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Efficacy and safety of GIA632 versus placebo in adults with moderate to severe cutaneous lichen planus

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study examines individuals with moderate to severe cutaneous lichen planus, a chronic skin disorder that produces itchy, flat, purple‑colored patches. The experimental medicine, referred to as GIA632, will be administered by subcutaneous injection (an injection placed under the skin) and will be compared with a placebo. The purpose is to learn how the drug works at different dose levels and whether it improves the skin condition.

People whose disease has not responded well to standard topical steroids or who cannot use such treatments will be screened and then randomly assigned to receive one of several doses of the study drug or the placebo for approximately 16 weeks. Throughout the study, doctors will rate the skin appearance using the Investigator’s Global Assessment (a scale from clear to severe), and participants will rate their itch using the Peak Pruritus Numerical Rating Scale (a 0‑10 number). Additional assessments include the LiPADI score, which evaluates how active and how damaged the lesions are, and safety will be monitored by recording any adverse events. After the initial period, participants may continue in an extension phase to collect longer‑term information.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Visit

    You will attend an initial clinic visit after joining the study. During this visit a health professional will examine your skin, record the severity of your cutaneous lichen planus, and ask you to complete questionnaires about itch and quality of life.

    If you are using any topical medication, you will be asked to continue or pause it according to the study instructions.

  2. Step 2

    Randomization

    You will be randomly assigned to receive either the investigational drug GIA632 or a matching placebo. The assignment is concealed, so you will not know which one you receive.

  3. Step 3

    First Injection

    You will receive a subcutaneous injection (injection under the skin) of the study medication or placebo. The exact amount and concentration are defined by the study protocol and may differ between dose levels.

    The injection will be administered by a trained staff member using a small needle.

  4. Step 4

    Scheduled Follow‑up Visits

    You will return to the clinic at Week 4, Week 8, Week 12, and Week 16. At each visit you will:

    Investigator’s Global Assessment (IGA) will be performed to rate your skin from 0 (clear) to 4 (severe).

    Answer the Peak Pruritus Numerical Rating Scale (PP‑NRS) questionnaire, which asks you to rate your itch each day on a scale of 0 to 10.

    Complete the Lichen Planus Activity and Damage Index (LiPADI) questionnaire, which evaluates disease activity and skin damage.

    Undergo safety checks, including blood tests and a review of any side effects you may have experienced.

    Receive additional subcutaneous injections of the study medication or placebo according to the schedule.

  5. Step 5

    Primary Efficacy Assessment

    At the Week 16 visit the main outcome will be determined. Your skin will be rated by the IGA score, and the study will record whether you achieve a score of 0 (clear) or 1 (almost clear).

  6. Step 6

    Extension Period

    After Week 16 you may be offered an optional extension period. If you choose to continue, you will keep receiving the same study medication or placebo for additional weeks.

    Visits during the extension will follow a similar pattern, with skin assessments, itch questionnaires, safety monitoring, and further injections as required.

  7. Step 7

    Safety Monitoring Throughout the Trial

    Throughout the study you will be asked to report any new symptoms, discomfort, or health problems. The study team will record any treatment‑emergent adverse events (AEs) and serious adverse events (SAEs).

Who can join the trial?

6 criteria

  • You must be 18 years of age or older at the time of screening and be male or female as assigned at birth.
  • You must have a diagnosis of cutaneous lichen planus (cLP) that has been confirmed by a skin biopsy (a tiny piece of skin taken and looked at under a microscope) within the past year or at the screening visit, and also confirmed by the doctor’s physical examination.
  • You must have moderate to severe cLP, which means:
    • The doctor’s overall rating of your skin condition, called the Investigator’s Global Assessment (IGA), is 3 or higher (higher numbers mean more severe disease).
    • Your average worst itch score over the past 24 hours, called the Peak 24‑hour Patient‑Reported Numeric Rating Scale (PP‑NRS), is 4 or higher on a 0‑10 scale.
    • You must have skin involvement in at least two different body regions (such as head/neck, trunk, arms/hands, or legs/feet) or at least 3% of your total skin surface area (body surface area, BSA) affected.
    • Your cLP must not be well‑controlled by at least one topical (applied to the skin) medication for three months or more, or the doctor must consider such medication not advisable. Topical medicines include steroid creams (topical corticosteroids), creams that affect the immune system (topical calcineurin inhibitors), vitamin D‑like creams (topical cholecalciferol analogues), and other similar skin‑applied treatments.

Who cannot join the trial?

7 criteria

  • Unable or unwilling to follow the study steps, use the electronic diary (eDiary), or fill out the study questionnaires.
  • Having a diagnosis of drug‑induced lichen planus (a skin rash caused by a medication) or lichen planus pigmentosus (a darker‑colored form of the same skin condition).
  • Having a diagnosis of the mainly hypertrophic type (thickened skin lesions) or mainly bullous type (blister‑like lesions) of cutaneous lichen planus. Small areas of these lesions are allowed only if the usual raised or flat patches are still the main pattern.
  • Having other skin problems that could interfere with the study’s measurements, including any unusual results seen when a skin sample is examined under a microscope (histologic findings from a biopsy).
  • Having previously taken biologic medicines that specifically target IL‑15 or any part of the IL‑15 receptor (these are special drugs made from living cells that affect the immune system).
  • Planning to receive a live vaccine (a vaccine that contains a weakened form of a virus or bacteria) during the study, within 4 weeks before randomization, or within 16 weeks after the study ends.
  • Using any medication or treatment that the study specifically forbids.
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Investigated drugs

  • Topical corticosteroid

    is a cream or ointment applied to the skin to reduce inflammation and itching. In this study it is used as the standard background treatment for participants who have cutaneous lichen planus. The medication works by calming the immune response in the skin, helping to control the rash while the new drug is being tested.

  • GIA632

    is an experimental medicine given by a subcutaneous injection under the skin. It is being studied to see if it can improve the skin condition in people with moderate to severe cutaneous lichen planus who do not respond well to usual topical treatments. The drug is designed to target specific parts of the immune system that cause the rash, with the goal of reducing lesions and improving overall skin health.

What is already known about the treatment

  • Topical corticosteroid

    This medication is applied to the skin as a cream or ointment and works locally on the affected area. It is an established drug that has been used for many years to treat inflammatory skin conditions such as eczema and lichen planus. It belongs to the class of plain corticosteroids and reduces inflammation by blocking signals that cause swelling and redness. It is widely available and listed in medical references as a standard treatment for skin inflammation.

  • GIA632

    GIA632 is given by a subcutaneous injection, meaning a small needle is used to deliver the liquid directly under the skin. It is an investigational drug that is being studied in early‑phase clinical trials for immune‑mediated skin disease and has not yet received marketing approval. The drug is designed to target specific immune cells that drive inflammation in cutaneous lichen planus, helping to calm the immune response. It is classified as a biologic agent aimed at modulating the immune system.

Investigated diseases

Cutaneous lichen planus - Cutaneous lichen planus is an inflammatory condition that produces itchy, flat‑topped, purplish bumps on the skin, often on the wrists, ankles, and lower back. The lesions may merge into larger patches and can become thickened or develop a rough surface over time. New spots can appear while older ones may fade, leading to a pattern of flare‑ups and partial remission. In some cases, the affected skin may develop discoloration or small scars as the disease progresses.
Trial detailsLast updated 5 Nov 2026
Age18+ yearsPhasePhase IITrial ID2025-522300-25-00Protocol codeCGIA632C12201Estimated enrolment169 patientsSponsorNovartis Pharma AG

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