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

2026. szeptember 7. frissítette: 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.

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

400

Fázis

  • 3. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

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

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

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.

-

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Négyszeres

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: TQH3906 Capsules + Deucravacitinib tablets placebo
Double-blind phase: TQH3906 capsule 24 mg + deucravacitinib tablet placebo; Open-label extension phase: TQH3906 capsule 24 mg monotherapy.
Drog: TQH3906 capsules
TQH3906 Capsules is an inhibitor that targets tyrosine kinase 2 (TYK2).
Drog: Deucravacitinib tablets placebo
No pharmacologically active substance
Aktív összehasonlító: 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.
Drog: Deucravacitinib tablets 6 mg
Deucravacitinib tablet is an inhibitor that targets tyrosine kinase 2 (TYK2).
Drog: TQH3906 Capsules placebo
No pharmacologically active substance
Placebo Comparator: TQH3906 Capsules placebo + Deucravacitinib tablets placebo
Double-blind phase: TQH3906 capsule placebo + Deucravacitinib tablet placebo; Open-label extension phase: TQH3906 capsule 24 mg monotherapy.
Drog: Deucravacitinib tablets placebo
No pharmacologically active substance
Drog: TQH3906 Capsules placebo
No pharmacologically active substance

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
static Physician's Global Assessment (sPGA)
Időkeret: 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)
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
static Physician's Global Assessment (sPGA)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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)
Időkeret: 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.

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

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

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2026. szeptember 2.

Elsődleges befejezés (Becsült)

2027. szeptember 1.

A tanulmány befejezése (Becsült)

2028. június 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. július 21.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. július 21.

Első közzététel (Tényleges)

2026. július 24.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. szeptember 9.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. szeptember 7.

Utolsó ellenőrzés

2026. szeptember 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • TQH3906-III-01

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

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