[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":126},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,73,99],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100551707","phase-3-efficacy-and-safety-of-a-new-formulation-of-oral-cladribine-compared-with-placebo-in-participants-with-generalized-myasthenia-gravis-myclad-100551707",false,"NCT06463587","Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm, 3-Period Study to Assess the Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)","Inclusion Criteria:\n\n* Adults of ≥ 18 years of age at the time of signing the informed consent.\n* Diagnosis of Myasthenia Gravis with generalized muscle weakness, meeting clinical criteria for Myasthenia Gravis Foundation of America Class II to IVa classification.\n\n  * In participants positive for Acetylcholine receptor antibody (anti-AChR) or muscle-specific kinase antibody(anti-MuSK)\n  * In participants that are autoantibody seronegative i.e. not positive for anti-AChR and anti-MuSK antibodies and participants who are positive for anti-low-density lipoprotein receptor-related protein 4 antibodies (anti-LRP4)\n* Has a Screening and Baseline MG-ADL score more than or equal to (\\>=) 6 with \\>= 50 percentage (%) of the total score due to non-ocular symptoms. Screening and Baseline MG-ADL scores must be stable. The difference between the Screening and Baseline scores should not be more than 2 and there should be no reported MG exacerbation during the Screening period\n* If treated with oral corticosteroids: should be on a stable daily dose for at least 3 months prior to and during screening. In such case, the daily dose of oral steroids should not exceed 20 milligrams(mg)\u002Fday for prednisone\u002F prednisolone, 16 mg\u002Fday for methylprednisolone, 3 mg\u002Fday for dexamethasone, or 80 mg for hydrocortisone or equivalent doses for other corticosteroids.\n* If treated with acetylcholinesterase inhibitor should be on a stable daily dose (pyridostigmine dose ≤ 480 mg\u002Fday or neostigmine ≤ 300 mg\u002Fday) for at least 3 months prior to and during screening\n* Have a body weight \\>= 40 kilograms\n* Other protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* Immunologic disorder other than MG or any other condition requiring chronic oral, intravenous, intramuscular, or intraarticular corticosteroid therapy. Well-controlled thyroid disease, as per the Treating Investigator or the participants regular treating physician recorded in the source documents, is not exclusionary\n* Molecularly characterized or suspected congenital myasthenic syndrome, Lambert-Eaton myasthenic syndrome, inherited myopathy, muscular dystrophy, acquired myopathy or any other neurologic or systematic disease that mimics MG muscular weakness\n* Active, clinically significant viral, bacterial, or fungal infection, including brain MRI or chest X-ray findings consistent with signs of infection such as PML or TB, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 8 weeks prior or during Screening, or completion of oral anti-infectives within 8 weeks prior or during Screening. Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus considered by the Investigator to be sufficiently controlled would not be exclusionary\n* Has a history of or current diagnosis of active tuberculosis (TB) or is currently undergoing treatment for latent TB infection or has an untreated latent TB infection as determined by documented results within 3 months of the Screening Visit of a positive TB skin test .\n* Active malignancy, or history of cancer or signs of malignancy in any Screening assessment\n* Treatment with nonsteroidal immunosuppressants, used in gMG, such as azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, cyclophosphamide, tacrolimus within 4 weeks prior to randomization\n* Treatment with FcRn or complement inhibitors (such as eculizumab, rozanolixizumab efgartigimod, ravulizumab, zilucoplan or nipocalimab) within 8 weeks prior to randomization\n* History of thymectomy within 6 months prior to Screening.\n* History of generalized seizures (except for history of febrile seizures during the participant's childhood).\n* Negative or indeterminate for Varicella Zoster Virus antibodies at screening\n* History of myasthenic crisis in the last 12 months prior to and during screening\n* History of recurrent infections (that is 3 or more infections per year documented in available source data) within the last 2 years\n* Discontinuation of treatment with any non-steroidal immunosuppressants used in gMG, such as azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, cyclophosphamide, tacrolimus within the last 6 months prior to Screening\n* If treated with non-steroidal immunosuppressants for gMG, the dose at Screening higher than 50 mg\u002Fday for azathioprine, 500 mg\u002Fday for mycophenolate mofetil, 1 mg\u002Fday for tacrolimus, 50 mg\u002Fday for cyclosporine, 25 mg\u002Fday for cyclophosphamide, or 7.5 mg\u002Fweek for methotrexate\n* Participation in clinical study of any investigational drug within 6 