A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatmen… (NCT07406035) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis
China156 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Sign a written Informed Consent Form, which must meet the following requirements
* Be willing to participate in the study and able to sign the informed consent form;
* Be willing and able to complete all study-specific procedures and visits;
* PsA trial participant disease characteristics
* Aged 18 to 70 years(inclusive);
* BMI ≥ 18 kg/m² at screening; diagnosed with PsA for at least 3 months prior to screening, and meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening;
* Active arthritis at screening and at baseline (Day 1);
* Has failed or was intolerant to at least one prior therapy;
* If receiving a conventional synthetic Disease-Modifying Antirheumatic Drug (csDMARD), trial participants must be on only one DMARD, which must have been administered for at least 3 months prior to screening, with a stable dose for at least 28 days prior to the first dose;
* If using NSAIDs, the dose must have been stable for at least 14 days before the first dose;
* If using oral corticosteroids, the dose must have been stable for at least 14 days before the first dose;
* Topical treatments for plaque psoriasis must have remained stable for at least 14 days before the first dose;
* Women of childbearing potential must agree to use effective contraception during the study and for 6 months after the end of the study; men must agree to use effective contraception during the study and for 6 months after the end of the study…
What they're measuring
1
American College of Rheumatology 20% Improvement Criteria
Timeframe: Day 1, 15, 29, 57, 85
Trial details
NCT IDNCT07406035
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.