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
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.
• 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.