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
Presence of non-plaque psoriasis (i.e., guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis) at screening or first dose;
Presence of any other autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus, etc.;
Presence of active (i.e., currently symptomatic) fibromyalgia;
Trial participants who are pregnant or breastfeeding;
Parallel
TQH3906 Capsule
DrugTQH3906 is a small-molecule inhibitor of tyrosine kinase.
TQH3906 Placebo Capsule
DrugPlacebo without drug substance.
Tofacitinib Citrate Tablet 5 mg
DrugTofacitinib Citrate Tablets are Janus kinase (JAK) inhibitors.
American College of Rheumatology 20% Improvement Criteria
The proportion of trial participants achieving an ACR20 response at Week 12.
ACR20 in the subgroup of trial participants
The proportion of biologic-naive trial participants in the subgroup who achieved ACR20 response.
American College of Rheumatology 50 (ACR50)
ACR50 response rate
American College of Rheumatology 70 (ACR70)
ACR70 response rate
Psoriasis Area and Severity Index (PASI) 75
PASI 75 response rate
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