| Primary | Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 | IGA is an instrument used in clinical trials to rate the severity of the participant's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). | Full analysis set: 106 subjects, all randomised and treated. | Posted | | Count of Participants | | Participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Tralokinumab+TCS | Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed. | | OG001 | Placebo+TCS | Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed. |
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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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| Responders were considered those meeting an IGA score of 0 or 1 (clear or almost clear). Subjects with missing data or subjects who had received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand. | | | | | Risk Difference (RD) | 5.7 | | | 2-Sided | 95 | -11.2 | 22.5 | | | Mantel-Haenzel risk difference, stratified by baseline IGA. | | Other | No formal testing was performed. Confidence intervals (CIs) are presented with two sided 95% degree of confidence. |
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| Primary | At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16 | Eczema Area and Severity Index (EASI) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition. | Full analysis set: 106 subjects, all randomised and treated. | Posted | | Count of Participants | | Participants | | Week 0 to Week 16 | | | | ID | Title | Description |
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| OG000 | Tralokinumab+TCS | Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed. | | OG001 | Placebo+TCS | Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed. |
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| Secondary | Change in Scoring Atopic Dermatitis (SCORAD) Total Score From Baseline to Week 16 | SCORAD is a validated tool to evaluate the AD disease based on 3 components:
- A) The extent of AD lesions. Assessed as percentage of each defined body area and reported as sum of all areas (max score = 100%).
- B) The severity of AD lesions. The intensity of 6 specific symptoms on a representative area was assessed using the scale: 0 = none/absent, 1 = mild, 2 = moderate, 3 = severe (max score = 18).
- C) Subjective symptoms. The itch and sleeplessness over the last 3 days/nights was recorded for each symptom by the subject on a VAS scale: 0 = no itch or trouble sleeping, 10 = unbearable itch or a lot of trouble sleeping (max score = 20).
The SCORAD was calculated as: A/5+7B/2+C. The maximum total score is 103, with higher values indicating more severe disease. | Full analysis set: 106 subjects, all randomised and treated. | Posted | | Least Squares Mean | Standard Error | change in score on a scale | | Week 0 to Week 16 | | | | ID | Title | Description |
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| OG000 | Tralokinumab+TCS | Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed. | | OG001 | Placebo+TCS | Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed. |
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| Secondary | Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16. | DLQI consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their health-related quality of life over the past week, such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0=not at all ⁄ not relevant; 1=a little; 2=a lot; 3=very much). The total score is the sum of the 10 items (ranging from 0 to 30), with higher scores indicating poorer health-related quality of life. | Full analysis set: 106 subjects, all randomised and treated. | Posted | | Least Squares Mean | Standard Error | change in score on a scale | | Week 0 to Week 16 | | | | ID | Title | Description |
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| OG000 | Tralokinumab+TCS | Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed. | | OG001 | Placebo+TCS | Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed. |
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| Secondary | Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) Score (Weekly Average) of at Least 4 From Baseline to Week 16 | Participants assessed the itch for the past 24 hours using the Worst Daily Pruritus NRS, consisting of 11 points, with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'. | Full analysis set: 106 subjects, all randomised and treated. | Posted | | Count of Participants | | Participants | | Week 0 to Week 16 | | | | ID | Title | Description |
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| OG000 | Tralokinumab+TCS | Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed. | | OG001 | Placebo+TCS | Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed. |
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| Secondary | At Least 90% Reduction in EASI (EASI90) at Week 16 | EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition. | Full analysis set: 106 subjects, all randomised and treated. | Posted | | Count of Participants | | Participants | | Week 0 to Week 16 | | | | ID | Title | Description |
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| OG000 | Tralokinumab+TCS | Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed. | | OG001 | Placebo+TCS | Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed. |
