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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJacobio Pharmaceuticals Co., Ltd.

About this trial

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 criteria

Qualifiers

Age ≥18 years old and <75 years old at the time of signing the informed consent form, regardless of gender;

Active rheumatoid arthritis, ESR or C-reactive protein> upper limit of normal

Meets the 2010 American College of Rheumatology ACR/EULAR RA classification standards

Participants have recovered from adverse reactions to previous antirheumatic treatment.

Disqualifiers

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;

Use of NSAIDs within 1 week before first dose of investigational product

Known or suspected allergies to the investigational product or any of its components;

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);

Trial design

Treatments tested in this trial

  • JAB-8263
  • JAB-8263

Treatment groups

32 Participants
are divided into 1 treatment group