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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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;
Primary outcome measure(s)
Evaluate the overall safety and tolerability of JAB-8263 — Up to approximately 12week Safety assessments including but not limited to TEAEs, SAEs, deaths and changes in clinical laboratory measures
Trial sites (1)
Facility
City
Region
Status
Beijing Hospital
Beijing
Beijing Municipality
More Jacobio Pharmaceuticals Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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