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

NCT07684157 | Not Yet Recruiting Phase 2

• 1 other identifier: JAB-8263-2001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis (RA)

Outcome Measures

Primary Outcomes (1)

• Evaluate the overall safety and tolerability of JAB-8263

  Safety assessments including but not limited to TEAEs, SAEs, deaths and changes in clinical laboratory measures

  Up to approximately 12week

Secondary Outcomes (5)

• American College of Rheumatology 20 Response Rate (ACR20 Response Rate)

  Up to approximately 12week

• American College of Rheumatology 50 Response Rate (ACR50 Response Rate)

  Up to approximately 12week

• American College of Rheumatology 70 Response Rate (ACR70 Response Rate)

  Up to approximately 12week

• Clinical Disease Activity Index Good Response Rate (CDAI Good Response Rate)

  Up to approximately 12week

• Simplified Disease Activity Index Good Response Rate (SDAI Good Response Rate)

  Up to approximately 12week

Study Arms (1)

JAB-8263

EXPERIMENTAL

Drug: JAB-8263

Interventions

JAB-8263 DRUG

Variable dose1, orally Q2D with 28 days

JAB-8263

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• Have evidence of active tuberculosis (TB) or have previously had evidence of active TB and have not received appropriate documented treatment;

Sponsors & Collaborators

• Jacobio Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Jun Yang Jun Project Director

CONTACT

clinicaltrials@jacobiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 29, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Locations

CN (1)