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Clinical trials
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

ClinicalTrials.gov identifier NCT07775924

Novartis reference CGIA632C12201

Show study information as

Condition Cutaneous Lichen Planus

Study status Recruiting

Phase 2

Number of participants 259

Gender All

Age 18 to 99 years

Learn More

Study details

The main purpose of this study is to investigate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP) across a range of dosing regimens and to identify the optimal dosing regimen to be promoted into the confirmatory Phase 3 program.

This study consists of a screening period (up to 4 weeks), a core treatment period (16 weeks double-blind), an extension period (52 weeks), and a safety follow-up period (12 weeks).

Interventions

DRUG: Placebo|DRUG: GIA632

Official title

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

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Who can take part?

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.

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.

Home
Clinical trials
NCT07775924

Study of an Investigational Treatment for Moderate to Severe Cutaneous Lichen Planus

ClinicalTrials.gov identifier NCT07775924

Novartis reference CGIA632C12201

Show study information as

Condition Cutaneous Lichen Planus

Study status Recruiting

Phase 2

Number of participants 259

Gender All

Age 18 to 99 years

Learn More

Study details

This text was simplified by AI to make it easier to read. It may contain mistakes. Switch to Original information for the official version.

The purpose of this research study is to learn about the effects and safety of an investigational treatment in adults with moderate to severe cutaneous lichen planus. Cutaneous lichen planus is a skin condition that can affect multiple areas of the body.

Participants will receive the investigational treatment at 1 of several dose levels. The study includes a main treatment period followed by a longer extension period, and then a safety follow-up period. Participants will also be asked to use an electronic diary (eDiary) and complete study questionnaires.

This study may be an option for
Adults with moderate to severe cutaneous lichen planus may be able to participate if they:

Are 18 years of age or older
Have cutaneous lichen planus confirmed by a skin biopsy (within the past year, or done at screening if needed) and by a physical exam at screening
Have 2 or more body regions affected (for example, head/neck, trunk, arms/hands, or legs/feet)
Have cutaneous lichen planus that has not been well controlled by at least 1 topical (skin) treatment tried for at least 3 months, or the topical treatment is not advised in the investigator’s judgment

Study timeline and visits:
The study includes screening for up to 4 weeks, a 16-week main treatment period, a 52-week extension period, and a 12-week safety follow-up period.

Interventions

DRUG: Placebo|DRUG: GIA632

Official title

Who can take part?

This text was simplified by AI to make it easier to read. It may contain mistakes. Switch to Original information for the official version.

You might be able to join if

Are male or female (as assigned at birth) and are 18 years of age or older at screening
Have cutaneous lichen planus that is confirmed by a skin biopsy (either from within 1 year before screening, or done at screening if a recent biopsy is not available) and confirmed by a physical exam by the study doctor at screening
Have moderate to severe cutaneous lichen planus
Have 2 or more body regions affected (any 2 or more of: head and neck, trunk, upper extremities including hands, lower extremities including feet)
Have cutaneous lichen planus that is not well controlled by at least 1 topical (skin) treatment used for at least 3 months (either used continuously or used off and on with a “burst and taper” plan), or the topical treatment is considered not advisable based on the study doctor’s judgment at screening

You might not be able to join if

Are unable or unwilling to follow the study procedures, use the electronic diary (eDiary), or complete the study questionnaires
Have drug-induced lichen planus (a lichen planus–like rash caused by a medicine) or lichen planus pigmentosus
Have other skin conditions that could interfere with the study checks, including biopsy findings, as assessed at screening and baseline
Have previously received biologic drugs that directly target IL-15 or any part of the IL-15 receptor
Use medications or treatments that are not allowed in this study

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