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 — DRUG
    Matching placebo
  • GIA632 — DRUG
    GIA632 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: Placebo
    Participants will receive matching placebo according to the treatment regimen assigned at randomization during the study treatment period.
  • Experimental: GIA632 - Treatment regimen 1
    Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
  • Experimental: GIA632 - Treatment regimen 2
    Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
  • Experimental: GIA632 - Treatment regimen 3
    Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
  • Experimental: GIA632 - Treatment regimen 4
    Participants 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

Locations (2)

FacilityCityStateZIPSite coordinators
Cahaba Derm and skin hlth ctr 27BirminghamAlabama35244
Wes Booth
+1 205 778 1564
Vlada Groysman (PRINCIPAL_INVESTIGATOR)
Dawes Fretzin Clinical Rea GroupIndianapolisIndiana46256
Megan Kirchner
+1 317 516 5030#102
Kenneth Dawes (PRINCIPAL_INVESTIGATOR)

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