- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07765628
A Phase 2 Study of HS-20118 to Evaluate the Efficacy and Safety in Participant With Moderate-to-Severe Plaque Psoriasis
A Phase II Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of HS-20118 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Yong Cui
- 전화번호: 15701625913
- 이메일: Wuhucuiyong@vip.163.com
연구 연락처 백업
- 이름: Liming Wu
- 이메일: 18957118053@163.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Participants voluntarily agree to comply with all study procedures and scheduled follow-up assessments, and to cooperate with the collection of lesion photographs and other protocol-specified requirements;
- Diagnosis of plaque psoriasis, with or without PsA, established for at least 26 weeks prior to the first administration of study intervention. If previously diagnosed with psoriasis, participants must have a documented history of psoriasis for at least 26 weeks and must be confirmed by the investigator during screening to have plaque psoriasis;
- At screening and baseline, participants must be confirmed by the investigator to have stable moderate-to-severe plaque psoriasis, as defined by meeting all of the following four criteria:
1) No morphological changes or significant disease flares during the 4 weeks preceding screening, as assessed by the investigator; 2) BSA≥10%; 3) PASI≥12; 4) IGA≥3; 4. Be a candidate for phototherapy or systemic treatment for plaque psoriasis; 5. Participants must have no plans for pregnancy or sperm/egg donation during the study period. If of childbearing age, women must not be pregnant or breastfeeding, and must have a negative blood pregnancy test within 7 days before randomization. Participants and their partners must voluntarily use highly effective contraception during the study period and for at least 3 months after the last dose.
Exclusion Criteria:
- Known allergy, hypersensitivity, or intolerance to biologics, study drugs, or their excipients.
- Non-plaque psoriasis (e.g., guttate, erythrodermic, pustular, or drug-induced psoriasis) at screening or randomization.
- Other skin lesions or systemic autoimmune diseases (e.g., systemic lupus erythematosus, Sjögren's syndrome, scleroderma) that may affect the safety and efficacy assessment of the study drug.
- Other skin lesions or systemic autoimmune diseases (e.g., systemic lupus erythematosus, Sjögren's syndrome, scleroderma) that may affect the safety and efficacy assessment of the study drug.
- Severe, progressive, or poorly controlled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, hematologic, rheumatologic, psychiatric, or metabolic disorders; or current signs or symptoms related to these conditions.
- History of malignancy within 5 years before screening (except for adequately treated skin basal cell carcinoma, in situ skin cancer, or in situ cervical cancer with no recurrence for at least 12 weeks before the first dose).
- History of lymphoproliferative disorders (e.g., lymphoma), unexplained monoclonal gammopathy, or signs and symptoms suggestive of lymphoproliferative disorders (e.g., splenomegaly or severe lymphadenopathy).
- Any other condition deemed by the investigator as unsuitable for participation in the clinical study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: 위약
|
Administered orally, once weekly (QW)
|
|
실험적: HS-20118 dose 1
|
Administered orally, once weekly (QW)
|
|
실험적: HS-20118 dose 2
|
Administered orally, once weekly (QW)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of participants achieving PASI 75 (≥75% improvement from baseline in PASI) at Week 16
기간: 16 weeks
|
Percentage of participants achieving PASI 75 response (>=75% improvement in PASI from baseline) at Week 16 will be reported.
The PASI is a system for assessing/grading psoriatic lesion severity and treatment response.
It divides the body into 4 regions (head, trunk, upper extremities, lower extremities), with each region separately scored for erythema, induration, scaling (0-4 scale each) and involvement extent (0-6 scale).
PASI yields a 0-72 numeric score, where higher scores mean more severe disease.
|
16 weeks
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- HS-20118-201
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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