A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ANB019 in the Treatment of Acneiform Rash in Subjects With Neoplasm Receiving EGFRi or MEKi Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 18
- 主要终点
- Change From Baseline in Facial Inflammatory Lesion Count (Papules and Pustules) at Week 8
研究概览
简要总结
Efficacy and Safety of imsidolimab in participants with epidermal growth factor receptor inhibitor (EGFRi)/mitogen-activated protein (MAP)/extracellular signal-regulated kinase (ERK) kinase inhibitor (MEKi)-associated acneiform Rash
详细描述
This study is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of imsidolimab compared with placebo in cancer participants with EGFRi/MEKi-associated acneiform rash. This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with EGFRi/MEKi-associated acneiform rash.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has cancer
- •Participant is treated with an oral or injectable Food and Drug Administration (FDA)-approved EGFRi or MEKi therapy
- •Participant has EGFRi/MEKi-related acneiform rash of Grade ≥ 2 as per common terminology criteria for adverse events (CTCAE) version 5.0, and ≥ 20 inflammatory lesions on the face at screening and Day 1.
排除标准
- •Participant has infected EGFRi/MEKi-associated acneiform rash according to investigator's evaluation.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
ANB019
Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
干预措施: Imsidolimab (Biological)
Placebo
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
干预措施: Placebo (Biological)
结局指标
主要结局
Change From Baseline in Facial Inflammatory Lesion Count (Papules and Pustules) at Week 8
时间窗: Baseline, Week 8
The number of facial inflammatory lesions (papules and pustules) on the face (excluding the neck and scalp area) was counted. Papule was a small, solid elevation 5 millimeters (mm) or less in diameter. Pastule was a small, circumscribed elevation of the skin that contains yellow-white exudate.
次要结局
- Percentage of Participants With an Improvement of at Least 1 Grade From Baseline in Acneiform Rash Common Terminology Criteria for Adverse Events (CTCAE) Grading Scale at Week 8(Baseline, Week 8)
- Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash CTCAE Grading Scale(Baseline up to 55 days)
- Percentage of Participants With an Improvement of at Least 1 Grade From Baseline in Acneiform Rash Modified Multinational Association for Supportive Care in Cancer (MASCC) EGFRi Skin Toxicity Tool (MESTT) Grading Scale (Total Score) at Week 8(Baseline, Week 8)
- Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 8(Baseline, Week 8)
- Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash Modified MESTT Grading Scale (Total Score)(Baseline to 55 days)
- Percentage of Participants With an Improvement of at Least 1 Grade From Baseline in Acneiform Rash Modified MESTT Grading Scale (Facial Assessment) at Week 8(Baseline, Week 8)
- Percent Change From Baseline in Pruritus NRS at Week 8(Baseline, Week 8)
- Percent Change From Baseline in Pain NRS at Week 8(Baseline, Week 8)
- Percent Change From Baseline in Facial Inflammatory Lesion Count (Papules and Pustules) at Week 8(Baseline, Week 8)
- Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash Modified MESTT Grading Scale (Facial Assessment)(Baseline to 55 days)
- Change From Baseline in Pain NRS at Week 8(Baseline, Week 8)
- Change From Baseline in Functional Assessment of Cancer Therapy - Epidermal Growth Factor Receptor Inhibitor 18 (FACT-EGFRi-18) at Week 8(Baseline, Week 8)
- Number of Participants With Treatment-Emergent Adverse Events(From first dose to 55 days)