| Primary | Percentage of Participants Achieving At Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. | Intent-to-treat population; non-responder imputation incorporating multiple imputation (MI) to handle missing data due to coronavirus pandemic 2019 (COVID-19) (NRI-C) was used in the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A. | | OG001 | Risankizumab 150 mg | Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A. | | OG002 | Risankizumab 300 mg | Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00011.8(0.9 to 22.6)
- OG00124.6(14.5 to 34.8)
- OG00221.7(12.0 to 31.5)
|
|
| | 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 |
|---|
| | Cochran-Mantel-Haenszel | Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate [vIGA-AD 3] versus severe [vIGA-AD 4]). | 0.084 | | Adjusted Difference | 13.0 | | | 2-Sided | 95 | -1.7 | 27.7 | | | Between Group Difference = Risankizumab - Placebo | | Superiority | | | |
|
| Secondary | Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 16 | Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) was used to assess the severity of AD based on lesion appearance on the following scale:
- 0 - Clear: No signs of AD;
- 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;
- 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;
- 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting;
- 4 - Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting.
| Intent-to-treat population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A. | | OG001 | Risankizumab 150 mg | Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A. | | OG002 | Risankizumab 300 mg |
|
| Secondary | Percentage of Participants Who Achieved a Reduction of ≥ 4 Points in Worst Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 | Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). | Intent-to-treat population with a Baseline Pruritus NRS of ≥ 4; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A. | | OG001 | Risankizumab 150 mg | Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A. | | OG002 | Risankizumab 300 mg | Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A. |
| |
| Secondary | Percent Change From Baseline in EASI Score at Week 16 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement. | Intent-to-treat population; missing data were handled using a mixed-effect model with repeated measurements (MMRM). The overall number of participants analyzed is based on the number of participants with non-missing Baseline and Week 16 values. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A. | | OG001 | Risankizumab 150 mg | |
|
| Secondary | Percent Change From Baseline in EASI Score at Week 28 and Week 52 | EASI is used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected and the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling), scratching, and lichenification (lined skin, prurigo nodules). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement. LS means were calculated from an analysis of covariance (ANCOVA) model with Baseline, treatment and vIGA-AD categories in the model. | Intent-to-treat population with available data at each time point. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Risankizumab 150 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG001 | Placebo / Risankizumab 300 mg | |
|
| Secondary | Percentage of Participants Who Achieved an EASI 75 Response at Week 28 and Week 52 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. | Intent-to-treat population with available data at each time point. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Risankizumab 150 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG001 | Placebo / Risankizumab 300 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. |
|
| Secondary | Percentage of Participants Who Achieved an EASI 50 Response at Week 16 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. EASI 50 response is defined as at least a 50% reduction (improvement) from Baseline in EASI score. | Intent-to-treat population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A. | | OG001 | Risankizumab 150 mg | |
|
| Secondary | Percentage of Participants Who Achieved an EASI 50 Response at Week 28 and Week 52 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. An EASI 50 response is defined as at least a 50% reduction (improvement) from Baseline in EASI score. | Intent-to-treat population with available data at each time point. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Risankizumab 150 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG001 | Placebo / Risankizumab 300 mg | |
|
| Secondary | Percentage of Participants Who Achieved an EASI 90 Response at Week 16 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. An EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score. | Intent-to-treat population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A. | | OG001 | Risankizumab 150 mg | |
|
| Secondary | Percentage of Participants Who Achieved an EASI 90 Response at Week 28 and Week 52 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. An EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score. | Intent-to-treat population with available data at each time point | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Risankizumab 150 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG001 | Placebo / Risankizumab 300 mg | |
|
| Secondary | Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 28 and Week 52 | Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) was used to assess the severity of AD based on lesion appearance on the following scale:
- 0 - Clear: No signs of AD;
- 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;
- 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;
- 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting;
- 4 - Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting.
