Evaluation of AMG 714 for Vitiligo
- Conditions
- Vitiligo
- Interventions
- Biological: AMG 714Biological: PlaceboProcedure: nbUVB phototherapy
- Registration Number
- NCT04338581
- Brief Summary
This study is designed to evaluate the efficacy of AMG 714 for the treatment of adult participants with vitiligo.
- Detailed Description
The primary objective of this trial is to determine the efficacy of interleukin-15 (IL-15) inhibition with AMG 714 at inducing facial repigmentation in vitiligo.
The secondary objectives are to:
-Evaluate the safety and tolerability of AMG 714 in vitiligo- -Determine the efficacy of IL-15 inhibition with AMG 714 at inducing total body skin repigmentation in vitiligo-
* Assess the durability of the skin repigmentation achieved by AMG 714 in vitiligo, and
* Evaluate the efficacy of AMG 714 followed by narrow band UVB (nbUVB) phototherapy.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 57
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AMG 714 AMG 714 Participants will be administered 300 mg AMG 714 subcutaneously on Day 0 and every 2 weeks thereafter through week 10 (for a total of 6 doses). Placebo nbUVB phototherapy Participants will be administered 300 mg AMG 714 subcutaneously on Day 0 and every 2 weeks thereafter through week 10 (for a total of 6 doses). AMG 714 nbUVB phototherapy Participants will be administered 300 mg AMG 714 subcutaneously on Day 0 and every 2 weeks thereafter through week 10 (for a total of 6 doses). Placebo Placebo Participants will be administered 300 mg AMG 714 subcutaneously on Day 0 and every 2 weeks thereafter through week 10 (for a total of 6 doses).
- Primary Outcome Measures
Name Time Method Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥35 (F-VASI35) at Week 24 Week 24 ≥35% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.
- Secondary Outcome Measures
Name Time Method Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥90 (F-VASI90) at Week 12, Week 24, Week 36 and Week 48 Week 12, Week 24, Week 36, Week 48 ≥90% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥35 (F-VASI35) at Week 12, Week 36, Week 48 Week 12, Week 36, Week 48 ≥35% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥25 (F-VASI25) at Week 12, Week 24, Week 36 and Week 48 Week 12, Week 24, Week 36, Week 48 ≥25% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥50 (F-VASI50) at Week 12, Week 24, Week 36 and Week 48 Week 12, Week 24, Week 36, Week 48 ≥50% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.
Proportion of Participants Achieving Face Vitiligo Area Scoring Index ≥75 (F-VASI75) at Week 12, Week 24, Week 36 and Week 48 Week 12, Week 24, Week 36, Week 48 ≥75% improvement from Baseline (Day 0) in Face Vitiligo Area Scoring Index (F-VASI) score.
Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥25 (T-VASI25) at Week 12, Week 24, Week 36 and Week 48 Week 12, Week 24, Week 36, Week 48 ≥ 25% improvement from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI)
Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥35 (T-VASI35) at Week 12, Week 24, Week 36 and Week 48 Week 12, Week 24, Week 36, Week 48 ≥ 35% improvement from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI)
Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥50 (T-VASI50) at Week 12, Week 24, Week 36 and Week 48 Week 12, Week 24, Week 36, Week 48 ≥ 50% improvement from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI)
Change from Baseline (Day 0) in the Vitiligo Noticeability Scale (VNS) at Week 12, Week 24, Week 36, and Week 48 Week 12, Week 24, Week 36, and Week 48 The Vitiligo Noticeability Scale (VNS) is a validated patient-reported outcome measure of vitiligo treatment.
Participants will be shown a pre-treatment photograph of their face and asked to answer the question, "Compared with before treatment, how noticeable is the vitiligo now?" There are five Response Options (Score). Success criteria are pre-defined.Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥75 (T-VASI75) at Week 12, Week 24, Week 36 and Week 48 Week 12, Week 24, Week 36, Week 48 ≥ 75% improvement from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI)
Change from Baseline (Day 0) in Vitiligo Extent Score (VES) at Week 12, Week 24, Week 36, and Week 48 Week 12, Week 24, Week 36, and Week 48 The Vitiligo Extent Score (VES) is a measurement of the overall vitiligo involvement of the body (extent) and is used by clinicians for the assessment of disease activity. Methodology: Using the VES calculator ( www.vitiligo-calculator.com) , the clinician chooses the pictures that best represent the participant's skin lesions, then the percentage of depigmented area is calculated.
Change from Baseline (Day 0) in the Vitiligo Quality of Life (VitiQoL) at Week 12, Week 24, Week 36, and Week 48 Week 12, Week 24, Week 36, and Week 48 The Vitiligo Quality of Life instrument (VitiQoL) is a validated instrument comprised of sixteen questions on a 7 point Likert scale that asks participants to rate aspects of their vitiligo during the past month (Range for each question: An answer of "Not at all" to "All of the Time.").
Proportion of Participants Achieving total body Vitiligo Area Scoring Index ≥90 (T-VASI90) at Week 12, Week 24, Week 36 and Week 48 Week 12, Week 24, Week 36, Week 48 ≥ 90% improvement from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI)
Change from Baseline in Face Vitiligo Area Scoring Index (F-VASI) at Week 12, Week 24, Week 36, and Week 48 Week 12, Week 24, Week 36, and Week 48 The Face Vitiligo Area Scoring Index (F-VASI) measures the amount of depigmented vitiligo skin expressed as a percentage of the total area of skin on the face (100%), measured by a clinician using the palmar method.
Occurrence of ≥ Grade 2 Adverse Events (AEs) Up to Week 48 Includes all ≥ Grade 2 untoward or unfavorable medical occurrence(s) associated with investigational product administration and/ or any study mandated procedures.
Change from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI) at Week 12, Week 24, Week 36, and Week 48 Week 12, Week 24, Week 36, and Week 48 The total body Vitiligo Area Scoring Index (T-VASI) is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities \[excluding hands\], trunk, lower extremities \[excluding feet\], and feet). Assessments are conducted by a clinician.
Percentage Change from Baseline in Face Vitiligo Area Scoring Index (F-VASI) at Week 12, Week 24, Week 36, and Week 48 Week 12, Week 24, Week 36, and Week 48 The Face Vitiligo Area Scoring Index (F-VASI) measures the percentage of depigmented vitiligo skin expressed as a percentage of the total area of skin on the face (100%), measured by a clinician using the palmar method.
Percentage Change from Baseline (Day 0) in total body Vitiligo Area Scoring Index (T-VASI) at Week 12, Week 24, Week 36, and Week 48 Week 12, Week 24, Week 36, and Week 48 The total body Vitiligo Area Scoring Index (T-VASI) is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities \[excluding hands\], trunk, lower extremities \[excluding feet\], and feet). Assessments are conducted by a clinician.
Occurrence of ≥ Grade 3 Infectious Adverse Events (AEs) Up to Week 48 Includes all ≥ Grade 3 infectious untoward or unfavorable medical occurrence(s).
Trial Locations
- Locations (8)
University of California, Irvine: Department of Dermatology
🇺🇸Irvine, California, United States
Tufts Medical Center: Department of Dermatology
🇺🇸Boston, Massachusetts, United States
Perelman School of Medicine, University of Pennsylvania: Department of Dermatology
🇺🇸Philadelphia, Pennsylvania, United States
Northwell Health
🇺🇸Lake Success, New York, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
University of California Davis Health System: Department of Dermatology
🇺🇸Sacramento, California, United States
Yale University School of Medicine: Department of Dermatology
🇺🇸New Haven, Connecticut, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States