with-ruxolitinib-in-participants-with-myeloproliferative-neoplasms-100518704","NCT06034002","A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms","A Phase 1, Open-Label, Multicenter Study of INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Life expectancy \\> 6 months.\n* Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).\n* Existing documentation from a qualified local laboratory of CALR exon-9 mutation.\n* Participants with MF or ET as defined in the protocol.\n\nExclusion Criteria:\n\n* Presence of any hematological malignancy other than ET, PMF, or post-ET MF.\n* Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment.\n* Participants with laboratory values exceeding the protocol defined thresholds.\n* Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned.\n* Active invasive malignancy over the previous 2 years.\n* History of clinically significant or uncontrolled cardiac disease.\n* Active or chronic HBV or active HCV or known history of HIV.\n* Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease, with the exception of ruxolitinib for TGBs only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.\n* Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any time within 4 weeks before the first dose of study treatment.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",{"count":543,"type":22},290,[139],"This study is being conducted to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and\u002For recommended dose(s) for expansion (RDE) of INCA033989 administered as a Monotherapy or in Combination With Ruxolitinib in participants with myeloproliferative neoplasms.",[405],[405,407,408,548],"CALR mutation","2026-04-14",{"date":551,"type":42},"2026-04-17",{"date":553,"type":42},"2023-12-04",{"date":555,"type":22},"2028-10-29",{"name":48,"class":49},13,{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":332,"enrollmentInfo":565,"targetDuration":4,"studyType":23,"phases":566,"briefSummary":567,"conditions":568,"keywords":570,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":582},"100504677","phase-2-a-study-to-evaluate-the-efficacy-and-safety-study-of-povorcitinib-in-participants-with-inadequately-controlled-moderate-to-severe-asthma-100504677","NCT05851443","A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma","A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma","Inclusion Criteria:\n\n* Physician-diagnosed asthma requiring treatment with medium- to high-dose ICS-LABA for at least 12 months prior to screening.\n* Pre-BD FEV1 \\\u003C 80% predicted according to central over read value at Visit 2.\n* Documented historical post-BD reversibility of FEV1 ≥ 12% and ≥ 200 mL in FEV1.\n* At least 2 documented asthma exacerbations (requiring treatment with systemic CS, hospitalization, or emergency department visit) within 12 months prior to screening but not within the past 4 weeks prior to screening\n* ACQ-6 ≥ 1.5 at screening.\n\nExclusion Criteria:\n\n* Maintenance use of asthma controllers other than ICS-LABA.\n* Have undergone bronchial thermoplasty.\n* Current smokers or participants with a smoking history of ≥ 10 pack-years and participants using vaping products, including electronic cigarettes.\n* Women who are pregnant (or who are considering pregnancy) or breastfeeding.\n* Current conditions or history of other diseases, as follows:\n* Clinically important pulmonary disease other than asthma ,Thrombocytopenia, coagulopathy, or platelet dysfunction.\n* Venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, moderate to severe heart failure (NYHA Class III or IV), cerebrovascular accident, myocardial infarction, coronary stenting, or CABG surgery.\n* Diagnosis of other significant cardiovascular diseases, including but not limited to angina, peripheral arterial disease, or uncontrolled arrhythmias such as atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, and forms of carditis.\n* Recipient of an organ transplant that requires continued immunosuppression.\n* Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).\n* Any malignancies or history of malignancies.\n* Chronic or recurrent infectious disease.\n* Receipt of any biologic drugs used for asthma \\\u003C 12 weeks or 5 half-lives (if known), whichever is longer, prior to screening",{"count":194,"type":22},[111],"The study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function",[569],"Moderate to Severe Asthma",[571,572,573,119,574],"Asthma","Moderate to Severe","INCB54707","ICS-LABA","2026-04-10",{"date":549,"type":42},{"date":578,"type":42},"2023-07-11",{"date":580,"type":22},"2027-01-31",{"name":48,"class":49},83,{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":23,"phases":592,"briefSummary":593,"conditions":594,"keywords":595,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":614,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":620},"100457617","phase-1-study-of-incb123667-in-subjects-with-advanced-solid-tumors-100457617","NCT05238922","Study of INCB123667 in Subjects With Advanced Solid Tumors","A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy and in Combination With Anticancer Therapies in Participants With Selected Advanced Solid Tumors","Inclusion Criteria:\n\n* Adults aged 18 years or older at the time of the signing of the ICF.