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

Sponsor
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Study ID
NCT07406035
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • TQH3906 Capsule — DRUG
    TQH3906 is a small-molecule inhibitor of tyrosine kinase.
  • TQH3906 Placebo Capsule — DRUG
    Placebo without drug substance.
  • Tofacitinib Citrate Tablet 5 mg — DRUG
    Tofacitinib Citrate Tablets are Janus kinase (JAK) inhibitors.

Study Details

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.

Key Dates

First listed
Feb 12, 2026
Start date
Jul 16, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TQH3906 Capsule 24 mg
    Oral administration daily from Day 1 (D1) to Day 85 (D85) Morning Fasting: 3 Capsules of 8 mg TQH3906
  • Experimental: TQH3906 Capsule 16 mg
    Oral administration daily from Day 1 (D1) to Day 85 (D85) Morning fasting: 2 capsules of 8 mg TQH3906
  • Placebo Comparator: TQH3906 Capsule 0 mg
    Oral administration daily from Day 1 (D1) to Day 85 (D85) Morning fasting: 3 placebo capsules of TQH3906
  • Active Comparator: Tofacitinib Citrate Tablet 5 mg
    Oral administration daily from Day 1 (D1) to Day 85 (D85): Morning fasting: 1 tablet of tofacitinib citrate Administer 1 tablet of Tofacitinib Citrate at bedtime.

Primary Outcome Measure

American College of Rheumatology 20% Improvement Criteria [ Time Frame: Day 1, 15, 29, 57, 85 ]

Central Contacts

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