| Outcome Type: | Primary Outcome |
| Measure: | Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline to Week 16. |
| Time Frame: | Baseline to Week 16 |
| Safety Issues: | False |
| Description: | The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of eryth |
| Outcome Type: | Primary Outcome |
| Measure: | Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction From Baseline in EASI Score) at Week 16 |
| Time Frame: | Baseline to Week 16 |
| Safety Issues: | False |
| Description: | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) eryt |
| Outcome Type: | Secondary Outcome |
| Measure: | Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score) at Week 16 |
| Time Frame: | Baseline to Week 16 |
| Safety Issues: | False |
| Description: | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) eryt |
| Outcome Type: | Secondary Outcome |
| Measure: | Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 |
| Time Frame: | Baseline, Week 16 |
| Safety Issues: | False |
| Description: | Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Least Squares (LS) Mean was calculated using analysis covariance (ANCOVA |
| Outcome Type: | Secondary Outcome |
| Measure: | Percentage of Participants With a Pruritus NRS of ≥4-Points at Baseline Who Achieve a ≥4-Point Reduction From Baseline to Week 16 |
| Time Frame: | Baseline to Week 16 |
| Safety Issues: | False |
| Description: | Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." |
| Outcome Type: | Secondary Outcome |
| Measure: | Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 16 |
| Time Frame: | Baseline to Week 16 |
| Safety Issues: | False |
| Description: | Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." |
| Outcome Type: | Secondary Outcome |
| Measure: | Percent Change in EASI Score From Baseline at Week 16 |
| Time Frame: | Baseline, Week 16 |
| Safety Issues: | False |
| Description: | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) eryt |
| Outcome Type: | Secondary Outcome |
| Measure: | Change From Baseline to Week 16 in Percent Body Surface Area (BSA) |
| Time Frame: | Baseline, Week 16 |
| Safety Issues: | False |
| Description: | The BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% t |
| Outcome Type: | Secondary Outcome |
| Measure: | Percentage of Participants Achieving EASI-90 at Week 4 |
| Time Frame: | Baseline to Week 4 |
| Safety Issues: | False |
| Description: | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) eryt |
| Outcome Type: | Secondary Outcome |
| Measure: | Percent Change in Sleep-loss Score From Baseline to Week 16 |
| Time Frame: | Baseline, Week 16 |
| Safety Issues: | False |
| Description: | Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and |
| Outcome Type: | Secondary Outcome |
| Measure: | Change From Baseline in Sleep-loss Score at Week 16 |
| Time Frame: | Baseline, Week 16 |
| Safety Issues: | False |
| Description: | Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and |
| Outcome Type: | Secondary Outcome |
| Measure: | Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4 |
| Time Frame: | Baseline to Week 4 |
| Safety Issues: | False |
| Description: | The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. |
| Outcome Type: | Secondary Outcome |
| Measure: | Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2 |
| Time Frame: | Baseline to Week 2 |
| Safety Issues: | False |
| Description: | The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. |
| Outcome Type: | Secondary Outcome |
| Measure: | Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1 |
| Time Frame: | Baseline to Week 1 |
| Safety Issues: | False |
| Description: | The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. |
| Outcome Type: | Secondary Outcome |
| Measure: | Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4 |
| Time Frame: | Baseline to Week 4 |
| Safety Issues: | False |
| Description: | The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. |
| Outcome Type: | Secondary Outcome |
| Measure: | Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2 |
| Time Frame: | Baseline to Week 2 |
| Safety Issues: | False |
| Description: | The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. |
| Outcome Type: | Secondary Outcome |
| Measure: | Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1 |
| Time Frame: | Baseline to Week 1 |
| Safety Issues: | False |
| Description: | The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. |
| Outcome Type: | Secondary Outcome |
