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

NCT07724366 | Not Yet Recruiting Phase 3

• 1 other identifier: TQH3906-III-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 43

Brief 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

Psoriasis

Outcome Measures

Primary Outcomes (2)

• static Physician's Global Assessment (sPGA)

  Proportion of participants achieving sPGA 0/1 at Week 16, comparing participants using TQH3906 capsules versus placebo.

  Baseline up to 16 weeks

• Psoriasis Area and Severity Index (PASI)

  Proportion of participants achieving PASI 90 at Week 16, comparing participants using TQH3906 capsules versus placebo.

  Baseline up to 16 weeks

Secondary Outcomes (38)

• static Physician's Global Assessment (sPGA)

  Baseline up to 16 weeks

• Psoriasis Area and Severity Index (PASI)

  Baseline up to 16 weeks

• Psoriasis Area and Severity Index (PASI)

  Baseline up to 52 weeks

• Psoriasis Area and Severity Index (PASI)

  Baseline up to 52 weeks

• Psoriasis Area and Severity Index (PASI)

  Baseline up to 52 weeks

Study Arms (3)

TQH3906 Capsules + Deucravacitinib tablets placebo

EXPERIMENTAL

Double-blind phase: TQH3906 capsule 24 mg + deucravacitinib tablet placebo; Open-label extension phase: TQH3906 capsule 24 mg monotherapy.

Drug: TQH3906 capsules; Drug: Deucravacitinib tablets placebo

TQH3906 Capsules placebo + Deucravacitinib tablets 6 mg

ACTIVE COMPARATOR

Double-blind phase: TQH3906 capsule placebo + deucravacitinib tablet 6 mg; Open-label extension phase: TQH3906 capsule 24 mg monotherapy.

Drug: Deucravacitinib tablets 6 mg; Drug: TQH3906 Capsules placebo

TQH3906 Capsules placebo + Deucravacitinib tablets placebo

PLACEBO COMPARATOR

Double-blind phase: TQH3906 capsule placebo + Deucravacitinib tablet placebo; Open-label extension phase: TQH3906 capsule 24 mg monotherapy.

Drug: TQH3906 Capsules placebo; Drug: Deucravacitinib tablets placebo

Interventions

Deucravacitinib tablets 6 mg DRUG

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

TQH3906 Capsules placebo + Deucravacitinib tablets 6 mg

TQH3906 Capsules placebo DRUG

No pharmacologically active substance

TQH3906 Capsules placebo + Deucravacitinib tablets 6 mg; TQH3906 Capsules placebo + Deucravacitinib tablets placebo

Deucravacitinib tablets placebo DRUG

No pharmacologically active substance

TQH3906 Capsules + Deucravacitinib tablets placebo; TQH3906 Capsules placebo + Deucravacitinib tablets placebo

TQH3906 capsules DRUG

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

TQH3906 Capsules + Deucravacitinib tablets placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Static Physician Global Assessment (sPGA) score ≥3;
• Psoriasis Area and Severity Index (PASI) score ≥12;
• Body Surface Area (BSA) affected by psoriasis ≥10%; 4. Deemed by the Investigator as suitable for systemic therapy or phototherapy; 5. Women of childbearing potential must have a negative pregnancy test at screening and baseline visits. Women of childbearing potential and male trial participants whose spouse or partner is a woman of childbearing potential must be willing to use at least one effective method of contraception as specified in the protocol during the study period (from signing the ICF until 30 days after the last dose of investigational drug). Male trial participants must also commit to not donating sperm during the study period and within 30 days after the last dose of study drug; 6. Before initiating any screening or study-specific procedures, trial participants must be able to understand and willing to comply with all protocol requirements, and voluntarily sign and date the ICF.

You may not qualify if:

• Prior exposure to TQH3906 Capsules or Deucravacitinib Tablets; 6.Receipt of any of the following medications or treatments within the specified time window:
• Any topical agents or treatments that may interfere with psoriasis assessment, administered within 2 weeks before the Baseline visit;
• Psoriasis phototherapy administered within 4 weeks before the Baseline visit;
• Any biologics or biosimilars thereof, administered within the specified time frame before the Baseline visit;
• Systemic non-biologic psoriasis therapy and/or systemic immunosuppressive treatment administered within 4 weeks before the Baseline visit; 5) Within 6 months prior to the baseline visit: Leflunomide; 6) Within 4 weeks prior to the baseline visit: Traditional Chinese medicines (TCM), Chinese proprietary medicines, or herbal preparations used for psoriasis treatment or with unknown composition/nature, including but not limited to Total Glucosides of Paeony, Tripterygium wilfordii preparations, Compound Glycyrrhizin preparations, Compound Qingdai preparations, etc.; 7) Within 4 weeks prior to the baseline visit: Any live vaccines or live-attenuated vaccines; OR anticipated need to receive live vaccines or live-attenuated vaccines during the study period including at least 4 weeks after the last dose of investigational product; 8) Within 3 months prior to the baseline visit (or 5 half-lives, whichever is longer): Investigational biological agent treatment; OR within 30 days prior to the baseline visit (or 5 half-lives, whichever is longer): Any other investigational drug treatment; OR currently participating in other clinical trials; 7. Active infection/history of infection, or receipt of specific anti-infective therapies within the specified time windows; 8. Previous or current presence of severe or unstable diseases or medical conditions involving neurological, cardiovascular, respiratory, digestive, urinary, hematological, or immune systems that, in the Investigator's judgment, may interfere with outcome assessment or affect participation safety 9. Laboratory test abnormalities meeting any of the following criteria during the screening period: 1) Hemoglobin \<90.0 g/L; 2) White blood cell count \<3.0×10⁹/L; 3) Neutrophil count \<1.0×10⁹/L; 4) Lymphocyte count \<0.5×10⁹/L; 5) Platelet count \<100×10⁹/L; 6) Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) \>3× Upper Limit of Normal (ULN); 7) Total bilirubin (TBIL) \>1.5× ULN; 8) Estimated creatinine clearance \<45 mL/min calculated based on the Cockcroft-Gault formula. (See Appendix 2 for calculation formula); 9) Thyroid-stimulating hormone (TSH) outside the normal reference range, concomitant with free T4 or T3 also outside the normal reference range.
• \. History of drug or alcohol abuse within 6 months prior to screening; 11. Known allergy, hypersensitivity, or intolerance to TQH3906 capsules, deucravacitinib tablets, or any excipient ingredients; 12. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial, and men who plan to father children or donate sperm during the trial; 13. Trial participants who are employees of the Sponsor, third-party agency staff, or direct research center staff involved in this study or their family members; 14. Per Investigator assessment, presence of any other medical, psychiatric, or other reasons that render the trial participant unsuitable for participation in this study.

Sponsors & Collaborators

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

Study Sites (43)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

The First Affiliated Hospital of Chongqing Medical University 。

Chongqing, Chongqing Municipality, 400010, China

Location

Chongqing Traditional Chinese Medicine Hospital

Chongqing, Chongqing Municipality, 400011, China

Location

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 519041, China

Location

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 518032, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

Guizhou Provincial People's Hospital

Guiyang, Guizhou, 550002, China

Location

Hainan Fifth People's Hospital

Haikou, Hainan, 570100, China

Location

Affiliated Hospital of Chengde Medical University

Chengde, Hebei, 067000, China

Location

Shijiazhuang Traditional Chinese Medicine Hospital

Shijiazhuang, Hebei, 050000, China

Location

Heilongjiang Provincial Hospital

Harbin, Heilongjiang, 150036, China

Location

The Second Affiliated Hospital of Henan University of science and technology

Luoyang, Henan, 471099, China

Location

Puyang Oilfield General Hospital

Puyang, Henan, 457001, China

Location

Zhengzhou Central Hospital

Zhengzhou, Henan, 450000, China

Location

The First Peopel's Hospital of Zhengzhou

Zhengzhou, Henan, 450004, China

Location

Jingzhou Central Hospital

Jingzhou, Hubei, 434020, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 10010, China

Location

The First People's Hospital of Lianyungang

Lianyungang, Jiangsu, 222061, China

Location

Nantong Cancer Hospital

Nantong, Jiangsu, 215004, China

Location

Suzhou Municipal Hospital

Suzhou, Jiangsu, 215002, China

Location

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, 212008, China

Location

The Second Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Zhongyi Northeast International Hospital Co., Ltd.

Shengyang, Liaoning, 110623, China

Location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110002, China

Location

Shenyang Seventh People's Hospital (Shenyang Hospital of Integrated Traditional Chinese and Western Medicine, Shenyang Dermatology Hospital)

Shenyang, Liaoning, 110003, China

Location

The First People's Hospital of Xining

Xining, Qinghai, 810000, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710004, China

Location

Qilu Hospital Dezhou Branch of Shandong University (Dezhou People's Hospital)

Dezhou, Shandong, 253000, China

Location

Jining No.1 People'S Hospital

Jining, Shandong, 272011, China

Location

Qingdao Municipal Hospital

Qingdao, Shandong, 266000, China

Location

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

The Second People's Hospital of ChangZhi

Changzhi, Shanxi, 46000, China

Location

Suining Central Hospital

Suining, Sichuan, 629000, China

Location

Gerneral Hospital of Ningxia Medical Univercity

Yinchuan, The Ningxia Hui Autonomous Region, 750000, China

Location

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, 300110, China

Location

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, Tianjin Municipality, 300120, China

Location

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

Jiaxing First Hospital

Jiaxing, Zhejiang, 314001, China

Location

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, 321000, China

Location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315020, China

Location

MeSH Terms

Conditions

Psoriasis

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Xinghua Gao, Doctor

CONTACT

13940152467; gaobarry@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

CN (43)