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

Sponsors and collaborators