A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • TQH3906 Capsule
  • TQH3906 Placebo Capsule
  • Tofacitinib Citrate Tablet 5 mg

Treatment groups

156 Participants
are divided into 4 treatment groups