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

2026年9月7日 更新者：Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Adult Patients With Moderate to Severe Plaque Psoriasis

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

400

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100191
        • 尚未招聘
        • Peking University Third Hospital
        • 接触：
    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国、400010
        • 尚未招聘
        • The First Affiliated Hospital of Chongqing Medical University 。
        • 接触：
      • Chongqing、Chongqing Municipality、中国、400011
        • 尚未招聘
        • Chongqing Traditional Chinese Medicine Hospital
        • 接触：
    • Guangdong
      • Guangzhou、Guangdong、中国、510000
        • 尚未招聘
        • Dermatology Hospital of Southern Medical University
        • 接触：
      • Guangzhou、Guangdong、中国、519041
        • 尚未招聘
        • Guangdong Provincial People's Hospital
        • 接触：
      • Shenzhen、Guangdong、中国、518032
        • 招聘中
        • Shenzhen Second People's Hospital
        • 接触：
    • Guangxi
      • Nanning、Guangxi、中国、530021
        • 尚未招聘
        • The First Affiliated Hospital of Guangxi Medical University
        • 接触：
    • Guizhou
      • Guiyang、Guizhou、中国、550002
        • 尚未招聘
        • Guizhou Provincial People's Hospital
        • 接触：
          • Xue Chen, Doctor
          • 电话号码：18685993699
          • 邮箱：cxe911@qq.com
    • Hainan
      • Haikou、Hainan、中国、570100
        • 尚未招聘
        • Hainan Fifth People's Hospital
        • 接触：
    • Hebei
      • Chengde、Hebei、中国、067000
        • 招聘中
        • Affiliated Hospital of Chengde Medical University
        • 接触：
      • Shijiazhuang、Hebei、中国、050000
        • 尚未招聘
        • Shijiazhuang Traditional Chinese Medicine Hospital
        • 接触：
    • Heilongjiang
      • Harbin、Heilongjiang、中国、150036
        • 招聘中
        • Heilongjiang Provincial Hospital
        • 接触：
    • Henan
      • Luoyang、Henan、中国、471099
        • 尚未招聘
        • The Second Affiliated Hospital of Henan University of Science and Technology
        • 接触：
      • Puyang、Henan、中国、457001
        • 尚未招聘
        • Puyang Oilfield General Hospital
        • 接触：
      • Zhengzhou、Henan、中国、450000
        • 尚未招聘
        • Zhengzhou Central Hospital
        • 接触：
      • Zhengzhou、Henan、中国、450004
        • 尚未招聘
        • The First Peopel's Hospital of Zhengzhou
        • 接触：
    • Hubei
      • Jingzhou、Hubei、中国、434020
        • 招聘中
        • Jingzhou Central Hospital
        • 接触：
    • Hunan
      • Changsha、Hunan、中国、410013
        • 招聘中
        • The Third XIANGYA Hospital of Central South University
        • 接触：
      • Changsha、Hunan、中国、410000
        • 尚未招聘
        • Xiangya Hospital of Central South University
        • 接触：
    • Inner Mongolia
      • Hohhot、Inner Mongolia、中国、10010
        • 尚未招聘
        • Affiliated Hospital of Inner Mongolia Medical University
        • 接触：
          • Xinxiang Lv, Bachelor
          • 电话号码：13171069661
          • 邮箱：lxx_08@126.com
    • Jiangsu
      • Lianyungang、Jiangsu、中国、222061
        • 尚未招聘
        • The first people's hospital of Lianyungang
        • 接触：
      • Nanjing、Jiangsu、中国、210042
        • 撤销
        • Chinese Academy of Medical Sciences Hospital for Skin Diseases
      • Nantong、Jiangsu、中国、215004
        • 尚未招聘
        • Nantong Cancer Hospital
        • 接触：
      • Suzhou、Jiangsu、中国、215002
        • 招聘中
        • Suzhou Municipal Hospital
        • 接触：
      • Zhenjiang、Jiangsu、中国、212008
        • 招聘中
        • Affiliated Hospital of Jiangsu University
        • 接触：
    • Jilin
      • Changchun、Jilin、中国、130000
        • 尚未招聘
        • The Second Hospital of Jilin University
        • 接触：
    • Liaoning
      • Shengyang、Liaoning、中国、110623
        • 招聘中
        • Zhongyi Northeast International Hospital Co., Ltd.
        • 接触：
      • Shenyang、Liaoning、中国、110002
        • 招聘中
        • The First Affiliated Hospital of China Medical University
        • 接触：
      • Shenyang、Liaoning、中国、110003
        • 撤销
        • Shenyang Seventh People's Hospital (Shenyang Hospital of Integrated Traditional Chinese and Western Medicine, Shenyang Dermatology Hospital)
      • Shenyang、Liaoning、中国、110023
        • 尚未招聘
        • Central Hospital Affiliated to Shenyang Medical College
        • 接触：
    • Qinghai
      • Xining、Qinghai、中国、810000
        • 尚未招聘
        • The First People's Hospital of Xining
        • 接触：
    • Shaanxi
      • Xi'an、Shaanxi、中国、710004
        • 尚未招聘
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • 接触：
    • Shandong
      • Dezhou、Shandong、中国、253000
        • 招聘中
        • Qilu Hospital Dezhou Branch of Shandong University (Dezhou People's Hospital)
        • 接触：
      • Jining、Shandong、中国、272011
        • 尚未招聘
        • Jining No.1 People's Hospital
        • 接触：
      • Qingdao、Shandong、中国、266000
        • 尚未招聘
        • Qingdao Municipal Hospital
        • 接触：
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200040
        • 尚未招聘
        • Huashan Hospital, Fudan University
        • 接触：
    • Shanxi
      • Changzhi、Shanxi、中国、46000
        • 尚未招聘
        • The Second People's Hospital of ChangZhi
        • 接触：
    • Sichuan
      • Suining、Sichuan、中国、629000
        • 招聘中
        • Suining Central Hospital
        • 接触：
    • The Ningxia Hui Autonomous Region
      • Yinchuan、The Ningxia Hui Autonomous Region、中国、750000
        • 尚未招聘
        • Gerneral Hospital of Ningxia Medical Univercity
        • 接触：
    • Tianjin Municipality
      • Tianjin、Tianjin Municipality、中国、300120
        • 尚未招聘
        • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
        • 接触：
        • 接触：
      • Tianjin、Tianjin Municipality、中国、300110
        • 尚未招聘
        • Tianjin First Central Hospital
        • 接触：
    • Yunnan
      • Kunming、Yunnan、中国、650032
        • 尚未招聘
        • The First Affiliated Hospital of Kunming Medical University
        • 接触：
    • Zhejiang
      • Jiaxing、Zhejiang、中国、314001
        • 尚未招聘
        • Jiaxing First Hospital
        • 接触：
      • Jinhua、Zhejiang、中国、321000
        • 招聘中
        • Jinhua Municipal Central Hospital
        • 接触：
      • Ningbo、Zhejiang、中国、315020
        • 招聘中
        • The First Affiliated Hospital of Ningbo University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:1. Participants must be between 18 and 75 years old when signing the informed consent form (ICF), regardless of gender; 2. Confirmed diagnosis of plaque psoriasis for at least 6 months at screenin 3. Disease is stable at screening and baseline visits, and the following criteria are met:

