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Recruiting NCT07431177

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

Phase II Interventional Non-segmental Vitiligo

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GIA632, Placebo.
Who it may be relevant to
Registry conditions: Non-segmental Vitiligo. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Canada, China, France +6
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug GIA632
    GIA632 will be administered during the 48-week core period.
  • Drug Placebo
    Placebo will be administered during the 48-week core period.

Primary outcome measures

  • Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) score. [Time frame: Baseline, Week 24]
Secondary outcome measures (6)
  • Achievement of ≥75% improvement from baseline in the F-VASI (F-VASI75) [Time frame: Baseline, Week 24]
  • Percentage change from baseline in Total body Vitiligo Area Scoring Index (T-VASI) score. [Time frame: Baseline, Week 24]
  • Achievement of ≥50% improvement from baseline in T-VASI (T-VASI50) [Time frame: Baseline, Week 24]
  • Achievement of F-VASI50, F-VASI75, and FVASI90 [Time frame: Baseline, Week 12, Week 24, Week 36, and Week 48]
  • Achievement of T-VASI50, T-VASI75, and TVASI90 [Time frame: Baseline, Week 12, Week 24, Week 36, and Week 48.]
  • Achievement of Vitiligo Noticeability Scale Score (VNS) of 4 or 5 [Time frame: Week 12, Week 24, Week 36, and at Week 48.]

Eligibility criteria

Inclusion criteria

  • Signed informed consent must be obtained prior to participation in the study
  • Male or female as assigned at birth ≥ 18 years of age at the time of screening
  • Individuals with a diagnosis of non-segmental vitiligo and confirmation of diagnosis through physical examination by the investigator
  • Non-segmental vitiligo, as assessed at screening, as
  • ≥ 0.5% Body Surface Area (BSA) on the face and F-VASI score ≥ 0.5
  • ≥ 3% BSA on non-facial areas (minimum of 3% should be calculated in addition to hands and feet) and T-VASI score = 3 to 60

Exclusion criteria

  • Individuals unable or unwilling to follow the study procedures and/or to complete the study-related questionnaires
  • Presence of segmental or mixed vitiligo, or other skin comorbidities that may interfere with study assessments (e.g., hypopigmented mycosis fungoides, genetic diseases with pigmentary aberrations \[such as piebaldism, Waardenburg, etc.\], chemical- or druginduced leukoderma, etc.)
  • Previous exposure to biologic drugs directly targeting IL-15 or IL-15 receptors
  • Individual who previously attempted or completed depigmentation therapy for NSV
  • Use of prohibited medication \& treatments. Other protocol-defined inclusion/exclusion criteria may apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 21 centers
  • Cahaba Derm and skin hlth ctr 27 — Birmingham
  • First OC Dermatology — Fountain Valley
  • MedDerm Associates — San Diego
  • Clinical Trials Research Institute — Thousand Oaks
  • Encore Medical Research — Hollywood
  • Mayo Clinic Jacksonville — Jacksonville
  • Miami Derm and Laser Institute — Miami
  • Global Clinical Professionals — St. Petersburg
  • … and 13 more centers
Canada · 6 centers
  • Novartis Investigative Site — Calgary
  • Novartis Investigative Site — Winnipeg
  • Novartis Investigative Site — Mississauga
  • Novartis Investigative Site — Newmarket
  • Novartis Investigative Site — Toronto
  • Novartis Investigative Site — Québec
India · 5 centers
  • Novartis Investigative Site — Ahmedabad
  • Novartis Investigative Site — Bangalore
  • Novartis Investigative Site — Belagavi
  • Novartis Investigative Site — Mysore
  • Novartis Investigative Site — Nashik
Germany · 4 centers
  • Novartis Investigative Site — Munich
  • Novartis Investigative Site — Bad Bentheim
  • Novartis Investigative Site — Hamburg
  • Novartis Investigative Site — Münster
Australia · 3 centers
  • Novartis Investigative Site — Sydney
  • Novartis Investigative Site — Waitara
  • Novartis Investigative Site — Melbourne
France · 3 centers
  • Novartis Investigative Site — Brest
  • Novartis Investigative Site — Rouen
  • Novartis Investigative Site — Toulouse
Japan · 3 centers
  • Novartis Investigative Site — Urayasu
  • Novartis Investigative Site — Kofu
  • Novartis Investigative Site — Niigata
China · 2 centers
  • Novartis Investigative Site — Beijing
  • Novartis Investigative Site — Shanghai
Italy · 2 centers
  • Novartis Investigative Site — Ancona
  • Novartis Investigative Site — Rozzano
Netherlands · 2 centers
  • Novartis Investigative Site — Amsterdam
  • Novartis Investigative Site — Rotterdam
Spain · 1 center
  • Novartis Investigative Site — Barcelona

Identifiers

NCT: NCT07431177 · CGIA632B12201 · 2025-522301-37-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