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

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Psoriasis

In brief

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 facts

Study ID

NCT07724366

Run by

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

People needed

400

Starts

2026-08-01

Expected to finish

2028-06-01

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Peking University Third Hospital — Beijing, Beijing Municipality, China
• The First Affiliated Hospital of Chongqing Medical University 。 — Chongqing, Chongqing Municipality, China
• Chongqing Traditional Chinese Medicine Hospital — Chongqing, Chongqing Municipality, China
• Dermatology Hospital of Southern Medical University — Guangzhou, Guangdong, China
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China
• Shenzhen Second People's Hospital — Shenzhen, Guangdong, China
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China
• Guizhou Provincial People's Hospital — Guiyang, Guizhou, China
• Hainan Fifth People's Hospital — Haikou, Hainan, China
• Affiliated Hospital of Chengde Medical University — Chengde, Hebei, China
• Shijiazhuang Traditional Chinese Medicine Hospital — Shijiazhuang, Hebei, China
• Heilongjiang Provincial Hospital — Harbin, Heilongjiang, China
• The Second Affiliated Hospital of Henan University of science and technology — Luoyang, Henan, China
• Puyang Oilfield General Hospital — Puyang, Henan, China
• Zhengzhou Central Hospital — Zhengzhou, Henan, China
• The First Peopel's Hospital of Zhengzhou — Zhengzhou, Henan, China
• Jingzhou Central Hospital — Jingzhou, Hubei, China
• Xiangya Hospital of Central South University — Changsha, Hunan, China
• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China
• Affiliated Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia, China
• The First People's Hospital of Lianyungang — Lianyungang, Jiangsu, China
• Nantong Cancer Hospital — Nantong, Jiangsu, China
• Suzhou Municipal Hospital — Suzhou, Jiangsu, China
• Affiliated Hospital of Jiangsu University — Zhenjiang, Jiangsu, China
• The Second Hospital of Jilin University — Changchun, Jilin, China

Full record on ClinicalTrials.gov

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