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A Clinical Trial of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis

StatusRecruiting
PhasePhase 2
Started2026-07-16
View on ClinicalTrials.gov ↗

Amendment history

2026-08-31
Study Status, Outcome Measures, Contacts/Locations v3
Secondary endpoints14 entries, revised
Numbers of subjects with incidence and Severity Level of adverse Event (AE), serious Adverse Event (SAE), adverse [...]
Study sitesdetails revised at 3 of 44 sites
2026-08-27
Study Status, Arms and Interventions, Outcome Measures, Eligibility v2
Eligibility criteria+74 characters
[...] ant disease characteristics Aged 18 to 70 years（inclusive）; BMI ≥ 18 kg/m² at screening; ii.diagnosed with PsA for at least 3 months prior to screening, [...] remained stable for at least 14 days before the first dose; WomenFemale participants of childbearingchild-bearing potential mustshall agree to use effective contraception during the study and for 630 monthsdays afterfollowing the endlast ofdose, and pregnancy tests at the studyscreening and baseline visits shall be negative; menmale mustparticipants shall agree to use effective contraception during the study and for 630 monthsdays afterfollowin [...] [...]
Secondary endpointsdetails revised at 12 of 14 entries
2026-07-23
Study Identification, Study Status, Contacts/Locations v1
Recruitment opened
Start dateestimated 2026-04→confirmed 2026-07-16
Study sites43→44
Study title-45 characters
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis
2026-02-05
Original filing
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.
Trial Details
NCT Number NCT07406035
Lead Sponsor Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Conditions Psoriatic Arthritis
Enrollment 156 participants
Start Date 2026-07-16
Primary Completion 2027-08 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-09-02