[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"uc---ulcerative-colitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:uc---ulcerative-colitis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,71,99,130],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100631772","phase-1-to-evaluate-the-safety-tolerability-pharmacokinetics-pharmacodynamics-and-immunogenicity-of-lync-101-for-injection-in-healthy-adult-participants-100631772",false,"NCT07505030","To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of LYNC-101 for Injection in Healthy Adult Participants","A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of LYNC-101 for Injection in Healthy Adult Participants","Inclusion Criteria:\n\n1. Healthy male or female participants aged 18-60 years (inclusive).\n2. Body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) of 18-32 kg\u002Fm² (inclusive).\n3. Able to fully understand the study, voluntarily agree to participate in the study, and sign the informed consent form.\n4. Participants agree to have no plans for conception, sperm donation, or egg donation from the date of signing the informed consent form until 3 months after the last dose and must use effective non-pharmacological contraception with partners of childbearing potential.\n\nExclusion Criteria:\n\n1. Participants with clinically significant abnormalities (as judged by the PI or delegate) in vital signs, physical examinations, laboratory tests, or 12-lead ECG during the screening period.\n2. Participants with positive test result for any of the following: hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or treponema pallidum-specific antibody (TP-Ab).\n3. Participants with history or current presence of any clinically significant disease or disorder of the circulatory, endocrine, metabolic, urinary, digestive, dermatologic, hematologic, nervous, or psychiatric systems, which, as assessed by the Investigator, precludes safe participation in the study.\n4. History of childhood asthma (regardless of resolution), depression, migraine, or Gilbert's Syndrome. Note: Participants with a history of cholecystectomy are eligible for inclusion.\n5. Participants with history of clinically significant infection (including upper or lower respiratory tract infection) requiring antibiotic or antiviral treatment within 14 days prior to or during screening, in the opinion of the PI or delegate.\n6. Participants who have received major surgery within 4 weeks prior to screening or will receive planned surgery during the study period.\n7. Alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) \\>1.5 × upper limit of normal (ULN) at Screening or Day -1. Repeat testing at Screening and Day -1 is acceptable for out-of-range values following approval by the PI or delegate.\n8. Participants with estimated glomerular filtration rate (eGFR) \\\u003C 90 mL\u002Fmin\u002F1.73m2(using Cockroft \\& Gault formula). And a repeat sample is allowed if required.\n9. Participants with known history of hypersensitivity, allergic constitution, or allergy to any ingredient of the IMP.\n10. Participants who have participated in other clinical studies and have received the IMP within 30 days or 5 half-lives (whichever is longer) prior to screening.\n11. Participants who have received treatment with any marketed or investigational biologic agent within 4 months or 5 half-lives (whichever is longer) prior to screening.\n12. Participants who have received any prescription drugs (excluding contraception), over-the-counter medications (excluding paracetamol), herbal products, or dietary supplements (excluding vitamin products) within 2 weeks or 5 half-lives (whichever is longer) prior to screening.\n13. Participants who have received or will receive any systemic cytotoxic or immunosuppressive agent within 6 months prior to screening or during the study, or any topical cytotoxic or immunosuppressive agent within 30 days or 5 half-lives (whichever is longer) prior to screening or during the study.\n14. Participants who have received B-cell or T-cell depleting agents (e.g., rituximab) within 6 months prior to screening.\n15. Participants who have been vaccinated 4 weeks prior to first dose or plan to be vaccinated during the study.\n16. Participants who have received immunoglobulins or blood products within 30 days prior to screening.\n17. Participants who have experienced blood loss or blood donation exceeding 400 mL within 3 months prior to screening.\n18. Participants with no ability to tolerate venipuncture, or with history of difficult blood collection, history of vasovagal syncope related to blood draws, or poor venous access.\n19. Participants who smoke \\> 5 cigarettes per day (or equivalent use of other nicotine-containing products) within 6 months prior to screening, or are unable to refrain from tobacco use during the study.\n20. Participants who have an alcohol consumption exceeding 14 units per week (1 unit = 285 mL beer, 25 mL spirits, or 100 mL wine) within 3 months prior to screening, or are unable to abstain from alcohol at least 24 hours before each Study Site admission and each outpatient visit and throughout the duration of each Study Site visit, or have a positive alcohol breath test at screening or Day -1, and a repeat test is allowed if required.