Clinical trial NCT03706040: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatitis
Keywords: Atopic dermatitis, Atopic dermatitis (atopic eczema)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-10-15
Enrollment: 172
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants Achieving At Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Who Achieved a Reduction of ≥ 4 Points in Worst Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
timeFrame: Baseline and Week 16
measure: Percent Change From Baseline in EASI Score at Week 16
timeFrame: Baseline and Week 16
measure: Percent Change From Baseline in EASI Score at Week 28 and Week 52
timeFrame: Baseline and Weeks 28 and 52
measure: Percentage of Participants Who Achieved an EASI 75 Response at Week 28 and Week 52
timeFrame: Baseline and Weeks 28 and 52
measure: Percentage of Participants Who Achieved an EASI 50 Response at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Who Achieved an EASI 50 Response at Week 28 and Week 52
timeFrame: Baseline and Weeks 28 and 52
measure: Percentage of Participants Who Achieved an EASI 90 Response at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants Who Achieved an EASI 90 Response at Week 28 and Week 52
timeFrame: Baseline and Weeks 28 and 52
measure: 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
timeFrame: Baseline and Weeks 28 and 52
measure: Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Percentage of BSA Affected by Atopic Dermatitis at Weeks 28 and 52
timeFrame: Baseline and Weeks 28 and 52
measure: Percentage of Participants Who Achieved a 50% Improvement in SCORing Atopic Dermatitis (SCORAD) Score (SCORAD 50) at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants Who Achieved a SCORAD 50 Response at Week 28 and Week 52
timeFrame: Baseline and Weeks 28 and 52
measure: Percentage of Participants Who Achieved a SCORAD 75 Response at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Who Achieved a SCORAD 75 Response at Week 28 and Week 52
timeFrame: Baseline and Weeks 28 and 52
measure: Percentage of Participants Who Achieved a SCORAD 90 Response at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Who Achieved a SCORAD 90 Response at Week 28 and Week 52
timeFrame: Baseline and Weeks 28 and 52
measure: Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of "0" or "1" at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved a DLQI Score of "0" or "1" at Week 28 and Week 52
timeFrame: Weeks 28 and 52
measure: Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of "0" or "1" at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved a CDLQI Score of "0" or "1" at Week 28 and Week 52
timeFrame: Weeks 28 and 52
measure: 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
timeFrame: Baseline and Week 16
measure: 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
timeFrame: Baseline and Weeks 28 and 52
measure: Change From Baseline in DLQI Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in DLQI Score at Week 28 and Week 52
timeFrame: Baseline and Weeks 28 and 52
measure: Change From Baseline in CDLQI Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in CDLQI Score at Week 28 and Week 52
timeFrame: Baseline and Weeks 28 and 52
measure: Change From Baseline in Worst Pruritus Numerical Rating Scale at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52
timeFrame: Baseline and Weeks 28 and 52
measure: Percentage of Participants Who Achieved a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52
timeFrame: Baseline and Weeks 28 and 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Department of Dermatology /ID# 211561
state: Alabama
city: Scottsdale
country: United States
facility: Cognitive Clinical Trials /ID# 208895
state: Arizona
city: Anaheim
country: United States
facility: Cosmetic Dermatology of Orange County /ID# 205801
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research /ID# 204950
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research /ID# 212486
state: California
city: San Diego
country: United States
facility: Cosmetic Laser Dermatology /ID# 210560
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research /ID# 203422
state: California
city: Centennial
country: United States
facility: Colorado Center for Dermatology, PLLC /ID# 216260
state: Colorado
city: Orange Park
country: United States
facility: Park Avenue Dermatology, PA /ID# 203378
state: Florida
city: Atlanta
country: United States
facility: MetroDerm ACC Research /ID# 205958
state: Georgia
city: Macon
country: United States
facility: Skin Care Physicians of Georgia /ID# 213188
state: Georgia
city: Darien
