A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study to Evaluate Clinical Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants With Alopecia Areata
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 94
- 试验地点
- 28
- 主要终点
- Change From Baseline in Severity of Alopecia Tool Score at Week 24 in Placebo-Controlled Treatment Period
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of deucravacitinib versus placebo at Week 24 and safety and tolerability of deucravacitinib versus placebo in adults with alopecia areata.
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, Care Provider)
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
- •Documented clinical diagnosis of alopecia areata (AA) for at least 6 months.
- •Current episode of scalp hair loss (at screening) must meet the following criteria: duration at least 6 months; duration of current hair loss episode of AA affecting ≥ 50% of the scalp not exceeding 8 years; scalp hair loss has been stable (no significant spontaneous regrowth [> 10%] over the last 6 months)
- •SALT score ≥ 50 at Screening and Day
- •Participant with complete scalp hair loss (SALT score of 100) with or without body hair involvement can be included.
排除标准
- •Participant with diffuse-type AA or other forms of hair loss, including traction alopecia, lichen planopilaris, central centrifugal cicatricial alopecia, frontal fibrosing alopecia, etc.
- •Other active skin diseases affecting the scalp that in the opinion of the investigator may interfere with accurate assessment of SALT score.
- •Extensive tattooing of the scalp that, in the opinion of the investigator, may interfere with the accurate assessment of SALT score.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Deucravacitinib Dose 1
干预措施: Deucravacitinib (Drug)
Deucravacitinib Dose 1
干预措施: Placebo (Other)
Deucravacitinib Dose 2
干预措施: Deucravacitinib (Drug)
Deucravacitinib Dose 2
干预措施: Placebo (Other)
Placebo, followed by Deucravacitinib Dose 1 or Dose 2.
干预措施: Deucravacitinib (Drug)
Placebo, followed by Deucravacitinib Dose 1 or Dose 2.
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline in Severity of Alopecia Tool Score at Week 24 in Placebo-Controlled Treatment Period
时间窗: Baseline (Day 1) and Week 24
The Severity of Alopecia Tool (SALT) score is a quantitative rating scale for measuring the severity of alopecia areata based on the amount of terminal hair loss in each of the 4 quadrants of the scalp: back region, top region, left and right regions of the scalp. To calculate a SALT score, the degree of scalp hair loss, as a percentage of each scalp region affected, is determined. Each region is multiplied by it's respective weighting factor (percentage surface area of the scalp in that area; back region \[24%\], top region \[40%\], left region \[18%\] and, right region \[18%\]), in order to achieve a subtotal for each region. The SALT score is the sum of the scalp hair loss in each area (sum of the subtotals). The score ranges from 0 to 100, the higher score reflects high severity of alopecia areata.
Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period
时间窗: From first dose (Day 1) and up to 30 days after last dose for all participants (up to approximately 28 weeks)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization. Adverse event of interest included herpes zoster, malignancy, opportunistic infection or tuberculosis infection.
Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period
时间窗: From first dose (Day 1) of Week 25 and up to 30 days after last dose for all participants (up to approximately 28 weeks)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization. Adverse event of interest included Herpes zoster, malignancy, opportunities infection or tuberculosis infection.
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
时间窗: From first dose (Day 1) through Week 24
Blood samples were collected for assessment of laboratory test results. All abnormalities were graded as per CTCAE v5.0 on a scale from 1 to 4, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
时间窗: From Week 25 to Week 52
Blood samples were collected for assessment of laboratory test results. All abnormalities are graded as per CTCAE v5.0 on a scale from 1 to 4, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.
Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period
时间窗: First dose (Day 1) to Week 24
A 12-lead ECG was performed after the participant remained supine for at least 5 minutes prior to the ECG. The ECG results read by the principal study investigator or a qualified and delegated designee as per local requirements
Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period
时间窗: Week 25 to Week 52
A 12-lead ECG should be performed after the participant has remained supine for at least 5 minutes prior to the ECG. The ECG results will be read by the principal study investigator or a qualified and delegated designee as per local requirements
Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period
时间窗: First dose (Day 1) to Week 24
Vital signs such as systolic blood pressures (SBP), diastolic blood pressure (DBP) and heart rate were assessed. The evaluation of the marked abnormality criteria is based on participants highest change from baseline in the period. Blood pressure and heart rate were to be measured after the participant has been resting quietly for at least 5 minutes.
Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period
时间窗: Week 25 to Week 52
Vital signs such as systolic blood pressures (SBP), diastolic blood pressure (DBP) and heart rate were assessed. The evaluation of the marked abnormality criteria is based on participants highest change from baseline in the period. Blood pressure and heart rate were to be measured after the participant had been resting quietly for at least 5 minutes.
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period
时间窗: First dose (Day 1) to Week 24
Participants were assessed for abnormalities in targeted physical parameters.
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters
时间窗: Week 25 to Week 52
Participants were assessed for abnormalities in targeted physical parameters.
次要结局
- Percentage of Participants Achieving a ≥ 50% Reduction in Severity of Alopecia Tool (SALT) Score (SALT50 Response) From Baseline at Week 24(Baseline (Day 1) and Week 24)
- Percentage of Participants Achieving a Severity of Alopecia Tool (SALT) Score ≤20 at Week 24(Baseline (Day 1) and Week 24)
- Percentage of Participants Achieving an Alopecia Areata Investigator Global Assessment (AA-IGA) Score of 0 or 1 at Week 24 With at Least a 2-Point Change From Baseline(Baseline (Day 1) and week 24)