GIA632 for moderate to severe cutaneous lichen planus: how well it works and is safe across doses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2 interventional trial evaluating the safety and efficacy of GIA632 across a range of doses in adults with moderate to severe cutaneous lichen planus. Participants will undergo a screening period, followed by 16 weeks of double-blind treatment, an extension period, and a safety follow-up. The study aims to identify which dosing regimen should move forward into a confirmatory phase 3 program, with placebo as a control alongside active treatment. Key outcomes include safety signals and changes in skin disease activity measured during the core treatment period. The trial is conducted at multiple sites in the United States and includes cross-site assessment to ensure consistent evaluation of efficacy and tolerability.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cahaba Derm and skin hlth ctr 27
  Birmingham, Alabama, United States Recruiting
• First OC Dermatology
  Fountain Valley, California, United States Recruiting
• Encore Medical Research
  Hollywood, Florida, 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

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.