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

Locations

43
Bozhou People's Hospital236805, BozhouAnhui, China
Peking Union Medical College Hospital100000, BeijingBeijing Municipality, China
Southwest Hospital, Third Military Medical University (Army Medical University)400038, ChongqingChongqing Municipality, China
Dongguan People's Hospital523109, DongguanGuangdong, China

Sponsors and collaborators

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Lead sponsor