A Phase 2, Randomized, Placebo-controlled, Double-blind Clinical Study to Evaluate Efficacy and Safety of LAD328 in Adult Subjects With Moderate-to-Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of Participants Achieving 55 Percent (%) Reduction from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4-55)
研究概览
简要总结
The main purpose of this study is to evaluate the effect of LAD328 compared to placebo in participants with moderate-to-severe Hidradenitis Suppurativa (HS), and to access the safety, tolerability, pharmacokinetic and immunogenicity in participants with moderate-to-severe HS.
详细描述
Hidradenitis suppurativa (HS) is a chronic skin disease of unclear etiology that affects approximately 1% of the general population.
The purpose of this study is to assess the efficacy of LAD328 compared to placebo in participants with moderate-to-severe HS.
The study participants will be randomized to one of the following treatment arms: LAD328 or Placebo.
The study includes up to 4 weeks screening period 12-week double-blind, placebo-controlled period and 8-week safety follow-up.
The total duration of study participation will be up to 20 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between 18 and 65 years old inclusive.
- •A diagnosis of moderate-to-severe HS defined as a total of >=5 inflammatory lesions (i.e., number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline visits, with a clinical history of HS for at least 6 months.
- •HS lesions present in at least 2 distinct anatomic areas (e.g., left and right axilla), one of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline visits.
- •History of inadequate response, or intolerance or contraindication, to a course of a systemic antibiotics for treatment of HS at the Screening visit.
- •Agree to regularly use, over-the-counter topical antiseptics on their HS lesions throughout the entirety of the study.
- •Participants who are woman of child-bearing potential (WOCBP) and male participants must agree to the requirements for the avoidance of pregnancy and exposure of the participant's partner to LAD328 during the trial.
排除标准
- •HS with >20 draining tunnels either at the Screening or Baseline visits.
- •Ongoing medical conditions (e.g., inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus and sarcoidosis) requiring systemic immunosuppressive/immunomodulating treatments (e.g., methotrexate, ciclosporin, corticosteroids, cytokine-targeted therapy and JAK inhibitors) during the trial.
- •Known or suspected hypersensitivity to trial product or any of its excipients.
- •Hypersensitivity or systemic reaction to a prior biologic (antibody-based) therapy (regardless of indication), that was clinically significant, as per judgment of Investigator.
- •Prior treatment with LAD
- •Live and attenuated vaccinations 4 weeks prior Pre-treatment or is planning to receive any such vaccine during the trial.
- •Females who are pregnant or breast-feeding or seeking to become pregnant during the trial.
研究组 & 干预措施
LAD328
Participants will receive LAD328 Dose A, intravenous (IV) infusion.
干预措施: LAD328 (Drug)
Placebo
Participants will receive placebo diluent solution for IV infusion.
干预措施: Placebo (Other)
结局指标
主要结局
Proportion of Participants Achieving 55 Percent (%) Reduction from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4-55)
时间窗: At Week 12
IHS4 assigns different weights to different lesion types: inflammatory nodules (1 point), abscesses (2 points), and draining tunnels (4 points). The number of each lesion type is multiplied by its respective weight and the three obtained values are then summed to obtain the IHS4 total score. IHS4-55 is a dichotomous IHS4 variable based on a \>=55% reduction of the total score.
次要结局
- Proportion of Participants Achieving 50% Reduction from Baseline in Hidradenitis Suppurativa Clinical Response (HiSCR50)(At Week 12)
- Proportion of Participants Achieving 75% Reduction from Baseline in HiSCR-75(At Week 12)
- Proportion of Participants Achieving 90% Reduction from Baseline in HiSCR-90(At Week 12)
- Change from Baseline in Skin Pain Numerical Rating Scale (NRS)(At Week 12)
- Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL)(At Week 12)