\n21. Participants with a history of drug abuse or positive urine drug screening or Day -1, and a repeat test is allowed if required.\n22. Participants who are unable to refrain from consuming xanthine-rich beverages (e.g., chocolate, coffee, tea), foods (e.g., animal liver), or fruits\u002Fjuices known to affect drug metabolism (e.g., grapefruit, pomelo, star fruit) from 3 days before dosing through the confinement period; or are unable to avoid strenuous exercise from 48 hours before dosing through the confinement period; or have any other behavior that could significantly affect drug absorption, distribution, metabolism, or excretion.\n23. Female participants who are pregnant, breastfeeding.\n24. Female participants of childbearing potential with positive pregnancy test at screening or Day -1.\n25. Participants with any other condition that, as assessed by the Investigator, would pose a safety risk to the participant, interfere with the study conduct, or compromise the participant's ability to complete the study or comply with relevant requirements.",true,"ALL","18 Days","60 Days",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This Phase I study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and cytokine profiles of LYNC-101 for Injection in healthy adult participants. The study consists of 2 parts: Part 1 is a single ascending dose (SAD) study and Part 2 is a multiple ascending dose (MAD) study. In Part 1, participants will receive a single intravenous infusion of LYNC-101 for Injection or placebo across sequential ascending dose cohorts. In Part 2, participants will receive intravenous infusions of LYNC-101 for Injection or placebo once every 3 weeks for a total of 3 doses across sequential ascending dose cohorts.",[28],"UC - Ulcerative Colitis","NOT_YET_RECRUITING","2026-04-14",{"date":32,"type":33},"2026-04-17","ACTUAL",{"date":35,"type":22},"2026-05-25",{"date":37,"type":22},"2027-04-11",{"name":39,"class":40},"LyncBio Therapeutics Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":41},"100631565","phase-4-upadacitinib-in-patients-hospitalized-with-acute-severe-ulcerative-colitis-100631565","NCT07502339","Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis","An Open-Label, Investigator-Initiated Study Evaluating the Use of Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis","Inclusion Criteria:\n\n* Male or female ≥18 and ≤75 years of age hospitalized with ASUC (Mayo score \\>10 or Truelove and Witts criteria)\n* Diagnosis of UC for at least 90 days, confirmed by colonoscopy; appropriate documentation of biopsy results consistent with the diagnosis of UC\n* No prior use of upadacitinib\n* Capable of providing informed consent\n* For women of childbearing potential: negative pregnancy test at screening and agreement to use acceptable contraception throughout study participation\n\nExclusion Criteria:\n\n* • Current diagnosis of Crohn's disease, indeterminate colitis, fulminant colitis, and\u002For toxic megacolon\n\n  * Disease limited to the rectum during screening endoscopy\n  * History of colectomy with ileoanal pouch, Kock pouch, or ileostomy for UC or was planning bowel surgery\n  * Infections requiring treatment with IV anti-infectives within 30 days before baseline or oral anti-infectives within 14 days before baseline\n  * Contraindication to IL-23 agent if advanced therapy-naïve\n  * Known hypersensitivity to upadacitinib or any excipients\n  * History of lymphoproliferative disorder, lymphoma, leukemia, or any malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ\n  * History of venous thromboembolic event (DVT, PE) within past 12 months\n  * Any condition that, in the investigator's opinion, would compromise the participant's safety or study outcomes\n  * History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months prior to Baseline.\n  * Meeting any of the following conditions at Baseline:\n  * Two or more prior episodes of herpes zoster, or one or more episodes of disseminated herpes zoster;\n  * One or more prior episodes of disseminated herpes simplex (including eczema herpeticum);\n  * Human immunodeficiency virus (HIV) infection, defined as confirmed positive anti-HIV antibody (HIV Ab) test or a positive HIV Ab\u002FAg test\n  * Active TB or meet TB exclusionary parameters (specific requirements for TB testing are provided in the operations manual);\n  * Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral\u002Fintramuscular anti-infectives within 14 days prior to the Baseline Visit;\n  * Chronic recurring infection and\u002For active viral infection that, based on the investigator's clinical assessment, makes the subject an unsuitable candidate for the study;\n  * COVID-19 infection: In subjects who tested positive for COVID-19, at least 5 days must have passed between a COVID-19 positive test result and the Baseline visit of asymptomatic subjects. Subjects with mild\u002Fmoderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Subjects may be rescreened if deemed appropriate by the investigator based upon the subject's health status.