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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorNovartis Pharmaceuticals

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • GIA632
  • Placebo

Treatment groups

210 Participants
are divided into 5 treatment groups

Locations

33
Australia
Novartis Investigative Site2010, SydneyNew South Wales, Australia
Novartis Investigative Site2077, WaitaraNew South Wales, Australia
Novartis Investigative Site3000, MelbourneVictoria, Australia
Canada
Novartis Investigative SiteT2J 7E1, CalgaryAlberta, Canada

Sponsors and collaborators

Novartis Pharmaceuticals

Lead sponsor