Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03706040
Registration number
NCT03706040
Ethics application status
Date submitted
11/10/2018
Date registered
15/10/2018
Date last updated
18/11/2021
Titles & IDs
Public title
A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2021-002203-34
Query!
Secondary ID [2]
0
0
M16-813
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Dermatitis
0
0
Query!
Condition category
Condition code
Skin
0
0
0
0
Query!
Dermatological conditions
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - Placebo
Other interventions - Risankizumab
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.
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.
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.
Other interventions: Placebo
subcutaneous (SC) injection
Other interventions: Risankizumab
subcutaneous (SC) injection
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants Achieving At Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline and Week 16
Query!
Secondary outcome [1]
0
0
Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of = 2 Points at Week 16
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline and Week 16
Query!
Secondary outcome [2]
0
0
Percentage of Participants Who Achieved a Reduction of = 4 Points in Worst Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
Query!
Assessment method [2]
0
0
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).
Query!
Timepoint [2]
0
0
Baseline and Week 16
Query!
Secondary outcome [3]
0
0
Percent Change From Baseline in EASI Score at Week 16
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline and Week 16
Query!
Secondary outcome [4]
0
0
Percent Change From Baseline in EASI Score at Week 28 and Week 52
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline and Weeks 28 and 52
Query!
Secondary outcome [5]
0
0
Percentage of Participants Who Achieved an EASI 75 Response at Week 28 and Week 52
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline and Weeks 28 and 52
Query!
Secondary outcome [6]
0
0
Percentage of Participants Who Achieved an EASI 50 Response at Week 16
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Baseline and Week 16
Query!
Secondary outcome [7]
0
0
Percentage of Participants Who Achieved an EASI 50 Response at Week 28 and Week 52
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Baseline and Weeks 28 and 52
Query!
Secondary outcome [8]
0
0
Percentage of Participants Who Achieved an EASI 90 Response at Week 16
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Baseline, Week 16
Query!
Secondary outcome [9]
0
0
Percentage of Participants Who Achieved an EASI 90 Response at Week 28 and Week 52
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Baseline and Weeks 28 and 52
Query!
Secondary outcome [10]
0
0
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
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Baseline and Weeks 28 and 52
Query!
Secondary outcome [11]
0
0
Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Baseline and Week 16
Query!
Secondary outcome [12]
0
0
Change From Baseline in Percentage of BSA Affected by Atopic Dermatitis at Weeks 28 and 52
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
Baseline and Weeks 28 and 52
Query!
Secondary outcome [13]
0
0
Percentage of Participants Who Achieved a 50% Improvement in SCORing Atopic Dermatitis (SCORAD) Score (SCORAD 50) at Week 16
Query!
Assessment method [13]
0
0
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).
Query!
Timepoint [13]
0
0
Baseline, Week 16
Query!
Secondary outcome [14]
0
0
Percentage of Participants Who Achieved a SCORAD 50 Response at Week 28 and Week 52
Query!
Assessment method [14]
0
0
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).
Query!
Timepoint [14]
0
0
Baseline and Weeks 28 and 52
Query!
Secondary outcome [15]
0
0
Percentage of Participants Who Achieved a SCORAD 75 Response at Week 16
Query!
Assessment method [15]
0
0
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.
Query!
Timepoint [15]
0
0
Baseline and Week 16
Query!
Secondary outcome [16]
0
0
Percentage of Participants Who Achieved a SCORAD 75 Response at Week 28 and Week 52
Query!
Assessment method [16]
0
0
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.
Query!
Timepoint [16]
0
0
Baseline and Weeks 28 and 52
Query!
Secondary outcome [17]
0
0
Percentage of Participants Who Achieved a SCORAD 90 Response at Week 16
Query!
Assessment method [17]
0
0
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.
Query!
Timepoint [17]
0
0
Baseline and Week 16
Query!
Secondary outcome [18]
0
0
Percentage of Participants Who Achieved a SCORAD 90 Response at Week 28 and Week 52
Query!
Assessment method [18]
0
0
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.
Query!
Timepoint [18]
0
0
Baseline and Weeks 28 and 52
Query!
Secondary outcome [19]
0
0
Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of "0" or "1" at Week 16
Query!
Assessment method [19]
0
0
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.
Query!
Timepoint [19]
0
0
Week 16
Query!
Secondary outcome [20]
0
0
Percentage of Participants Who Achieved a DLQI Score of "0" or "1" at Week 28 and Week 52
Query!
Assessment method [20]
0
0
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.
Query!
Timepoint [20]
0
0
Weeks 28 and 52
Query!
Secondary outcome [21]
0
0
Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of "0" or "1" at Week 16
Query!
Assessment method [21]
0
0
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.
Query!
Timepoint [21]
0
0
Week 16
Query!
Secondary outcome [22]
0
0
Percentage of Participants Who Achieved a CDLQI Score of "0" or "1" at Week 28 and Week 52
Query!
