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

21 июля 2026 г. обновлено: 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.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

400

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Xinghua Gao, Doctor
  • Номер телефона: 13940152467
  • Электронная почта: gaobarry@hotmail.com

Места учебы

  • Китай
    • Beijing Municipality
      • Beijing, Beijing Municipality, Китай, 100191
        • Peking University Third Hospital
        • Контакт:
          • wenhui wang, Doctor
          • Номер телефона: 18618269437
          • Электронная почта: wangwenhui@puh3.net.cn
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Китай, 400010
        • The First Affiliated Hospital of Chongqing Medical University 。
        • Контакт:
          • Kun Huang, Doctor
          • Номер телефона: 13883688696
          • Электронная почта: feelingkun@126.com
      • Chongqing, Chongqing Municipality, Китай, 400011
        • Chongqing Traditional Chinese Medicine Hospital
        • Контакт:
          • Qingchun Diao, Doctor
          • Номер телефона: 13983735555
          • Электронная почта: qchdiao@vip.sina.com
    • Guangdong
      • Guangzhou, Guangdong, Китай, 519041
        • Guangdong Provincial People's Hospital
        • Контакт:
          • Zhu Shen, Doctor
          • Номер телефона: 13983174426
          • Электронная почта: zhshencq@163.com
      • Guangzhou, Guangdong, Китай, 510000
        • Dermatology Hospital of Southern Medical University
        • Контакт:
          • Xiaohua Wang, Doctor
          • Номер телефона: 13763359607
          • Электронная почта: wxh_21773@163.com
      • Shenzhen, Guangdong, Китай, 518032
        • Shenzhen Second People's Hospital
        • Контакт:
          • Cuihong Lian, Doctor
          • Номер телефона: 15814692161
          • Электронная почта: 15814692161@163.com
    • Guangxi
      • Nanning, Guangxi, Китай, 530021
        • The First Affiliated Hospital of Guangxi Medical University
        • Контакт:
          • Qiuju Li, Doctor
          • Номер телефона: 15807816066
          • Электронная почта: llqj000@126.com
    • Guizhou
      • Guiyang, Guizhou, Китай, 550002
        • Guizhou Provincial People's Hospital
        • Контакт:
          • Xue Chen, Doctor
          • Номер телефона: 18685993699
          • Электронная почта: cxe911@qq.com
    • Hainan
      • Haikou, Hainan, Китай, 570100
        • Hainan Fifth People's Hospital
        • Контакт:
          • Huiming Zeng, Master
          • Номер телефона: 13976598200
          • Электронная почта: 13976598200@163.com
    • Hebei
      • Chengde, Hebei, Китай, 067000
        • Affiliated Hospital of Chengde Medical University
        • Контакт:
          • Xinsuo Duan, Master
          • Номер телефона: 15633142680
          • Электронная почта: 15633142680@126.com
      • Shijiazhuang, Hebei, Китай, 050000
        • Shijiazhuang Traditional Chinese Medicine Hospital
        • Контакт:
          • Ling'e Li, Bachelor
          • Номер телефона: 13323043660
          • Электронная почта: zyypfk2008@126.com
    • Heilongjiang
      • Harbin, Heilongjiang, Китай, 150036
        • Heilongjiang Provincial Hospital
        • Контакт:
          • Xiguang Liu, Bachelor
          • Номер телефона: 13945675477
          • Электронная почта: liuxiguang5741@163.com
    • Henan
      • Luoyang, Henan, Китай, 471099
        • The Second Affiliated Hospital of Henan University of Science and Technology
        • Контакт:
          • Xinggang Ju, Master
          • Номер телефона: 15225538050
          • Электронная почта: jxgwfmc@126.com
      • Puyang, Henan, Китай, 457001
        • Puyang Oilfield General Hospital
        • Контакт:
          • QiJun Li, Master
          • Номер телефона: 13839277965
          • Электронная почта: lqj_2008@163.com
      • Zhengzhou, Henan, Китай, 450000
        • Zhengzhou Central Hospital
        • Контакт:
          • Yuhong Zhang, Master
          • Номер телефона: 15837180902
          • Электронная почта: zyhdyxiang@126.com
      • Zhengzhou, Henan, Китай, 450004
        • The First Peopel's Hospital of Zhengzhou
        • Контакт:
          • Ziguang Zhou, Master
          • Номер телефона: 15237167989
          • Электронная почта: zzg2006619@126.com
    • Hubei
      • Jingzhou, Hubei, Китай, 434020
        • Jingzhou Central Hospital
        • Контакт:
          • Yi Sun, Doctor
          • Номер телефона: 18071883358
          • Электронная почта: jzzxyysy@163.com
    • Hunan
      • Changsha, Hunan, Китай, 410000
        • Xiangya Hospital of Central South University
        • Контакт:
          • Juan Su, Doctor
          • Номер телефона: 15116408921
          • Электронная почта: 3694944834@qq.com
      • Changsha, Hunan, Китай, 410013
        • The Third Xiangya Hospital of Central South University
        • Контакт:
          • Lina Tan, Doctor
          • Номер телефона: 13973162345
          • Электронная почта: tanlinawork@163.com
    • Inner Mongolia
      • Hohhot, Inner Mongolia, Китай, 10010
        • Affiliated Hospital of Inner Mongolia Medical University
        • Контакт:
          • Xinxiang Lv, Bachelor
          • Номер телефона: 13171069661
          • Электронная почта: lxx_08@126.com
    • Jiangsu
      • Lianyungang, Jiangsu, Китай, 222061
        • The First People's Hospital of Lianyungang
        • Контакт:
          • Hong Ren, Bachelor
          • Номер телефона: 18961326020
          • Электронная почта: doctorrenh@126.com
      • Nantong, Jiangsu, Китай, 215004
