A Study to Assess the Efficacy and Safety of GIA632 Across a Range of Doses in Participants With Moderate to Severe Cutaneous Lichen Planus
A Phase IIb Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-range Study to Assess the Efficacy and Safety of GIA632 in Participants With Moderate to Severe Cutaneous Lichen Planus, Followed by an Extension Period
- Cutaneous Lichen Planus
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Novartis Pharmaceuticals
- Enrolment target
- 259
- Started
- 10 September 2026
- Main results due
- 22 November 2028
- Study sites
- 18
- Registry updated
- 25 September 2026
Can you take part?
- Ages 18 years to 99 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
This study will evaluate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP).
Study sites(18)
Cahaba Derm and skin hlth ctr 27
Birmingham, Alabama, United States
Recruiting
First OC Dermatology
Fountain Valley, California, United States
Recruiting
Miami Derm and Laser Institute
Miami, Florida, United States
Recruiting
Global Clinical Professionals
St. Petersburg, Florida, United States
Recruiting
Skin Care Physicians Of Georgia
Macon, Georgia, United States
Recruiting
Dawes Fretzin Clinical Rea Group
Indianapolis, Indiana, United States
Recruiting
Essential Medical Research
Overland Park, Kansas, United States
Recruiting
Louisiana Dermatology Associates
Baton Rouge, Louisiana, United States
Recruiting
Delricht Research
New Orleans, Louisiana, United States
Recruiting
Uni Of Michigan Health System
Ann Arbor, Michigan, United States
Recruiting
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
Recruiting
Skin Specialists PC
Omaha, Nebraska, United States
Recruiting
NextGen Clinical Research and Innovation Inc-Network
Mansfield, Texas, United States
Recruiting
Austin Inst for Clinical Research
Pflugerville, Texas, United States
Recruiting
RFSA Dermatology
San Antonio, Texas, United States
Recruiting
Novartis Investigative Site
Sydney, New South Wales, Australia
Recruiting
Novartis Investigative Site
Waitara, New South Wales, Australia
Recruiting
Novartis Investigative Site
Melbourne, Victoria, Australia
Recruiting
Showing 18 of 18 sites. 18 of the 18 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07775924. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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