NCT04338581

Evaluation of AMG 714 for Vitiligo

Evaluation of AMG 714 for Vitiligo: A Phase 2a Randomized Double Blind Placebo Controlled Trial (ITN086AI)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 * Evaluate the efficacy of AMG 714 followed by narrow band UVB (nbUVB) phototherapy

Conditions

• Vitiligo

Interventions

Type	Name	Description
BIOLOGICAL	AMG 714	anti-IL-15 monoclonal antibody (Anti-IL-15 MAB)
BIOLOGICAL	Placebo	Placebo for AMG 714
PROCEDURE	nbUVB phototherapy	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.

Timeline

• Start date: 2020-12-11
• Primary completion: 2024-10-16
• Completion: 2025-04-02
• First posted: 2020-04-08
• Last updated: 2025-12-09
• Results posted: 2025-11-17

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study