Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Program Consisting of a Phase 2b Trial and a Phase 3 Trial to Evaluate the Efficacy and Safety of TEV-53408 in Participants With Non-Segmental Vitiligo
The goal of these clinical trials is to learn if TEV-53408 can help adults with Non-Segmental Vitiligo (NSV). Vitiligo causes patches of skin to lose their color.
The main questions the trials aim to answer are:
Can TEV-53408 help bring color back to the skin on the face? Can TEV-53408 help bring color back to the skin on the body? What side effects may happen with TEV-53408?
TEV-53408 will be compared with placebo to see if it helps bring color back to the skin.
Participants will:
Receive TEV-53408 or placebo as an injection under the skin Have their skin checked during the trials Answer questions about how vitiligo affects their daily life Have blood tests and other health checks
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Teva U.S. Medical Information
- 전화번호: 1-888-483-8279
- 이메일: USMedInfo@tevapharm.com
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- The participant must have a diagnosis of Non-Segmental Vitiligo (NSV) for at least 3 months prior to screening. Participants of all skin types, as assessed by the Fitzpatrick scale, may be included.
- Stable or active NSV for at least 3 months prior to screening and the VASI scores: The participant has an F-VASI score ≥0.5 and a T-VASI score ≥5 and ≤60.
- A female participant is not pregnant or breastfeeding and agrees to refrain from donating oocytes throughout the duration of the trial.
- A male participant agrees to Refrain from donating sperm, EITHER abstains from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR agrees to use a male condom with female partner.
NOTE- Additional criteria may apply at screening for clinical trial participation.
Exclusion Criteria:
- The participant has autoimmune diseases for which systemic immunotherapy is or may be warranted including, but not limited to, rheumatoid arthritis, inflammatory bowel disease (Crohn's disease/ulcerative colitis), systemic lupus erythematosus, psoriasis, psoriatic arthritis, or multiple sclerosis. Conditions such as type 1 diabetes, stable hypothyroidism (Hashimoto's disease), and alopecia are not exclusionary.
- The participant has current or history of malignancy or treatment of malignancy in the last 5 years, excluding treated basal cell carcinoma.
- The participant has a body mass index outside the range of 18.5 to 40.0 kg/m2 (inclusive).
- The participant has an active infection(s) requiring treatment with intravenous (iv) anti-infectives (antibiotics, antivirals, antifungals) within 30 days prior to screening or oral anti-infectives (antibiotics, antivirals, antifungals) within 14 days prior to screening.
- The participant has a known genetic or acquired immune deficiency.
- The participant has a history of disseminated herpes simplex, multidermatomal, ophthalmic or recurrent herpes zoster, or herpes encephalitis.
- The participant has used skin bleaching treatments for past treatment of vitiligo or other pigmented areas. If necessary, the sponsor can be contacted for assessment of eligibility regarding history of prior vitiligo therapy and/or prior clinical trial experience.
- The participant has a history of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo.
- The participant has a history of chronic alcohol or substance abuse disorder within the previous 2 years.