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| Secondary | At Least 50% Reduction in EASI (EASI50) at Week 16 | EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition. | Full analysis set: 106 subjects, all randomised and treated. | Posted | | Count of Participants | | Participants | | Week 0 to Week 16 | | | | ID | Title | Description |
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| OG000 | Tralokinumab+TCS | Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed. | | OG001 | Placebo+TCS | Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed. |
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| Secondary | Percentage Change in EASI Score From Baseline to Week 16 | EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition. | Full analysis set: 106 subjects, all randomised and treated. | Posted | | Least Squares Mean | Standard Error | percentage change in score on a scale | | Week 0 to Week 16 | | | | ID | Title | Description |
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| OG000 | Tralokinumab+TCS | Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed. | | OG001 | Placebo+TCS | Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed. |
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| Secondary | Change in Worst Daily Pruritus NRS Score (Weekly Average) From Baseline to Week 16 | Participants assessed the itch for the past 24 hours using the Worst Daily Pruritus NRS, consisting of 11 points, with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'. | Full analysis set:106 subjects, all randomised and treated. | Posted | | Least Squares Mean | Standard Error | change in score on a scale | | Week 0 to Week 16 | | | | ID | Title | Description |
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| OG000 | Tralokinumab+TCS | Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed. | | OG001 | Placebo+TCS | Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed. |
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| Secondary | Change in Eczema-related Sleep NRS Score (Weekly Average) From Baseline to Week 16 | Participants rated how much their eczema interfered with their sleep the last night using an 11-point NRS (0 indicating that it 'did not interfere' and 10 indicating that it 'completely interfered'). | Full analysis set: 106 subjects, all randomised and treated. | Posted | | Least Squares Mean | Standard Error | change in score on a scale | | Week 0 to Week 16 | | | | ID | Title | Description |
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| OG000 | Tralokinumab+TCS | Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed. | | OG001 | Placebo+TCS | Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed. |
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| Secondary | Change in Patient-Oriented Eczema Measure (POEM) Score Form Baseline to Week 16 | POEM consists of 7 items, each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Participants score how often they have experienced each symptom over the previous week, using a 5-point categorical response scale (0=no days; 1=1 to 2 days; 2=3 to 4 days; 3=5 to 6 days; 4=every day). The total score is the sum of the 7 items (ranging from 0 to 28) and reflects disease-related morbidity; higher scores indicate more severe disease. | Full analysis set: 106 subjects, all randomised and treated. | Posted | | Least Squares Mean | Standard Error | change in score on a scale | | Week 0 to Week 16 | | | | ID | Title | Description |
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| OG000 | Tralokinumab+TCS | Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed. | | OG001 | Placebo+TCS | Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed. |
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| Secondary | Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject | Number of events divided by patient years of exposure (= rate). | Safety analysis set: 106 subjects. Included all subjects exposed to IMP at least 1 time. | Posted | | Number | | events per patient year of exposure | | Week 0 to Week 16 | | | | ID | Title | Description |
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| OG000 | Tralokinumab+TCS | Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed. | | OG001 | Placebo+TCS | Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed. |
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| Secondary | Number of Subjects With Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16 | Anti-tralokinumab antibody levels were analyzed using a validated bioanalytical method. Positive treatment-emergent ADA was defined as ADA negative or missing at baseline, and at least one positive post-baseline ADA response. Negative treatment-emergent ADA was defined as ADA negative or missing at baseline, and all post-baseline ADA assessments negative. | Safety analysis set. Included all subjects exposed to IMP at least 1 time. | Posted | | Number | | participants with treatment-emergent ADA | | Week 0 to Week 16 | | | | ID | Title | Description |
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| OG000 | Tralokinumab+TCS | Treatment period (Week 0 to Week 16): Participants were treated with 300 mg tralokinumab every 2 weeks until Week 14, after a loading dose of 600 mg tralokinumab at Week 0. TCS was applied on the skin as needed. | | OG001 | Placebo+TCS | Treatment period (Week 0 to Week 16): Participants received placebo every 2 weeks until Week 14, after a loading dose of placebo at Week 0. TCS was applied on the skin as needed. |
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