Evaluation of AMG 714 for Vitiligo

Completed · Phase 2 · Has a placebo group

Conditions studied: Vitiligo

In brief

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

Key facts

Study ID

NCT04338581

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

60

Starts

2020-12-11

Expected to finish

2025-04-02

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.
• Acute or chronic infection, including current use of suppressive therapy for chronic infection, hospitalization for treatment of infection within 90 days prior to Visit 0, or parenteral anti-microbial (including anti-bacterial, anti-viral, or anti-fungal agents) use within 90 days prior to Visit 0.
• Evidence of infection, including:
• Human immunodeficiency virus (HIV)
• Current or prior infection with hepatitis B (HBV), as indicated by positive HBsAg or positive HBcAb
• Current or prior hepatitis C (HCV), unless treated with anti-viral therapy with achievement of a sustained virologic response (undetectable viral load 12 weeks after cessation of therapy)
• Positive Quantiferon-TB Gold or Quantiferon-TB Gold Plus test. PPD or T-SPOT.TB test may be substituted for Quantiferon-TB Gold or Quantiferon-TB Gold Plus test
• Any of the following laboratory abnormalities:
• White blood count (WBC) < 3.5 x 10\^3/μL
• Hemoglobin < 10 g/dL
• Platelets (Plt) < 125,000/mm\^3

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.