[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zenas BioPharma (USA), LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":119},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,61,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100598128","phase-3-a-study-of-orelabrutinib-in-patients-with-primary-progressive-multiple-sclerosis-100598128",false,"NCT07067463","A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis","A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis","Inclusion Criteria:\n\n* 18 to 60 years of age, inclusive\n* Diagnosed with Primary Progressive MS (PPMS) according to 2017 McDonald criteria\n* Participant must have documented evidence of disability progression observed during the 24 months before screening.\n* Expanded disability status scale (EDSS) score between 3.0 to 6.5 points, inclusive, at Screening.\n\nExclusion Criteria:\n\n* Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)\n* Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy.\n* History or current diagnosis of other neurological disorders that may mimic MS\n* History of any other significant active medical condition\n* History of suicidal behavior within 6 months prior to Screening\n* Any prior history of malignancy if no recurrence within 5 years\n* Patients on anticoagulation, or antiplatelet therapy will be excluded\n* Patients took strong\u002Fmoderate CYP3A inhibitors or strong\u002Fmoderate CYP3A inducerswithin 14 days\n* Clinically significant laboratory abnormalities at Screening.\n* Any allergy, contraindication, or inability to tolerate orelabrutinib or any of the excipients in the study intervention\n* Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening\n* History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.","ALL","18 Years","60 Years",{"count":20,"type":21},705,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with PPMS. Patients will be treated for approximately 30 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 705 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.",[27],"Multiple Sclerosis (MS) Primary Progressive","RECRUITING","2026-06-26",{"date":31,"type":32},"2026-06-29","ACTUAL",{"date":34,"type":32},"2026-03-23",{"date":36,"type":21},"2030-07",{"name":38,"class":39},"Zenas BioPharma (USA), LLC","INDUSTRY",17,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":58,"leadSponsor":59,"locationsCount":60},"100615931","phase-3-a-study-of-orelabrutinib-in-patients-with-secondary-progressive-multiple-sclerosis-100615931","NCT07299019","A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis","A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-active Secondary Progressive Multiple Sclerosis","Inclusion Criteria:\n\n1. 18 to 60 years of age, inclusive, at the time of signing the informed consent.\n2. Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria\n3. Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013\n4. Participant must have documented evidence of disability progression independent of clinical relapse observed during the 24 months before screening. A written summary of the clinical evidence of disability progression must be discussed and aligned between the Investigator and the Sponsor's dedicated qualified person(s).\n5. Absence of clinical relapses for at least 24 months.\n\nExclusion Criteria:\n\n1. The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria\n2. Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy.\n3. History or current diagnosis of other neurological disorders that may mimic MS\n4. History or current diagnosis of progressive multifocal leukoencephalopathy\n5. Active, clinically significant viral, bacterial, or fungal infection\n6. History of any other significant active medical condition\n7. History of suicidal behavior within 6 months prior to Screening\n8. Any prior history of malignancy\n9. Patients on anticoagulation, or antiplatelet therapy\n10. Patients took strong\u002Fmoderate CYP3A inhibitors or strong\u002Fmoderate CYP3A inducers within 14 days\n11. Clinically significant laboratory abnormalities at Screening.\n12. Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening\n13. History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.",{"count":49,"type":21},990,[24],"Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.",[53],"Secondary Progressive Multiple Sclerosis","2026-06-25",{"date":56,"type":32},"2026-06-30",{"date":34,"type":32},{"date":36,"type":21},{"name":38,"class":39},13,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100559056","phase-2-a-study-of-obexelimab-in-patients-with-systemic-lupus-erythematosus-100559056","NCT06559163","A Study of Obexelimab in Patients With Systemic Lupus Erythematosus","A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With Systemic Lupus Erythematosus","SunStone","Inclusion Criteria:\n\n1. Males and females, ≥ 18 to ≤ 70 years of age\n2. Diagnosed with SLE at least 24 weeks prior to screening and meets the 2019 EULAR\u002FACR classification criteria.\n3. Patient has all 3 of the following based on features active on the day of the visits:\n\n   1. hSLEDAI ≥ 6 and clinical hSLEDAI ≥ 4 at screening, and clinical hSLEDAI ≥ 4 at Day 1 Note: Clinical points exclude laboratory tests, except proteinuria.\n   2. BILAG-2004 Grade A or B in ≥ 1 organ system at screening and Day 1.\n   3. In the opinion of the investigator and the central adjudicator, there is sufficient disease activity to warrant enrollment into a clinical study with an investigational agent.\n4. Patients must be treated with one or more of the following background nonbiologic lupus standard of care therapies: oral corticosteroid, antimalarial, and\u002For immunosuppressant.\n\nExclusion Criteria:\n\n1. Active lupus nephritis for which, in the opinion of the investigator or the central adjudicator, current medications are insufficient for patient's safety or additional therapy that is not permitted in the protocol is needed.\n2. A history of thrombosis or embolism in the previous 6 months before the Screening visit, or previous 12 months associated with antiphospholipid syndrome (APS) or another relevant hypercoagulable state.\n3. Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE such as, but not limited to, psoriasis, dermatomyositis, and systemic sclerosis.\n4. Active severe neuropsychiatric or central nervous system SLE.\n5. Current inflammatory disease other than SLE (including, but not limited to, rheumatoid arthritis, psoriatic arthritis, spondyloarthropathy, reactive arthritis, scleroderma, dermatomyositis) that may interfere with the assessment of lupus signs and symptoms in the opinion of the investigator or central adjudicator.","70 Years",{"count":71,"type":21},190,[73],"PHASE2","This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus (SLE).",[76],"Systemic Lupus Erythematosus",[76,78,79],"SLE","Lupus","2025-07-25",{"date":82,"type":32},"2025-07-30",{"date":84,"type":32},"2024-09-17",{"date":86,"type":21},"2026-09",{"name":38,"class":39},82,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":16,"minAge":17,"maxAge":69,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},"100488341","phase-1-a-study-to-evaluate-safety-and-pharmacokinetics-of-zb002-in-healthy-participants-and-participants-with-rheumatoid-arthritis-100488341","NCT05638854","A Study to Evaluate Safety and Pharmacokinetics of ZB002 in Healthy Participants and Participants With Rheumatoid Arthritis","A Phase 1, 2-Part, Single Ascending Dose (SAD) Study to Evaluate the Safety and Pharmacokinetics (PK) of ZB002 in Healthy Volunteers (HVs) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety and PK of ZB002 in Participants With Rheumatoid Arthritis (RA)","Main Inclusion Criteria\n\nPart A SAD (HV):\n\n* Healthy male or female participants 18 to 55 years of age.\n* Body weight ≥ 50 kg for male participants and ≥ 45 kg for female participants; body mass index of 18 to 35 kg\u002Fm\\^2 for both male and female participants.\n* Considered in good health as determined by the Investigator.\n* Female participants of child-bearing potential must agree to abstinence or use an effective form of contraception.\n* Male participants must be surgically sterile or agree to use effective contraception.\n* Willing and able to understand the characteristics and purposes of the study, including possible risks involved, and willing to comply with all the study requirements and provide written informed consent for the study.\n\nPart B MAD (RA Participants):\n\n* Male or female participants 18 to 70 years (inclusive) of age at Screening.\n* Body mass index of ≥ 18.0 and ≤ 40.0 kg\u002Fm2.\n* Diagnosis of RA and meeting the 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism classification criteria for RA ≥ 3 months before Screening.\n* Use of methotrexate at 7.5 to 25 mg\u002Fweek for ≥ 3 months, with stable dosing for ≥ 4 weeks, before randomization. Hydroxychloroquine\u002Fchloroquine and\u002For sulfasalazine are allowed if started ≥ 3 months before randomization and a stable dose is maintained after the Screening Visit.\n\nMain Exclusion Criteria\n\nPart A SAD (HV):\n\n* Surgery within 4 weeks before Screening or planned surgery during the clinical study.\n* Use of prescription medications, biological products, or other medicines within 2 weeks before Study Day 1 or 5 half-lives of the product, whichever is greater. Use of over-the-counter medications or vitamins\u002Fdietary supplements within 7 days of dosing unless considered by the Investigator to not pose a risk or impact the study results.\n* Treatment with any investigational drug within 30 days or 5 half-lives, whichever is greater, before the first dose of the study drug, or currently enrolled in another clinical study.\n* Clinically significant ECG abnormality.\n* Positive for HIV infection, active hepatitis C, or hepatitis B.\n* Positive for COVID-19 virus.\n* Positive QuantiFERON®-TB Gold or T-SPOT® test for Mycobacterium tuberculosis.\n* Bacteria, viruses, systemic fungi, parasites, or other opportunistic infections within 30 days before Study Day 1.\n* Documented history of drug abuse in the previous 12 months before Screening, or positive for urine drug screen on Screening and\u002For Day -1.\n* Donated blood (including component blood) or lost \\> 400 mL within 3 months before Screening or received a transfusion within 3 months of Screening.\n* History of relevant allergies (including allergy to any murine or human-derived protein or immunoglobulin products, rubber or latex, or other allergies that in the opinion of the Investigator make inclusion in the study inappropriate).\n* Average daily smoking \\> 10 cigarettes or cigarette equivalents per day within 6 months of Screening.\n* Consume \\> 14 standard units of alcohol per week (1 standard unit is equivalent to approximately 360 mL of beer, 45 mL of spirits with 40% alcohol, or 150 mL of wine) or a positive alcohol breath test on Day -1.\n\nPart B MAD (RA Participants):\n\n* Inflammatory joint disease other than RA. Note: Current diagnosis of secondary Sjogren's Syndrome is permitted.\n* Surgery within 4 weeks before Screening or planned surgery during the clinical study.\n* History of any malignancy within 5 years, except for successfully treated nonmelanoma skin cancer or localized carcinoma in situ of the cervix.\n* Documented history of drug abuse in the previous 12 months before Screening (Days -28 to -1), or positive for urine drug screen for nonprescribed drugs other than cannabinoid at Screening.\n* Any condition considered by the investigator to make participation in the study inappropriate.\n* Donated blood (including component blood) or lost \\> 400 mL within 1 month before Screening or received a transfusion within 3 months of Screening.\n* After the Screening Visit, corticosteroid use \\> 10 mg\u002Fday (prednisone equivalent) or increase in dose\n* Positive for HIV infection, active hepatitis C, or hepatitis B.\n* Test positive for Mycobacterium tuberculosis.\n* Bacterial, viral, systemic fungal, parasitic, or opportunistic infection not resolved at least 14 days before Study Day 1 or expected to be treated with antibiotics during the Treatment Period, or history of recurrent infections.\n* Employees or related personnel of the study site, the sponsor, or contract research organization.",true,{"count":98,"type":21},72,[100],"PHASE1","This double-blind, randomized, placebo-controlled study will assess the safety and pharmacokinetics of ZB002 in healthy participants and in participants with rheumatoid arthritis (RA). The study consists of 2 parts. Part A: Single Ascending Dose (SAD), which will include only healthy volunteers. Part B: Multiple Ascending Dose (MAD), will commence after completion of the SAD study and will include RA participants.",[103,104],"Healthy Volunteers","Rheumatoid Arthritis",[103,106,107,108,104,109],"Healthy Subjects","Healthy Participants","Patients","RA","2025-04-04",{"date":112,"type":32},"2025-04-08",{"date":114,"type":32},"2022-12-08",{"date":116,"type":21},"2025-07",{"name":38,"class":39},2,""]