| Intent-to-treat population with available data at each time point | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Risankizumab 150 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG001 | Placebo / Risankizumab 300 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG002 |
|
| Secondary | Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16 | Body surface area (BSA) affected by atopic dermatitis was assessed by the physician and is expressed as a percentage of the total BSA. For purposes of the estimation, the total surface of the participant's palm plus five digits was assumed to be approximately equivalent to 1% BSA. A negative change from Baseline indicates improvement. | Intent-to-treat population; missing data were handled using a mixed-effect model with repeated measurements. The overall number of participants analyzed is based on the number of participants with non-missing Baseline and Week 16 values. | Posted | | Least Squares Mean | Standard Error | percentage of body surface area | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A. | | OG001 | Risankizumab 150 mg | Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A. | | OG002 | Risankizumab 300 mg | Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A. |
|
| Secondary | Change From Baseline in Percentage of BSA Affected by Atopic Dermatitis at Weeks 28 and 52 | Body surface area (BSA) affected by atopic dermatitis was assessed by the physician and is expressed as a percentage of the total BSA. For purposes of the estimation, the total surface of the participant's palm plus five digits was assumed to be approximately equivalent to 1% BSA. A negative change from Baseline indicates improvement. LS means and standard errors were calculated from ANCOVA with Baseline, treatment and stratum (Baseline vIGA-AD categories) in the model. | Intent-to-treat population with available data at each time point | Posted | | Least Squares Mean | Standard Error | percentage of body surface area | | Baseline and Weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Risankizumab 150 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG001 | Placebo / Risankizumab 300 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG002 | Risankizumab 150 mg / Risankizumab 150 mg | |
|
| Secondary | Percentage of Participants Who Achieved a 50% Improvement in SCORing Atopic Dermatitis (SCORAD) Score (SCORAD 50) at Week 16 | SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). | Intent-to-treat population; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A. | | OG001 | Risankizumab 150 mg | Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A. | | OG002 | Risankizumab 300 mg |
|
| Secondary | Percentage of Participants Who Achieved a SCORAD 50 Response at Week 28 and Week 52 | SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). | Intent-to-treat population with available data at each time point. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Risankizumab 150 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG001 | Placebo / Risankizumab 300 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG002 |
|
| Secondary | Percentage of Participants Who Achieved a SCORAD 75 Response at Week 16 | SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A SCORAD 75 response is defined as at least a 75% reduction (improvement) from Baseline in SCORAD score. | Intent-to-treat population; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A. | | OG001 | Risankizumab 150 mg | Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A. | | OG002 |
|
| Secondary | Percentage of Participants Who Achieved a SCORAD 75 Response at Week 28 and Week 52 | SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A SCORAD 75 response is defined as at least a 75% reduction (improvement) from Baseline in SCORAD score. | Intent-to-treat population with available data at each time point. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Risankizumab 150 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG001 | Placebo / Risankizumab 300 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. |
|
| Secondary | Percentage of Participants Who Achieved a SCORAD 90 Response at Week 16 | SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A SCORAD 90 response is defined as at least a 90% reduction (improvement) from Baseline in SCORAD score. | Intent-to-treat population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A. | | OG001 | Risankizumab 150 mg | Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A. | | OG002 |
|
| Secondary | Percentage of Participants Who Achieved a SCORAD 90 Response at Week 28 and Week 52 | SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A SCORAD 90 response is defined as at least a 90% reduction (improvement) from Baseline in SCORAD score. | Intent-to-treat population with available data at each time point. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Risankizumab 150 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG001 | Placebo / Risankizumab 300 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. |
|
| Secondary | Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of "0" or "1" at Week 16 | The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all. | Intent-to-treat population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A. | | OG001 | Risankizumab 150 mg | Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A. | | OG002 |
|
| Secondary | Percentage of Participants Who Achieved a DLQI Score of "0" or "1" at Week 28 and Week 52 | The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all. | Intent-to-treat population with available data at each time point | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Risankizumab 150 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG001 | Placebo / Risankizumab 300 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG002 |
|
| Secondary | Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of "0" or "1" at Week 16 | The CDLQI is a 10-item, validated questionnaire used to assess the impact of AD disease symptoms and treatment on QoL. The CDLQI has been validated for use in individuals 4-16 years old. It consists of 10 questions assessing impact of skin diseases on different aspects of a patient's QoL over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale (0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much). Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all. In this study, the CDLQI was administered to participants who were < 16 years old at Baseline. | Intent-to-treat population < 16 years old at the Baseline visit; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | Posted | | Number | | percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A. | | OG001 | Risankizumab 150 mg | Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A. |
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| Secondary | Percentage of Participants Who Achieved a CDLQI Score of "0" or "1" at Week 28 and Week 52 | The CDLQI is a 10-item, validated questionnaire used to assess the impact of AD disease symptoms and treatment on QoL. The CDLQI has been validated for use in individuals 4-16 years old. It consists of 10 questions assessing impact of skin diseases on different aspects of a patient's QoL over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale (0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much). Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all. In this study, the CDLQI was administered to participants who were < 16 years old at Baseline. | Intent-to-treat population < 16 years old at the Baseline visit with available data at each time point | Posted | | Number | | percentage of participants | | Weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Risankizumab 150 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG001 | Placebo / Risankizumab 300 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. |
