A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis
NCT07406035 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156
Last updated 2026-02-12
Summary
This study is a marketing-oriented clinical trial of TQH3906 Capsules. A total of 156 participants are planned to be enrolled, aiming to evaluate the dose-effect relationship of TQH3906 versus placebo in the treatment of active Psoriatic Arthritis (PsA) at Week 12, with the proportion of participants achieving an American College of Rheumatology 20% (ACR20) Improvement Criteria (ACR20) response at Week 12 as the primary endpoint.
Conditions
Interventions
- DRUG
-
TQH3906 Capsule
TQH3906 is a small-molecule inhibitor of tyrosine kinase.
- DRUG
-
TQH3906 Placebo Capsule
Placebo without drug substance.
- DRUG
-
Tofacitinib Citrate Tablet 5 mg
Tofacitinib Citrate Tablets are Janus kinase (JAK) inhibitors.
Sponsors & Collaborators
-
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2027-08-31
- Completion
- 2027-11-30
Countries
- China
Study Locations
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