NOTE- Additional criteria may apply at screening for clinical trial participation.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: 그룹 3: 위약
|
Injectable- Subcutaneous administration. |
|
실험적: Group 1: TEV-53408
|
Injectable- Subcutaneous administration. |
|
실험적: Group 2: TEV-53408
|
Injectable- Subcutaneous administration. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Trial 1: Proportion of Participants Achieving a ≥75% Reduction in Facial Vitiligo Area Scoring Index (F-VASI75)
기간: Baseline, Week 24
|
The F-VASI assesses the percentage of facial area affected by vitiligo. It ranges from 0 to 3.5, with 0 representing no vitiligo on the face and 3.5 representing complete depigmentation of the assessed facial areas. |
Baseline, Week 24
|
|
Trial 2: Proportion of Participants Achieving F-VASI75
기간: Baseline, Week 48
|
Baseline, Week 48
|
|
|
Trial 2: Proportion of Participants Achieving T-VASI50 (US Only)
기간: Baseline, Week 48
|
T-VASI is the sum for all body sites of the product of percentage of BSA affected multiplied by the degree of depigmentation. T-VASI ranges from 0 to 100, with 0 representing no vitiligo and 100 representing complete depigmentation of the entire body. |
Baseline, Week 48
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Trial 1: Proportion of Participants Achieving a ≥50% Reduction in Facial Vitiligo Area Scoring Index (F-VASI50)
기간: Baseline, Week 24
|
Baseline, Week 24
|
|
Trial 1: Proportion of Participants Achieving F-VASI75
기간: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 1: Proportion of Participants Achieving a ≥50% Reduction in Total Vitiligo Area Scoring Index (T-VASI50)
기간: Baseline, Week 24
|
Baseline, Week 24
|
|
Trial 1: Proportion of Participants Achieving T-VASI50
기간: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 1: Percent Change in Facial Vitiligo Area Scoring Index (F-VASI)
기간: Baseline, Week 24
|
Baseline, Week 24
|
|
Trial 1: Percent Change in F-VASI
기간: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 1: Percent Change in Total Vitiligo Area Scoring Index (T-VASI)
기간: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 1: Proportion of Participants Achieving a Vitiligo Noticeability Scale (VNS) score of "A lot less noticeable (4)" or "No longer noticeable (5)"
기간: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 1: Proportion of Participants Achieving (1) "Very much improved" or (2) "Much improved" on Patient Global Impression of Change -Vitiligo (PaGIC-V)
기간: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 1: Incidence of Treatment-Emergent Adverse Events (TEAEs)
기간: Week 88
|
Week 88
|
|
Trial 1: Incidence of Serious Adverse Events (SAEs)
기간: Week 88
|
Week 88
|
|
Trial 1: Incidence of Adverse Events (AEs) Leading to Discontinuation
기간: Week 88
|
Week 88
|
|
Trial 1: Incidence of Protocol-Defined AEs of Special Interest (PDAESIs)
기간: Week 88
|
Week 88
|
|
Trial 2: Proportion of Participants Achieving T-VASI50 (non-US only)
기간: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 2: Proportion of Participants Achieving F-VASI75
기간: Baseline, Week 24
|
Baseline, Week 24
|
|
Trial 2: Percent Change in Facial Vitiligo Area Scoring Index (F-VASI)
기간: Baseline, Week 24
|
Baseline, Week 24
|
|
Trial 2: Proportion of Participants Achieving F-VASI50
기간: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 2: Percent Change in F-VASI
기간: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 2: Percent Change in T-VASI
기간: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 2: Proportion of Participants Achieving a Vitiligo Noticeability Scale (VNS) score of "A lot less noticeable (4)" or "No longer noticeable (5)"
기간: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 2: Proportion of Participants Achieving (1) "Very much improved" or (2) "Much improved" on PaGIC-V
기간: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 2: Proportion of Participants Achieving a ≥90% Reduction in Facial Vitiligo Area Scoring Index (F-VASI90)
기간: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 2: Proportion of Participants Achieving a ≥75% Reduction in Total Vitiligo Area Scoring Index (T-VASI75)
기간: Baseline, Week 48
|
Baseline, Week 48
|
|
Trial 2: Incidence of Treatment-Emergent Adverse Events (TEAEs)
기간: Week 88
|
Week 88
|
|
Trial 2: Incidence of Serious Adverse Events (SAEs)
기간: Week 88
|
Week 88
|
|
Trial 2: Incidence of Adverse Events (AEs) Leading to Discontinuation
기간: Week 88
|
Week 88
|
|
Trial 2: Incidence of Protocol-Defined AEs of Special Interest (PDAESIs)
기간: Week 88
|
Week 88
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D LLC
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- TV53408-IMM-30105
- 2026-527760-32-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
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