Change in SALT score in each treatment group at 48 compares to baseline
The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time. The scalp is divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). The percentage of hair loss in these areas is multiplied by the percent surface area of the scalp in that area. The SALT score is the sum of the percentage of hair loss in all areas. The SALT score ranges from 0 (no hair loss) to 100 (complete scalp hair loss), with a lower score indicating better health outcomes/less hair loss.
Change in SALT score in each treatment group at Week 96 compared to baseline
The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time. The scalp is divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). The percentage of hair loss in these areas is multiplied by the percent surface area of the scalp in that area. The SALT score is the sum of the percentage of hair loss in all areas. The SALT score ranges from 0 (no hair loss) to 100 (complete scalp hair loss), with a lower score indicating better health outcomes/less hair loss.
Proportion of subjects achieving an absolute SALT score of ≤ 20 at Week 48 in dupilumab vs. placebo-treated subjects
The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time. The scalp is divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). The percentage of hair loss in these areas is multiplied by the percent surface area of the scalp in that area. The SALT score is the sum of the percentage of hair loss in all areas. The SALT score ranges from 0 (no hair loss) to 100 (complete scalp hair loss), with a lower score indicating better health outcomes/less hair loss.
Proportion of subjects achieving an absolute SALT score of ≤ 20 at Week 48 in each treatment group
The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time. The scalp is divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). The percentage of hair loss in these areas is multiplied by the percent surface area of the scalp in that area. The SALT score is the sum of the percentage of hair loss in all areas. The SALT score ranges from 0 (no hair loss) to 100 (complete scalp hair loss), with a lower score indicating better health outcomes/less hair loss.
Proportion of subjects achieving an absolute SALT score of ≤ 20 at Week 96 in each treatment group
The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time. The scalp is divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). The percentage of hair loss in these areas is multiplied by the percent surface area of the scalp in that area. The SALT score is the sum of the percentage of hair loss in all areas. The SALT score ranges from 0 (no hair loss) to 100 (complete scalp hair loss), with a lower score indicating better health outcomes/less hair loss.
Proportion of subjects achieving Improvement in SALT score at Week 48 in dupilumab vs placebo-treated subjects
The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss. The proportion of subjects achieving at least 30%/50%/75%/90% improvement in Severity of Alopecia Tool (SALT) score (SALT-30/50/75/90) at Week 48 in dupilumab compared to placebo.
Proportion of subjects achieving Improvement in SALT score at Week 48 in each treatment group
Proportion of subjects achieving Improvement in SALT score. The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss. The proportion of subjects achieving at least 30%/50%/75%/90% improvement in Severity of Alopecia Tool (SALT) score (SALT-30/50/75/90) at Week 48 in each treatment group.
Proportion of subjects achieving Improvement in SALT score at 96 in each treatment group
Proportion of subjects achieving Improvement in SALT score. The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss. The proportion of subjects achieving at least 30%/50%/75%/90% improvement in Severity of Alopecia Tool (SALT) score (SALT-30/50/75/90) at Week 48 in each treatment group.
Change in the Alopecia Areata Symptom Impact Scale (AASIS) at Week 48 in dupilumab vs placebo-treated
The AASIS is a 13-item, disease specific measure that asks patients with AA about the severity of their symptoms and how these symptoms interfere with their daily functioning. The AASIS uses a 0-10 numeric rating scale that patients find simple to understand and that is easily translated into different languages. AASIS scale 0-10: 0 indicates the symptom was not present and 10 indicates the symptom was as bad as one can imagine, where higher scores indicate worse symptoms.
Change in the Alopecia Areata Symptom Impact Scale (AASIS) at Week 48 in each treatment group
The AASIS is a 13-item, disease specific measure that asks patients with AA about the severity of their symptoms and how these symptoms interfere with their daily functioning. The AASIS uses a 0-10 numeric rating scale that patients find simple to understand and that is easily translated into different languages. AASIS scale 0-10: 0 indicates the symptom was not present and 10 indicates the symptom was as bad as one can imagine, where higher scores indicate worse symptoms.
Change in the Alopecia Areata Symptom Impact Scale (AASIS) at Week 96 in each treatment group
The AASIS is a 13-item, disease specific measure that asks patients with AA about the severity of their symptoms and how these symptoms interfere with their daily functioning. The AASIS uses a 0-10 numeric rating scale that patients find simple to understand and that is easily translated into different languages. AASIS scale 0-10: 0 indicates the symptom was not present and 10 indicates the symptom was as bad as one can imagine, where higher scores indicate worse symptoms.
Patient's Global Impression of Change (PGIC) Scale score at Week 48 in dupilumab vs. placebo-treated subjects
PGIC is a self-administered questionnaire evaluating improvement or worsening of the participant's alopecia areata as compared to the start of the study and uses a single item, "Since the start of the study, my alopecia areata has…", with 7 responses ranging from 0 "no change or worse" to 7 "a great deal better" where higher scores indicate greater improvement.
Patient's Global Impression of Change (PGIC) Scale score at Week 48 in each treatment group
PGIC is a self-administered questionnaire evaluating improvement or worsening of the participant's alopecia areata as compared to the start of the study and uses a single item, "Since the start of the study, my alopecia areata has…", with 7 responses ranging from 0 "no change or worse" to 7 "a great deal better" where higher scores indicate greater improvement.
Patient's Global Impression of Change (PGIC) Scale score at Week 96 in each treatment group
PGIC is a self-administered questionnaire evaluating improvement or worsening of the participant's alopecia areata as compared to the start of the study and uses a single item, "Since the start of the study, my alopecia areata has…", with 7 responses ranging from 0 "no change or worse" to 7 "a great deal better" where higher scores indicate greater improvement.
Proportion of subjects achieving Alopecia Areata Physician's Global Assessment (aaPGA) = 0-1 at Week 48 in dupilumab vs placebo-treated subjects
The proportion of alopecia areata subjects with aaPGA score of 0 or 1 at Week 48. The aaPGA is used to assess the clinical response to treatment based on a 6-point scale ranging from 0 (no regrowth) to 5 (100% regrowth), where higher scores indicate greater hair regrowth.
Proportion of subjects achieving Alopecia Areata Physician's Global Assessment (aaPGA) = 0-1 at Week 48 in each treatment group
The proportion of alopecia areata subjects with aaPGA score of 0 or 1 at Week 48. The aaPGA is used to assess the clinical response to treatment based on a 6-point scale ranging from 0 (no regrowth) to 5 (100% regrowth), where higher scores indicate greater hair regrowth.
Proportion of subjects achieving Alopecia Areata Physician's Global Assessment (aaPGA) = 0-1 at Week 96 in each treatment group
The proportion of alopecia areata subjects with aaPGA score of 0 or 1 at Week 96. The aaPGA is used to assess the clinical response to treatment based on a 6-point scale ranging from 0 (no regrowth) to 5 (100% regrowth), where higher scores indicate greater hair regrowth.
Number of adverse events reported
Number of adverse events reported throughout the study. The adverse event will be described and categorized as treatment emergent, serious, abnormal in vital signs, and abnormal in lab parameters.