Evaluation of AMG 714 for Vitiligo

NCT04338581 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: DAIT ITN086AINIAID CRMS ID#: 38677
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

Brief Summary

This study is designed to evaluate the efficacy of AMG 714 for the treatment of adult participants with vitiligo.

Conditions

Vitiligo

Keywords

efficacy; facial repigmentation; randomized placebo-controlled phase 2a trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 24

Study Arms (2)

AMG 714

EXPERIMENTAL

Participants will be administered 300 mg AMG 714 beginning at Week 0 and every 2 weeks thereafter through Week 10 (for a total of 6 doses). Each dose will be administered as 2 subcutaneous injections (1.5 mL each).

Biological: AMG 714; Procedure: nbUVB phototherapy

Placebo

PLACEBO COMPARATOR

Participants will be administered placebo as 2 subcutaneous injections (1.5 mL each) beginning at Week 0 and every 2 weeks thereafter through Week 10 (for a total of 6 doses).

Biological: Placebo; Procedure: nbUVB phototherapy

Interventions

AMG 714 BIOLOGICAL

anti-IL-15 monoclonal antibody (Anti-IL-15 MAB)

AMG 714

Placebo BIOLOGICAL

Placebo for AMG 714

Placebo

nbUVB phototherapy PROCEDURE

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.

Also known as: narrow band ultraviolet B phototherapy

AMG 714; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Individuals who meet any of the following criteria are not eligible for enrollment as study participants:
• Inability or unwillingness of a participant to give written informed consent or comply with the study protocol.
• Segmental vitiligo.
• Contraindication to nbUVB phototherapy.
• More than 33% leukotrichia on the face or on the total body.
• Use of biologic immunosuppressive or immunomodulatory agents, or investigational therapy or procedure within 12 weeks or 5 half-lives prior to Visit 0 (whichever is longer), except agents authorized for prevention and treatment of SARS-CoV-2 infection according to FDA Emergency Use Authorization (EUA).
• Use of laser or light-based treatment (phototherapy) including tanning beds within 8 weeks prior to Visit 0.
• Use of non-biologic systemic or topical immunosuppressive or immunomodulatory agents within 4 weeks prior to Visit 0.
• History of melanocyte-keratinocyte transplantation procedure (MKTP) or other surgical treatment for vitiligo.
• Current or past use of the depigmenting agent monobenzyl ether of hydroquinone, including Benoquin® (Monobenzone).
• Presence of skin conditions or lesions that would confound the vitiligo assessments.
• Spontaneous repigmentation within 6 months prior to Visit 0 (repigmentation without any treatment and significant in amount as determined by the investigator).
• Uncontrolled thyroid function at screening as determined by the investigator. If the participant has a history of thyroid disease and is on treatment, the participant must be on a stable thyroid regimen for at least three months prior to Visit 0.
• Greater than 3 adequately treated nonmetastatic basal cell carcinomas (BCC) or squamous cell carcinomas (SCC) within 12 months prior to Visit 0; or previous history of multiple BCC or SCC which may pose additional risks from participation in the study in the opinion of the investigator.
• Previous or current diagnosis of other cancer, except adequately treated cervical carcinoma in situ.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Amgen: collaborator
• Immune Tolerance Network (ITN): collaborator
• PPD Development, LP: collaborator
• Rho Federal Systems Division, Inc.: collaborator

Study Sites (7)

University of California, Irvine: Department of Dermatology

Irvine, California, 92697, United States

Location

University of California Davis Health System: Department of Dermatology

Sacramento, California, 95816, United States

Location

Yale University School of Medicine: Department of Dermatology

New Haven, Connecticut, 06520, United States

Location

Tufts Medical Center: Department of Dermatology

Boston, Massachusetts, 02111, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01605, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Northwell Health

Lake Success, New York, 11042, United States

Location

Related Links

• Immune Tolerance Network (ITN)
• Division of Allergy, Immunology, and Transplantation (DAIT)
• National Institute of Allergy and Infectious Diseases (NIAID)
• NIH health information: Vitiligo

MeSH Terms

Conditions

Vitiligo

Interventions

AMG-714

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Director, Clinical Research Operations Program
• Organization: DAIT/NIAID

DAITClinicalTrialsGov@niaid.nih.gov

301-594-7669

Study Officials

• Brett A. King, MD, PhD

  Yale University School of Medicine: Department of Dermatology

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Model Details: Phase 2a, double blind, placebo-controlled, multi-center, proof of concept trial of AMG 714 for the treatment of vitiligo. Participants will be randomized 2:1 to receive AMG 714 or placebo for AMG 714. Random assignment will be stratified by active versus stable vitiligo.

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 8, 2020
• Study Start: December 11, 2020
• Primary Completion: October 16, 2024
• Study Completion: April 2, 2025
• Last Updated: December 9, 2025
• Results First Posted: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: After completion of the trial, within 24 months status post database lock.
• Access Criteria: The Immunology Database and Analysis Portal (ImmPort) is an open access platform for research data sharing and a long-term archive of clinical and mechanistic data, a National Institute of Allergy and Infectious Diseases Division of Allergy, Immunology and Transplantation (NIAID DAIT)-funded data repository. This archive is in support of the NIH mission to share data with the public. Data shared through ImmPort is provided by NIH-funded programs, other research organizations and individual scientists, ensuring these discoveries will be the foundation of future research.

Locations

US (7)