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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Phase IIb Study to Assess the Efficacy and Safety of GIA632 in Adults With Non-Segmental Vitiligo Followed by an Extension Period
Led by Novartis Pharmaceuticals · Updated on 2026-06-05
210
Participants Needed
28
Research Sites
85 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of GIA632 in adults aged 18 years and older with non-segmental vitiligo (NSV). This Phase 2b, multicenter, randomized, double-blind, placebo-controlled study aims to identify the optimal dose of GIA632 for further testing in a Phase 3 program. The study focuses on assessing how GIA632 affects vitiligo by comparing various doses against a placebo. Participants will receive GIA632 or a placebo during a 48-week core treatment period. The study includes multiple groups receiving different doses of GIA632, each administered over the same time frame. After the core period, an extension phase will assess the longer-term safety and effectiveness of the treatment. Throughout the study, participants will undergo regular assessments, including measurements of vitiligo severity using the Facial Vitiligo Area Scoring Index (F-VASI) and Total body Vitiligo Area Scoring Index (T-VASI) at baseline and multiple intervals up to week 48. Researchers will also evaluate improvements using the Vitiligo Noticeability Scale. Safety and efficacy will be monitored during and after treatment, with the total participation lasting at least 48 weeks during the core and extension periods.
CONDITIONS
Brief Title
A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent prior to participation
- Male or female as assigned at birth, aged 18 years or older at screening
- Diagnosed with non-segmental vitiligo confirmed by physical examination
- At least 0.5% body surface area affected on the face and an F-VASI score of 0.5 or higher
- At least 3% body surface area affected on non-facial areas (excluding hands and feet) with a T-VASI score between 3 and 60
You will not qualify if you...
- Unable or unwilling to follow study procedures or complete study questionnaires
- Presence of segmental or mixed vitiligo, or other skin conditions that interfere with assessments
- Previous use of biologic drugs targeting IL-15 or IL-15 receptors
- Previous attempt or completion of depigmentation therapy for non-segmental vitiligo
- Use of prohibited medications or treatments as defined by the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 weeks
Participants receive GIA632 or placebo during the 48-week core treatment period to assess efficacy and safety.
Multiple visits including baseline and follow-up visits at Week 12, Week 24, Week 36, and Week 48
Duration - Duration not specified
Participants continue to be assessed for longer term safety and efficacy after the core treatment period.
Visit schedule varies during the extension period
Trial Site Locations
Total: 28 locations
1
Cahaba Derm and skin hlth ctr 27
Birmingham, Alabama, United States, 35244
Actively Recruiting
2
MedDerm Associates
San Diego, California, United States, 92103
Actively Recruiting
3
Clinical Trials Research Institute
Thousand Oaks, California, United States, 91320
Actively Recruiting
4
Encore Medical Research
Hollywood, Florida, United States, 33024
Actively Recruiting
5
Miami Derm and Laser Institute
Miami, Florida, United States, 33173
Actively Recruiting
6
Global Clinical Professionals
St. Petersburg, Florida, United States, 33714
Actively Recruiting
7
Dawes Fretzin Clinical Rea Group
Indianapolis, Indiana, United States, 46256
Actively Recruiting
8
Hamzavi Dermatology
Fort Gratiot, Michigan, United States, 48059
Actively Recruiting
9
Revival Research Institute
Troy, Michigan, United States, 48084
Actively Recruiting
10
Skin Specialists PC
Omaha, Nebraska, United States, 68144
Actively Recruiting
11
Las Vegas Dermatology
Las Vegas, Nevada, United States, 89144
Actively Recruiting
12
Equity Medical
The Bronx, New York, United States, 10455
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13
Oregon Medical Research Center
Portland, Oregon, United States, 97223
Actively Recruiting
14
International Clinical Research Tennessee LCC
Murfreesboro, Tennessee, United States, 37130
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15
Center for Clinical Studies
Houston, Texas, United States, 77030
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16
Austin Inst for Clinical Research
Pflugerville, Texas, United States, 78660
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17
ACRC Trials
Plano, Texas, United States, 75024
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18
Virginia Clinical Research
Norfolk, Virginia, United States, 23507
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19
Novartis Investigative Site
Sydney, New South Wales, Australia, 2010
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20
Novartis Investigative Site
Waitara, New South Wales, Australia, 2077
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21
Novartis Investigative Site
Melbourne, Victoria, Australia, 3000
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22
Novartis Investigative Site
Mississauga, Ontario, Canada, L4Y 4C5
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23
Novartis Investigative Site
Newmarket, Ontario, Canada, L3Y 5G8
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24
Novartis Investigative Site
Toronto, Ontario, Canada, M3H 5Y8
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25
Novartis Investigative Site
Québec, Quebec, Canada, G1V 4X7
Actively Recruiting
26
Novartis Investigative Site
Shanghai, China, 200040
Actively Recruiting
27
Novartis Investigative Site
Urayasu, Chiba, Japan, 279-0021
Actively Recruiting
28
Novartis Investigative Site
Kofu, Yamanashi, Japan, 400-8506
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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