A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata
- Registration Number
- NCT05556265
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 94
- 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 1. Participant with complete scalp hair loss (SALT score of 100) with or without body hair involvement can be included.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Deucravacitinib Dose 1 Deucravacitinib - Deucravacitinib Dose 1 Placebo - Deucravacitinib Dose 2 Deucravacitinib - Deucravacitinib Dose 2 Placebo - Placebo, followed by Deucravacitinib Dose 1 or Dose 2. Deucravacitinib - Placebo, followed by Deucravacitinib Dose 1 or Dose 2. Placebo -
- Primary Outcome Measures
Name Time Method Change From Baseline in Severity of Alopecia Tool Score at Week 24 in Placebo-Controlled Treatment Period 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 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 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 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 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 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 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 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 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 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 Week 25 to Week 52 Participants were assessed for abnormalities in targeted physical parameters.
- Secondary Outcome Measures
Name Time Method 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 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 its respective weighting factor (percentage surface area of the scalp in that area; Back region \[24%\], Left Region \[18%\], Right Region \[18%\], Top Region \[40%\]), 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. SALT50 response indicates at least a 50% improvement from baseline in the SALT score at a particular time point, indicating 50% hair regrowth.
Percentage of Participants Achieving a Severity of Alopecia Tool (SALT) Score ≤20 at Week 24 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 its respective weighting factor (percentage surface area of the scalp in that area; Back region \[24%\], Left Region \[18%\], Right Region \[18%\], Top Region \[40%\]), 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. percentage of participants achieving an absolute SALT score ≤ 20, indicates ≤ 20% scalp hair loss.
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 The AA-IGA utilizes a 5-points scale, in which the investigator assesses scalp hair loss based on the SALT assessment. The AA-IGA measures alopecia areata severity at a single point in time(without taking into account the baseline disease condition).The participant's scalp hair loss, as it look at the time of evaluation is scored as none (0) (0% scalp hair loss), limited (1) (1%-20% scalp hair loss), moderate (2) (21%-49% scalp hair loss), severe (3) (50%-94% scalp hair loss), or very severe (4)(95%-100 % scalp hair loss).
Trial Locations
- Locations (28)
Local Institution - 0013
🇺🇸Houston, Texas, United States
Local Institution - 0025
🇵🇱Warsaw, Poland
Local Institution - 0012
🇺🇸Austin, Texas, United States
Local Institution - 0019
🇺🇸Chapel Hill, North Carolina, United States
Local Institution - 0032
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0016
🇺🇸Santa Monica, California, United States
Local Institution - 0026
🇵🇱Wroclaw, DS, Poland
Local Institution - 0018
🇺🇸Tampa, Florida, United States
Local Institution - 0011
🇺🇸Portland, Oregon, United States
Local Institution - 0036
🇺🇸New Haven, Connecticut, United States
Local Institution - 0023
🇺🇸Clinton Township, Michigan, United States
Local Institution - 0024
🇺🇸New York, New York, United States
Local Institution - 0014
🇺🇸San Antonio, Texas, United States
Local Institution - 0017
🇺🇸South Jordan, Utah, United States
Local Institution - 0003
🇦🇺Kogarah, New South Wales, Australia
Local Institution - 0009
🇨🇦Peterborough, Ontario, Canada
Local Institution - 0015
🇨🇦Winnipeg, Manitoba, Canada
Local Institution - 0010
🇨🇦Richmond Hill, Ontario, Canada
Local Institution - 0033
🇫🇷Nice, France
Local Institution - 0034
🇨🇦Montreal, Quebec, Canada
Local Institution - 0027
🇨🇦Québec, Quebec, Canada
Local Institution - 0028
🇯🇵Koto-Ku, Japan
Local Institution - 0031
🇯🇵Hamamatsu-Shi, Japan
Local Institution - 0020
🇫🇷Paris, France
Local Institution - 0030
🇯🇵Mitaka-Shi, Japan
Local Institution - 0029
🇯🇵Shinjuku-Ku, Japan
Local Institution - 0021
🇨🇦Markham, Ontario, Canada
Local Institution - 0005
🇦🇺Carlton, Victoria, Australia