A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 131
- 试验地点
- 71
- 主要终点
- Percent change from Baseline in the weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) score at Week 16
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with Atopic Dermatitis
详细描述
This is a multicenter, randomized, double-blind, parallel group, placebo controlled phase 2 study to assess the efficacy and safety of barzolvolimab (CDX-0159) in adult participants with Atopic Dermatitis.
There is a screening period of up to 28 days, a 16-week double-blind, placebo-controlled treatment period, a 16-week double-blind, active treatment period, and a 16-week follow-up period. On Day 1, participants will be randomly assigned on a 1:1:1 ratio to receive barzolvolimab (CDX-0159) by subcutaneous injections of 150 mg every 4 weeks (Q4W) after an initial loading dose of 450 mg [Arm 1], 300 mg Q4W after an initial loading dose of 450 mg [Arm 2], or placebo Q4W [Arm 3]. At Week 16, participants on placebo will be re-randomized on a 1:1 ratio to receive barzolvolimab by subcutaneous injections of 150 mg every 4 weeks (Q4W) after an initial loading dose of 450 mg, 300 mg Q4W after an initial loading dose of 450 mg. Participants on Arms 1 and 2 will undergo a mock re-randomization at Week 16 to maintain the blind.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years of age
- •Diagnosis of chronic atopic dermatitis (AD) for at least 1 year
- •Onset of symptoms at least 1 year prior and current symptoms consistent with moderate to severe AD as defined by:
- •EASI ≥ 12 at Visit 1 and EASI ≥ 16 at Visit 2
- •Body Surface Area of Involvement (BSA) ≥ 10% at Visit 1 and Visit 2
- •IGA score ≥ 3 at Visit 1 and Visit 2
- •Severe itch, defined by weekly average of daily PP-NRS score of ≥ 5, during the 7 days prior to treatment
- •Documented history of inadequate response to treatment with topical medications or for whom topical medications are otherwise medically inadvisable.
- •Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.
排除标准
- •Any other active pruritic skin diseases that would confound AD assessments based on the Investigator's clinical judgment.
- •Phototherapy with ultraviolet (UV) A or UVB within 4 weeks of Visit
- •Planned or anticipated use of any prohibited medications at any time during the study.
- •Prior receipt of barzolvolimab or other anti-KIT therapy. There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
研究组 & 干预措施
Placebo then barzolvolimab 300 mg
Placebo subcutaneous injection every 4 weeks for 16 weeks and then barzolvolimab loading dose of 450 mg followed by 300 mg administered every 4 weeks for 16 weeks.
干预措施: Matching placebo (Drug)
Barzolvolimab 300 mg
Barzolvolimab loading dose of 450 mg subcutaneous injection followed by 300 mg administered every 4 weeks for 32 weeks
干预措施: Barzolvolimab (Biological)
Barzolvolimab 150 mg
Barzolvolimab loading dose of 450 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 32 weeks
干预措施: Barzolvolimab (Biological)
Placebo then barzolvolimab 150 mg
Placebo subcutaneous injection every 4 weeks for 16 weeks and then barzolvolimab loading dose of 450 mg followed by 150 mg administered every 4 weeks for 16 weeks.
干预措施: Barzolvolimab (Biological)
Placebo then barzolvolimab 300 mg
Placebo subcutaneous injection every 4 weeks for 16 weeks and then barzolvolimab loading dose of 450 mg followed by 300 mg administered every 4 weeks for 16 weeks.
干预措施: Barzolvolimab (Biological)
Placebo then barzolvolimab 150 mg
Placebo subcutaneous injection every 4 weeks for 16 weeks and then barzolvolimab loading dose of 450 mg followed by 150 mg administered every 4 weeks for 16 weeks.
干预措施: Matching placebo (Drug)
结局指标
主要结局
Percent change from Baseline in the weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) score at Week 16
时间窗: From Day 1 (first dose) to Day 113 (week 16)
Evaluate the clinical efficacy of 2 dose levels (150 mg and 300 mg) of barzolvolimab, compared to placebo, in adult participants with moderate to severe atopic dermatitis (AD) using the PP-NRS. The PP-NRS ranges from 0 = "no itch" to 10 ="worst imaginable itch" for the worst intensity itch in the preceding 24-hr period.
次要结局
- Percent change from Baseline in Eczema Area Severity Index (EASI) score at Week 16.(From Day 1 (first dose) to Day 113 (week 16))
- Proportion of participants achieving an Investigator Global Assessment (IGA) score of "0" or "1" at Week 16.(From Day 1 (first dose) to Day 113 (week 16))