JAB-8263 in active rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multi-center Phase 2a trial that explores the safety, pharmacokinetics/pharmacodynamics, and early effectiveness of JAB-8263 in adults with active RA. The first phase focuses on safety after 4 weeks of JAB-8263 treatment given alone. The study uses an inclusion framework aligned with established RA criteria and requires prior tolerance to antirheumatic therapy, with exclusions for recent glucocorticoid exposure and certain infections. Lead sponsorship is by Jacobio Pharmaceuticals, with the trial conducted at Beijing Hospital in China.

Why it matters

Who can join: the full rules

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;

Where it's running

• Beijing Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Jun Yang Jun Project Director
• Email: clinicaltrials@jacobiopharma.com
• Phone: 86 010-05615464

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.