This study evaluates the efficacy and safety of deuruxolitinib in Japanese Adults between 18 and 65 years of age who have 50% or greater scalp hair loss.
The efficacy and safety of deuruxolitinib in adult subjects with severe alopecia areata will be evaluated in this study, beginning with a double-blind, randomized, placebo-controlled Treatment Period of 24 weeks. Subjects between 18 and 65 years of age having at least 50% hair loss as measured by SALT and meeting eligibility criteria will be randomized to deuruxolitinib or placebo treatment. In the Open-label Extension part of the study, all participants from the Treatment Period will receive deuruxolitinib for 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
78
Deuruxolitinib will be dosed orally as tablets at a dose of 8 mg
Deuruxolitinib matching placebo will be dosed orally as tablets for up to 24 weeks and then deuruxolitinib will be dosed for up to 52 weeks
Percentage of subjects achieving an absolute SALT score of 20 or less
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Time frame: Week 24
Percentage of responders (defined as "satisfied" or "very satisfied") on the Satisfaction of Hair Patient Reported Outcome (SPRO) scale
SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Higher scores indicate the greater hair dissatisfaction.
Time frame: Week 24
Percentage of subjects achieving an absolute SALT score of 20 or less
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Time frame: Weeks 12, 16, and 20
Relative change in SALT scores from baseline
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Time frame: Weeks 4, 8, 12, 16, 20, and 24
Percentage of responders (defined as "much improved" or "very much improved") using the CGI-I
The CGI-I is a questionnaire that asks the clinician to evaluate the improvement or worsening of the participant's alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders will defined as participants with responses of 6 (much improved) or 7 (very much improved).
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Time frame: Weeks 12, 16, 20, and 24
Percentage of responders (defined as "much improved" or "very much improved") using the PGI-I
The PGI-I is a self-administered questionnaire that asks the participant to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders will be defined as participants with responses of 6 (much improved) or 7 (very much improved).
Time frame: Weeks 12, 16, 20, and 24
Change from baseline in CGI-S
The CGI-S is a questionnaire that asks the clinician to evaluate the symptom severity of the participant's alopecia areata at the time of assessment. The symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.
Time frame: Weeks 12, 16, 20, and 24
Change from baseline in PGI-S
The PGI-S is a self-administered questionnaire that asks the participant to evaluate the symptom severity of their alopecia areata at the time of assessment. Symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.
Time frame: Weeks 12, 16, 20, and 24
Percentage of subjects achieving at least a 75% relative reduction in SALT score from baseline
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Time frame: Weeks 12 and 24
Percentage of subjects achieving at least a 90% relative reduction in SALT score from baseline
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Time frame: Weeks 12 and 24
Change from baseline in the Eyebrow Clinician-Reported Outcome (ClinRO) score
The Clinician-Reported Outcome Measure of Eyebrow Hair is a clinician-rated scale that assesses the total eyebrow hair present, with scores ranging from 0 to 3. A score of 0 indicates full eyebrow coverage with no areas of hair loss, and a score of 3 indicates no notable eyebrow hair. Higher scores indicate worse outcomes (greater hair loss).
Time frame: Weeks 12 and 24
Change from baseline in the Eyelash Clinician-Reported Outcome (ClinRO) score
The Clinician-Reported Outcome Measure of Eyelash Hair is a clinician-rated scale that assesses the total eyelash hair present, with scores ranging from 0 to 3. A score of 0 indicates that eyelashes form a continuous line along the eyelids on both eyes, and a score of 3 indicates no notable eyelashes. Higher scores indicate worse outcomes (greater hair loss).
Time frame: Weeks 12 and 24
Percentage of responders (defined as "satisfied" or "very satisfied") on the Satisfaction of Hair Patient Reported Outcome (SPRO) scale
SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Higher scores indicate the greater hair dissatisfaction.
Time frame: Weeks 12, 16, and 20
Change from baseline in SPRO scale
SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Higher scores indicate the greater hair dissatisfaction.
Time frame: Weeks 12, 16, 20, and 24
Percentage of subjects achieving a 2-point or greater improvement from baseline in SPRO scale
SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Higher scores indicate the greater hair dissatisfaction.
Time frame: Weeks 12, 16, 20, and 24
Change from baseline on the individual items of the Quality of Hair Patient Reported Outcome (QPRO) scale
The QPRO questionnaire provides additional details on key attributes of hair and helps provide context to the SPRO response. The individual items of QPRO are: Satisfied thickness hair coverage; Satisfied evenness hair coverage; How satisfied with your eyebrows; How satisfied with your eyelashes, scored on a scale ranging from 1 to 5 where 1=very satisfied, 2=satisfied, 3=neither satisfied nor dissatisfied, 4=dissatisfied, 5=very dissatisfied. Higher scores indicate the greater dissatisfaction on hair quality. A negative change from baseline indicate the greater satisfaction on hair quality.
Time frame: Weeks 12, 16, 20, and 24
Change from baseline in the depression scale of the Hospital Anxiety and Depression Scale (HADS)
HADS is a questionnaire designed to assess anxiety and depression symptoms which is completed by participants. The questionnaire is comprised of two separate scales with a total of 14 items: A 7-item scale related to anxiety and 7-item scale related to depression. Each item within both scales is scored using a 4-point scale, ranging from 0 to 3 and the total scores in each scale can range from 0 to 21. Separate scores were created for anxiety and depression. A score between 0-7 is considered normal, 8-10 is mild, 11-14 is moderate, and \>14 is severe anxiety or depression. Higher scores indicate greater severity. A negative change from baseline indicates less severity.
Time frame: Week 24
Change from baseline in the anxiety scale of the Hospital Anxiety and Depression Scale (HADS)
HADS is a questionnaire designed to assess anxiety and depression symptoms which is completed by participants. The questionnaire is comprised of two separate scales with a total of 14 items: A 7-item scale related to anxiety and 7-item scale related to depression. Each item within both scales is scored using a 4-point scale, ranging from 0 to 3 and the total scores in each scale can range from 0 to 21. Separate scores were created for anxiety and depression. A score between 0-7 is considered normal, 8-10 is mild, 11-14 is moderate, and \>14 is severe anxiety or depression. Higher scores indicate greater severity. A negative change from baseline indicates less severity.
Time frame: Week 24
Percentage of subjects achieving an absolute SALT score of 20 or less
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Time frame: Weeks 4 and 8
Percentage of subjects achieving an absolute SALT score of 10 or less
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Time frame: Weeks 4, 8, 12, 16, 20, and 24