A Phase 3 interventional study of Rocatinlimab and Placebo in Atopic Dermatitis, sponsored by Amgen. Completed at 246 sites in 22 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent participants.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 532 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with loading dose at Week 2 (+ topical corticosteroids (TCS)/ topical calcineurin inhibitor (TCI) if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 1 Q4W or every 8 weeks (Q8W) for 28 weeks (+ TCS/TCI if within combination therapy cohort).
Drug: Rocatinlimab
Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 2 Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 2 Q4W or Q8W for 28 weeks (with TCS/TCI if within combination therapy cohort).
Drug: Rocatinlimab
Part 1 (Initial Period); Week 0 to Week 24: Placebo Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be reassigned at Week 24 with Placebo Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort).
Drug: Placebo
Part 2; Week 24 to Week 52: Part 1 Non-Responders will be reassigned at Week 24 with Rocatinlimab Open-label Dose 1 Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort). Participants in Arms A, B or C Maintenance Period will be reassigned with Rocatinlimab Open-label Dose 1 Q4W (with TCS/TCI if within combination therapy cohort) upon relapse after Week 24.
Drug: Rocatinlimab
Subcutaneous (SC) injection
Also known as: AMG 451
SC injection
Number of Participants Who Achieved vIGA-AD 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24
vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity. Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'. For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?" If "Yes," participant met rIGA 0/1; if "No," they did not. If vIGA-AD = 0, participant met rIGA 0/1. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Time frame: Baseline and Week 24
Number of Participants Who Achieved EASI 75 at Week 24
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Time frame: Baseline and Week 24
Number of Participants Who Achieved EASI 75 at Week 16
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Time frame: Baseline and Week 16
Number of Participants Who Achieved vIGA-AD 0/1 at Week 16
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe. Higher scores indicated greater disease severity. Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Time frame: Baseline and Week 16
Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Time frame: Baseline and Week 16
Number of Participants Who Achieved vIGA-AD 0/1 at Week 24
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe. Higher scores indicated greater disease severity. Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Time frame: Baseline and Week 24
Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Only participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Time frame: Baseline and Week 24
Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
The EASI was designed by modifying the Psoriasis Area and Severity Index, widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 90 was defined as a ≥ 90% improvement from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Time frame: Baseline and Week 24
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
AD skin pain was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Time frame: Baseline and Week 24
Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 16
Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.
Time frame: Up to Week 16
Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 24
Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.
Time frame: Up to Week 24
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
The Worst Pruritus was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (worst observation carried forward \[WOCF\]) to all subsequent time points. A negative change from baseline indicated a reduction in itch intensity.
Time frame: Baseline and Week 16
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
The Worst Pruritus was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in itch intensity.
Time frame: Baseline and Week 24
Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data. Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD severity.
Time frame: Baseline and Week 16
Change From Baseline in SCORAD Itch VAS Score at Week 24
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data. Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD severity.
Time frame: Baseline and Week 24
Number of Participants ≥ 16 Years Old at Enrollment Who Achieved ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI ≥ 4
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of adolescent patients suffering from skin disease. The DLQI measured participants' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Time frame: Baseline and Week 24
Change From Baseline in DLQI Score at Week 24 For Participants ≥ 16 Years Old at Enrollment
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of adolescent patients suffering from skin disease. The DLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
Time frame: Baseline and Week 24
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 24 For Participants < 16 Years Old at Enrollment
The CDLQI was a 10-item questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of child patients suffering from skin disease. The CDLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
Time frame: Baseline and Week 24
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants With Baseline POEM Score ≥ 4
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD. It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Time frame: Baseline and Week 24
Change From Baseline in POEM Score at Week 24
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD. It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD.
Time frame: Baseline and Week 24
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Time frame: Baseline and Week 16
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD skin pain intensity.
Time frame: Baseline and Week 24
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD skin pain intensity.
Time frame: Baseline and Week 16
Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Time frame: Baseline and Week 24
Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Time frame: Baseline and Week 16
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Average of Daily Sleep Disturbance NRS Score was defined as the mean of daily scores reported by participants in an electronic diary assessing the quality of their sleep over the past 24 hours. Sleep disturbance was measured using an NRS consisting of a single item ranging from 0 to 10, where 10 indicated the highest level of sleep disturbance. Participants were asked to rate the intensity of their sleep disturbance using this scale each day. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in level of sleep disturbance.
