A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT07431177
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- GIA632 — DRUGGIA632 will be administered during the 48-week core period.
- Placebo — DRUGPlacebo will be administered during the 48-week core period.
Study Details
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.
Key Dates
- First listed
- Feb 24, 2026
- Start date
- Mar 9, 2026
- Status verified
- Aug 2026
- Primary completion
- Jun 6, 2028
- Completion
- Jan 28, 2030
Study Design
- Enrollment
- 210 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: GIA632 Arm 1GIA632 will be administered during the 48-week core period.
- Experimental: GIA632 Arm 2GIA632 will be administered during the 48-week core period.
- Experimental: GIA632 Arm 3GIA632 will be administered during the 48-week core period.
- Experimental: GIA632 Arm 4GIA632 will be administered during the 48-week core period.
- Placebo Comparator: PlaceboPlacebo will be administered during the 48-week core period.
Primary Outcome Measure
Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) score. [ Time Frame: Baseline, Week 24 ]
Central Contacts
- Novartis Pharmaceuticals1-888-669-6682
- Novartis Pharmaceuticals+41613241111
Locations (21)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cahaba Derm and skin hlth ctr 27 | Birmingham | Alabama | 35244 | Vlada Groysman (PRINCIPAL_INVESTIGATOR) |
| First OC Dermatology | Fountain Valley | California | 92708 | Vivian Laquer (PRINCIPAL_INVESTIGATOR) |
| MedDerm Associates | San Diego | California | 92103 | Michelle Pelle (PRINCIPAL_INVESTIGATOR) |
| Clinical Trials Research Institute | Thousand Oaks | California | 91320 | Navid Ezra (PRINCIPAL_INVESTIGATOR) |
| Encore Medical Research | Hollywood | Florida | 33024 | Jerome Obed (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | Ashley Wentworth (PRINCIPAL_INVESTIGATOR) |
| Miami Derm and Laser Institute | Miami | Florida | 33173 | Jill Waibel (PRINCIPAL_INVESTIGATOR) |
| Global Clinical Professionals | St. Petersburg | Florida | 33714 | Wanda M Boote (PRINCIPAL_INVESTIGATOR) |
| Dawes Fretzin Clinical Rea Group | Indianapolis | Indiana | 46256 | Kenneth Dawes (PRINCIPAL_INVESTIGATOR) |
| Hamzavi Dermatology | Fort Gratiot | Michigan | 48059 | Iltefat Hamzavi (PRINCIPAL_INVESTIGATOR) |
| Revival Research Institute | Troy | Michigan | 48084 | Ali Moiin (PRINCIPAL_INVESTIGATOR) |
| Skin Specialists PC | Omaha | Nebraska | 68144 | Joel Schlessinger (PRINCIPAL_INVESTIGATOR) |
| Las Vegas Dermatology | Las Vegas | Nevada | 89144 | Harry Lawrence Greenberg (PRINCIPAL_INVESTIGATOR) |
| Equity Medical | The Bronx | New York | 10455 | Luana Cabreja Michael Cameron (PRINCIPAL_INVESTIGATOR) |
| Oregon Medical Research Center | Portland | Oregon | 97223 | Benjamin D Ehst (PRINCIPAL_INVESTIGATOR) |
| International Clinical Research Tennessee LCC | Murfreesboro | Tennessee | 37130 | Christina Feser (PRINCIPAL_INVESTIGATOR) |
| Bellaire Dermatology Associates | Bellaire | Texas | 77401 | Craig F Teller (PRINCIPAL_INVESTIGATOR) |
| Center for Clinical Studies | Houston | Texas | 77030 | Stephen K Tyring (PRINCIPAL_INVESTIGATOR) |
| Austin Inst for Clinical Research | Pflugerville | Texas | 78660 | Edward Lain (PRINCIPAL_INVESTIGATOR) |
| ACRC Trials | Plano | Texas | 75024 | Seemal Rohit Desai (PRINCIPAL_INVESTIGATOR) |
| Virginia Clinical Research | Norfolk | Virginia | 23507 | David M Pariser (PRINCIPAL_INVESTIGATOR) |
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