RecruitingNCT07684157JAB-8263Updated Sep 28, 2026

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

A Phase 2 interventional study of JAB-8263 and JAB-8263 in Rheumatoid Arthritis (RA), sponsored by Jacobio Pharmaceuticals Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Jacobio Pharmaceuticals Co., Ltd. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 32
Allocation: Not applicable
Ages: 18 Years to 75 Years
Sex: All

Study 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 studied

Rheumatoid Arthritis (RA)

Browse trials for

Arthritis, Rheumatoid 2,885

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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;

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 32 participants (estimated)

Study arms

Experimental
JAB-8263
Drug: JAB-8263

Interventions

DrugJAB-8263
Variable dose1, orally Q2D with 28 days
DrugJAB-8263
Variable dose2, orally Q2D with 28 days

What researchers measure

Primary outcomes

Evaluate the overall safety and tolerability of JAB-8263
Safety assessments including but not limited to Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), deaths and changes in clinical laboratory measures
Time frame: Up to approximately 12 weeks

Secondary outcomes

American College of Rheumatology 20 Response Rate (ACR20 Response Rate)
the percentage of patients who meet the ACR20 response criteria
Time frame: Up to approximately 12 weeks
American College of Rheumatology 50 Response Rate (ACR50 Response Rate)
the percentage of participants who meet the ACR50 response criteria
Time frame: Up to approximately 12 weeks
American College of Rheumatology 70 Response Rate (ACR70 Response Rate)
the percentage of participants who meet the ACR70 response criteria
Time frame: Up to approximately 12 weeks
Clinical Disease Activity Index Good Response Rate (CDAI Good Response Rate)
the percentage of participants who achieve a good clinical response based on the Clinical Disease Activity Index (CDAI)
Time frame: Up to approximately 12 weeks
Simplified Disease Activity Index Good Response Rate (SDAI Good Response Rate)
the percentage of participants who achieve a good clinical response according to the Simplified Disease Activity Index (SDAI)
Time frame: Up to approximately 12 weeks

Study locations

1 of 1 sites recruiting

Beijing Hospital
Beijing, Beijing Municipality, China
- Xuan Dr. Zhang · Contact · zxlab@outlook.com · +86 010-58115094
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT07684157
Lead sponsor: Jacobio Pharmaceuticals Co., Ltd.
Responsible party: Sponsor
First posted: Jul 6, 2026
Start date: Jul 23, 2026
Primary completion: Jun 30, 2027 (estimated)
Completion: Dec 31, 2027 (estimated)
Last update: Sep 28, 2026

Study contacts

Jun Yang Jun Project Director

Contact

clinicaltrials@jacobiopharma.com

86 010-05615464

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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