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NCT07775924PHASE2Recruiting

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

Novartis Pharmaceuticals

Start Date

9/29/2026

Completion Date

2/13/2030

Summary

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

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).

Eligibility Criteria

Age Range: 18 years to 99 years

Key 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. Key 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.

Interventions

DRUG

Placebo

DRUG

GIA632

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Conditions

Cutaneous Lichen Planus

Locations

Cahaba Derm and skin hlth ctr 27

Birmingham, Alabama 35244

United States

First OC Dermatology

Fountain Valley, California 92708

United States

Miami Derm and Laser Institute

Miami, Florida 33173

United States

Global Clinical Professionals

St. Petersburg, Florida 33714

United States

Skin Care Physicians Of Georgia

Macon, Georgia 31217

United States

Dawes Fretzin Clinical Rea Group

Indianapolis, Indiana 46256

United States

Essential Medical Research

Overland Park, Kansas 66213

United States

Louisiana Dermatology Associates

Baton Rouge, Louisiana 70809

United States

Delricht Research

New Orleans, Louisiana 70115

United States

Uni Of Michigan Health System

Ann Arbor, Michigan 48109

United States

Hamzavi Dermatology

Fort Gratiot, Michigan 48059

United States

Skin Specialists PC

Omaha, Nebraska 68144

United States

NextGen Clinical Research and Innovation Inc-Network

Mansfield, Texas 76063

United States

Austin Inst for Clinical Research

Pflugerville, Texas 78660

United States

RFSA Dermatology

San Antonio, Texas 78213

United States

Novartis Investigative Site

Sydney, New South Wales 2010

Australia

Novartis Investigative Site

Waitara, New South Wales 2077

Australia

Novartis Investigative Site

Melbourne, Victoria 3000

Australia

Novartis Investigative Site

London, Ontario N6H 5L5

Canada

Novartis Investigative Site

Toronto, Ontario M5A 3R6

Canada

Novartis Investigative Site

Shanghai, 200040

China