A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03706040 |
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Recruitment Status :
Completed
First Posted : October 15, 2018
Results First Posted : November 18, 2021
Last Update Posted : November 18, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dermatitis | Biological: Placebo Biological: Risankizumab | Phase 2 |
This study includes a screening period of up to 35 days, a 16-week double-blind treatment period (Period A), and a 36-week double-blind treatment period (Period B).
Participants who meet eligibility criteria will be randomized at Baseline in a 2:2:1 ratio to one of 3 treatment groups: (1) risankizumab 150 mg, (2) risankizumab 300 mg, or (3) matching placebo. Randomization will be stratified by Baseline disease severity (Validated Investigator Global Assessment scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]) and geographic region (Japan versus rest of world).
At Week 16, participants in the placebo group will be re-randomized in a 1:1 ratio to receive either risankizumab 150 mg or 300 mg for the remainder of the study. Participants originally randomized to the risankizumab 150 mg or 300 mg arms will stay on their previously-assigned treatment through the end of the study.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 172 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Risankizumab in Adult and Adolescent Subjects With Moderate to Severe Atopic Dermatitis |
| Actual Study Start Date : | December 27, 2018 |
| Actual Primary Completion Date : | October 28, 2020 |
| Actual Study Completion Date : | April 26, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Participants randomized to receive placebo for 16 weeks in Period A followed by either risankizumab 150 mg or risankizumab 300 mg for 36 weeks in Period B.
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Biological: Placebo
subcutaneous (SC) injection Biological: Risankizumab subcutaneous (SC) injection
Other Names:
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Experimental: Risankizumab 150 mg
Participants randomized to receive risankizumab 150 mg for 16 weeks in Period A followed by risankizumab 150 mg for 36 weeks in Period B.
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Biological: Risankizumab
subcutaneous (SC) injection
Other Names:
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Experimental: Risankizumab 300 mg
Participants randomized to receive risankizumab 300 mg for 16 weeks in Period A followed by risankizumab 300 mg for 36 weeks in Period B.
|
Biological: Risankizumab
subcutaneous (SC) injection
Other Names:
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- Percentage of Participants Achieving At Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16 [ Time Frame: Baseline and 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.
- Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 16 [ Time Frame: Baseline and 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.
- Percentage of Participants Who Achieved a Reduction of ≥ 4 Points in Worst Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 [ Time Frame: Baseline and 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).
- Percent Change From Baseline in EASI Score at Week 16 [ Time Frame: Baseline and 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.
- Percent Change From Baseline in EASI Score at Week 28 and Week 52 [ Time Frame: Baseline and Weeks 28 and 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.
- Percentage of Participants Who Achieved an EASI 75 Response at Week 28 and Week 52 [ Time Frame: Baseline and Weeks 28 and 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.
- Percentage of Participants Who Achieved an EASI 50 Response at Week 16 [ Time Frame: Baseline and 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.
- Percentage of Participants Who Achieved an EASI 50 Response at Week 28 and Week 52 [ Time Frame: Baseline and Weeks 28 and 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.
- Percentage of Participants Who Achieved an EASI 90 Response at Week 16 [ Time Frame: Baseline, 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.
- Percentage of Participants Who Achieved an EASI 90 Response at Week 28 and Week 52 [ Time Frame: Baseline and Weeks 28 and 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.
- 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 [ Time Frame: Baseline and Weeks 28 and 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.
- Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16 [ Time Frame: Baseline and 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.
- Change From Baseline in Percentage of BSA Affected by Atopic Dermatitis at Weeks 28 and 52 [ Time Frame: Baseline and 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.
- Percentage of Participants Who Achieved a 50% Improvement in SCORing Atopic Dermatitis (SCORAD) Score (SCORAD 50) at Week 16 [ Time Frame: Baseline, 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).
- Percentage of Participants Who Achieved a SCORAD 50 Response at Week 28 and Week 52 [ Time Frame: Baseline and Weeks 28 and 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).
- Percentage of Participants Who Achieved a SCORAD 75 Response at Week 16 [ Time Frame: Baseline and 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.
- Percentage of Participants Who Achieved a SCORAD 75 Response at Week 28 and Week 52 [ Time Frame: Baseline and Weeks 28 and 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.
- Percentage of Participants Who Achieved a SCORAD 90 Response at Week 16 [ Time Frame: Baseline and 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.
- Percentage of Participants Who Achieved a SCORAD 90 Response at Week 28 and Week 52 [ Time Frame: Baseline and Weeks 28 and 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.
- Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of "0" or "1" at Week 16 [ Time Frame: 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.
- Percentage of Participants Who Achieved a DLQI Score of "0" or "1" at Week 28 and Week 52 [ Time Frame: Weeks 28 and 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.
- Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of "0" or "1" at Week 16 [ Time Frame: 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.
- Percentage of Participants Who Achieved a CDLQI Score of "0" or "1" at Week 28 and Week 52 [ Time Frame: Weeks 28 and 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.
- 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 [ Time Frame: Baseline and 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 change in DLQI score of at least 4 points is considered the minimum clinically important difference (MCID).
- 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 [ Time Frame: Baseline and Weeks 28 and 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 change in DLQI score of at least 4 points is considered the minimum clinically important difference (MCID).
- Change From Baseline in DLQI Score at Week 16 [ Time Frame: Baseline and 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.
- Change From Baseline in DLQI Score at Week 28 and Week 52 [ Time Frame: Baseline and Weeks 28 and 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.
- Change From Baseline in CDLQI Score at Week 16 [ Time Frame: Baseline and 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.
- Change From Baseline in CDLQI Score at Week 28 and Week 52 [ Time Frame: Baseline and Weeks 28 and 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.
- Change From Baseline in Worst Pruritus Numerical Rating Scale at Week 16 [ Time Frame: Baseline and 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.
- Change From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52 [ Time Frame: Baseline and Weeks 28 and 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.
- Percentage of Participants Who Achieved a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52 [ Time Frame: Baseline and Weeks 28 and 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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- adults who are ≥ 18 years old and, where locally permissible and approved, adolescent subjects who are at least 12 years old
- a diagnosis of atopic dermatitis (AD) with onset of symptoms at least 2 years prior to Baseline and subject meets Hanifin and Rajka criteria
- moderate to severe AD at the Baseline Visit
- history of inadequate response to previous topical corticosteroid and/or topical calcineurin inhibitor treatments or a medical inability to receive these treatments
Exclusion Criteria:
- prior exposure to any biologic immunomodulatory agent or Janus kinase (JAK) inhibitor
- concurrent treatment with systemic therapy for AD (biologic or non-biologic) or topical and/or phototherapy treatments
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706040
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| Study Director: | ABBVIE INC. | AbbVie |
Documents provided by AbbVie:
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT03706040 |
| Other Study ID Numbers: |
M16-813 2021-002203-34 ( EudraCT Number ) |
| First Posted: | October 15, 2018 Key Record Dates |
| Results First Posted: | November 18, 2021 |
| Last Update Posted: | November 18, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
| Time Frame: | For details on when studies are available for sharing, please refer to the link below. |
| Access Criteria: | Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link. |
| URL: | https://vivli.org/ourmember/abbvie/ |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Atopic dermatitis, Atopic dermatitis (atopic eczema) |
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Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |