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RECRUITING Phase 2 ClinicalTrials.gov

A Phase IIa Study of JAB-8263 in Patients With Active Rheumatoid Arthritis

Sponsor: Jacobio Pharmaceuticals Co., Ltd. • ClinicalTrials.gov ID: NCT07684157

Registry updated: 2026-09-28
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Description

This study is an open-label, multi-center Phase IIa study. The study is divided into two phases. The first phase is a safety exploration phase. Participants with active rheumatoid arthritis were enrolled and treated with JAB-8263 alone for 4 weeks. The purpose is to evaluate the safety, PK/PD characteristics and preliminary effectiveness of JAB-8263 in participants with active RA.

Interventions

  • JAB-8263 (Drug)
    Variable dose1, orally Q2D with 28 days
  • JAB-8263 (Drug)
    Variable dose2, orally Q2D with 28 days

Eligibility criteria

Inclusion Criteria: 1. Age ≥18 years old and \<75 years old at the time of signing the informed consent form, regardless of gender; 2. Active rheumatoid arthritis, ESR or C-reactive protein\> upper limit of normal 3. Meets the 2010 American College of Rheumatology ACR/EULAR RA classification standards 4. Participants have recovered from adverse reactions to previous antirheumatic treatment. Exclusion Criteria: 1. Use of topical glucocorticoids within 2 weeks before the first dose of investigational product or have received epidural, intraarticular, intramuscular, oral or intravenous glucocorticoids within 4 weeks, and do not use adrenocorticotropin; 2. Use of NSAIDs within 1 week before first dose of investigational product 3. Known or suspected allergies to the investigational product or any of its components; 4. Current active shingles virus infection, including shingles or herpes simplex types 1 and 2 (confirmed by physical examination and medical history); participants had a history of severe herpes infection, including any disseminated disease, shingles in multiple skin areas, herpes encephalitis, ocular herpes, or recurrent shingles (2 episodes greater than or equal to 2 episodes within 2 years); 5. Have evidence of active tuberculosis (TB) or have previously had evidence of active TB and have not received appropriate documented treatment;

Conditions

Rheumatoid Arthritis (RA)

Locations

  • Beijing Hospital — Beijing, Beijing Municipality, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record