        • Nantong Cancer Hospital
        • Контакт:
          • Zhichun Liu, Doctor
          • Номер телефона: 1377194276
          • Электронная почта: lzchun5190@sina.com
      • Suzhou, Jiangsu, Китай, 215002
        • Suzhou Municipal Hospital
        • Контакт:
          • Jun Gu, Master
          • Номер телефона: 18930939371
          • Электронная почта: gujun79@163.com
      • Zhenjiang, Jiangsu, Китай, 212008
        • Affiliated Hospital of Jiangsu University
        • Контакт:
          • Hui Xu, Doctor
          • Номер телефона: 13815474886
          • Электронная почта: xuhuiraian@sina.com
    • Jilin
      • Changchun, Jilin, Китай, 130000
        • The Second Hospital of Jilin University
        • Контакт:
          • Fuqiu Wang, Doctoral candidate
          • Номер телефона: 13039123758
          • Электронная почта: Lifuqiu1234@126.com
    • Liaoning
      • Shengyang, Liaoning, Китай, 110623
        • Zhongyi Northeast International Hospital Co., Ltd.
        • Контакт:
          • Shifa Zhang, Doctor
          • Номер телефона: 13190010100
          • Электронная почта: zhangshifa_1963@126.com
      • Shenyang, Liaoning, Китай, 110002
        • The First Affiliated Hospital of China Medical University
        • Контакт:
          • Xinghua Gao, Doctor
          • Номер телефона: 13940152467
          • Электронная почта: gaobarry@hotmail.com
      • Shenyang, Liaoning, Китай, 110003
        • Shenyang Seventh People's Hospital (Shenyang Hospital of Integrated Traditional Chinese and Western Medicine, Shenyang Dermatology Hospital)
        • Контакт:
          • Xiaodong Sun, Doctor
          • Номер телефона: 13591454517
          • Электронная почта: gemmapeter@163.com
    • Qinghai
      • Xining, Qinghai, Китай, 810000
        • The First People's Hospital of Xining
        • Контакт:
          • Hengjin Li, Bachelor
          • Номер телефона: 13911333214
          • Электронная почта: lhengjin@163.com
    • Shaanxi
      • Xi'an, Shaanxi, Китай, 710004
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Контакт:
          • Songmei Geng, Doctor
          • Номер телефона: 13060423612
          • Электронная почта: gsm12@yahoo.com
    • Shandong
      • Dezhou, Shandong, Китай, 253000
        • Qilu Hospital Dezhou Branch of Shandong University (Dezhou People's Hospital)
        • Контакт:
          • Jun Peng, Bachelor
          • Номер телефона: 18553498197
          • Электронная почта: 13881702998@163.com
      • Jining, Shandong, Китай, 272011
        • Jining No.1 People'S Hospital
        • Контакт:
          • Dongmei Shi, Doctor
          • Номер телефона: 15069760108
          • Электронная почта: shidongmei28@163.com
      • Qingdao, Shandong, Китай, 266000
        • Qingdao Municipal Hospital
        • Контакт:
          • Changyuan Wang, Doctor
          • Номер телефона: 18660290075
          • Электронная почта: changyuanwang2008@163.com
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Китай, 200040
        • Huashan Hospital, Fudan University
        • Контакт:
          • Zhenghua Zhang, Doctor
          • Номер телефона: 13918416280
          • Электронная почта: verzhang@foxmail.com
    • Shanxi
      • Changzhi, Shanxi, Китай, 46000
        • The Second People's Hospital of ChangZhi
        • Контакт:
          • Yufei Li, Bachelor
          • Номер телефона: 15635580696
          • Электронная почта: 119023217@qq.com
    • Sichuan
      • Suining, Sichuan, Китай, 629000
        • Suining Central Hospital
        • Контакт:
          • Fei Ouyang, Master
          • Номер телефона: 15982006350
          • Электронная почта: 945951644@qq.com
    • The Ningxia Hui Autonomous Region
      • Yinchuan, The Ningxia Hui Autonomous Region, Китай, 750000
        • Gerneral Hospital of Ningxia Medical Univercity
        • Контакт:
          • Nan Yu, Master
          • Номер телефона: 13895095009
          • Электронная почта: 13895095009@163.com
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Китай, 300120
        • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
        • Контакт:
          • Litao Zhang, Doctor
          • Номер телефона: 18602228122
          • Электронная почта: ZhanglitaoYG@163.com
        • Контакт:
          • Junying Li, Doctor
          • Номер телефона: 13512270412
          • Электронная почта: Lijunying2016@126.com
      • Tianjin, Tianjin Municipality, Китай, 300110
        • Tianjin First Central Hospital
        • Контакт:
          • Sanwu Zeng, Master
          • Номер телефона: 13702066935
          • Электронная почта: 13702066935@139.com
    • Yunnan
      • Kunming, Yunnan, Китай, 650032
        • The First Affiliated Hospital of Kunming Medical University
        • Контакт:
          • Ying Tu, Doctor
          • Номер телефона: 13608711764
          • Электронная почта: 747307239@qq.com
    • Zhejiang
      • Jiaxing, Zhejiang, Китай, 314001
        • Jiaxing First Hospital
        • Контакт:
          • Wenhao Yin, master
          • Номер телефона: 13957323606
          • Электронная почта: whyin69@sina.com
      • Jinhua, Zhejiang, Китай, 321000
        • Jinhua Municipal Central Hospital
        • Контакт:
          • Meiyan wang, Bachelor
          • Номер телефона: 13757984755
          • Электронная почта: wmy196501@163.com
      • Ningbo, Zhejiang, Китай, 315020
        • The First Affiliated Hospital of Ningbo University
        • Контакт:
          • Bingjiang Lin, Master
          • Номер телефона: 17757461212
          • Электронная почта: linbingj@163.com

