MedTrace Logo

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

NCT07724366 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-07-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

TQH3906 capsules

TQH3906 Capsules is an inhibitor that targets tyrosine kinase 2 (TYK2).

DRUG

Deucravacitinib tablets 6 mg

Deucravacitinib tablet is an inhibitor that targets tyrosine kinase 2 (TYK2).

DRUG

TQH3906 Capsules placebo

No pharmacologically active substance

DRUG

Deucravacitinib tablets placebo

No pharmacologically active substance

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-09-30
Completion
2028-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07724366 on ClinicalTrials.gov