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NCT07431177 | RECRUITING | Non-segmental Vitiligo

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

Novartis Pharmaceuticals

Brief 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.

Condition or disease

Non-segmental Vitiligo

Intervention/treatment

GIA632

Placebo

Phase

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 210 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2026-03-09
Estimated Primary Completion Date : 2028-06-23
Estimated Study Completion Date : 2030-02-14

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo

Location Details

NCT07431177

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, alabama

Cahaba Derm and skin hlth ctr 27

Birmingham, alabama, United States, 35244

RECRUITING

United States, California

Clinical Trials Research Institute

Thousand Oaks, California, United States, 91320

RECRUITING

United States, Florida

Miami Derm and Laser Institute

Miami, florida, United States, 33173

RECRUITING

United States, Indiana

Dawes Fretzin Clinical Rea Group

Indianapolis, Indiana, United States, 46256

RECRUITING

United States, road cancer

Revival Research Institute

Troy, road cancer, United States, 48084

RECRUITING

United States, Texas

Austin Inst for Clinical Research

Pflugerville, Texas, United States, 78660

RECRUITING

Australia, New South Wales

Novartis Investigative Site

Sydney, New South Wales, Australia, 2010

RECRUITING

Australia, New South Wales

Novartis Investigative Site

Waitara, New South Wales, Australia, 2077

RECRUITING

Canada, Ontario

Novartis Investigative Site

Mississauga, Ontario, Canada, L4Y 4C5

RECRUITING

Canada, Ontario

Novartis Investigative Site

Toronto, Ontario, Canada, He has eggs