CompletedPhase 2

Evaluation of AMG 714 for Vitiligo

United States60 participantsStarted 2020-12-11

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. 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.

Proportion of Participants Achieving a ≥ 35% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI35) at Week 24

Timeframe: Week 24

NCT IDNCT04338581

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2024-10-16

Results submitted2025-10-16