A Phase 2, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 15
- 主要终点
- Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
研究概览
简要总结
Efficacy and Safety of Imsidolimab in Participants with Acne Vulgaris
详细描述
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab in adolescent and adult participants with acne vulgaris (AV). This study also will characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with AV.
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
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of moderate to severe facial AV
- •Facial IGA) score of 3 (moderate) or 4 (severe)
- •At least 20 and no more than 100 inflammatory lesions on the face
- •No more than 100 non-inflammatory lesions on the face.
- •No more than 5 nodules (≥5 millimeter [mm]) on the face
排除标准
- •A participant with acne fulminans or conglobate or secondary acne will be excluded.
研究组 & 干预措施
Imsidolimab 400/200 mg
Participants received imsidolimab 400 milligrams (mg) by subcutaneous (SC) injection on Day 1, followed by 200 mg on Days 29 and 57.
干预措施: Imsidolimab (Drug)
Imsidolimab 200/100 mg
Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57.
干预措施: Imsidolimab (Drug)
Placebo
Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57.
干预措施: Placebo (Biological)
结局指标
主要结局
Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
时间窗: Baseline, Week 12
The number of facial inflammatory lesions (pustules, papules, and nodular lesions) on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
次要结局
- Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20(Baseline, Weeks 2, 4, 8, 12 and 20)
- Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20(Baseline, Weeks 2, 4, 8, 12, and 20)
- Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20(Baseline, Weeks 2, 4, 8, and 20)
- Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20(Baseline, Weeks 2, 4, 8, 12, and 20)
- Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20(Baseline, Weeks 2, 4, 8, 12, and 20)
- Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20(Baseline, Weeks 2, 4, 8, 12, and 20)
- Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20(Baseline, Weeks 2, 4, 8, 12, and 20)
- Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20(Baseline, Weeks 2, 4, 8, 12, and 20)
- Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20(Baseline, Weeks 2, 4, 8, 12, and 20)
- Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20(Baseline, Weeks 2, 4, 8, 12, and 20)
- Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20(Baseline, Weeks 2, 4, 8, 12, and 20)
- Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20(Baseline, Weeks 2, 4, 8, 12, and 20)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(First dose of study drug until end of study (up to 20 weeks))