Time frame: Baseline and Week 24
Number of Participants Who Achieved Hospital Anxiety and Depression Scale (HADS)-Anxiety Subscale Score < 8 at Week 24 in Participants With Baseline HADS-anxiety Subscale Score ≥ 8
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-anxiety subscale score ranged from 0 to 21, with higher scores representing worse anxiety. Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Time frame: Baseline and Week 24
Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-depression subscale score ranged from 0 to 21, with higher scores representing worse depression. Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Time frame: Baseline and Week 24
Change From Baseline in HADS-anxiety Subscale Score at Week 24
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-Anxiety subscale score ranged from 0 to 21, with higher scores representing worse anxiety. Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the anxiety.
Time frame: Baseline and Week 24
Change From Baseline in HADS-depression Subscale Score at Week 24
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-depression subscale score ranged from 0 to 21, with higher scores representing worse depression. Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the depression.
Time frame: Baseline and Week 24
Number of Participants Who Achieved a ≥ 8.7-point Reduction From Baseline in SCORAD Total Score at Week 24 in Participants With Baseline SCORAD Total Score ≥ 8.7
The SCORAD total score used to assess the severity of AD using both physician and patient-reported data. SCORAD total score ranged from 0 to 103 with a higher score indicating more severe AD. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Time frame: Baseline and Week 24
This trial was conducted at 247 centers in Asia, Europe, Latin America, and North America between April 2023 to November 2025. Adolescent participants with moderate to severe atopic dermatitis (AD) were randomized 4:3:3 into 3 treatment groups during initiation period (24 Weeks).
| Milestone | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI | Maintenance Period: Placebo ± TCS/TCI | Maintenance Period: Roca 150mg Q8W ± TCS/TCI | Maintenance Period: Roca 150mg Q4W ± TCS/TCI | Maintenance Period: Roca 300mg Q8W ± TCS/TCI | Maintenance Period: Roca 300mg Q4W ± TCS/TCI | OLRT Period: Roca 300mg Q4W OL From Placebo | OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q8W | OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q4W | OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q8W | OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q4W | Open-label Period: Roca 300mg Q4W OL From Placebo | Open-label Period: Roca 300mg Q4W OL From Roca 150mg Q4W | Open-label Period: Roca 300mg Q4W OL From Roca 300mg Q4W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 157 | 158 | 217 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Full analysis set (fas) | 157 | 158 | 217 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Participants received investigational product (ip) | 157 | 157 | 215 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 141 | 144 | 203 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 16 | 14 | 14 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Decision by sponsor | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Ineligibility determined | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Non-compliance | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Participant request | 13 | 9 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Requirement for alternative therapy | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Participants never received ip | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI | Maintenance Period: Placebo ± TCS/TCI | Maintenance Period: Roca 150mg Q8W ± TCS/TCI | Maintenance Period: Roca 150mg Q4W ± TCS/TCI | Maintenance Period: Roca 300mg Q8W ± TCS/TCI | Maintenance Period: Roca 300mg Q4W ± TCS/TCI | OLRT Period: Roca 300mg Q4W OL From Placebo | OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q8W | OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q4W | OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q8W | OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q4W | Open-label Period: Roca 300mg Q4W OL From Placebo | Open-label Period: Roca 300mg Q4W OL From Roca 150mg Q4W | Open-label Period: Roca 300mg Q4W OL From Roca 300mg Q4W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 34 | 48 | 43 | 33 | 88 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 16 | 39 | 37 | 25 | 73 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 18 | 9 | 6 | 8 | 15 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Non-compliance | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Participant request | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Switched to olrt | 0 | 0 | 0 | 15 | 7 | 5 | 7 | 14 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI | Maintenance Period: Placebo ± TCS/TCI | Maintenance Period: Roca 150mg Q8W ± TCS/TCI | Maintenance Period: Roca 150mg Q4W ± TCS/TCI | Maintenance Period: Roca 300mg Q8W ± TCS/TCI | Maintenance Period: Roca 300mg Q4W ± TCS/TCI | OLRT Period: Roca 300mg Q4W OL From Placebo | OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q8W | OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q4W | OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q8W | OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q4W | Open-label Period: Roca 300mg Q4W OL From Placebo | Open-label Period: Roca 300mg Q4W OL From Roca 150mg Q4W | Open-label Period: Roca 300mg Q4W OL From Roca 300mg Q4W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 15 | 7 | 5 | 7 | 14 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 13 | 7 | 5 | 6 | 14 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Participant request | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Milestone | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI | Maintenance Period: Placebo ± TCS/TCI | Maintenance Period: Roca 150mg Q8W ± TCS/TCI | Maintenance Period: Roca 150mg Q4W ± TCS/TCI | Maintenance Period: Roca 300mg Q8W ± TCS/TCI | Maintenance Period: Roca 300mg Q4W ± TCS/TCI | OLRT Period: Roca 300mg Q4W OL From Placebo | OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q8W | OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q4W | OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q8W | OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q4W | Open-label Period: Roca 300mg Q4W OL From Placebo | Open-label Period: Roca 300mg Q4W OL From Roca 150mg Q4W | Open-label Period: Roca 300mg Q4W OL From Roca 300mg Q4W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 107 | 53 | 82 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 102 | 51 | 73 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 2 | 9 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 |
