A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy, Safety, and Tolerability of BLU-5937 for the Treatment of Chronic Pruritus in Adult Subjects With Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 33
- 主要终点
- Change from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, parallel design study of BLU-5937 for the treatment of chronic pruritus in adult subjects with atopic dermatitis (AD).
详细描述
The study will consist of a 37-day Screening period (including a 7-day Run-In period), a 4-week Treatment period followed by a Follow-Up visit approximately 2 weeks after the last dose of study drug.
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
- •Willing to participate and is capable of giving informed consent
- •Clinically confirmed diagnosis of active AD with at least a 6-month history of AD
- •Chronic pruritus related to AD for at least 3 months
- •Moderate to severe itch associated with mild to moderate AD
- •Female of childbearing potential must agree to use a highly effective contraceptive method during the study and until at least 4 weeks after the last study drug administration
排除标准
- •History of skin disease or presence of skin condition that would interfere with the study assessments
- •Clearly defined etiology for pruritus other than AD, including but not limited to: urticaria, psoriasis, or other non-atopic dermatologic conditions, hepatic or renal disease, psychogenic pruritus, drug reaction, uncontrolled hyperthyroidism, and infection
- •Presence of any acute skin condition other than AD which may risk inducing a pruritus flare/worsening during the course of the study, including but not limited to: impetigo, active herpes simplex infection, or allergic contact dermatitis
- •Subject is >65 years of age and has developed pruritus at age of ≥50 years
- •History of cancer or lymphoproliferative disease within 5 years with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix
- •Known history of, or active, parasitic infection, including skin parasites such as scabies within 12 months prior to Screening
- •Known history of chronic infectious disease (e.g. hepatitis B, hepatitis C, or human immunodeficiency virus [HIV])
- •Known history of clinically significant drug or alcohol abuse in the last year
- •Previous participation in a BLU-5937 trial
研究组 & 干预措施
BLU-5937 oral tablet
Eligible participants will receive BLU-5937 twice a day (BID) orally for 4 weeks.
干预措施: BLU-5937 (Drug)
Placebo oral tablet
Eligible participants will receive matching Placebo BID orally for 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score
时间窗: Week 4
Assessed by Worst Itch Numeric Rating Scale \[WI-NRS\] The WI-NRS is a single item questionnaire assessing the patient-reported severity of itch at its most intense during the previous 24-hour period on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'the worst itch imaginable'. Higher scores indicate worse severity.
次要结局
- Change from baseline in Itching Quality of Life Survey (ItchyQOL)(Week 4)
- Proportion of subjects achieving at least 4-point improvement from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score(Week 4)
- Change from baseline in Average Itch Numeric Rating Scale (AI-NRS) score(Week 4)
- Proportion of subjects in each category of the Patient Global Impression of Change (PGIC) questionnaire(Week 4)