A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-64304500 in Patients With Alopecia Areata
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 22
- 主要终点
- Percentage of Participants Achieving a Severity of Alopecia Tool (SALT)90 Response
研究概览
简要总结
The purpose of this study is to evaluate the clinical response of 22 weeks of study intervention with JNJ-64304500, compared with placebo, in participants with moderate to severe alopecia areata (AA).
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
- Double (Participant, Investigator)
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
- •Participant has a physician confirmed diagnosis of moderate to severe Alopecia Areata (AA) (greater than or equal to [>=] 50 percent [%] scalp involvement) as measured using the severity of Alopecia tool (SALT) score; or participant has >=95% loss of scalp hair for enrollment as alopecia totalis (AT) or alopecia universalis (AU) subtypes at the time of screening and baseline
- •Current episode of hair loss is greater than (>) 6 months (without evidence of spontaneous terminal hair regrowth within 6 months at the time of screening and baseline), but less than or equal to (<=8) years
- •Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at either screening or Week
- •Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
- •Medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel or hematology are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
排除标准
- •History of liver or renal insufficiency (estimated creatinine clearance below 60 milliliters per minute (mL/min)); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine (except stable thyroid diseases), neurologic, hematologic, rheumatologic, psychiatric disorders, or metabolic disturbances
- •Currently has a malignancy or has a history of malignancy (with the exceptions of participants having adequately treated and cured basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ occurring more than 5 years prior to randomization)
- •Known allergies, hypersensitivity, or intolerance to JNJ-64304500 or its excipients
- •Participants with current episode of hair loss for >8 years
- •Has previous treatment with an oral janus kinase (JAK) inhibitor
研究组 & 干预措施
JNJ-64304500
Participants will receive JNJ-64304500 dose 1 subcutaneous (SC) injection at Week 0 and then dose 2 SC injection every 2 weeks from Week 2 through Week 22.
干预措施: JNJ-64304500 (Drug)
Placebo
Participants will receive matching placebo SC injection at Week 0 and then every 2 weeks from Week 2 through Week 22.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving a Severity of Alopecia Tool (SALT)90 Response
时间窗: Week 24
The SALT score is a global severity score that captures percentage of hair loss by dividing the scalp into 4 quadrants (left side, right side, top and back quadrant) with assigned percent of scalp surface area (SSA) in each quadrant. After indicating the percent of loss per quadrant the value is multiplied by the percent (%) of hair for each section (18% sides, 40% top, and 24% back) and the values are summed to generate the total percentage of scalp hair loss or SALT score. The range in score is from 0-100 reflecting the percent hair loss on the scalp (0=no hair loss and 100= total hair loss). SALT90 is defined as 90% or more regrowth compared with baseline.
次要结局
- Number of Participants With Clinically Significant Abnormalities in Vital Signs(Up to Weeks 24 and 38)
- Number of Participants With Clinically Significant Abnormalities in Laboratory Tests(Up to Weeks 24 and 38)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Up to Weeks 24 and 38)
- Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)(Up to Weeks 24 and 38)
- Number of Participants With Adverse Events Leading to Discontinuation of Study Intervention(Up to Weeks 24 and 38)
- Number of Participants With Adverse Events Reasonably Related to Study Intervention(Up to Weeks 24 and 38)
- Number of Participants With Adverse Events of Injection-Site Reactions(Up to Weeks 24 and 38)
- Number of Participants with Adverse Events of Infections(Up to Weeks 24 and 38)
- Percentage of Participants Achieving SALT50 Response(Week 24)
- Percentage of Participants Achieving SALT75 Response(Week 24)
- Percentage of Participants Achieving SALT Score <=20(Week 24)
- Change From Baseline in SALT Score at Week 24(Baseline and Week 24)
- Percentage of Participants Achieving SALT Score Less Than or Equal to (<=) 10(Week 24)
- Percent Change in SALT Score from Baseline at Week 24(Baseline and Week 24)