  • 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.

Exclusion Criteria:1.Presence of non-plaque psoriasis during the Screening period or at the Baseline visit; 2.Past or current diagnosis of drug-induced psoriasis; 3.Concomitant other autoimmune diseases, including but not limited to rheumatoid arthritis, sarcoidosis, and systemic lupus erythematosus; 4.Receiving therapeutic agents for psoriatic arthritis (PsA) other than stable-dose non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics.

5.Prior exposure to TQH3906 Capsules or Deucravacitinib Tablets; 6.Receipt of any of the following medications or treatments within the specified time window:

  1. Any topical agents or treatments that may interfere with psoriasis assessment, administered within 2 weeks before the Baseline visit;
  2. Psoriasis phototherapy administered within 4 weeks before the Baseline visit;
  3. Any biologics or biosimilars thereof, administered within the specified time frame before the Baseline visit;
  4. 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.

10. 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.

-

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：TQH3906 Capsules + Deucravacitinib tablets placebo
Double-blind phase: TQH3906 capsule 24 mg + deucravacitinib tablet placebo; Open-label extension phase: TQH3906 capsule 24 mg monotherapy.
药品：TQH3906 capsules
TQH3906 Capsules is an inhibitor that targets tyrosine kinase 2 (TYK2).
药品：Deucravacitinib tablets placebo
No pharmacologically active substance
有源比较器：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.
药品：Deucravacitinib tablets 6 mg
Deucravacitinib tablet is an inhibitor that targets tyrosine kinase 2 (TYK2).
药品：TQH3906 Capsules placebo
No pharmacologically active substance
安慰剂比较：TQH3906 Capsules placebo + Deucravacitinib tablets placebo
Double-blind phase: TQH3906 capsule placebo + Deucravacitinib tablet placebo; Open-label extension phase: TQH3906 capsule 24 mg monotherapy.
药品：Deucravacitinib tablets placebo
No pharmacologically active substance
药品：TQH3906 Capsules placebo
No pharmacologically active substance

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
static Physician's Global Assessment (sPGA)
大体时间：Baseline up to 16 weeks
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)
大体时间：Baseline up to 16 weeks
Proportion of participants achieving PASI 90 at Week 16, comparing participants using TQH3906 capsules versus placebo.
Baseline up to 16 weeks