| Withdrew: Participant request | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 4 |
| Withdrew: Protocol deviation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Protocol specified criteria | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 3 |
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
| Participants | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Number of Participants Who Achieved EASI 75 at Week 16 | 43 | 83 | 113 |
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe. Higher scores indicated greater disease severity. Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
| Participants | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Number of Participants Who Achieved vIGA-AD 0/1 at Week 16 | 20 | 34 | 60 |
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
| Participants | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4 | 20 | 38 | 60 |
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe. Higher scores indicated greater disease severity. Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
| Participants | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Number of Participants Who Achieved vIGA-AD 0/1 at Week 24 | 19 | 63 | 89 |
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Only participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
| Participants | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4 | 16 | 41 | 68 |
The EASI was designed by modifying the Psoriasis Area and Severity Index, widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 90 was defined as a ≥ 90% improvement from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
| Participants | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24 | 21 | 63 | 88 |
AD skin pain was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
| Participants | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4 | 17 | 41 | 62 |
Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.
| percentage of participants | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 16 | 17.2 | 8.9 | 10.6 |
Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.
| percentage of participants | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 24 | 24.2 | 10.8 | 11.5 |
The Worst Pruritus was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (worst observation carried forward \[WOCF\]) to all subsequent time points. A negative change from baseline indicated a reduction in itch intensity.
| score on a scale | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16 | -1.16 ± 0.28 | -2.44 ± 0.28 | -2.61 ± 0.25 |
The Worst Pruritus was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in itch intensity.
| score on a scale | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 | -0.91 ± 0.29 | -2.60 ± 0.29 | -2.84 ± 0.26 |
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data. Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD severity.
| score on a scale | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16 | -1.5 ± 0.3 | -2.9 ± 0.3 | -3.2 ± 0.3 |
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data. Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD severity.
| score on a scale | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Change From Baseline in SCORAD Itch VAS Score at Week 24 | -1.1 ± 0.3 | -3.2 ± 0.3 | -3.5 ± 0.3 |
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of adolescent patients suffering from skin disease. The DLQI measured participants' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
| Participants | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Number of Participants ≥ 16 Years Old at Enrollment Who Achieved ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI ≥ 4 | 14 | 27 | 47 |
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of adolescent patients suffering from skin disease. The DLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
| score on a scale | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Change From Baseline in DLQI Score at Week 24 For Participants ≥ 16 Years Old at Enrollment | -1.6 ± 0.8 | -5.1 ± 0.8 | -6.4 ± 0.7 |
The CDLQI was a 10-item questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of child patients suffering from skin disease. The CDLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
| score on a scale | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 24 For Participants < 16 Years Old at Enrollment | -3.4 ± 0.5 | -5.4 ± 0.5 | -5.6 ± 0.5 |
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD. It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
| Participants | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants With Baseline POEM Score ≥ 4 | 54 | 103 | 143 |
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD. It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD.
| score on a scale | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Change From Baseline in POEM Score at Week 24 | -1.7 ± 0.9 | -6.9 ± 0.8 | -7.7 ± 0.8 |
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
| Participants | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4 | 22 | 38 | 56 |
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD skin pain intensity.
| score on a scale | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 | -0.80 ± 0.29 | -2.31 ± 0.29 | -2.37 ± 0.26 |
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD skin pain intensity.
| score on a scale | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 | -1.19 ± 0.28 | -2.26 ± 0.28 | -2.20 ± 0.26 |
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
| Participants | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3 | 22 | 57 | 75 |
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
| Participants | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3 | 32 | 50 | 78 |
Average of Daily Sleep Disturbance NRS Score was defined as the mean of daily scores reported by participants in an electronic diary assessing the quality of their sleep over the past 24 hours. Sleep disturbance was measured using an NRS consisting of a single item ranging from 0 to 10, where 10 indicated the highest level of sleep disturbance. Participants were asked to rate the intensity of their sleep disturbance using this scale each day. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in level of sleep disturbance.
