This study is designed to evaluate the efficacy of AMG 714 for the treatment of adult participants with vitiligo.
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 * Evaluate the efficacy of AMG 714 followed by narrow band UVB (nbUVB) phototherapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
anti-IL-15 monoclonal antibody (Anti-IL-15 MAB)
Placebo for AMG 714
Participants will undergo narrow band ultraviolet B (nbUVB) phototherapy if their total body Vitiligo Area Scoring Index (T-VASI) does not improve by ≥ 25% at Week 24 compared to Week 0. Phototherapy will be administered in accordance with the Vitiligo Working Group expert recommendations.
University of California, Irvine: Department of Dermatology
Irvine, California, 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
Proportion of Participants Achieving a ≥ 35% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI35) at Week 24
An F-VASI35 responder is defined as a participant who has at least 35% improvement from Baseline in the facial vitiligo area scoring index (F-VASI). F-VASI assesses the area of the face affected by vitiligo. F-VASI is determined by the product of the percent of vitiligo involvement (percent of body surface area \[BSA\]) and the degree of depigmentation estimated to the nearest of the following percentages: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The percentage of BSA (hand or thumb unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator. F-VASI has a possible range from 0 to 3.5, with higher scores indicating more severe disease. Participants missing the F-VASI assessment at Week 24 are imputed as F-VASI35 non-responders.
Time frame: Week 24
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Tufts Medical Center: Department of Dermatology
Boston, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Northwell Health
Lake Success, New York, United States