Can a new drug clear the skin in lichen planus?
NCT ID NCT07775924
First seen Aug 20, 2026 · Last updated Sep 04, 2026 · Updated 6 times
Summary
This trial is testing an investigational drug called GIA632 in people with moderate-to-severe cutaneous lichen planus, a skin condition that causes itchy, purple bumps. The study aims to see if GIA632 can clear or nearly clear the skin rash and reduce itching compared to a placebo. Participants will be randomly assigned to receive different doses of GIA632 or a placebo, and the trial includes an extension period for continued follow-up.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GIA632 (an investigational drug)
- What this could lead to
- If successful, GIA632 could become a new treatment option for people with moderate-to-severe cutaneous lichen planus, potentially clearing skin lesions and reducing itch.
- What could go wrong
- This is a phase IIb trial, so the drug is still being tested for safety and efficacy. It may not work better than placebo, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 259 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cahaba Derm and skin hlth ctr 27
RECRUITINGBirmingham, Alabama, 35244, United States
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Dawes Fretzin Clinical Rea Group
RECRUITINGIndianapolis, Indiana, 46256, United States
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Delricht Research
RECRUITINGNew Orleans, Louisiana, 70115, United States
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Hamzavi Dermatology
RECRUITINGFort Gratiot, Michigan, 48059, United States
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Miami Derm and Laser Institute
RECRUITINGMiami, Florida, 33173, United States
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Novartis Investigative Site
RECRUITINGWaitara, New South Wales, 2077, Australia
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