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NCT Number: NCT07684157

A Phase 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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;

Treatment and study plan

JAB-8263

Drug

Variable dose1, orally Q2D with 28 days

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Yang Jun Project Director

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Jacobio Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: JAB-8263

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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