| score on a scale | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24 | -1.07 ± 0.27 | -2.22 ± 0.27 | -2.12 ± 0.25 |
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-anxiety subscale score ranged from 0 to 21, with higher scores representing worse anxiety. Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
| Participants | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Number of Participants Who Achieved Hospital Anxiety and Depression Scale (HADS)-Anxiety Subscale Score < 8 at Week 24 in Participants With Baseline HADS-anxiety Subscale Score ≥ 8 | 10 | 13 | 14 |
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-depression subscale score ranged from 0 to 21, with higher scores representing worse depression. Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
| Participants | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8 | 3 | 9 | 6 |
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-Anxiety subscale score ranged from 0 to 21, with higher scores representing worse anxiety. Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the anxiety.
| score on a scale | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Change From Baseline in HADS-anxiety Subscale Score at Week 24 | -0.4 ± 0.3 | -0.8 ± 0.3 | -0.7 ± 0.3 |
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-depression subscale score ranged from 0 to 21, with higher scores representing worse depression. Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the depression.
| score on a scale | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Change From Baseline in HADS-depression Subscale Score at Week 24 | 0.3 ± 0.3 | -0.2 ± 0.3 | 0.1 ± 0.2 |
The SCORAD total score used to assess the severity of AD using both physician and patient-reported data. SCORAD total score ranged from 0 to 103 with a higher score indicating more severe AD. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
| Participants | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Number of Participants Who Achieved a ≥ 8.7-point Reduction From Baseline in SCORAD Total Score at Week 24 in Participants With Baseline SCORAD Total Score ≥ 8.7 | 78 | 117 | 161 |
vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity. Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'. For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?" If "Yes," participant met rIGA 0/1; if "No," they did not. If vIGA-AD = 0, participant met rIGA 0/1. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
| Participants | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Number of Participants Who Achieved vIGA-AD 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24 | 17 | 56 | 79 |
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
| Participants | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI |
|---|---|---|---|
| Number of Participants Who Achieved EASI 75 at Week 24 | 38 | 90 | 132 |
Collected over For mortality, from randomization until the end of trial; median (min, max) time on trial was 52.1 (0.1, 78.0) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 52.1 (1.3, 78.0) weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Initiation Period: Placebo ± TCS/TCI | 0/157 (0%) | 6/157 (3.8%) | 65/157 (41.4%) |
| Initiation Period: Roca 150mg Q4W ± TCS/TCI | 0/157 (0%) | 2/156 (1.3%) | 88/156 (56.4%) |
| Initiation Period: Roca 300mg Q4W ± TCS/TCI | 0/218 (0%) | 4/216 (1.9%) | 122/216 (56.5%) |
| Maintenance Period: Placebo ± TCS/TCI | 0/34 (0%) | 1/34 (2.9%) | 13/34 (38.2%) |
| Maintenance Period: Roca 150mg Q8W ± TCS/TCI | 0/48 (0%) | 1/48 (2.1%) | 22/48 (45.8%) |
