Beijing Hospital
Beijing, Beijing Municipality, China
NCT Number: NCT07684157
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 2
Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Variable dose1, orally Q2D with 28 days
Time frame: Up to approximately 12week
Safety assessments including but not limited to TEAEs, SAEs, deaths and changes in clinical laboratory measures
Time frame: Up to approximately 12week
the percentage of patients who meet the ACR20 response criteria
Time frame: Up to approximately 12week
the percentage of participants who meet the ACR50 response criteria
Time frame: Up to approximately 12week
the percentage of participants who meet the ACR70 response criteria
Time frame: Up to approximately 12week
the percentage of participants who achieve a good clinical response based on the Clinical Disease Activity Index (CDAI)
Time frame: Up to approximately 12week
the percentage of participants who achieve a good clinical response according to the Simplified Disease Activity Index (SDAI)
Contact information is provided by the study sponsor or research team.
Jacobio Pharmaceuticals Co., Ltd.
Industry
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
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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