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| Secondary | Percentage of Participants Who Achieved a Reduction in DLQI of ≥ 4 Points From Baseline at Week 16 Among Those With a DLQI ≥ 4 at Baseline | The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A change in DLQI score of at least 4 points is considered the minimum clinically important difference (MCID). | Intent-to-treat population with a Baseline DLQI of ≥ 4; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A. | | OG001 | Risankizumab 150 mg | Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A. |
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| Secondary | Percentage of Participants Who Achieved a Reduction in DLQI of ≥ 4 Points From Baseline at Week 28 and Week 52 Among Those With a DLQI ≥ 4 at Baseline | The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A change in DLQI score of at least 4 points is considered the minimum clinically important difference (MCID). | Intent-to-treat population with a Baseline DLQI of ≥ 4 and with available data at each time point. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Risankizumab 150 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG001 | Placebo / Risankizumab 300 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. |
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| Secondary | Change From Baseline in DLQI Score at Week 16 | The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A negative change from Baseline indicates improvement. | Intent-to-treat population; missing data were handled using a mixed-effect model with repeated measurements. The overall number of participants analyzed is based on the number of participants with non-missing Baseline and Week 16 values. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A. | | OG001 | Risankizumab 150 mg | Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A. | | OG002 |
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| Secondary | Change From Baseline in DLQI Score at Week 28 and Week 52 | The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A negative change from Baseline indicates improvement. LS means and standard errors were calculated from an ANCOVA model with Baseline, treatment and stratum (Baseline vIGA-AD categories) in the model. | Intent-to-treat population with available data at each time point. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Risankizumab 150 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG001 | Placebo / Risankizumab 300 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. |
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| Secondary | Change From Baseline in CDLQI Score at Week 16 | The CDLQI is a 10-item, validated questionnaire used to assess the impact of AD disease symptoms and treatment on QoL. The CDLQI has been validated for use in individuals 4-16 years old. It consists of 10 questions assessing impact of skin diseases on different aspects of a patient's QoL over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale (0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much). Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of QoL. A negative change from Baseline indicates improvement. In this study, the CDLQI was administered to participants who were < 16 years old at the Baseline visit. | Intent-to-treat population < 16 years old at the Baseline visit; missing data were handled using a mixed-effect model with repeated measurements. The overall number of participants analyzed is based on the number of participants with non-missing Baseline and Week 16 values. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A. | | OG001 | Risankizumab 150 mg | Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A. |
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| Secondary | Change From Baseline in CDLQI Score at Week 28 and Week 52 | The CDLQI is a 10-item, validated questionnaire used to assess the impact of AD disease symptoms and treatment on QoL. The CDLQI has been validated for use in individuals 4-16 years old. It consists of 10 questions assessing impact of skin diseases on different aspects of a patient's QoL over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale (0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much). Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of QoL. A negative change from Baseline indicates improvement. In this study, the CDLQI was administered to participants who were < 16 years old at the Baseline visit. LS means were calculated from ANCOVA with Baseline and treatment in the model. | Intent-to-treat population < 16 years old at the Baseline visit with available data at each time point. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Risankizumab 150 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG001 | Placebo / Risankizumab 300 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. |
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| Secondary | Change From Baseline in Worst Pruritus Numerical Rating Scale at Week 16 | Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Change from Baseline was calculated from a rolling weekly average. A negative change from Baseline indicates improvement. | Intent-to-treat population; missing data were handled using a mixed-effect model with repeated measurements. The overall number of participants analyzed is based on the number of participants with non-missing Baseline and Week 16 values. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A. | | OG001 | Risankizumab 150 mg | Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A. | | OG002 | Risankizumab 300 mg | Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A. |
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| Secondary | Change From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52 | Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Change from Baseline was calculated from a rolling weekly average. A negative change from Baseline indicates improvement. LS means and standard errors were calculated from an ANCOVA with Baseline, treatment and stratum (Baseline vIGA-AD categories) in the model. | Intent-to-treat population with available data at each time point. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Risankizumab 150 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG001 | Placebo / Risankizumab 300 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG002 | Risankizumab 150 mg / Risankizumab 150 mg | Participants initially randomized to 150 mg risankizumab in Period A continued to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. |
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| Secondary | Percentage of Participants Who Achieved a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52 | Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). | Intent-to-treat population with a Baseline Pruritus NRS of ≥ 4, and with available data at each time point. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Weeks 28 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo / Risankizumab 150 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG001 | Placebo / Risankizumab 300 mg | Participants initially randomized to placebo were re-randomized at Week 16 to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | | OG002 | Risankizumab 150 mg / Risankizumab 150 mg | Participants initially randomized to 150 mg risankizumab in Period A continued to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B. | |
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