\n  * HBV and HCV screening values that meet the following criteria at the most recent testing prior to the first dose of study drug :\n  * HBV: hepatitis B surface antigen (HBs Ag) positive (+) test or detectable HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) qualitative test for subjects who are hepatitis B core antibody (HBc Ab) positive (+)\n  * HCV: detectable HCV ribonucleic acid (RNA) in any subject with anti-HCV antibody (HCV Ab).\n  * At Baseline any of the following medical diseases or disorders:\n  * Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, (note: include the following only for new protocols) aorto-coronary bypass surgery, or venous thromboembolism;\n  * History of an organ transplant which requires continued immunosuppression;\n  * History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and\u002For other products in the same class;\n  * History of GI perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment;\n  * Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; subjects with a history of gastric banding\u002Fsegmentation are not excluded;\n  * History of malignancy except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix;\n  * Females of child-bearing potential who do not meet the following:\n  * Subjects must not have a positive serum pregnancy test at the Screening Visit and must have a negative urine pregnancy test at Baseline prior to the first dose of study drug (local practices may require serum pregnancy testing at Baseline).\n  * Subjects with a borderline serum pregnancy test at Screening must have absence of clinical suspicion of pregnancy or other pathological causes of borderline results and a serum pregnancy test ≥ 3 days later to document continued lack of a positive result (unless inclusion of subjects with a borderline pregnancy test may be prohibited by local requirements).\n  * Subjects with a urine pregnancy test at Baseline that is borderline or ambiguous must have a serum pregnancy test performed. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n  * Female subjects of childbearing potential who are not able and\u002For willing to practice at least 1 protocol-specified method of birth control that is highly effective from Study Day 1 through at least 30 days after the last dose of study drug (local practices may require an additional method of contraception) (refer to Section 5.2 for more detail on contraception). Female subjects of non-childbearing potential do not need to use birth control.\n  * Female subjects who are pregnant, breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug.\n  * Subjects who have been treated with any investigational drug of chemical or biologic nature within 30 days or five half-lives (whichever is longer) prior to the first dose of study drug or who are currently enrolled in another interventional clinical study.\n  * Subjects with systemic use of known strong cytochrome P450 3A (CYP3A) inhibitors at Screening or strong CYP3A inducers 30 days prior to study drug administration. Herbal therapies and other traditional medicines with unknown effect on CYP3A taken systemically are prohibited within 30 days prior to Baseline. Herbal therapies and other traditional medicines are defined as any herbal formulation that is intended to treat or prevent health problems and may include supplements based on herbs which the subject is taking.\n  * Subjects who have received any live vaccine with replicating potential within 30 days (or longer if required locally) prior to the first dose of study drug, or have expected need of vaccination with any live vaccine with replicating potential during study participation including at least 30 days (or longer if required locally) after the last dose of study drug. Live vaccines that are incapable of replicating are permitted.\n  * Screening laboratory values that meet the following criteria at the most recent testing prior to the first dose of study drug:\n  * Serum aspartate transaminase (AST) \\> 2 × ULN;\n  * Serum alanine transaminase (ALT) \\> 2 × ULN;\n  * Estimated glomerular filtration rate (GFR) by simplified 4-variable MDRD formula \\\u003C 30 mL\u002Fmin\u002F1.73 m2;\n  * Total white blood cell (WBC) count \\\u003C 2,500\u002FµL;\n  * Absolute neutrophil count (ANC) \\\u003C 1,200\u002FµL;\n  * Platelet count \\\u003C 100,000\u002FµL;\n  * Absolute lymphocyte count \\\u003C 750\u002FµL;\n  * Hemoglobin \\\u003C 9 g\u002FdL.","18 Years","75 Years",{"count":21,"type":22},[53],"PHASE4","The goal of this clinical trial is to learn if the oral medication upadacitinib can safely and effectively treat acute severe ulcerative colitis (ASUC) in adults who are hospitalized. It will also evaluate whether upadacitinib can be used without corticosteroids during initial treatment.\n\nThe main questions it aims to answer are:\n\n1. Does upadacitinib reduce treatment failure by Day 14 (defined as need for colectomy or rescue therapy)?