A Study to Assess the Efficacy and Safety of GIA632 Across a Range of Doses in Participants With Moderate to Severe Cutaneous Lichen Planus

Purpose

This study will evaluate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP).

Condition

  • Cutaneous Lichen Planus

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Male or female (as assigned at birth) participants ≥ 18 years of age at the time of screening. - Individuals with a diagnosis of cLP, confirmed - histologically by a skin biopsy (either historically within 1 year prior to screening or at screening if historical one not available), and - by physical examination by the investigator at screening. - Moderate to severe cLP - Two or more body regions affected (any two or more of the following: head and neck, trunk, upper extremities including hands, lower extremities including feet). - Diagnosis of cLP inadequately controlled by at least one topical treatment for at least 3 months (either via continuous use or burst and taper regimen), or such treatment being considered not advisable, as per investigator judgement, assessed at screening. Topical treatment includes, but is not limited to, topical corticosteroids, topical calcineurin inhibitors, topical cholecalciferol analogues, topical PDE4 inhibitors, topical JAK inhibitors, and topical aryl hydrocarbon receptor agonists.

Exclusion Criteria

  • Individuals unable or unwilling to follow the study procedures, handle the electronic diary (eDiary), and/or to complete the study-related questionnaires. - Diagnosis of drug-induced lichen planus (lichenoid drug eruption) or lichen planus pigmentosus. - Presence of skin conditions that may interfere with study assessments, including histologic findings in the biopsy, as assessed at screening and baseline. - Previous exposure to biologic drugs directly targeting IL-15 or any subunit of the IL-15 receptor. - Use of prohibited medication and treatments. Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

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

Recruiting Locations

Cahaba Derm and skin hlth ctr 27
Birmingham, Alabama 35244
Contact:
Wes Booth
+1 205 778 1564
wbooth@cahabaderm.com

Dawes Fretzin Clinical Rea Group
Indianapolis, Indiana 46256
Contact:
Megan Kirchner
+1 317 516 5030#102
mkirchner@ecommunity.com

Delricht Research
New Orleans, Louisiana 70115
Contact:
Emily Krambeck
+1 504 336 2667
ekrambeck@delricht.com

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Detailed Description

The main purpose of this study is to investigate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP) across a range of dosing regimens and to identify the optimal dosing regimen to be promoted into the confirmatory Phase 3 program. This study consists of a screening period (up to 4 weeks), a core treatment period (16 weeks double-blind), an extension period (52 weeks), and a safety follow-up period (12 weeks).