Trial Outcomes & Findings for A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon) (NCT NCT05651711)

Results Overview

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," the participant met rIGA 0/1; if "No," they did not. If vIGA-AD = 0, the participant met rIGA 0/1. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

726 participants

Primary outcome timeframe

Baseline and Week 24

Results posted on

2026-06-26

Participant Flow

This trial was conducted at 151 centers in North America, Europe, Asia, Oceania, Latin America, and Africa between 14 December 2022 to 27 August 2024.

Participants with moderate-to-severe atopic dermatitis (AD) were randomized in a 3:1 ratio into two treatment groups for a duration of 24 weeks to receive either rocatinlimab or matching placebo.

Participant milestones

Participant milestones
Measure	Placebo Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Overall Study STARTED	183	543
Overall Study COMPLETED	155	481
Overall Study NOT COMPLETED	28	62

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants were administered matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Overall Study Decision by sponsor	1	3
Overall Study Withdrawal by Subject	21	49
Overall Study Lost to Follow-up	6	10

Baseline Characteristics

A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=183 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=543 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.	Total n=726 Participants Total of all reporting groups
Age, Continuous	40.4 years STANDARD_DEVIATION 15.6 • n=20 Participants	37.8 years STANDARD_DEVIATION 14.6 • n=20 Participants	38.4 years STANDARD_DEVIATION 14.9 • n=40 Participants
Sex: Female, Male Female	81 Participants n=20 Participants	248 Participants n=20 Participants	329 Participants n=40 Participants
Sex: Female, Male Male	102 Participants n=20 Participants	295 Participants n=20 Participants	397 Participants n=40 Participants
Race/Ethnicity, Customized Hispanic/Latino	22 Participants n=20 Participants	63 Participants n=20 Participants	85 Participants n=40 Participants
Race/Ethnicity, Customized Not Hispanic/Latino	161 Participants n=20 Participants	480 Participants n=20 Participants	641 Participants n=40 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=20 Participants	15 Participants n=20 Participants	17 Participants n=40 Participants
Race/Ethnicity, Customized Asian	61 Participants n=20 Participants	161 Participants n=20 Participants	222 Participants n=40 Participants
Race/Ethnicity, Customized Black or African American	10 Participants n=20 Participants	19 Participants n=20 Participants	29 Participants n=40 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=20 Participants	3 Participants n=20 Participants	3 Participants n=40 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=20 Participants	2 Participants n=20 Participants	3 Participants n=40 Participants
Race/Ethnicity, Customized White	107 Participants n=20 Participants	325 Participants n=20 Participants	432 Participants n=40 Participants
Race/Ethnicity, Customized Other	2 Participants n=20 Participants	18 Participants n=20 Participants	20 Participants n=40 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to randomized treatment.

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," the participant met rIGA 0/1; if "No," they did not. If vIGA-AD = 0, the participant met rIGA 0/1. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=543 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Number of Participants Who Achieved Validated Investigator's Global Assessment for AD (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	9 Participants	89 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.

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.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=543 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24	25 Participants	178 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.

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.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=543 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Number of Participants Who Achieved EASI 75 at Week 16	23 Participants	159 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.

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.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=543 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Number of Participants Who Achieved a vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) (vIGA-AD 0/1) at Week 16	5 Participants	69 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline weekly average of daily worst pruritus NRS score ≥ 4 were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Placebo n=162 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=505 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
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	18 Participants	110 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline weekly average of daily worst pruritus NRS score ≥ 4 were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Placebo n=162 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=505 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
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	17 Participants	121 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.

The 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 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.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=543 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24	9 Participants	108 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline weekly average of AD skin pain NRS score ≥ 4 were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Placebo n=138 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=418 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
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	14 Participants	109 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.

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.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=543 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Number of Participants Who Achieved a vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) With a ≥ 2-Point Reduction From Baseline (vIGA-AD 0/1) at Week 24	12 Participants	105 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with facial AD severity scale ≥ 1 at baseline were included in the analysis.

