A Clinical Trial of TQH3906 Capsules in Adult Patients With Moderate to Severe Plaque Psoriasis

Sponsor
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Study ID
NCT07724366
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • TQH3906 capsules — DRUG
    TQH3906 Capsules is an inhibitor that targets tyrosine kinase 2 (TYK2).
  • Deucravacitinib tablets 6 mg — DRUG
    Deucravacitinib tablet is an inhibitor that targets tyrosine kinase 2 (TYK2).
  • TQH3906 Capsules placebo — DRUG
    No pharmacologically active substance
  • Deucravacitinib tablets placebo — DRUG
    No pharmacologically active substance

Study Details

This study is a multicenter, randomized, double-blind, placebo- and active-controlled Phase III clinical trial sponsored by Nanjing Shunxin Pharmaceutical Co., Ltd., a subsidiary of Chiatai Tianqing Pharmaceutical Group. The study aims to evaluate the efficacy and safety of once-daily oral TQH3906 capsules (24 mg) in adult participants with moderate to severe plaque psoriasis. TQH3906 is a highly selective TYK2 allosteric inhibitor targeting the JH2 domain, which blocks the IL-23 and Type I interferon inflammatory pathways. Approximately 400 eligible participants aged 18-75 years will be enrolled. Participants will be stratified based on prior biologic use and randomized in a 2:2:1 ratio to the TQH3906 group, the deucravacitinib active control group, or the placebo group. The trial includes a screening period, a 16-week double-blind controlled treatment phase, a 36-week open-label extension phase (during which all participants will receive TQH3906), and a 4-week safety follow-up after the last dose. The co-primary endpoints are the proportion of participants achieving sPGA 0/1 and PASI 90 response at Week 16. Secondary endpoints include improvements in scalp, nail, and palmoplantar psoriasis, Dermatology Life Quality Index (DLQI), long-term safety, and steady-state pharmacokinetic parameters. This study will collect comprehensive efficacy and safety data over 52 weeks to support the New Drug Application (NDA) for TQH3906 for the treatment of plaque psoriasis.

Key Dates

First listed
Jul 24, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2027
Completion
Jun 30, 2028

Study Design

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

Arms

  • Experimental: TQH3906 Capsules + Deucravacitinib tablets placebo
    Double-blind phase: TQH3906 capsule 24 mg + deucravacitinib tablet placebo; Open-label extension phase: TQH3906 capsule 24 mg monotherapy.
  • Active Comparator: TQH3906 Capsules placebo + Deucravacitinib tablets 6 mg
    Double-blind phase: TQH3906 capsule placebo + deucravacitinib tablet 6 mg; Open-label extension phase: TQH3906 capsule 24 mg monotherapy.
  • Placebo Comparator: TQH3906 Capsules placebo + Deucravacitinib tablets placebo
    Double-blind phase: TQH3906 capsule placebo + Deucravacitinib tablet placebo; Open-label extension phase: TQH3906 capsule 24 mg monotherapy.

Primary Outcome Measure

static Physician's Global Assessment (sPGA) [ Time Frame: Baseline up to 16 weeks ]

Central Contacts

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