Assessment method [22]
0
0
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.
Query!
Timepoint [22]
0
0
Weeks 28 and 52
Query!
Secondary outcome [23]
0
0
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
Query!
Assessment method [23]
0
0
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).
Query!
Timepoint [23]
0
0
Baseline and Week 16
Query!
Secondary outcome [24]
0
0
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
Query!
Assessment method [24]
0
0
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).
Query!
Timepoint [24]
0
0
Baseline and Weeks 28 and 52
Query!
Secondary outcome [25]
0
0
Change From Baseline in DLQI Score at Week 16
Query!
Assessment method [25]
0
0
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.
Query!
Timepoint [25]
0
0
Baseline and Week 16
Query!
Secondary outcome [26]
0
0
Change From Baseline in DLQI Score at Week 28 and Week 52
Query!
Assessment method [26]
0
0
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.
Query!
Timepoint [26]
0
0
Baseline and Weeks 28 and 52
Query!
Secondary outcome [27]
0
0
Change From Baseline in CDLQI Score at Week 16
Query!
Assessment method [27]
0
0
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.
Query!
Timepoint [27]
0
0
Baseline and Week 16
Query!
Secondary outcome [28]
0
0
Change From Baseline in CDLQI Score at Week 28 and Week 52
Query!
Assessment method [28]
0
0
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.
Query!
Timepoint [28]
0
0
Baseline and Weeks 28 and 52
Query!
Secondary outcome [29]
0
0
Change From Baseline in Worst Pruritus Numerical Rating Scale at Week 16
Query!
Assessment method [29]
0
0
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.
Query!
Timepoint [29]
0
0
Baseline and Week 16
Query!
Secondary outcome [30]
0
0
Change From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52
Query!
Assessment method [30]
0
0
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.
Query!
Timepoint [30]
0
0
Baseline and Weeks 28 and 52
Query!
Secondary outcome [31]
0
0
Percentage of Participants Who Achieved a Reduction of = 4 Points From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52
Query!
Assessment method [31]
0
0
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).
Query!
Timepoint [31]
0
0
Baseline and Weeks 28 and 52
Query!
Eligibility
Key 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
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
27/12/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
26/04/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
172
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Woden Dermatology /ID# 204778 - Phillip
Query!
Recruitment hospital [2]
0
0
St George Hospital /ID# 204780 - Kogarah
Query!
Recruitment hospital [3]
0
0
Veracity Clinical Research /ID# 204786 - Woolloongabba
Query!
Recruitment hospital [4]
0
0
North Eastern Health Specialists /ID# 204785 - Hectorville
Query!
Recruitment hospital [5]
0
0
Skin Health Institute Inc /ID# 204779 - Carlton
Query!
Recruitment hospital [6]
0
0
Fremantle Dermatology /ID# 204784 - Fremantle
Query!
Recruitment postcode(s) [1]
0
0
2606 - Phillip
Query!
Recruitment postcode(s) [2]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [3]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [4]
0
0
5073 - Hectorville
Query!
Recruitment postcode(s) [5]
0
0
3053 - Carlton
Query!
Recruitment postcode(s) [6]
0
0
6160 - Fremantle
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Louisiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Maryland
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Nevada
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New Jersey
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
North Carolina
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Ohio
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Oklahoma
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Oregon
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Pennsylvania
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Rhode Island
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
South Dakota
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Tennessee
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Texas
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Virginia
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Washington
Query!
Country [25]
0
0
Canada
Query!
State/province [25]
0
0
Alberta
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
Ontario
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Quebec
Query!
Country [28]
0
0
Japan
Query!
State/province [28]
0
0
Aichi
Query!
Country [29]
0
0
Japan
Query!
State/province [29]
0
0
Fukuoka
Query!
Country [30]
0
0
Japan
Query!
State/province [30]
0
0
Kanagawa
Query!
Country [31]
0
0
Japan
Query!
State/province [31]
0
0
Niigata
Query!
Country [32]
0
0
Japan
Query!
State/province [32]
0
0
Okinawa
Query!
Country [33]
0
0
Japan
Query!
State/province [33]
0
0
Osaka
Query!
Country [34]
0
0
Japan
Query!
State/province [34]
0
0
Shizuoka
Query!
Country [35]
0
0
Japan
Query!
State/province [35]
0
0
Tokyo
Query!
Country [36]
0
0
Puerto Rico
Query!
State/province [36]
0
0
Caguas
Query!
Country [37]
0
0
Puerto Rico
Query!
State/province [37]
0
0
Carolina
Query!
Country [38]
0
0
Puerto Rico
Query!
State/province [38]
0
0
San Juan
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
AbbVie
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to assess the safety and efficacy of risankizumab for the
treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03706040
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
ABBVIE INC.
Query!
Address
0
0
AbbVie
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03706040
Download to PDF