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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
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522301-37-00
Enrollment
59
Registered
2026-06-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonsegmental vitiligo

Brief summary

Percentage change from baseline to Week 24 in F-VASI score.

Detailed description

Achievement of ≥75% improvement from baseline in the F-VASI (F-VASI75) at Week 24., Percentage change from baseline to Week 24 in T-VASI score., Achievement of ≥50% improvement from baseline in T-VASI (T-VASI50) at Week 24., Achievement of F-VASI50, F-VASI75, and F- VASI90 at Week 12, Week 24, Week 36, and Week 48., Achievement of T-VASI50, T-VASI75, and T- VASI90 at Weeks 12, Week 24, Week 36, and Week 48., Achievement of VNS of 4 or 5, at Week 12, Week 24, Week 36, and at Week 48., Occurrence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

Interventions

DRUGGIA632
DRUGPlacebo to GIA632

Sponsors

Novartis Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage change from baseline to Week 24 in F-VASI score.

Secondary

MeasureTime frame
Achievement of ≥75% improvement from baseline in the F-VASI (F-VASI75) at Week 24., Percentage change from baseline to Week 24 in T-VASI score., Achievement of ≥50% improvement from baseline in T-VASI (T-VASI50) at Week 24., Achievement of F-VASI50, F-VASI75, and F- VASI90 at Week 12, Week 24, Week 36, and Week 48., Achievement of T-VASI50, T-VASI75, and T- VASI90 at Weeks 12, Week 24, Week 36, and Week 48., Achievement of VNS of 4 or 5, at Week 12, Week 24, Week 36, and at Week 48., Occurrence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 11, 2026