The severity of facial AD was assessed using the Facial AD Severity Scale (FASS). The FASS was an instrument used to rate the overall severity of facial AD based on a 5-category scale: clear (0), almost clear (1), mild (2), moderate (3), and severe (4), with higher scores indicating more severe disease. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

Outcome measures

Outcome measures
Measure	Placebo n=153 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=468 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Number of Participants Who Achieved Facial AD Severity Score of Clear at Week 24 for Participants With Facial AD at Baseline	9 Participants	84 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with hand AD severity scale ≥ 1 at baseline were included in the analysis.

The severity of hand AD was assessed using the Hand Atopic Dermatitis Severity Scale (HASS). The HASS was an instrument used to rate the overall severity of hand AD based on a 5-category scale: clear (0), almost clear (1), mild (2), moderate (3), and severe (4), with higher scores indicating more severe disease. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=405 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Number of Participants Who Achieved Hand AD Severity Score of Clear at Week 24 for Participants With Hand AD at Baseline	6 Participants	65 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.

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 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.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=543 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16	-0.38 score on a scale Standard Error 0.21 • Interval 0.21 to	-1.59 score on a scale Standard Error 0.15 • Interval 0.15 to

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.

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 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.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=543 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24	-0.29 score on a scale Standard Error 0.23 • Interval 0.23 to	-1.71 score on a scale Standard Error 0.17 • Interval 0.17 to

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.

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 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.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=543 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16	-0.6 score on a scale Standard Error 0.3 • Interval 0.3 to	-2.1 score on a scale Standard Error 0.2 • Interval 0.2 to

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.

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 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.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=543 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Change From Baseline in SCORAD Itch VAS Score at Week 24	-0.5 score on a scale Standard Error 0.3 • Interval 0.3 to	-2.1 score on a scale Standard Error 0.2 • Interval 0.2 to

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline DLQI ≥ 4 were included in the analysis.

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 adult 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.

Outcome measures

Outcome measures
Measure	Placebo n=171 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=496 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI ≥ 4	43 Participants	228 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.

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 adult 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.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=543 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Change From Baseline in DLQI Score at Week 24	-0.6 score on a scale Standard Error 0.6 • Interval 0.6 to	-3.7 score on a scale Standard Error 0.4 • Interval 0.4 to

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline POEM score ≥ 4 were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Placebo n=178 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=530 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
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	45 Participants	250 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.

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.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=543 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Change From Baseline in POEM Score at Week 24	-0.8 score on a scale Standard Error 0.7 • Interval 0.7 to	-5.3 score on a scale Standard Error 0.5 • Interval 0.5 to

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline weekly average of AD skin pain NRS score ≥ 4 were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Placebo n=138 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=418 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4	21 Participants	95 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.

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.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=543 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24	0.00 score on a scale Standard Error 0.23 • Interval 0.23 to	-1.47 score on a scale Standard Error 0.16 • Interval 0.16 to

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.

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.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=543 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16	-0.24 score on a scale Standard Error 0.22 • Interval 0.22 to	-1.33 score on a scale Standard Error 0.16 • Interval 0.16 to

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline weekly average of daily AD skin pain NRS score ≥ 3 were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Placebo n=153 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=451 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
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	21 Participants	148 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline weekly average of daily AD skin pain NRS score ≥ 3 were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Placebo n=153 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=451 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
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	23 Participants	132 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.

Weekly 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.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=543 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24	-0.22 score on a scale Standard Error 0.23 • Interval 0.23 to	-1.29 score on a scale Standard Error 0.16 • Interval 0.16 to

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline HADS-anxiety subscale score ≥ 8 were included in the analysis.

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 a greater impact of AD. 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.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=102 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
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 Participants	30 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline HADS-depression subscale score ≥ 8 were included in the analysis.

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 a greater impact of AD. 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.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=85 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8	9 Participants	29 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.

