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A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis

Primary Purpose

Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Risankizumab
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis focused on measuring Atopic dermatitis, Atopic dermatitis (atopic eczema)

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UAB Department of Dermatology /ID# 211561
  • Cognitive Clinical Trials /ID# 208895
  • Cosmetic Dermatology of Orange County /ID# 205801
  • Center for Dermatology Clinical Research /ID# 204950
  • Integrative Skin Science and Research /ID# 212486
  • Cosmetic Laser Dermatology /ID# 210560
  • Therapeutics Clinical Research /ID# 203422
  • Colorado Center for Dermatology, PLLC /ID# 216260
  • Park Avenue Dermatology, PA /ID# 203378
  • MetroDerm ACC Research /ID# 205958
  • Skin Care Physicians of Georgia /ID# 213188
  • University Dermatology and Vein Clinic, LLC /ID# 210702
  • The Indiana Clinical Trials Center /ID# 211618
  • Tulane University /ID# 203214
  • DermAssociates /ID# 206189
  • Oakland Hills Dermatology /ID# 217453
  • Duplicate_Great Lakes Research, Inc. /ID# 206447
  • Grekin Skin Institute /ID# 210485
  • Skin Cancer and Dermatology Institute (SCDI) /ID# 213041
  • Psoriasis Treatment Center of Central New Jersey /ID# 203203
  • Darst Dermatology /ID# 215100
  • Dermatologists of Southwest Ohio, Inc /ID# 215104
  • Unity Clinical Research /ID# 217461
  • Oregon Derm & Res. Ctr /ID# 202880
  • Dermatologic SurgiCenter /ID# 208972
  • Dermdox Dermatology Centers, PC /ID# 212259
  • University of Pittsburgh MC /ID# 203296
  • Derm Assoc of Plymouth Meeting /ID# 208925
  • RI SkinDoc /ID# 203417
  • Omega Medical Research /ID# 216022
  • Health Concepts /ID# 203205
  • Rivergate Dermatology & Skin Care Center /ID# 203372
  • Arlington Research Center, Inc /ID# 215899
  • Tekton Research, Inc. /ID# 211558
  • Center for Clinical Studies - Houston (Binz) /ID# 203383
  • Acclaim Dermatology /ID# 213026
  • Virginia Dermatology & Skin Cancer Center /ID# 210154
  • Dominion Medical Associates /ID# 212986
  • The Vancouver Clinic, INC. PS /ID# 202930
  • Woden Dermatology /ID# 204778
  • St George Hospital /ID# 204780
  • Veracity Clinical Research /ID# 204786
  • North Eastern Health Specialists /ID# 204785
  • Skin Health Institute Inc /ID# 204779
  • Fremantle Dermatology /ID# 204784
  • Kirk Barber Research, CA /ID# 201046
  • Beacon Dermatology Inc /ID# 213003
  • University of Alberta Hospital - Division of Hematology /ID# 213008
  • Dr. Wei Jing Loo Medicine Prof /ID# 208849
  • Lynderm Research Inc. /ID# 201050
  • Medicor Research Inc /ID# 211274
  • Dre Angelique Gagne-Henley M.D. inc. /ID# 208189
  • Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 213667
  • Kurume University Hospital /ID# 203139
  • Nippon Medical School Musashi Kosugi Hospital /ID# 213961
  • Nagaoka Red Cross Hospital /ID# 214140
  • University of the Ryukyus Hospital /ID# 203974
  • Osaka City University Hospital /ID# 203410
  • Hamamatsu University Hospital /ID# 203270
  • Teikyo University Hospital /ID# 202884
  • Tokyo Medical University Hospital /ID# 203647
  • Tokyo Medical University Hospital /ID# 204101
  • Dr. Samuel Sanchez PSC /ID# 213117
  • Cruz-Santana, Carolina, PR /ID# 213229
  • Clinical Research Puerto Rico /ID# 213118

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Risankizumab 150 mg

Risankizumab 300 mg

Arm Description

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.

Participants randomized to receive risankizumab 150 mg for 16 weeks in Period A followed by risankizumab 150 mg for 36 weeks in Period B.

Participants randomized to receive risankizumab 300 mg for 16 weeks in Period A followed by risankizumab 300 mg for 36 weeks in Period B.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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).

Full Information

First Posted
October 11, 2018
Last Updated
October 20, 2021
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03706040
Brief Title
A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 27, 2018 (Actual)
Primary Completion Date
October 28, 2020 (Actual)
Study Completion Date
April 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis
Keywords
Atopic dermatitis, Atopic dermatitis (atopic eczema)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Risankizumab 150 mg
Arm Type
Experimental
Arm Description
Participants randomized to receive risankizumab 150 mg for 16 weeks in Period A followed by risankizumab 150 mg for 36 weeks in Period B.
Arm Title
Risankizumab 300 mg
Arm Type
Experimental
Arm Description
Participants randomized to receive risankizumab 300 mg for 16 weeks in Period A followed by risankizumab 300 mg for 36 weeks in Period B.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
subcutaneous (SC) injection
Intervention Type
Biological
Intervention Name(s)
Risankizumab
Other Intervention Name(s)
ABBV-066, BI 655066
Intervention Description
subcutaneous (SC) injection
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving At Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16
Description
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.
Time Frame
Baseline and Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 16
Description
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.
Time Frame
Baseline and Week 16
Title
Percentage of Participants Who Achieved a Reduction of ≥ 4 Points in Worst Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
Description
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).
Time Frame
Baseline and Week 16
Title
Percent Change From Baseline in EASI Score at Week 16
Description
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.
Time Frame
Baseline and Week 16
Title
Percent Change From Baseline in EASI Score at Week 28 and Week 52
Description
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.
Time Frame
Baseline and Weeks 28 and 52
Title
Percentage of Participants Who Achieved an EASI 75 Response at Week 28 and Week 52
Description
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.
Time Frame
Baseline and Weeks 28 and 52
Title
Percentage of Participants Who Achieved an EASI 50 Response at Week 16
Description
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.
Time Frame
Baseline and Week 16
Title
Percentage of Participants Who Achieved an EASI 50 Response at Week 28 and Week 52
Description
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.
Time Frame
Baseline and Weeks 28 and 52
Title
Percentage of Participants Who Achieved an EASI 90 Response at Week 16
Description
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.
Time Frame
Baseline, Week 16
Title
Percentage of Participants Who Achieved an EASI 90 Response at Week 28 and Week 52
Description
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.
Time Frame
Baseline and Weeks 28 and 52
Title
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
Description
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.
Time Frame
Baseline and Weeks 28 and 52
Title
Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16
Description
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.
Time Frame
Baseline and Week 16
Title
Change From Baseline in Percentage of BSA Affected by Atopic Dermatitis at Weeks 28 and 52
Description
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.
Time Frame
Baseline and Weeks 28 and 52
Title
Percentage of Participants Who Achieved a 50% Improvement in SCORing Atopic Dermatitis (SCORAD) Score (SCORAD 50) at Week 16
Description
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).
Time Frame
Baseline, Week 16
Title
Percentage of Participants Who Achieved a SCORAD 50 Response at Week 28 and Week 52
Description
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).
Time Frame
Baseline and Weeks 28 and 52
Title
Percentage of Participants Who Achieved a SCORAD 75 Response at Week 16
Description
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.
Time Frame
Baseline and Week 16
Title
Percentage of Participants Who Achieved a SCORAD 75 Response at Week 28 and Week 52
Description
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.
Time Frame
Baseline and Weeks 28 and 52
Title
Percentage of Participants Who Achieved a SCORAD 90 Response at Week 16
Description
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.
Time Frame
Baseline and Week 16
Title
Percentage of Participants Who Achieved a SCORAD 90 Response at Week 28 and Week 52
Description
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.
Time Frame
Baseline and Weeks 28 and 52
Title
Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of "0" or "1" at Week 16
Description
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.
Time Frame
Week 16
Title
Percentage of Participants Who Achieved a DLQI Score of "0" or "1" at Week 28 and Week 52
Description
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.
Time Frame
Weeks 28 and 52
Title
Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of "0" or "1" at Week 16
Description
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.
Time Frame
Week 16
Title
Percentage of Participants Who Achieved a CDLQI Score of "0" or "1" at Week 28 and Week 52
Description
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.
Time Frame
Weeks 28 and 52
Title
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
Description
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).
Time Frame
Baseline and Week 16
Title
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
Description
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).
Time Frame
Baseline and Weeks 28 and 52
Title
Change From Baseline in DLQI Score at Week 16
Description
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.
Time Frame
Baseline and Week 16
Title
Change From Baseline in DLQI Score at Week 28 and Week 52
Description
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.
Time Frame
Baseline and Weeks 28 and 52
Title
Change From Baseline in CDLQI Score at Week 16
Description
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.
Time Frame
Baseline and Week 16
Title
Change From Baseline in CDLQI Score at Week 28 and Week 52
Description
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.
Time Frame
Baseline and Weeks 28 and 52
Title
Change From Baseline in Worst Pruritus Numerical Rating Scale at Week 16
Description
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.
Time Frame
Baseline and Week 16
Title
Change From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52
Description
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.
Time Frame
Baseline and Weeks 28 and 52
Title
Percentage of Participants Who Achieved a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52
Description
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).
Time Frame
Baseline and Weeks 28 and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
UAB Department of Dermatology /ID# 211561
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Cognitive Clinical Trials /ID# 208895
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258-4446
Country
United States
Facility Name
Cosmetic Dermatology of Orange County /ID# 205801
City
Anaheim
State/Province
California
ZIP/Postal Code
92807-4780
Country
United States
Facility Name
