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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
259
Cahaba Derm and skin hlth ctr 27
Birmingham, Alabama, United States
RECRUITINGFirst OC Dermatology
Fountain Valley, California, United States
RECRUITINGNumber 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.
Time frame: Week 16
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).
Time frame: Baseline and Week 16
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.
Time frame: Weeks 4, 8, and 12
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.
Time frame: Baseline, Weeks 4, 8, 12, and 16
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.
Time frame: Baseline, Weeks 4, 8, 12, and 16
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Miami Derm and Laser Institute
Miami, Florida, United States
Global Clinical Professionals
St. Petersburg, Florida, United States
RECRUITINGSkin Care Physicians Of Georgia
Macon, Georgia, United States
RECRUITINGDawes Fretzin Clinical Rea Group
Indianapolis, Indiana, United States
RECRUITINGDelricht Research
New Orleans, Louisiana, United States
RECRUITINGHamzavi Dermatology
Fort Gratiot, Michigan, United States
RECRUITINGNovartis Investigative Site
Waitara, New South Wales, Australia
RECRUITINGAbsolute 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/atrophy.
Time frame: Baseline, Weeks 4, 8, 12, and 16
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.
Time frame: Up to 80 weeks