Condition: Psoriasis · Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
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.
This description comes directly from the study's public registry record.
Xinghua Gao, Doctor · 13940152467 · gaobarry@hotmail.com
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| 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 | — |
+ 31 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07724366