GIA632: GIA632 administered according to the assigned study treatment regimen.
Study summary
This study will evaluate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP).
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of participants achieving an Investigator Global Assessment (IGA) response — Week 16 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.
Trial sites (18)
Facility
City
Region
Status
Cahaba Derm and skin hlth ctr 27
Birmingham
Alabama
Recruiting
First OC Dermatology
Fountain Valley
California
Recruiting
Miami Derm and Laser Institute
Miami
Florida
Recruiting
Global Clinical Professionals
St. Petersburg
Florida
Recruiting
Skin Care Physicians Of Georgia
Macon
Georgia
Recruiting
Dawes Fretzin Clinical Rea Group
Indianapolis
Indiana
Recruiting
Essential Medical Research
Overland Park
Kansas
Recruiting
Louisiana Dermatology Associates
Baton Rouge
Louisiana
Recruiting
Delricht Research
New Orleans
Louisiana
Recruiting
Uni Of Michigan Health System
Ann Arbor
Michigan
Recruiting
Hamzavi Dermatology
Fort Gratiot
Michigan
Recruiting
Skin Specialists PC
Omaha
Nebraska
Recruiting
NextGen Clinical Research and Innovation Inc-Network
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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