| Measure: | Percentage of Topical Corticosteroid (TCS)/Topical Calcineurin Inhibitors (TCI) Free Days From Baseline to Week 16 |
| Time Frame: | Baseline to Week 16 |
| Safety Issues: | False |
| Description: | Number of the total TCS/TCI free days divided by total number of days during the treatment period. The mixed model repeated measures (MMRM) includes treatment, visit, the interaction of treatment by-visit, geographic region, age group, baseline IGA score. |
| Outcome Type: | Secondary Outcome |
| Measure: | Median Time (Days) to TCS/TCI-free Use From Baseline to Week 16 |
| Time Frame: | Baseline to Week 16 |
| Safety Issues: | False |
| Description: | Days from first study drug injection to the day participant stopped using all TCS/TCI (if a participant started and stopped using low or midpotency TCS/TCI multiple times, use the last stop date as the stop date for this participant). |
| Outcome Type: | Secondary Outcome |
| Measure: | Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16 |
| Time Frame: | Baseline, Week 16 |
| Safety Issues: | False |
| Description: | The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scal |
| Outcome Type: | Secondary Outcome |
| Measure: | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 |
| Time Frame: | Baseline, Week 16 |
| Safety Issues: | False |
| Description: | The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisur |
| Outcome Type: | Secondary Outcome |
| Measure: | Percentage of Participants With a DLQI Score ≥4 Points at Baseline Who Achieve a ≥4 Points |
| Time Frame: | Baseline to Week 16 |
| Safety Issues: | False |
| Description: | The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisur |
| Outcome Type: | Secondary Outcome |
| Measure: | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Health State Index |
| Time Frame: | Baseline, Week 16 |
| Safety Issues: | False |
| Description: | The EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems |
| Outcome Type: | Secondary Outcome |
| Measure: | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Visual Analog Score (VAS) |
| Time Frame: | Baseline, Week 16 |
| Safety Issues: | False |
| Description: | The EQ-5D-5L is a 2-part measurement. The second part is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Mean was calculated using the ANCOVA model |
| Outcome Type: | Secondary Outcome |
| Measure: | Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16 |
| Time Frame: | Baseline, Week 16 |
| Safety Issues: | False |
| Description: | POEM is a 7-item, validated, questionnaire used by the participant to assess disease symptoms over the last week. The participant is asked to respond to 7 questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding and weeping. All 7 answe |
| Outcome Type: | Secondary Outcome |
| Measure: | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adults |
| Time Frame: | Baseline, Week 16 |
| Safety Issues: | False |
| Description: | PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS anxiety has 8 questions on Emotion Dis |
| Outcome Type: | Secondary Outcome |
| Measure: | Change From Baseline in PROMIS Depression at Week 16 - Adults |
| Time Frame: | Baseline, Week 16 |
| Safety Issues: | False |
| Description: | PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS depression has 8 questions on Emotion |
| Outcome Type: | Secondary Outcome |
| Measure: | Change From Baseline in PROMIS Anxiety at Week 16 - Pediatrics |
| Time Frame: | Baseline, Week 16 |
| Safety Issues: | False |
| Description: | PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on E |
| Outcome Type: | Secondary Outcome |
| Measure: | Change From Baseline in PROMIS Depression at Week 16 - Pediatrics |
| Time Frame: | Baseline, Week 16 |
| Safety Issues: | False |
| Description: | PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS depression has 8 questions o |
| Outcome Type: | Secondary Outcome |
| Measure: | Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma |
| Time Frame: | Baseline, Week 16 |
| Safety Issues: | False |
| Description: | The ACQ-5 has been shown to reliably measure asthma control and distinguish participants with well-controlled asthma (score ≤0.75 points) from those with uncontrolled asthma (score ≥1.5 points). It consists of 5 questions that are scored on a 7- point Lik |
| Outcome Type: | Secondary Outcome |
| Measure: | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16 |
| Time Frame: | Baseline, Week 16 |
| Safety Issues: | False |
| Description: | The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. The scoring of e |