protocolSection identificationModule nctId: NCT06276998, orgStudyIdInfo id: LK001304, briefTitle: A Study of LNK01001 Capsule in Subjects With Active Rheumatoid Arthritis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-12, primaryCompletionDateStruct date: 2025-08-04, completionDateStruct date: 2026-11-20, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Lynk Pharmaceuticals Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: Brief Summary: This is a randomized, double-blind study comparing LNK01001 to placebo in Chinese participants with moderately to severely active rheumatoid arthritis who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response or Intolerance to biologic DMARDs(bDMARDs).The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of LNK01001 12 mg twice daily (BID) versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.The study objective of Period 2 (Week 24 to Week 76) is to evaluate the long-term safety, tolerability, and efficacy of LNK01001 12 mg BID in participants with RA who completed Period 1., conditionsModule conditions: Rheumatoid Arthritis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 430, type: ESTIMATED, armsInterventionsModule interventions name: LNK01001, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24, secondaryOutcomes measure: Change from Baseline in Disease Activity Score 28 (DAS28) (CRP) at week 24, secondaryOutcomes measure: Percentage of Participants with an American College of Rheumatology 50% (ACR50) Response at week 24, secondaryOutcomes measure: Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at all visits., secondaryOutcomes measure: Percentage of Participants with an American College of Rheumatology 70% (ACR70) Response at all visits., secondaryOutcomes measure: Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at all visits., secondaryOutcomes measure: Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at all visits, secondaryOutcomes measure: Percentage of Participants with an American College of Rheumatology 20% (ACR20) Response at all visits (except week 24)., secondaryOutcomes measure: Change from Baseline in the Severity of Morning Stiffness at all visits., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Xiaofeng Zeng, role: CONTACT, phone: 0086-010-69158793, email: xiaofeng.zeng@cstar.org.cn, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False