\n* Life expectancy greater than 12 weeks.\n* ECOG performance status score of 0 or 1.\n* Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available treatment to improve the disease outcome.\n* Availability of a baseline archival tumor specimen or willingness to undergo a pretreatment and an on-treatment tumor biopsy.\n\nFor Part 1:\n\nParticipants in Part 1A (dose escalation): Histologically or cytologically confirmed advanced or metastatic solid tumors.\n\nParticipants in Part 1B (dose expansion):\n\n* Disease Group 1: Ovarian\u002FFallopian\u002FPrimary Peritoneal Cancer\n* Disease Group 2: Endometrial\u002FUterine Cancer\n* Disease Group 3: Gastric, GEJ, and esophageal carcinomas\n* Disease Group 4: TNBC\n* Disease Group 5: HR+\u002FHER2- breast cancer\n* Disease Group 6: Other tumor indications excluding bone cancers\n\nFor Part 2:\n\nParticipants in Part 2A (dose escalation): Histologically or cytologically confirmed advanced or metastatic solid tumors.\n\n* TGA, TGC, TGE, TGF, and TGG: Participants with HR+\u002FHER2- breast cancer or participants with a different tumor.\n* TGB and TGD: Participants with HR+\u002FHER2- breast cancer.\n\nParticipants in Part 2b (dose expansion):\n\n* TGH and TGJ:\n\n  * Participants with HR+\u002FHER2- breast cancer.\n  * Participants with any other advanced or metastatic solid tumor.\n* TGI and TGK:\n\n  • Participants with HR+\u002FHER2- breast cancer.\n* TGL, TGM and TGN:\n\n  • Participants with advanced or metastatic epithelial ovarian\u002Ffallopian\u002Fprimary peritoneal carcinoma.\n* Measurable lesions by CT or MRI based on RECIST v1.1 criteria.\n\nExclusion Criteria:\n\n* History of clinically significant or uncontrolled cardiac disease.\n* History or presence of an ECG abnormality that, in the investigator's opinion, is clinically meaningful.\n* Presence of chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.\n* Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed.\n* Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of the first dose of study drug.\n* Specific laboratory values.\n* Significant concurrent, uncontrolled medical conditions, including but not limited to Hepatic and Gastrointestinal.\n* Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and\u002For complications from prior surgical intervention before starting study drug.\n* Prior treatment with any CDK2 inhibitor.\n* Any change in endocrine therapy within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug or any administration of targeted therapy, antibody, or hypomethylating agent to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug.\n* Any major surgery within 28 days before the first dose of study drug.\n* Any prior radiation therapy within 28 days before the first dose of study drug.\n* Undergoing treatment with another investigational medication or having been treated with an investigational medication within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug.\n* Active HBV or HCV infection that requires treatment.\n* Known history of HIV.\n* Known hypersensitivity or severe reaction to any component of study treatment or formulation components.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",{"count":591,"type":22},604,[139],"This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy and in combination with anticancer therapies in participants with selected advanced or metastatic solid tumors. This study will consist of 2 parts. In Part 1, INCB123667 will be administered as monotherapy and in Part 2, INCB123667 will be administered in combination with anticancer therapies of interest. Each part will comprise a dose escalation portion (Parts 1a and 2a, respectively) and a dose-expansion portion (Parts 1b and 2b, respectively).",[28],[596,597,598,599,600,601,602,603,604,605,606,607,608,609,610,611,612,613],"advanced solid tumors","metastatic solid tumors","Gynecological Tumors,","GI Tumors,","Breast Cancer,","Tumor Agnostic","cyclin E1 gene","epithelial ovarian carcinoma","fallopian carcinoma","primary peritoneal carcinoma","clear cell ovarian cancer","endometrial adenocarcinoma","uterine carcinosarcoma","uterine papillary serous carcinoma","gastrointestinal tumors","gastric adenocarcinomas","GEJ adenocarcinomas","esophageal adenocarcinomas",{"date":549,"type":42},{"date":616,"type":42},"2022-07-05",{"date":618,"type":22},"2027-08-31",{"name":48,"class":49},42,{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":18,"minAge":106,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":23,"phases":627,"briefSummary":520,"conditions":628,"keywords":629,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":636,"locationsCount":637},"100589730","phase-3-study-to-evaluate-the-efficacy-and-safety-of-ruxolitinib-cream-in-participants-with-hidradenitis-suppurativa-true-hs2-100589730","NCT06958211","Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2)",{"count":518,"type":22},[25],[116],[523,524,525],"2026-04-07",{"date":632,"type":42},"2026-04-08",{"date":634,"type":42},"2025-06-12",{"date":532,"type":22},{"name":48,"class":49},107,""]