A Study to Assess the Efficacy and Safety of GIA632 Across a Range of Doses in Participants With Moderate to Severe Cutaneous Lichen Planus (ELIPSI)

Novartis

Status and phase: Enrolling; Phase 2

Conditions: Cutaneous Lichen Planus

Treatments: Drug: GIA632; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07775924

2025-522300-25-00 (Other Identifier)

2025

CGIA632C12201

Details and patient eligibility

About

This study will evaluate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP).

Full description

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).

Enrollment: 259 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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259 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo according to the treatment regimen assigned at randomization during the study treatment period.

Treatment:

Drug: Placebo

Drug: GIA632

GIA632 - Treatment regimen 1

Experimental group

Description:

Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.

Treatment:

Drug: GIA632

GIA632 - Treatment regimen 2

Experimental group

Description:

Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.

Treatment:

Drug: GIA632

GIA632 - Treatment regimen 3

Experimental group

Description:

Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.

Treatment:

Drug: GIA632

GIA632 - Treatment regimen 4

Experimental group

Description:

Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.

Treatment:

Drug: GIA632