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

2026年7月21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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

400

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100191
        • Peking University Third Hospital
        • コンタクト：
    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国、400010
        • The First Affiliated Hospital of Chongqing Medical University 。
        • コンタクト：
      • Chongqing、Chongqing Municipality、中国、400011
        • Chongqing Traditional Chinese Medicine Hospital
        • コンタクト：
    • Guangdong
      • Guangzhou、Guangdong、中国、519041
        • Guangdong Provincial People's Hospital
        • コンタクト：
      • Guangzhou、Guangdong、中国、510000
        • Dermatology Hospital of Southern Medical University
        • コンタクト：
      • Shenzhen、Guangdong、中国、518032
        • Shenzhen Second People's Hospital
        • コンタクト：
    • Guangxi
      • Nanning、Guangxi、中国、530021
        • The First Affiliated Hospital of Guangxi Medical University
        • コンタクト：
    • Guizhou
      • Guiyang、Guizhou、中国、550002
        • Guizhou Provincial People's Hospital
        • コンタクト：
          • Xue Chen, Doctor
          • 電話番号：18685993699
          • メール：cxe911@qq.com
    • Hainan
      • Haikou、Hainan、中国、570100
        • Hainan Fifth People's Hospital
        • コンタクト：
    • Hebei
      • Chengde、Hebei、中国、067000
        • Affiliated Hospital of Chengde Medical University
        • コンタクト：
      • Shijiazhuang、Hebei、中国、050000
        • Shijiazhuang Traditional Chinese Medicine Hospital
        • コンタクト：
    • Heilongjiang
      • Harbin、Heilongjiang、中国、150036
        • Heilongjiang Provincial Hospital
        • コンタクト：
    • Henan
      • Luoyang、Henan、中国、471099
        • The Second Affiliated Hospital of Henan University of Science and Technology
        • コンタクト：
          • Xinggang Ju, Master
          • 電話番号：15225538050
          • メール：jxgwfmc@126.com
      • Puyang、Henan、中国、457001
        • Puyang Oilfield General Hospital
        • コンタクト：
      • Zhengzhou、Henan、中国、450000
        • Zhengzhou Central Hospital
        • コンタクト：
      • Zhengzhou、Henan、中国、450004
        • The First Peopel's Hospital of Zhengzhou
        • コンタクト：
    • Hubei
      • Jingzhou、Hubei、中国、434020
        • Jingzhou Central Hospital
        • コンタクト：
    • Hunan
      • Changsha、Hunan、中国、410000
        • Xiangya Hospital of Central South University
        • コンタクト：
      • Changsha、Hunan、中国、410013
        • The Third Xiangya Hospital of Central South University
        • コンタクト：
    • Inner Mongolia
      • Hohhot、Inner Mongolia、中国、10010
        • Affiliated Hospital of Inner Mongolia Medical University
        • コンタクト：
          • Xinxiang Lv, Bachelor
          • 電話番号：13171069661
          • メール：lxx_08@126.com
    • Jiangsu
      • Lianyungang、Jiangsu、中国、222061
        • The First People's Hospital of Lianyungang
        • コンタクト：
      • Nantong、Jiangsu、中国、215004
        • Nantong Cancer Hospital
        • コンタクト：
      • Suzhou、Jiangsu、中国、215002
        • Suzhou Municipal Hospital
        • コンタクト：
      • Zhenjiang、Jiangsu、中国、212008
        • Affiliated Hospital of Jiangsu University
        • コンタクト：
    • Jilin
      • Changchun、Jilin、中国、130000
        • The Second Hospital of Jilin University
        • コンタクト：
    • Liaoning
      • Shengyang、Liaoning、中国、110623
        • Zhongyi Northeast International Hospital Co., Ltd.
        • コンタクト：
      • Shenyang、Liaoning、中国、110002
        • The First Affiliated Hospital of China Medical University
        • コンタクト：
      • Shenyang、Liaoning、中国、110003
        • Shenyang Seventh People's Hospital (Shenyang Hospital of Integrated Traditional Chinese and Western Medicine, Shenyang Dermatology Hospital)
        • コンタクト：
    • Qinghai
      • Xining、Qinghai、中国、810000
        • The First People's Hospital of Xining
        • コンタクト：
    • Shaanxi
      • Xi'an、Shaanxi、中国、710004
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • コンタクト：
          • Songmei Geng, Doctor
          • 電話番号：13060423612
          • メール：gsm12@yahoo.com
    • Shandong
      • Dezhou、Shandong、中国、253000
        • Qilu Hospital Dezhou Branch of Shandong University (Dezhou People's Hospital)
        • コンタクト：
      • Jining、Shandong、中国、272011
        • Jining No.1 People's Hospital
        • コンタクト：
      • Qingdao、Shandong、中国、266000
        • Qingdao Municipal Hospital
        • コンタクト：
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200040
        • Huashan Hospital, Fudan University
        • コンタクト：
    • Shanxi
      • Changzhi、Shanxi、中国、46000
        • The Second People's Hospital of ChangZhi
        • コンタクト：
    • Sichuan
      • Suining、Sichuan、中国、629000
        • Suining Central Hospital
        • コンタクト：
    • The Ningxia Hui Autonomous Region
      • Yinchuan、The Ningxia Hui Autonomous Region、中国、750000
        • Gerneral Hospital of Ningxia Medical Univercity
        • コンタクト：
    • Tianjin Municipality
      • Tianjin、Tianjin Municipality、中国、300120
        • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
        • コンタクト：
        • コンタクト：
      • Tianjin、Tianjin Municipality、中国、300110
        • Tianjin First Central Hospital
        • コンタクト：
    • Yunnan
      • Kunming、Yunnan、中国、650032
        • The First Affiliated Hospital of Kunming Medical University
        • コンタクト：
    • Zhejiang
      • Jiaxing、Zhejiang、中国、314001
        • Jiaxing First Hospital
        • コンタクト：
      • Jinhua、Zhejiang、中国、321000
        • Jinhua Municipal Central Hospital
        • コンタクト：
      • Ningbo、Zhejiang、中国、315020
        • The first affiliated Hospital of Ningbo University
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

