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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 259
- 试验地点
- 9
- 主要终点
- Number of participants achieving an Investigator Global Assessment (IGA) response
研究概览
简要总结
This study will evaluate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
Participants will receive matching placebo according to the treatment regimen assigned at randomization during the study treatment period.
干预措施: GIA632 (Drug)
GIA632 - Treatment regimen 4
Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
干预措施: GIA632 (Drug)
GIA632 - Treatment regimen 3
Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
干预措施: GIA632 (Drug)
GIA632 - Treatment regimen 2
Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
干预措施: GIA632 (Drug)
Placebo
Participants will receive matching placebo according to the treatment regimen assigned at randomization during the study treatment period.
干预措施: Placebo (Drug)
GIA632 - Treatment regimen 1
Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period.
干预措施: GIA632 (Drug)
结局指标
主要结局
Number of participants achieving an Investigator Global Assessment (IGA) response
时间窗: 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.
次要结局
- Absolute change from baseline in weekly mean daily Peak Pruritus Numerical Rating Scale (PP-NRS) score(Baseline and Week 16)
- Number of participants achieving an IGA score of Clear (0) or Almost Clear (1)(Weeks 4, 8, and 12)
- Number of participants achieving a ≥2-Point improvement from baseline in IGA score(Baseline, Weeks 4, 8, 12, and 16)
- Absolute change from baseline in Lichen Planus Activity and Damage Index (LiPADI) Activity score(Baseline, Weeks 4, 8, 12, and 16)
- Absolute Change From Baseline in Lichen Planus Activity and Damage Index (LiPADI) Damage Score(Baseline, Weeks 4, 8, 12, and 16)
- Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to 80 weeks)