months, or 5 half-lives of the investigational drug used in the previous clinical study prior to randomization, whichever is longer. However, participants with any prior exposure to cladribine may not enter the study regardless of timing of exposure\n* Other protocol defined exclusion criteria could apply","ALL","18 Years",{"count":19,"type":20},264,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The purpose of this clinical study is to determine the efficacy and safety of a new oral cladribine formulation in participants with Generalized Myasthenia Gravis (gMG) in comparison to placebo. It will also investigate the sustained efficacy, the need for retreatment, and the long-term safety of oral cladribine in gMG. An additional component is included to characterize the Pharmacokinetics (PK) of the new cladribine formulation in gMG participants. This study is divided into 3 periods: the double-blind placebo control (DBPC) pivotal period, and 2 extensions, the blinded extension (BE) and the retreatment (RT) period. Furthermore, in trial interviews will be conducted as a sub-study to MyClad with a sub-set of participants to gain an in depth understanding of the participant cladribine treatment and study experience.",[26],"Generalized Myasthenia Gravis",[28,29,30,31],"Anti-AChR antibody positive","anti-MuSK antibody positive","anti-LRP4 antibody positive","seronegative gMG","RECRUITING","2026-06-25",{"date":35,"type":36},"2026-06-29","ACTUAL",{"date":38,"type":36},"2024-06-25",{"date":40,"type":20},"2030-11-12",{"name":42,"class":43},"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany","INDUSTRY",144,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100631337","phase-2-study-of-pimicotinib-in-japanese-participants-with-tenosynovial-giant-cell-tumor-tgct-j-maneuver-100631337","NCT07499362","Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER)","Phase 2, Single-arm Study to Investigate the Tolerability, Pharmacokinetics, Efficacy, and Safety of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor","Inclusion Criteria:\n\n* Japanese participants with a diagnosis of TGCT that has been histologically confirmed at the local laboratory and is unresectable (that is \\[i.e.\\] it is located in a complex anatomical site, extensively invasive, and cannot be completely resected; or a surgical operation may cause dysfunction or serious complications). Symptomatic disease because of active TGCT, defined as a worst pain of greater than or equal to \\[\\>=\\] 4 within 2 weeks prior to enrollment (based on scale of 0 to 10, with 10 representing \"pain as bad as you can imagine\"), and\u002For a worst stiffness of \\>= 4 within 2 weeks prior to first dose of pimicotinib (based on a scale of 0 to 10, with 10 representing \"stiffness as bad as you can imagine\")\n* Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to \\[\\\u003C=\\] 1\n* Participants with adequate hepatic, renal hematologic functions\n* Other protocol defined inclusion criteria may apply\n\nExclusion Criteria:\n\n* Known additional malignancy that required active treatment and may affect the participant's participation in the study or affect the outcome of the study as assessed by the Investigator. Exceptions include cured basal cell carcinoma of skin, squamous cell carcinoma of skin, and other carcinoma in situ\n* Serious gastrointestinal bleeding within 3 months of first dose of pimicotinib or factors that significantly affected the absorption of oral drug, such as inability to take oral medication or significant nausea and vomiting, malabsorption, external bile duct drainage, massive small-bowel resection, etc.\n* Impaired cardiac function or clinically significant cardiac disease, including any one of the following: New York Heart Association (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure; prolongation of the rate corrected QT interval based on repeated demonstration of QT interval corrected using Fridericia's formula (QTcF) greater than (\\>) 480 milliseconds (ms), or history of long QT interval corrected (QTc) syndrome; Left ventricular ejection fraction (LVEF) less than (\\\u003C) 50 percent (%) or below the lower limit of normal, whichever is higher\n* Cerebrovascular accident\u002Fstroke (within 6 months of first dose of pimicotinib)\n* Other protocol defined exclusion criteria may apply",{"count":53,"type":20},20,[55],"PHASE2","The primary purpose of this study is to assess the tolerability, pharmacokinetics, and efficacy of pimicotinib in Japanese participants with TGCT",[58],"Tenosynovial Giant Cell Tumor",[60,61,62,63],"Nodular TGCT","diffuse TGCT","giant cell tumor of tendon sheath","colony-stimulating factor 1 receptor (CSF-1R) inhibitor","2026-06-15",{"date":66,"type":36},"2026-06-16",{"date":68,"type":36},"2026-03-26",{"date":70,"type":20},"2029-11-22",{"name":42,"class":43},3,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":80,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100619146","phase-3-a-study-to-compare-the-efficacy-and-safety-of-follitropin-alfalutropin-alfa-versus-hmg-in-japanese-participants-with-lh-and-fsh-deficiency-undergoing-art-hinata-100619146","NCT07340827","A Study to Compare the Efficacy and Safety of Follitropin Alfa\u002FLutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)","A Parallel-group Treatment, 2-arm Study to Compare the Efficacy and Safety of Follitropin Alfa and Lutropin Alfa Fixed Dose Combination Versus hMG for Inducing Follicular Development in Japanese Participants With LH and FSH Deficiency Undergoing ART","Inclusion Criteria:\n\n* Participants who are premenopausal wishing to conceive\n* Participants with maximum 1 previous stimulation for assisted reproductive technology (ART) without pregnancy\n* Japanese Participants\n* Participants are women with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency congenital or acquired\n* Participants have a vaginal ultrasound scan showing both ovaries and no clinically significant uterine abnormality and a normal antral follicle count (AFC) of at least 5 follicles 2 to 10 millimeter (mm) in diameter per ovary\n* A semen analysis of the male partner been performed within 3 months prior to signature of informed consent and suitable for assisted reproductive technology\n* Participants have a normal cervical ThinPrep® cytologic test, (TCT) or Pap smear within 12 months of Screening. If not available, a cervical smear will be performed as part of screening\n* Other protocol defined criteria may apply\n\nExclusion Criteria:\n\n* Participants with history of severe OHSS in any previous ovarian stimulation cycle\n* Participants with Polycystic ovarian syndrome (PCOS) according to Rotterdam modified definition\n* Participants with contraindication to treatment with gonadotropins, hypersensitivity to gonadotropins or to any of the excipients\n* Participants with presence of known or suspected gonadotropin- or estrogen dependent malignancy (example. ovarian-, uterine-, or mammary carcinoma)\n* Participants with ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst greater than 25 millimeters before Day 1\n* other protocol defined exclusion criteria may apply","FEMALE","42 Years",{"count":83,"type":20},266,[23],"The purpose of this study is to assess the efficacy and safety of follitropin alfa\u002Flutropin alfa in Japanese participants with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency undergoing Assisted reproductive technology (ART).\n\nThe study duration is approximately 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy in Part A.",[87],"Infertility",[89],"Gonadotropins, infertility, prefilled pen","2026-06-09",{"date":92,"type":36},"2026-06-11",{"date":94,"type":36},"2026-02-05",{"date":96,"type":20},"2028-07-05",{"name":42,"class":43},11,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":16,"minAge":17,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"100560453","phase-1-phase-1-single-ascending-doses-sad-of-m5542-in-healthy-participants-100560453","NCT06577337","Phase 1 Single Ascending Doses (SAD) of M5542 in Healthy Participants","A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Single Ascending Doses of M5542 Administered Subcutaneously in Healthy Participants","Inclusion Criteria:\n\n* Participants are overtly healthy, as determined by medical evaluation, by physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection, or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion at Screening and Day -1\n* Participants have a body weight within the range 50 to 100 kilograms (kg) (inclusive) and body mass index (BMI) within the range 18 to 30.0 kilograms per square meter kg\u002Fm\\^2 (inclusive) at Screening\n* Other protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, musculoskeletal, genitourinary, immunological, dermatological, connective tissue, psychiatric and other diseases or disorders, and epilepsy, as determined by medical evaluation at Screening and Day -1\n* Any condition, including findings in the laboratory tests or other screening assessments, that in the opinion of the Investigator constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study's objectives, conduct, or evaluation at Screening and on Day -1\n* History of any malignancy\n* History of chronic or recurrent acute infection or any bacterial, viral, parasitic, or fungal infections within 30 days prior to Screening and at any time between Screening and admission, or hospitalization due to infection within 6 months prior to Screening\n* Immunization with any vaccine 42 days prior to dosing on Day 1 or planned within 3 months after the last administration of study intervention\n* Other protocol defined exclusion criteria could apply",true,"50 Years",{"count":109,"type":20},49,[111],"PHASE1","The present study in healthy participants will assess the safety, tolerability, immunogenicity, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses (SAD) of subcutaneously administered M5542.",[114],"Healthy",[116],"First-in-Human","2026-04-22",{"date":119,"type":36},"2026-04-27",{"date":121,"type":36},"2024-09-12",{"date":123,"type":20},"2027-03-09",{"name":42,"class":43},1,""]