Center for Dermatology Clinical Research /ID# 204950
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Integrative Skin Science and Research /ID# 212486
City
Sacramento
State/Province
California
ZIP/Postal Code
95815-4500
Country
United States
Facility Name
Cosmetic Laser Dermatology /ID# 210560
City
San Diego
State/Province
California
ZIP/Postal Code
92121-2119
Country
United States
Facility Name
Therapeutics Clinical Research /ID# 203422
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Colorado Center for Dermatology, PLLC /ID# 216260
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80111-1724
Country
United States
Facility Name
Park Avenue Dermatology, PA /ID# 203378
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
MetroDerm ACC Research /ID# 205958
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-1418
Country
United States
Facility Name
Skin Care Physicians of Georgia /ID# 213188
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
University Dermatology and Vein Clinic, LLC /ID# 210702
City
Darien
State/Province
Illinois
ZIP/Postal Code
60561
Country
United States
Facility Name
The Indiana Clinical Trials Center /ID# 211618
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Tulane University /ID# 203214
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2699
Country
United States
Facility Name
DermAssociates /ID# 206189
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Oakland Hills Dermatology /ID# 217453
City
Auburn Hills
State/Province
Michigan
ZIP/Postal Code
48326-4600
Country
United States
Facility Name
Duplicate_Great Lakes Research, Inc. /ID# 206447
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Grekin Skin Institute /ID# 210485
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Skin Cancer and Dermatology Institute (SCDI) /ID# 213041
City
Reno
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Psoriasis Treatment Center of Central New Jersey /ID# 203203
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Darst Dermatology /ID# 215100
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Dermatologists of Southwest Ohio, Inc /ID# 215104
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040-4520
Country
United States
Facility Name
Unity Clinical Research /ID# 217461
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Oregon Derm & Res. Ctr /ID# 202880
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Dermatologic SurgiCenter /ID# 208972
City
Drexel Hill
State/Province
Pennsylvania
ZIP/Postal Code
19026-1101
Country
United States
Facility Name
Dermdox Dermatology Centers, PC /ID# 212259
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
University of Pittsburgh MC /ID# 203296
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Facility Name
Derm Assoc of Plymouth Meeting /ID# 208925
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Facility Name
RI SkinDoc /ID# 203417
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02910-4423
Country
United States
Facility Name
Omega Medical Research /ID# 216022
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Health Concepts /ID# 203205
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Rivergate Dermatology & Skin Care Center /ID# 203372
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072-2301
Country
United States
Facility Name
Arlington Research Center, Inc /ID# 215899
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Tekton Research, Inc. /ID# 211558
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Center for Clinical Studies - Houston (Binz) /ID# 203383
City
Houston
State/Province
Texas
ZIP/Postal Code
77004-8097
Country
United States
Facility Name
Acclaim Dermatology /ID# 213026
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479-2645
Country
United States
Facility Name
Virginia Dermatology & Skin Cancer Center /ID# 210154
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502-2233
Country
United States
Facility Name
Dominion Medical Associates /ID# 212986
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
The Vancouver Clinic, INC. PS /ID# 202930
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Woden Dermatology /ID# 204778
City
Phillip
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Facility Name
St George Hospital /ID# 204780
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Veracity Clinical Research /ID# 204786
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
North Eastern Health Specialists /ID# 204785
City
Hectorville
State/Province
South Australia
ZIP/Postal Code
5073
Country
Australia
Facility Name
Skin Health Institute Inc /ID# 204779
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Fremantle Dermatology /ID# 204784
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Kirk Barber Research, CA /ID# 201046
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2G 1B1
Country
Canada
Facility Name
Beacon Dermatology Inc /ID# 213003
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 0B2
Country
Canada
Facility Name
University of Alberta Hospital - Division of Hematology /ID# 213008
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Dr. Wei Jing Loo Medicine Prof /ID# 208849
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
Lynderm Research Inc. /ID# 201050
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
Medicor Research Inc /ID# 211274
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3A 1W8
Country
Canada
Facility Name
Dre Angelique Gagne-Henley M.D. inc. /ID# 208189
City
Saint-Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 7E2
Country
Canada
Facility Name
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 213667
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
455-8530
Country
Japan
Facility Name
Kurume University Hospital /ID# 203139
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Nippon Medical School Musashi Kosugi Hospital /ID# 213961
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
211-8533
Country
Japan
Facility Name
Nagaoka Red Cross Hospital /ID# 214140
City
Nagaoka-shi
State/Province
Niigata
ZIP/Postal Code
940-2085
Country
Japan
Facility Name
University of the Ryukyus Hospital /ID# 203974
City
Nakagami-gun
State/Province
Okinawa
ZIP/Postal Code
903-0215
Country
Japan
Facility Name
Osaka City University Hospital /ID# 203410
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Hamamatsu University Hospital /ID# 203270
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Teikyo University Hospital /ID# 202884
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8606
Country
Japan
Facility Name
Tokyo Medical University Hospital /ID# 203647
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Tokyo Medical University Hospital /ID# 204101
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Dr. Samuel Sanchez PSC /ID# 213117
City
Caguas
ZIP/Postal Code
00727
Country
Puerto Rico
Facility Name
Cruz-Santana, Carolina, PR /ID# 213229
City
Carolina
ZIP/Postal Code
00985
Country
Puerto Rico
Facility Name
Clinical Research Puerto Rico /ID# 213118
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
For details on when studies are available for sharing, please refer to the link below.
IPD Sharing 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.
IPD Sharing URL
https://vivli.org/ourmember/abbvie/

Learn more about this trial

A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis

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