次要结果测量

结果测量
措施说明
大体时间
static Physician's Global Assessment (sPGA)
大体时间：Baseline up to 16 weeks
Proportion of participants achieving sPGA 0/1 at Week 16, comparing participants using TQH3906 capsules versus Deucravacitinib..
Baseline up to 16 weeks
Psoriasis Area and Severity Index (PASI)
大体时间：Baseline up to 16 weeks
Proportion of participants achieving PASI 90 at Week 16, comparing participants using TQH3906 capsules versus Deucravacitinib.
Baseline up to 16 weeks
Psoriasis Area and Severity Index (PASI)
大体时间：Baseline up to 52 weeks
Proportion of participants achieving PASI 75 at each assessment visits, comparing participants using TQH3906 capsules versus placebo.
Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
大体时间：Baseline up to 52 weeks
Proportion of participants achieving PASI 75 at each assessment visits, comparing participants using TQH3906 capsules versus Deucravacitinib.
Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
大体时间：Baseline up to 52 weeks
Proportion of participants achieving PASI 90 at each assessment visits, comparing participants using TQH3906 capsules versus placebo.
Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
大体时间：Baseline up to 52 weeks
Proportion of participants achieving PASI 90 at each assessment visits, comparing participants using TQH3906 capsules versus Deucravacitinib.
Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
大体时间：Baseline up to 52 weeks
Proportion of participants achieving PASI 100 at each assessment visits, comparing participants using TQH3906 capsules versus placebo.
Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
大体时间：Baseline up to 52 weeks
Proportion of participants achieving PASI 100 at each assessment visits, comparing participants using TQH3906 capsules versus Deucravacitinib.
Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
大体时间：Baseline up to 52 weeks
Proportion of participants achieving PASI 50 at each assessment visits, comparing participants using TQH3906 capsules versus placebo.
Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
大体时间：Baseline up to 52 weeks
Proportion of participants achieving PASI 50 at each assessment visits, comparing participants using TQH3906 capsules versus Deucravacitinib.
Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
大体时间：Baseline up to 52 weeks
Change from baseline in PASI scores and percent change at each assessment visit; comparing participants using TQH3906 capsules versus placebo.
Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
大体时间：Baseline up to 52 weeks
Change from baseline in PASI scores and percent change at each assessment visit; comparing participants using TQH3906 capsules versus Deucravacitinib.
Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
大体时间：Baseline up to 52 weeks
The proportion of trial participants achieving PASI score < 3 at each assessment visits, comparing participants using TQH3906 capsules versus placebo.
Baseline up to 52 weeks
Psoriasis Area and Severity Index (PASI)
大体时间：Baseline up to 52 weeks
The proportion of trial participants achieving PASI score < 3 at each assessment visits, comparing participants using TQH3906 capsules versus Deucravacitinib.
Baseline up to 52 weeks
static Physician's Global Assessment (sPGA)
大体时间：Baseline up to 52 weeks
Proportion of participants achieving sPGA 0/1 at each assessment visits, comparing participants using TQH3906 capsules versus placebo.
Baseline up to 52 weeks
static Physician's Global Assessment (sPGA)
大体时间：Baseline up to 52 weeks
Proportion of participants achieving sPGA 0/1 at each assessment visits, comparing participants using TQH3906 capsules versus Deucravacitinib..
Baseline up to 52 weeks
static Physician's Global Assessment (sPGA)
大体时间：Baseline up to 52 weeks
Proportion of participants achieving sPGA 0 at each assessment visits, comparing participants using TQH3906 capsules versus placebo.
Baseline up to 52 weeks
Scalp static Physician's Global Assessment (sPGA)
大体时间：Baseline up to 52 weeks
