NCT07431177

A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo

A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase IIb Study to Assess the Efficacy and Safety of GIA632 in Adult Participants With Non-segmental Vitiligo Followed by an Extension Period

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this multicenter, randomized, double-blind, placebo-controlled Phase 2b study is to investigate the safety and efficacy of GIA632 in participants with NSV and to identify the optimal dose to be promoted into the confirmatory Phase 3 program.

Detailed description

This trial in adult participants ≥ 18 years with non-segmental vitiligo (NSV) consists of a randomized, double-blind, placebo-controlled period to establish and characterize the dose-response relationship of GIA632 and estimate the targeted doses treatment effect compared with placebo, followed by the assessment of longer term safety and efficacy in extension period.

Conditions

• Non-segmental Vitiligo

Interventions

Type	Name	Description
DRUG	GIA632	GIA632 will be administered during the 48-week core period.
DRUG	Placebo	Placebo will be administered during the 48-week core period.

Timeline

• Start date: 2026-03-09
• Primary completion: 2028-06-23
• Completion: 2030-02-14
• First posted: 2026-02-24
• Last updated: 2026-04-06

Locations

10 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study