\n2. What side effects and safety events occur when using upadacitinib in hospitalized patients with ASUC?\n\nResearchers will compare outcomes in participants receiving upadacitinib to a historical group of similar patients previously treated with standard therapies, including intravenous corticosteroids and infliximab, to determine if upadacitinib improves outcomes.\n\nParticipants will:\n\n1. Take oral upadacitinib once daily during hospitalization.\n2. Undergo routine clinical monitoring, including blood tests and symptom assessments.\n3. Be followed after discharge with clinic visits or phone calls for up to 12 months to assess outcomes such as need for additional treatment, surgery, and safety events",[28],[57,58,59,60],"ulcerative colitis","inpatient","upadacitinib","corticosteroid-free","2026-04-13",{"date":63,"type":33},"2026-04-16",{"date":65,"type":22},"2026-07-01",{"date":67,"type":22},"2028-08-01",{"name":69,"class":70},"University of California, San Francisco","OTHER",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100581470","phase-2-safety-and-efficacy-of-od-07656-and-of-subsequent-vedolizumab-therapy-in-moderately-to-severely-active-ulcerative-colitis-100581470","NCT06850727","Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis","A Phase 2a, Two-Part, Open-Label and Randomized Study to Evaluate the Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Patients With Moderately to Severely Active Ulcerative Colitis","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a confirmed diagnosis of ulcerative colitis (UC)\n* Has moderate to severely active UC as defined by the 3-component Modified Mayo clinic score\n* Has an inadequate response, loss of response, or intolerance\u002Fmedical contraindication to at least one of the following therapies: oral aminosalicylates, corticosteroids, immunosuppressants, anti-tumor necrosis factor biologic, anti-interleukin 12\u002F23 biologic, Janus kinase inhibitors, or sphingosine-1-phosphate (S1P) modulators\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has diagnosis of Crohn's disease or indeterminate colitis\n* Has had extensive colonic resection\n* Has colostomy or ileostomy\n* Has uncontrolled primary sclerosing cholangitis",{"count":79,"type":22},57,[81],"PHASE2","The purpose of this study is to evaluate the clinical efficacy and safety of OD-07656 in participants with moderately to severely active ulcerative colitis (UC). In addition, the study will evaluate the potential of OD-07656 to enhance the therapeutic benefit of vedolizumab when given after OD-07656.",[84,28],"Ulcerative Colitis (UC)",[86,87],"Ulcertative colitis","Inflammatory Bowel Diseases","RECRUITING","2026-02-09",{"date":91,"type":33},"2026-02-11",{"date":93,"type":33},"2025-06-02",{"date":95,"type":22},"2026-11",{"name":97,"class":40},"Odyssey Therapeutics",32,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":111,"phases":4,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":41},"100622554","prophylactic-dexamethasone-before-infliximab-in-moderate-to-severe-ibd-100622554","NCT07385131","Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD","Should Routine Prophylactic Dexamethasone Be Administered Before Intravenous Infliximab in Moderate-to-Severe Inflammatory Bowel Disease: A Prospective, Multicenter, Observational Cohort Study","PA","Inclusion Criteria:\n\n* Aged 14 to 80 years.\n* Confirmed cases of inflammatory bowel disease (IBD) with a definitive diagnosis of Crohn's disease (CD) or ulcerative colitis (UC), based on the diagnostic criteria specified in the Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (Guangzhou, 2023) and the Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (Xi'an, 2023). The diagnosis shall be made by comprehensive analysis of clinical manifestations, laboratory tests, imaging examinations, endoscopic examinations and histopathological findings, with infectious colitis and other non-infectious colitis ruled out.\n* Moderate to severe CD: for adults aged 18 years and above, baseline Crohn's Disease Activity Index (CDAI) score \\>220 or Harvey-Bradshaw Index (HBI) score ≥5; for adolescents aged 14 to 17 years, baseline Pediatric Crohn's Disease Activity Index (PCDAI) score ≥31. Or moderate to severe UC: for adults aged 18 years and above, baseline Mayo score ≥6; for adolescents aged 14 to 17 years, baseline Pediatric Ulcerative Colitis Activity Index (PUCAI) score ≥36.\n* Not receiving immunosuppressant therapy (e.g., azathioprine) at present, with no plan to add such medications within the next two months.\n* Current glucocorticoid dosage ≤ 10 tablets, and a definite plan has been made for tapering down the dosage to complete discontinuation within the next two months.\n* Planned to receive the first dose of infliximab within the next two weeks.\n\nExclusion Criteria:\n\n* Patients with severe disease who, as judged by the attending clinician, require biological agent intensification therapy, switch therapy or elective surgery within 2 months, such as those with obvious stenosis, perforation, fistula and other conditions leading to obstruction, hemorrhage, infection, etc.