Novartis Pharmaceuticals
This study will evaluate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP).
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).
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 control…
Matching placebo
GIA632 administered according to the assigned study treatment regimen.
Arctuva estimate
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