A Phase IIa Study of JAB-8263 in Patients With Active Rheumatoid Arthritis
ConditionRheumatoid Arthritis (RA)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJacobio Pharmaceuticals Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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);
Trial design
Design model
Single group
Treatments tested in this trial
JAB-8263
DrugVariable dose1, orally Q2D with 28 days
JAB-8263
DrugVariable dose2, orally Q2D with 28 days
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: JAB-8263Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
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Source ClinicalTrials.gov