\n* Patients at high risk of infusion reactions, including those with a history of any biological agent-related infusion reactions, or a history of allergy to any drugs such as penicillins, cephalosporins, sulfonamides, non-steroidal anti-inflammatory drugs (NSAIDs), contrast media, etc.\n* Patients with a definite history of food allergy, as well as a past history of asthma or urticaria.\n* Patients on chronic daily use of antihistamine antiallergic drugs such as loratadine, cetirizine, diphenhydramine, chlorpheniramine maleate tablets, terfenadine, etc.\n* Patients with relative contraindications to biological agents, such as active tuberculosis with positive chest X-ray, strongly positive purified protein derivative (PPD) skin test or positive T-SPOT test; a history of myocardial infarction, heart failure or demyelinating neurological diseases in the past 5 years, etc.\n* Patients with relative contraindications to glucocorticoids, such as active tuberculosis, severe infection, gastrointestinal ulcer, etc.\n* Patients currently suffering from solid tumors, with a past history of lymphoma or melanoma, or undergoing chemotherapy or radiotherapy.\n* Patients complicated with massive gastrointestinal hemorrhage, severe hepatic and renal dysfunction, active bacterial or viral infection, shock, intractable vomiting, severe malabsorption syndrome, etc.\n* Patients with psychiatric disorders or insufficient educational level to fully understand the study content.\n* Pregnant or lactating patients.\n* Patients with severe hemodynamic and vital sign instability, or those with rapidly progressive or end-stage diseases.","14 Years","80 Years",{"count":110,"type":22},300,"OBSERVATIONAL","This comparative observational cohort clinical study aims to investigate the necessity of premedication for allergy prevention prior to infliximab injection, and is designed to evaluate whether non-routine administration of dexamethasone before intravenous infusion of infliximab yields greater benefits than routine prophylactic medication in patients with moderate-to-severe inflammatory bowel disease (IBD). This study is designed to optimize the prophylactic strategy prior to Infliximab treatment and advocate for risk stratification-based individualized prophylaxis regimens to avoid hormonal abuse. Additionally, it will construct a risk score using biomarkers to accurately identify high-risk populations in need of prophylaxis and establish a corresponding predictive model. The study is also intended to reduce the use of unnecessary medications, shorten infusion duration and alleviate the medical burden. It is expected to provide targeted clinical support during the early stage of the disease or the course of treatment, improve the efficacy and precision of individualized treatment for patients, and reduce the physical, psychological and economic burdens caused by ineffective treatment.",[114,115,28],"Inflammatory Bowel Disease (IBD)","CD - Crohn's Disease",[117,118,119,120],"Infliximab","Dexamethasone","Preventive medication","Infusion reaction","2026-01-27",{"date":123,"type":33},"2026-02-03",{"date":125,"type":33},"2025-10-08",{"date":127,"type":22},"2029-12-31",{"name":129,"class":70},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":41},"100595637","phase-2-a-phase-2-study-of-d-2570-in-subjects-with-moderately-to-severely-active-ulcerative-colitis-100595637","NCT07035041","A Phase 2 Study of D-2570 in Subjects With Moderately to Severely Active Ulcerative Colitis","A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of D-2570 as Induction Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis","D2570-202","Inclusion Criteria:\n\nSubjects who meet all of the following criteria can be included in this study:\n\n1. Subjects voluntarily take part in the study after being fully informed, sign a written informed consent form (ICF), and agree to follow procedures specified in the study protocol;\n2. Males and females, 18 to 70 years of age, inclusive at the time of signing of ICF;\n3. Have had an established diagnosis of ulcerative colitis (UC) of ≥ 3 months in duration prior to signing of ICF, which is supported by endoscopy reports, histopathology reports and clinical manifestations consistent with UC, as determined by investigators;\n4. Involved intestinal segment extending ≥ 15 cm from the anal verge as confirmed by a screening endoscopy;\n5. Active moderate to severe UC, defined by a modified Mayo score of 5 to 9 points at screening, which includes a stool frequency (SF) subscore of ≥ 2, a rectal bleeding (RB) subscore ≥ 1 and an endoscopic (ES) subscore of ≥ 2 (based on a screening endoscopy, confirmed by central reading);\n6. Documentation of an inadequate response, loss of response, or intolerance (defined as interruption of drug due to an adverse reaction as evaluated by the investigator) to a treatment course of 1 or more of the following standard of care medications:\n7. If a subject is using oral 5-ASAs, and\u002For oral glucocorticoids (≤ 20 mg\u002Fday of prednisone or equivalent dose, or ≤ 9 mg\u002Fday of budesonide or equivalent dose), and\u002For probiotics