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NCT07775924From ClinicalTrials.govRecruiting

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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A Study to Assess the Efficacy and Safety of GIA632 Across a Range of Doses in Participants With Moderate to S | Trialion