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

2026년 7월 21일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

400

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

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아니

설명

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.

-

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: TQH3906 Capsules + Deucravacitinib tablets placebo
Double-blind phase: TQH3906 capsule 24 mg + deucravacitinib tablet placebo; Open-label extension phase: TQH3906 capsule 24 mg monotherapy.
의약품: TQH3906 capsules
TQH3906 Capsules is an inhibitor that targets tyrosine kinase 2 (TYK2).
의약품: Deucravacitinib tablets placebo
No pharmacologically active substance
활성 비교기: 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.
의약품: Deucravacitinib tablets 6 mg
Deucravacitinib tablet is an inhibitor that targets tyrosine kinase 2 (TYK2).
의약품: TQH3906 Capsules placebo
No pharmacologically active substance
위약 비교기: TQH3906 Capsules placebo + Deucravacitinib tablets placebo
Double-blind phase: TQH3906 capsule placebo + Deucravacitinib tablet placebo; Open-label extension phase: TQH3906 capsule 24 mg monotherapy.
의약품: Deucravacitinib tablets placebo
No pharmacologically active substance
의약품: TQH3906 Capsules placebo
No pharmacologically active substance

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
static Physician's Global Assessment (sPGA)
기간: 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)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
static Physician's Global Assessment (sPGA)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2027년 9월 1일

연구 완료 (추정된)

2028년 6월 1일

연구 등록 날짜

최초 제출

2026년 7월 21일

QC 기준을 충족하는 최초 제출

2026년 7월 21일

처음 게시됨 (실제)

2026년 7월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 21일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TQH3906-III-01

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

TQH3906 capsules에 대한 임상 시험

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