Proportion of participants achieving sPGA 0 at each assessment visits, comparing participants using TQH3906 capsules versus Deucravacitinib..
Baseline up to 52 weeks
Scalp static Physician's Global Assessment (ssPGA)
大体时间：Baseline up to 52 weeks
Proportion of participants achieving ssPGA 0/1 at each assessment visits, comparing participants using TQH3906 capsules versus placebo.
Baseline up to 52 weeks
Scalp static Physician's Global Assessment (ssPGA)
大体时间：Baseline up to 52 weeks
Proportion of participants achieving ssPGA 0/1 at each assessment visits, comparing participants using TQH3906 capsules versus Deucravacitinib..
Baseline up to 52 weeks
Palmoplantar Psoriasis Physician Global Assessment (pp-PGA)
大体时间：Baseline up to 52 weeks
Proportion of participants achieving ssPGA 0/1 at each assessment visits, comparing participants using TQH3906 capsules versus placebo.
Baseline up to 52 weeks
Palmoplantar Psoriasis Physician Global Assessment (pp-PGA)
大体时间：Baseline up to 52 weeks
Proportion of participants achieving pp-PGA 0/1 at each assessment visits, comparing participants using TQH3906 capsules versus Deucravacitinib..
Baseline up to 52 weeks
Physician's Global Assessment of Fingernail Psoriasis (PGA-F)
大体时间：Baseline up to 52 weeks
Proportion of participants achieving PGA-F 0/1 at each assessment visits, comparing participants using TQH3906 capsules versus placebo.
Baseline up to 52 weeks
Physician's Global Assessment of Fingernail Psoriasis (PGA-F)
大体时间：Baseline up to 52 weeks
Proportion of participants achieving PGA-F 0/1 at each assessment visits, comparing participants using TQH3906 capsules versus Deucravacitinib.
Baseline up to 52 weeks
Dermatology Life Quality Index (DLQI)
大体时间：Baseline up to 52 weeks
Change from baseline in Dermatology Life Quality Index (DLQI) at each assessment visit;comparing participants using TQH3906 capsules versus placebo.
Baseline up to 52 weeks
Dermatology Life Quality Index (DLQI)
大体时间：Baseline up to 52 weeks
Change from baseline in Dermatology Life Quality Index (DLQI) at each assessment visit;comparing participants using TQH3906 capsules versus Deucravacitinib.
Baseline up to 52 weeks
Dermatology Life Quality Index (DLQI)
大体时间：Baseline up to 52 weeks
Proportion of participants achieving DLQI 0/1 at each assessment visit;comparing participants using TQH3906 capsules versus placebo.
Baseline up to 52 weeks
Dermatology Life Quality Index (DLQI)
大体时间：Baseline up to 52 weeks
Proportion of participants achieving DLQI 0/1 at each assessment visit;comparing participants using TQH3906 capsules versus Deucravacitinib.
Baseline up to 52 weeks
Psoriatic Lesion Body Surface Area (BSA)
大体时间：Baseline up to 52 weeks
Change from baseline in Psoriatic Lesion Body Surface Area (BSA) at each assessment visit; comparing participants using TQH3906 capsules versus placebo.
Baseline up to 52 weeks
Psoriatic Lesion Body Surface Area (BSA)
大体时间：Baseline up to 52 weeks
Change from baseline in Psoriatic Lesion Body Surface Area (BSA) at each assessment visit; comparing participants using TQH3906 capsules versus Deucravacitinib.
Baseline up to 52 weeks
Effects on participants' Psoriasis Area and Severity Index (PASI)
大体时间：Baseline up to 52 weeks
Questionnaire: Psoriasis Area and Severity Index (PASI) total score, range 0-72. The body is divided into 4 regions (head, upper extremities, trunk, lower extremities) weighted by 0.1, 0.2, 0.3, 0.4 respectively. Each region is scored for erythema, induration, desquamation (0-4 each) and lesion area (0-6). Higher scores indicate more severe psoriasis.
Baseline up to 52 weeks
Effects on participants' static Physician's Global Assessment (sPGA)
大体时间：Baseline up to 52 weeks

Questionnaire: Static Physician's Global Assessment (sPGA) is a single-item static global severity scale (0-4 points) assessing overall psoriasis lesion severity at a single timepoint, based on equal-weighted evaluation of 3 lesion features: erythema, induration, desquamation (each scored 0-4, averaged to final global score).