| Maintenance Period: Roca 150mg Q4W ± TCS/TCI | 0/43 (0%) | 1/43 (2.3%) | 21/43 (48.8%) |
| Maintenance Period: Roca 300mg Q8W ± TCS/TCI | 0/33 (0%) | 1/33 (3%) | 13/33 (39.4%) |
| Maintenance Period: Roca 300mg Q4W ± TCS/TCI | 0/88 (0%) | 1/88 (1.1%) | 28/88 (31.8%) |
| OLRT Period: Roca 300mg Q4W OL From Placebo | 0/15 (0%) | 0/15 (0%) | 7/15 (46.7%) |
| OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q8W | 0/7 (0%) | 0/7 (0%) | 2/7 (28.6%) |
| OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q4W | 0/5 (0%) | 0/5 (0%) | 1/5 (20%) |
| OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q8W | 0/7 (0%) | 0/7 (0%) | 2/7 (28.6%) |
| OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q4W | 0/14 (0%) | 0/14 (0%) | 6/14 (42.9%) |
| Open-label Period: Roca 300mg Q4W OL From Placebo | 0/107 (0%) | 5/107 (4.7%) | 45/107 (42.1%) |
| Open-label Period: Roca 300mg Q4W OL From Roca 150mg Q4W | 0/53 (0%) | 1/53 (1.9%) | 24/53 (45.3%) |
| Open-label Period: Roca 300 mg Q4W OL From Roca 300mg Q4W | 0/82 (0%) | 1/81 (1.2%) | 39/81 (48.1%) |
| Event | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI | Maintenance Period: Placebo ± TCS/TCI | Maintenance Period: Roca 150mg Q8W ± TCS/TCI | Maintenance Period: Roca 150mg Q4W ± TCS/TCI | Maintenance Period: Roca 300mg Q8W ± TCS/TCI | Maintenance Period: Roca 300mg Q4W ± TCS/TCI | OLRT Period: Roca 300mg Q4W OL From Placebo | OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q8W | OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q4W | OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q8W | OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q4W | Open-label Period: Roca 300mg Q4W OL From Placebo | Open-label Period: Roca 300mg Q4W OL From Roca 150mg Q4W | Open-label Period: Roca 300 mg Q4W OL From Roca 300mg Q4W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Appendicitis perforatedInfections and infestations | 0/157 | 0/156 | 0/216 | 0/34 | 0/48 | 0/43 | 1/33 | 0/88 | 0/15 | 0/7 | 0/5 | 0/7 | 0/14 | 0/107 | 0/53 | 0/81 |
| GastritisGastrointestinal disorders | 0/157 | 0/156 | 0/216 | 1/34 | 0/48 | 0/43 | 0/33 | 0/88 | 0/15 | 0/7 | 0/5 | 0/7 | 0/14 | 0/107 | 0/53 | 0/81 |
| Wrist fractureInjury, poisoning and procedural complications | 0/157 | 0/156 | 0/216 | 0/34 | 0/48 | 1/43 | 0/33 | 0/88 | 0/15 | 0/7 | 0/5 | 0/7 | 0/14 | 0/107 | 0/53 | 0/81 |
| Upper respiratory tract infectionInfections and infestations | 0/157 | 0/156 | 0/216 | 0/34 | 1/48 | 0/43 | 0/33 | 0/88 | 0/15 | 0/7 | 0/5 | 0/7 | 0/14 | 0/107 | 0/53 | 0/81 |
| Inflammatory myofibroblastic tumourNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/157 | 0/156 | 0/216 | 0/34 | 0/48 | 0/43 | 0/33 | 0/88 | 0/15 | 0/7 | 0/5 | 0/7 | 0/14 | 0/107 | 1/53 | 0/81 |
| Testicular torsionReproductive system and breast disorders | 0/157 | 0/156 | 0/216 | 0/34 | 0/48 | 0/43 | 0/33 | 0/88 | 0/15 | 0/7 | 0/5 | 0/7 | 0/14 | 0/107 | 0/53 | 1/81 |
| Ligament sprainInjury, poisoning and procedural complications | 0/157 | 0/156 | 0/216 | 0/34 | 0/48 | 0/43 | 0/33 | 1/88 | 0/15 | 0/7 | 0/5 | 0/7 | 0/14 | 0/107 | 0/53 | 0/81 |
| Crohn's diseaseGastrointestinal disorders | 0/157 | 0/156 | 0/216 | 0/34 | 0/48 | 0/43 | 0/33 | 0/88 | 0/15 | 0/7 | 0/5 | 0/7 | 0/14 | 1/107 | 0/53 | 0/81 |
| PyrexiaGeneral disorders | 0/157 | 0/156 | 0/216 | 0/34 | 0/48 | 0/43 | 0/33 | 0/88 | 0/15 | 0/7 | 0/5 | 0/7 | 0/14 | 1/107 | 0/53 | 0/81 |
| Herpes simplexInfections and infestations | 0/157 | 0/156 | 0/216 | 0/34 | 0/48 | 0/43 | 0/33 | 0/88 | 0/15 | 0/7 | 0/5 | 0/7 | 0/14 | 1/107 | 0/53 | 0/81 |
