A Randomized, Placebo- and Active Drug-Controlled, Double-Blind, Multicenter, Parallel-Group Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis
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.
• 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);
⁃ ii.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;
• Female participants of child-bearing potential shall agree to use effective contraception during the study and for 30 days following the last dose, and pregnancy tests at the screening and baseline visits shall be negative; male participants shall agree to use effective contraception during the study and for 30 days following the last dose.