Scoring grading:

0 = Cleared (no active lesions, residual pigmentation allowed)

  1. = Almost cleared
  2. = Mild
  3. = Moderate
  4. = Severe sPGA 0/1 responder = score 0 or 1 at target visit;
Baseline up to 52 weeks
Effects on participants' Scalp static Physician's Global Assessment (ssPGA)
大体时间：Baseline up to 52 weeks

Questionnaire: ssPGA is a static 5-point single-item scale (0 to 4) exclusively evaluating scalp psoriatic lesions, comprehensively and equally assessing three lesion features: erythema, plaque induration/thickening, and scaling limited to scalp only.

Scoring grading:

0 = Clear

  1. = Almost clear
  2. = Mild
  3. = Moderate
  4. = Severe
Baseline up to 52 weeks
Effects on participants' Palmoplantar Psoriasis Physician Global Assessment (pp-PGA)
大体时间：Baseline up to 52 weeks

Questionnaire: Palmoplantar Psoriasis Physician Global Assessment (pp-PGA). is a static single-item 5-point scale (score range 0-4), exclusively evaluating plaque psoriasis lesions limited to palms and soles. Investigators equally assess three core lesion features: erythema, hyperkeratosis/induration, scaling (fissures/pain secondary to plaques are referenced as auxiliary manifestations).

Grading definition:

0 = Clear

  1. = Almost clear
  2. = Mild
  3. = Moderate
  4. = Severe
Baseline up to 52 weeks
Effects on participants' Physician's Global Assessment of Fingernail Psoriasis (PGA-F)
大体时间：Baseline up to 52 weeks

Questionnaire: Physician's Global Assessment of Fingernail Psoriasis (PGA-F) is a static single-item 5-point scale (score range 0-4), exclusively evaluating psoriatic lesions of all fingernails. Investigators comprehensively assess core nail psoriasis manifestations: nail pitting, onycholysis, subungual hyperkeratosis, splinter hemorrhages, nail discoloration, crumbling.

Grading definition:

0 = Clear

  1. = Almost clear
  2. = Mild
  3. = Moderate
  4. = Severe
Baseline up to 52 weeks
Effects on participants' Dermatology Life Quality Index (DLQI)
大体时间：Baseline up to 52 weeks
Questionnaire: The Dermatology Life Quality Index (DLQI) is a validated self-administered 10-item patient-reported questionnaire evaluating the impact of skin disease on quality of life over the prior 7 days. The scale covers 6 domains: symptoms & feelings, daily activities, leisure, work/school, personal relationships, treatment burden. Each question is scored 0 (not at all/not relevant) to 3 (very much); total score ranges from 0 to 30. Lower scores indicate less impairment to quality of life.
Baseline up to 52 weeks
Adverse event rate
大体时间：Baseline up to 56 weeks
The occurrence of all adverse events (AEs), serious adverse events (SAEs) ,Adverse Events of Special Interest (AESIs) and treatment-related adverse events (TEAEs).
Baseline up to 56 weeks
Plasma concentration of TQH3906 at steady state (Cav, SS)
大体时间：1 hour Pre-dose of day 1 and 30 minutes Pre-dose of day 29, day 57, day 113, day 225, day 365 during treatment.
The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.
1 hour Pre-dose of day 1 and 30 minutes Pre-dose of day 29, day 57, day 113, day 225, day 365 during treatment.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

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

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月2日

初级完成 (估计的)

2027年9月1日

研究完成 (估计的)

2028年6月1日

研究注册日期

首次提交

2026年7月21日

首先提交符合 QC 标准的

2026年7月21日

首次发布 (实际的)

2026年7月24日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月7日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • TQH3906-III-01

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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