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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.","Week 16",[14,18,22,25,28,31],{"measure":15,"description":16,"timeFrame":17},"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).","Baseline and Week 16",{"measure":19,"description":20,"timeFrame":21},"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.","Weeks 4, 8, and 12",{"measure":23,"description":20,"timeFrame":24},"Number of participants achieving a ≥2-Point improvement from baseline in IGA score","Baseline, Weeks 4, 8, 12, and 16",{"measure":26,"description":27,"timeFrame":24},"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.",{"measure":29,"description":30,"timeFrame":24},"Absolute Change From Baseline in Lichen Planus Activity and Damage Index (LiPADI) Damage 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 damage score assesses disease-related damage based on morphologic features including hyperpigmentation and scarring\u002Fatrophy.",{"measure":32,"description":33,"timeFrame":34},"Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)","Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.","Up to 80 weeks",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":35,"primaryPurpose":39,"observationalModel":35,"timePerspective":35,"maskingInfo":40},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":41,"maskingDescription":35,"whoMasked":42},"DOUBLE",[43,44],"PARTICIPANT","INVESTIGATOR","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.\n\nThis 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).",[47,54,59,62,65],{"label":48,"type":49,"description":50,"interventionNames":51},"Placebo","PLACEBO_COMPARATOR","Participants will receive matching placebo according to the treatment regimen assigned at randomization during the study treatment period.",[52,53],"Drug: Placebo","Drug: GIA632",{"label":55,"type":56,"description":57,"interventionNames":58},"GIA632 - Treatment regimen 1","EXPERIMENTAL","Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.",[53],{"label":60,"type":56,"description":57,"interventionNames":61},"GIA632 - Treatment regimen 2",[53],{"label":63,"type":56,"description":57,"interventionNames":64},"GIA632 - Treatment regimen 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5L5","Canada","CA",{"type":98,"coordinates":372},[373,374],-81.23304,42.98339,{"lat":374,"lon":373},{"facility":337,"status":91,"city":377,"state":367,"zip":378,"country":369,"countryCode":370,"cosmosGeoPoint":379,"geoPoint":383,"contacts":35},"Toronto","M5A 3R6",{"type":98,"coordinates":380},[381,382],-79.39864,43.70643,{"lat":382,"lon":381},{"facility":337,"status":91,"city":385,"state":35,"zip":386,"country":387,"countryCode":388,"cosmosGeoPoint":389,"geoPoint":393,"contacts":35},"Shanghai","200040","China","CN",{"type":98,"coordinates":390},[391,392],121.45806,31.22222,{"lat":392,"lon":391},{"type":395,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100652585","phase-2-a-study-to-assess-the-efficacy-and-safety-of-gia632-across-a-range-of-doses-in-participants-with-moderate-to-severe-cutaneous-lichen-planus-100652585",false,"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","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","ELIPSI","Key Inclusion Criteria:\n\n* Male or female (as assigned at birth) participants ≥ 18 years of age at the time of screening.\n* Individuals with a diagnosis of cLP, confirmed\n* histologically by a skin biopsy (either historically within 1 year prior to screening or at screening if historical one not available), and\n* by physical examination by the investigator at screening.\n* Moderate to severe cLP\n* 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).\n* 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.\n\nTopical 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.\n\nKey Exclusion Criteria:\n\n* Individuals unable or unwilling to follow the study procedures, handle the electronic diary (eDiary), and\u002For to complete the study-related questionnaires.\n* Diagnosis of drug-induced lichen planus (lichenoid drug eruption) or lichen planus pigmentosus.\n* Presence of skin conditions that may interfere with study assessments, including histologic findings in the biopsy, as assessed at screening and baseline.\n* Previous exposure to biologic drugs directly targeting IL-15 or any subunit of the IL-15 receptor.\n* Use of prohibited medication and treatments.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years","99 Years",{"count":408,"type":409},259,"ESTIMATED","INTERVENTIONAL",[412],"PHASE2","This study will evaluate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP).",[415],"Cutaneous Lichen Planus",[417,418,419,420,421],"Phase 2","interventional","lichen planus","efficacy","safety","2026-10-12",{"date":424,"type":425},"2026-10-13","ACTUAL",{"date":427,"type":425},"2026-09-29",{"date":429,"type":409},"2030-02-13",{"name":79,"class":6},21]