-

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：TQH3906 Capsules + Deucravacitinib tablets placebo
Double-blind phase: TQH3906 capsule 24 mg + deucravacitinib tablet placebo; Open-label extension phase: TQH3906 capsule 24 mg monotherapy.
薬：TQH3906 capsules
TQH3906 Capsules is an inhibitor that targets tyrosine kinase 2 (TYK2).
薬：Deucravacitinib tablets placebo
No pharmacologically active substance
アクティブコンパレータ：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.
薬：Deucravacitinib tablets 6 mg
Deucravacitinib tablet is an inhibitor that targets tyrosine kinase 2 (TYK2).
薬：TQH3906 Capsules placebo
No pharmacologically active substance
プラセボコンパレーター：TQH3906 Capsules placebo + Deucravacitinib tablets placebo
Double-blind phase: TQH3906 capsule placebo + Deucravacitinib tablet placebo; Open-label extension phase: TQH3906 capsule 24 mg monotherapy.
薬：Deucravacitinib tablets placebo
No pharmacologically active substance
薬：TQH3906 Capsules placebo
No pharmacologically active substance

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
static Physician's Global Assessment (sPGA)
時間枠：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)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
static Physician's Global Assessment (sPGA)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

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

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2027年9月1日

研究の完了 (推定)

2028年6月1日

試験登録日

最初に提出

2026年7月21日

QC基準を満たした最初の提出物

2026年7月21日

最初の投稿 (実際)

2026年7月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月24日

QC基準を満たした最後の更新が送信されました

2026年7月21日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • TQH3906-III-01

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

TQH3906 capsulesの臨床試験

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Mozambique

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

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