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

June 29, 2026 updated by: Jacobio Pharmaceuticals Co., Ltd.

A Phase Randomized, Double-blind, Placebo-controlled Evaluate the Efficacy and Safety IIa Study of JAB-8263 in Patients With Active Rheumatoid Arthritis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Beijing Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JAB-8263
Drug: JAB-8263
Variable dose1, orally Q2D with 28 days
Drug: JAB-8263
Variable dose2, orally Q2D with 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the overall safety and tolerability of JAB-8263
Time Frame: Up to approximately 12week
Safety assessments including but not limited to TEAEs, SAEs, deaths and changes in clinical laboratory measures
Up to approximately 12week

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jacobio Pharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 29, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 29, 2026

First Submitted That Met QC Criteria

June 29, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JAB-8263-2001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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