to treat UC, the dosage must remain stable for ≥ 2 weeks prior to the screening endoscopy and during the study period;\n8. If 5-ASAs and glucocorticoids have already been discontinued, they must have been discontinued for ≥ 2 weeks prior to the screening endoscopy;\n\n   * Exclusion Criteria\n\nSubjects cannot be included in the study if any of the following exclusion criteria is met:\n\n1. Diagnosed or suspected Crohn's disease, indeterminate colitis, fulminant colitis, toxic megacolon, microscopic colitis, ischemic colitis, radiation colitis, or colitis associated with diverticula;\n2. History of colonic resection, subtotal or total colectomy, or surgical intervention for UC, or anticipated need for, as assessed by the investigator, surgical intervention for UC during the study, or with other gastrointestinal diseases or surgical histories that may affect the absorption of study treatment;\n3. Current gastrointestinal dysplasia or past confirmed gastrointestinal dysplasia that has not been eradicated; For subjects diagnosed with UC for more than 8 years, a colonoscopy to screen for dysplasia should have been performed within 1 year prior to randomization or may be conducted during the screening colonoscopy.\n\n   Subjects with a history of adenomatous polyps are eligible if the polyps have been completely removed (as documented in the medical records), and no residual polyps or evidence of dysplasia is found in the colonoscopy and histological examination at screening.\n4. Previous history of serious herpes zoster\u002Fherpes simplex infection, including but not limited to disseminated herpes simplex\u002Fherpes zoster infection, generalized herpes zoster, herpetic encephalitis\u002Fmeningitis, ocular herpes, recurrent herpes zoster, or other serious herpes zoster\u002Fherpes simplex infections assessed by the investigator, or presence of herpes zoster\u002Fherpes simplex infection at screening;\n5. History of tuberculosis, active tuberculosis, latent tuberculosis, or clinical manifestations suggestive of tuberculosis infection; for subjects with latent tuberculosis infection (i.e., tested positive interferon-gamma release assay \\[IGRA\\] for Mycobacterium tuberculosis at screening) but without any symptoms, signs, laboratory findings, or imaging evidence of tuberculosis infection, re-screening is allowed after completing at least 4 weeks of standard preventive anti-tuberculosis treatment and evaluation by the investigator; subjects with indeterminate IGRA results must undergo a repeat test for confirmation, if the second test result is also indeterminate, the subject will be excluded from the study;\n6. Test positive for human immunodeficiency virus (HIV) antibody, or syphilis antibody (that is the subject develops an active or latent syphilis infection), or positive for hepatitis C virus (HCV) antibody and hepatitis C virus ribonucleic acid (HCV RNA) test or a viral load greater than the upper limit of normal at the study site, or positive for hepatitis B surface antigen (HBsAg). For subjects who are HBsAg-negative but positive for hepatitis B core antibody (HBcAb), further hepatitis B virus deoxyribonucleic acid (HBV DNA) test is required. If HBV DNA is tested positive or the viral load exceeds the upper limit of normal at the study site, they will also be excluded;\n7. Previous administration of a live vaccine within 3 months or an inactivated vaccine within 30 days prior to randomization, or planning to administer a live vaccine during the study or within 1 month after the last dose of investigational product;\n8. Have undergone a major surgery within 8 weeks prior to randomization, or planning to undergo any surgery during the study, unless the investigator determines that the surgery will not increase the subject's risk or affect his\u002Fher ability to receive study treatment and comply with the study requirements;\n9. History of a serious viral, bacterial, or fungal infection which requires intravenous (IV) anti-infectives, or hospitalization for treatment within 3 months prior to randomization, or develops a viral, bacterial, or fungal infection which requires antibiotics\u002Fanti-viral treatment within 2 weeks prior to randomization;\n10. History of stool positive for C. difficile test or evidence for other enteric pathogen infections within 3 months prior to randomization or at screening. Subjects may be re-screened 30 days after completion of a standard of care course with anti-infectives, and subsequent negative testing for corresponding tests and no persistent symptoms of infection with the pathogen, upon evaluation by the investigator;","70 Years",{"count":140,"type":22},120,[81],"This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The target population is patients with moderately to severely active ulcerative colitis. A total of 120 subjects are planned to be included.",[28,144],"Moderately to Severely Active Ulcerative Colitis",[144,146],"UC","2025-06-16",{"date":149,"type":33},"2025-06-24",{"date":151,"type":33},"2025-05-22",{"date":153,"type":22},"2026-12-31",{"name":155,"class":40},"InventisBio Co., Ltd"]