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 a greater impact of AD. 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 impact of AD.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=543 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Change From Baseline in HADS-anxiety Subscale Score at Week 24	0.7 score on a scale Standard Error 0.2 • Interval 0.2 to	-0.1 score on a scale Standard Error 0.2 • Interval 0.2 to

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment.

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 a greater impact of AD. 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 impact of AD.

Outcome measures

Outcome measures
Measure	Placebo n=183 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=543 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
Change From Baseline in HADS-depression Subscale Score at Week 24	1.2 score on a scale Standard Error 0.2 • Interval 0.2 to	0.3 score on a scale Standard Error 0.2 • Interval 0.2 to

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline SCORAD score ≥ 8.7 were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Placebo n=180 Participants Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=534 Participants Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
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	58 Participants	291 Participants

Adverse Events

Placebo

Serious events: 8 serious events

Other events: 71 other events

Deaths: 0 deaths

Rocatinlimab 300 mg Q4W

Serious events: 10 serious events

Other events: 228 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=180 participants at risk Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2.	Rocatinlimab 300 mg Q4W n=544 participants at risk Participants were administered 300 mg rocatinlimab via SC injection Q4W for 24 weeks, with a loading dose of 300 mg at Week 2.
General disorders Chills	1.1% 2/180 • For all-cause mortality, from randomization until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug (Safety Analysis Set). One participant enrolled in the placebo arm inadvertently received a single dose of 300 mg rocatinlimab.	6.1% 33/544 • For all-cause mortality, from randomization until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug (Safety Analysis Set). One participant enrolled in the placebo arm inadvertently received a single dose of 300 mg rocatinlimab.
General disorders Pyrexia	1.1% 2/180 • For all-cause mortality, from randomization until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug (Safety Analysis Set). One participant enrolled in the placebo arm inadvertently received a single dose of 300 mg rocatinlimab.	10.3% 56/544 • For all-cause mortality, from randomization until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug (Safety Analysis Set). One participant enrolled in the placebo arm inadvertently received a single dose of 300 mg rocatinlimab.
Infections and infestations Nasopharyngitis	11.7% 21/180 • For all-cause mortality, from randomization until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug (Safety Analysis Set). One participant enrolled in the placebo arm inadvertently received a single dose of 300 mg rocatinlimab.	8.8% 48/544 • For all-cause mortality, from randomization until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug (Safety Analysis Set). One participant enrolled in the placebo arm inadvertently received a single dose of 300 mg rocatinlimab.
Infections and infestations Upper respiratory tract infection	3.3% 6/180 • For all-cause mortality, from randomization until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug (Safety Analysis Set). One participant enrolled in the placebo arm inadvertently received a single dose of 300 mg rocatinlimab.	6.2% 34/544 • For all-cause mortality, from randomization until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug (Safety Analysis Set). One participant enrolled in the placebo arm inadvertently received a single dose of 300 mg rocatinlimab.
Nervous system disorders Headache	3.9% 7/180 • For all-cause mortality, from randomization until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug (Safety Analysis Set). One participant enrolled in the placebo arm inadvertently received a single dose of 300 mg rocatinlimab.	7.2% 39/544 • For all-cause mortality, from randomization until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug (Safety Analysis Set). One participant enrolled in the placebo arm inadvertently received a single dose of 300 mg rocatinlimab.
Skin and subcutaneous tissue disorders Dermatitis atopic	26.7% 48/180 • For all-cause mortality, from randomization until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug (Safety Analysis Set). One participant enrolled in the placebo arm inadvertently received a single dose of 300 mg rocatinlimab.	19.1% 104/544 • For all-cause mortality, from randomization until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. For Adverse events, from first dose of trial drug until the end of trial; median (min, max) time on trial was 24.1 (0.6, 40.3) weeks. All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug (Safety Analysis Set). One participant enrolled in the placebo arm inadvertently received a single dose of 300 mg rocatinlimab.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER