| Secondary | 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. | FAS: All randomized participants. Participants were analyzed according to the randomized treatment. | Posted | | Count of Participants | | Participants | | Baseline and Week 16 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The Mantel-Haenszel common risk difference between rocatinlimab 300 mg and placebo was calculated and stratified by randomization strata. The p-value was derived from the common odds ratio using the CMH test, adjusted for randomization strata. | Cochran-Mantel-Haenszel | | < 0.001 | CMH test was adjusted for the stratification factors of baseline disease severity and geographic region. | Common risk difference percentage | 16.8 | | | 2-Sided | 95 | 10.3 | 22.6 | | | | | Superiority | | |
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| Secondary | Number of Participants Who Achieved a vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) (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. | FAS: All randomized participants. Participants were analyzed according to the randomized treatment. | Posted | | Count of Participants | | Participants | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | 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. | 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. | Posted | | Count of Participants | | Participants | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | 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. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points. | 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. | Posted | | Count of Participants | | Participants | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24 | 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. | FAS: All randomized participants. Participants were analyzed according to the randomized treatment. | Posted | | Count of Participants | | Participants | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | 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. | 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. | Posted | | Count of Participants | | Participants | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Primary | 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 | 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. | FAS: All randomized participants. Participants were analyzed according to randomized treatment. | Posted | | Count of Participants | | Participants | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | 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 | 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. | FAS: All randomized participants. Participants were analyzed according to the randomized treatment. | Posted | | Count of Participants | | Participants | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | Number of Participants Who Achieved Facial AD Severity Score of Clear at Week 24 for Participants With Facial AD at Baseline | 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. | 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. | Posted | | Count of Participants | | Participants | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | Number of Participants Who Achieved Hand AD Severity Score of Clear at Week 24 for Participants With Hand AD at Baseline | 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. | 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. | Posted | | Count of Participants | | Participants | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16 | 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. | FAS: All randomized participants. Participants were analyzed according to the randomized treatment. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Week 16 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
| |
| Secondary | Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 | 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. | FAS: All randomized participants. Participants were analyzed according to the randomized treatment. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | 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 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. | FAS: All randomized participants. Participants were analyzed according to the randomized treatment. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | 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 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. | FAS: All randomized participants. Participants were analyzed according to the randomized treatment. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | 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 | 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. | FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline DLQI ≥ 4 were included in the analysis. | Posted | | Count of Participants | | Participants | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | Change From Baseline in DLQI Score at Week 24 | 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. | FAS: All randomized participants. Participants were analyzed according to the randomized treatment. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | 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. | FAS: All randomized participants. Participants were analyzed according to the randomized treatment. Only participants with baseline POEM score ≥ 4 were included in the analysis. | Posted | | Count of Participants | | Participants | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | 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. | FAS: All randomized participants. Participants were analyzed according to the randomized treatment. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | 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 | 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. | 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. | Posted | | Count of Participants | | Participants | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | 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. | FAS: All randomized participants. Participants were analyzed according to the randomized treatment. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | 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. | FAS: All randomized participants. Participants were analyzed according to the randomized treatment. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | 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. | 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. | Posted | | Count of Participants | | Participants | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | 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. | 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. | Posted | | Count of Participants | | Participants | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24 | 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. | FAS: All randomized participants. Participants were analyzed according to the randomized treatment. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | 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 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. | 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. | Posted | | Count of Participants | | Participants | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | 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 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. | 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. | Posted | | Count of Participants | | Participants | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | 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 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. | FAS: All randomized participants. Participants were analyzed according to the randomized treatment. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
| |
| Secondary | 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 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. | FAS: All randomized participants. Participants were analyzed according to the randomized treatment. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Secondary | 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. | 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. | Posted | | Count of Participants | | Participants | | Baseline and Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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| Primary | Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (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. | FAS: All randomized participants. Participants were analyzed according to the randomized treatment. | Posted | | Count of Participants | | Participants | | Baseline and Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants were administered matching placebo via SC injection Q4W for 24 weeks, with a loading dose at Week 2. | | OG001 | 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. |
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