NCT07775924 A Study to Assess the Efficacy and Safety of GIA632 Across a Range of Doses in Participants With Moderate to Severe Cutaneous Lichen Planus
| NCT ID | NCT07775924 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Cutaneous Lichen Planus |
| Study Type | INTERVENTIONAL |
| Enrollment | 259 participants |
| Start Date | 2026-09-10 |
| Primary Completion | 2028-11-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 259 participants in total. It began in 2026-09-10 with a primary completion date of 2028-11-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP).
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.
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT07775924 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Cutaneous Lichen Planus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07775924 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07775924 currently recruiting?
Yes, NCT07775924 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT07775924 trial being conducted?
This trial is being conducted at Birmingham, United States, Miami, United States, Indianapolis, United States, New Orleans, United States and 2 additional locations.
Who is sponsoring the NCT07775924 clinical trial?
NCT07775924 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 259 participants.