| Event | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI | Maintenance Period: Placebo ± TCS/TCI | Maintenance Period: Roca 150mg Q8W ± TCS/TCI | Maintenance Period: Roca 150mg Q4W ± TCS/TCI | Maintenance Period: Roca 300mg Q8W ± TCS/TCI | Maintenance Period: Roca 300mg Q4W ± TCS/TCI | OLRT Period: Roca 300mg Q4W OL From Placebo | OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q8W | OLRT Period: Roca 300mg Q4W OL From Roca 150mg Q4W | OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q8W | OLRT Period: Roca 300mg Q4W OL From Roca 300mg Q4W | Open-label Period: Roca 300mg Q4W OL From Placebo | Open-label Period: Roca 300mg Q4W OL From Roca 150mg Q4W | Open-label Period: Roca 300 mg Q4W OL From Roca 300mg Q4W |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PyrexiaGeneral disorders | 8/157 | 37/156 | 41/216 | 0/34 | 2/48 | 2/43 | 0/33 | 1/88 | 0/15 | 0/7 | 0/5 | 0/7 | 0/14 | 9/107 | 1/53 | 2/81 |
| Mouth ulcerationGastrointestinal disorders | 0/157 | 3/156 | 9/216 | 0/34 | 2/48 | 6/43 | 0/33 | 1/88 | 0/15 | 0/7 | 1/5 | 0/7 | 2/14 | 3/107 | 2/53 | 3/81 |
| Dermatitis atopicSkin and subcutaneous tissue disorders | 24/157 | 7/156 | 12/216 | 2/34 | 0/48 | 0/43 | 0/33 | 0/88 | 0/15 | 0/7 | 0/5 | 0/7 | 0/14 | 4/107 | 1/53 | 6/81 |
| HeadacheNervous system disorders | 6/157 | 14/156 | 33/216 | 0/34 | 2/48 | 1/43 | 0/33 | 3/88 | 0/15 | 0/7 | 0/5 | 0/7 | 1/14 | 5/107 | 2/53 | 2/81 |
| InfluenzaInfections and infestations | 3/157 | 8/156 | 7/216 | 1/34 | 7/48 | 4/43 | 2/33 | 6/88 | 0/15 | 0/7 | 0/5 | 0/7 | 1/14 | 5/107 | 2/53 | 2/81 |
| Tooth impactedGastrointestinal disorders | 1/157 | 1/156 | 0/216 | 0/34 | 0/48 | 0/43 | 0/33 | 0/88 | 0/15 | 0/7 | 0/5 | 1/7 | 0/14 | 0/107 | 1/53 | 0/81 |
| Dengue feverInfections and infestations | 1/157 | 0/156 | 0/216 | 0/34 | 0/48 | 0/43 | 0/33 | 0/88 | 0/15 | 1/7 | 0/5 | 0/7 | 0/14 | 0/107 | 0/53 | 0/81 |
| TonsillitisInfections and infestations | 3/157 | 0/156 | 2/216 | 0/34 | 2/48 | 0/43 | 0/33 | 1/88 | 0/15 | 0/7 | 0/5 | 1/7 | 0/14 | 0/107 | 0/53 | 1/81 |
| Upper respiratory tract infectionInfections and infestations | 12/157 | 14/156 | 16/216 | 3/34 | 3/48 | 4/43 | 3/33 | 3/88 | 1/15 | 1/7 | 0/5 | 0/7 | 2/14 | 5/107 | 3/53 | 3/81 |
| Viral upper respiratory tract infectionInfections and infestations | 0/157 | 1/156 | 0/216 | 0/34 | 0/48 | 0/43 | 1/33 | 1/88 | 0/15 | 0/7 | 0/5 | 1/7 | 0/14 | 0/107 | 0/53 | 0/81 |
FAS: All randomized participants. Participants were analyzed according to the randomized treatment.
| Age, Continuous(years) | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI | Total |
|---|---|---|---|---|
| Mean | 14.8 ± 1.6 | 14.7 ± 1.7 | 14.6 ± 1.7 | 14.7 ± 1.7 |
| Sex: Female, Male(Participants) | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI | Total |
|---|---|---|---|---|
| Female | 69 | 77 | 109 | 255 |
| Male | 88 | 81 | 108 | 277 |
| Race/Ethnicity, Customized(Participants) | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI | Total |
|---|---|---|---|---|
| White | 91 | 79 | 116 | 286 |
| Asian | 57 | 57 | 84 | 198 |
| Black or African American | 5 | 14 | 11 | 30 |
| Other | 4 | 8 | 6 | 18 |
| Race/Ethnicity, Customized(Participants) | Initiation Period: Placebo ± TCS/TCI | Initiation Period: Roca 150mg Q4W ± TCS/TCI | Initiation Period: Roca 300mg Q4W ± TCS/TCI | Total |
|---|---|---|---|---|
| Hispanic/Latino | 21 | 27 | 34 | 82 |
| Not Hispanic/Latino | 136 | 131 | 183 | 450 |
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Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Sap, Icf, Csr
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