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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.

-

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Четырехместный

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: TQH3906 Capsules + Deucravacitinib tablets placebo
Double-blind phase: TQH3906 capsule 24 mg + deucravacitinib tablet placebo; Open-label extension phase: TQH3906 capsule 24 mg monotherapy.
Лекарство: TQH3906 capsules
TQH3906 Capsules is an inhibitor that targets tyrosine kinase 2 (TYK2).
Лекарство: Deucravacitinib tablets placebo
No pharmacologically active substance
Активный компаратор: 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.
Лекарство: Deucravacitinib tablets 6 mg
Deucravacitinib tablet is an inhibitor that targets tyrosine kinase 2 (TYK2).
Лекарство: TQH3906 Capsules placebo
No pharmacologically active substance
Плацебо Компаратор: TQH3906 Capsules placebo + Deucravacitinib tablets placebo
Double-blind phase: TQH3906 capsule placebo + Deucravacitinib tablet placebo; Open-label extension phase: TQH3906 capsule 24 mg monotherapy.
Лекарство: Deucravacitinib tablets placebo
No pharmacologically active substance
Лекарство: TQH3906 Capsules placebo
No pharmacologically active substance

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
static Physician's Global Assessment (sPGA)
Временное ограничение: 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)
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
static Physician's Global Assessment (sPGA)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

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

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 августа 2026 г.

Первичное завершение (Оцененный)

1 сентября 2027 г.

Завершение исследования (Оцененный)

1 июня 2028 г.

Даты регистрации исследования

Первый отправленный

21 июля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

21 июля 2026 г.

Первый опубликованный (Действительный)

24 июля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

24 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

21 июля 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • TQH3906-III-01

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования TQH3906 capsules

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