Cutaneous Lichen Planus
Conditions
Keywords
Phase 2, interventional, lichen planus, efficacy, safety
Brief summary
This study will evaluate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP).
Detailed description
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).
Interventions
DRUGPlacebo
Matching placebo
DRUGGIA632
GIA632 administered according to the assigned study treatment regimen.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change from baseline in weekly mean daily Peak Pruritus Numerical Rating Scale (PP-NRS) score | Baseline and Week 16 | 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). |
| Number of participants achieving an IGA score of Clear (0) or Almost Clear (1) | Weeks 4, 8, and 12 | 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. |
| Number of participants achieving a ≥2-Point improvement from baseline in IGA score | Baseline, Weeks 4, 8, 12, and 16 | 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. |
| Absolute change from baseline in Lichen Planus Activity and Damage Index (LiPADI) Activity score | Baseline, Weeks 4, 8, 12, and 16 | 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. |
| Absolute Change From Baseline in Lichen Planus Activity and Damage Index (LiPADI) Damage Score | Baseline, Weeks 4, 8, 12, and 16 | 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. |
| Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 80 weeks | Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs. |
Countries
Australia, United States
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed