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: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Cahaba Derm and skin hlth ctr 27
RECRUITING
Birmingham
California
Clinical Trials Research Institute
RECRUITING
Thousand Oaks
Florida
Miami Derm and Laser Institute
RECRUITING
Miami
Indiana
Dawes Fretzin Clinical Rea Group
RECRUITING
Indianapolis
Michigan
Revival Research Institute
RECRUITING
Troy
Texas
Austin Inst for Clinical Research
RECRUITING
Pflugerville
Other Locations
Australia
Novartis Investigative Site
RECRUITING
Sydney
Novartis Investigative Site
RECRUITING
Waitara
Canada
Novartis Investigative Site
RECRUITING
Mississauga
Novartis Investigative Site
RECRUITING
Toronto
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date:2026-03-09
Estimated Completion Date:2030-02-14
Participants
Target number of participants:210
Treatments
Experimental: GIA632 Arm 1
GIA632 will be administered during the 48-week core period.
Experimental: GIA632 Arm 2
GIA632 will be administered during the 48-week core period.
Experimental: GIA632 Arm 3
GIA632 will be administered during the 48-week core period.
Experimental: GIA632 Arm 4
GIA632 will be administered during the 48-week core period.
Placebo_comparator: Placebo
Placebo will be administered during the 48-week core period.