This study will evaluate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP).
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.
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.
Parallel
Placebo
DrugMatching placebo
GIA632
DrugGIA632 administered according to the assigned study treatment regimen.
Number of participants achieving an Investigator Global Assessment (IGA) response
IGA response is defined as an Investigator Global Assessment score of 0 (clear) or 1 (almost clear). The IGA is measured on a 5-point scale ranging from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Absolute change from baseline in weekly mean daily Peak Pruritus Numerical Rating Scale (PP-NRS) score
The Peak Pruritus Numerical Rating Scale (PP-NRS) is used to assess participant-reported intensity of worst itch during the previous 24 hours. Participants rate their worst itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
Number of participants achieving an IGA score of Clear (0) or Almost Clear (1)
The IGA is measured on a 5-point scale ranging from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Number of participants achieving a ≥2-Point improvement from baseline in IGA score
The IGA is measured on a 5-point scale ranging from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Absolute change from baseline in Lichen Planus Activity and Damage Index (LiPADI) Activity score
The Lichen Planus Activity and Damage Index (LiPADI) is a clinical assessment tool used to evaluate the severity and extent of lichen planus. The activity score assesses active inflammation based on morphologic features including erythema, hypertrophy, and scaling.
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