A Study to Assess the Efficacy and Safety of GIA632 Across a Range of Doses in Participants With Moderate to Severe Cutaneous Lichen Planus
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT07775924
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Cutaneous Lichen Planus
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- Placebo — DRUGMatching placebo
- GIA632 — DRUGGIA632 administered according to the assigned study treatment regimen.
Study Details
This study will evaluate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP).
Key Dates
- First listed
- Aug 20, 2026
- Start date
- Sep 10, 2026
- Status verified
- Aug 2026
- Primary completion
- Nov 22, 2028
- Completion
- Feb 13, 2030
Study Design
- Enrollment
- 259 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: PlaceboParticipants will receive matching placebo according to the treatment regimen assigned at randomization during the study treatment period.
- Experimental: GIA632 - Treatment regimen 1Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
- Experimental: GIA632 - Treatment regimen 2Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
- Experimental: GIA632 - Treatment regimen 3Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
- Experimental: GIA632 - Treatment regimen 4Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
Primary Outcome Measure
Number of participants achieving an Investigator Global Assessment (IGA) response [ Time Frame: Week 16 ]
Central Contacts
- Novartis Pharmaceuticals1-888-669-6682
- Novartis Pharmaceuticals+41613241111
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cahaba Derm and skin hlth ctr 27 | Birmingham | Alabama | 35244 | Vlada Groysman (PRINCIPAL_INVESTIGATOR) |
| Dawes Fretzin Clinical Rea Group | Indianapolis | Indiana | 46256 | Kenneth Dawes (PRINCIPAL_INVESTIGATOR) |