country: United States
facility: University Dermatology and Vein Clinic, LLC /ID# 210702
state: Illinois
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center /ID# 211618
state: Indiana
city: New Orleans
country: United States
facility: Tulane University /ID# 203214
state: Louisiana
city: Rockville
country: United States
facility: DermAssociates /ID# 206189
state: Maryland
city: Auburn Hills
country: United States
facility: Oakland Hills Dermatology /ID# 217453
state: Michigan
city: Bay City
country: United States
facility: Duplicate_Great Lakes Research, Inc. /ID# 206447
state: Michigan
city: Warren
country: United States
facility: Grekin Skin Institute /ID# 210485
state: Michigan
city: Reno
country: United States
facility: Skin Cancer and Dermatology Institute (SCDI) /ID# 213041
state: Nevada
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey /ID# 203203
state: New Jersey
city: Charlotte
country: United States
facility: Darst Dermatology /ID# 215100
state: North Carolina
city: Mason
country: United States
facility: Dermatologists of Southwest Ohio, Inc /ID# 215104
state: Ohio
city: Oklahoma City
country: United States
facility: Unity Clinical Research /ID# 217461
state: Oklahoma
city: Portland
country: United States
facility: Oregon Derm & Res. Ctr /ID# 202880
state: Oregon
city: Drexel Hill
country: United States
facility: Dermatologic SurgiCenter /ID# 208972
state: Pennsylvania
city: Hazleton
country: United States
facility: Dermdox Dermatology Centers, PC /ID# 212259
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh MC /ID# 203296
state: Pennsylvania
city: Plymouth Meeting
country: United States
facility: Derm Assoc of Plymouth Meeting /ID# 208925
state: Pennsylvania
city: Johnston
country: United States
facility: RI SkinDoc /ID# 203417
state: Rhode Island
city: Warwick
country: United States
facility: Omega Medical Research /ID# 216022
state: Rhode Island
city: Rapid City
country: United States
facility: Health Concepts /ID# 203205
state: South Dakota
city: Goodlettsville
country: United States
facility: Rivergate Dermatology & Skin Care Center /ID# 203372
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center, Inc /ID# 215899
state: Texas
city: Austin
country: United States
facility: Tekton Research, Inc. /ID# 211558
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies - Houston (Binz) /ID# 203383
state: Texas
city: Sugar Land
country: United States
facility: Acclaim Dermatology /ID# 213026
state: Texas
city: Norfolk
country: United States
facility: Virginia Dermatology & Skin Cancer Center /ID# 210154
state: Virginia
city: Richmond
country: United States
facility: Dominion Medical Associates /ID# 212986
state: Virginia
city: Vancouver
country: United States
facility: The Vancouver Clinic, INC. PS /ID# 202930
state: Washington
city: Phillip
country: Australia
facility: Woden Dermatology /ID# 204778
state: Australian Capital Territory
city: Kogarah
country: Australia
facility: St George Hospital /ID# 204780
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research /ID# 204786
state: Queensland
city: Hectorville
country: Australia
facility: North Eastern Health Specialists /ID# 204785
state: South Australia
city: Carlton
country: Australia
facility: Skin Health Institute Inc /ID# 204779
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Dermatology /ID# 204784
state: Western Australia
city: Calgary
country: Canada
facility: Kirk Barber Research, CA /ID# 201046
state: Alberta
city: Calgary
country: Canada
facility: Beacon Dermatology Inc /ID# 213003
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital - Division of Hematology /ID# 213008
state: Alberta
city: London
country: Canada
facility: Dr. Wei Jing Loo Medicine Prof /ID# 208849
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc. /ID# 201050
state: Ontario
city: Sudbury
country: Canada
facility: Medicor Research Inc /ID# 211274
state: Ontario
city: Saint-Jerome
country: Canada
facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 208189
state: Quebec
city: Nagoya-shi
country: Japan
facility: Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 213667
state: Aichi
city: Kurume-shi
country: Japan
facility: Kurume University Hospital /ID# 203139
state: Fukuoka
city: Kawasaki-shi
country: Japan
facility: Nippon Medical School Musashi Kosugi Hospital /ID# 213961
state: Kanagawa
city: Nagaoka-shi
country: Japan
facility: Nagaoka Red Cross Hospital /ID# 214140
state: Niigata
city: Nakagami-gun
country: Japan
facility: University of the Ryukyus Hospital /ID# 203974
state: Okinawa
city: Osaka-shi
country: Japan
facility: Osaka City University Hospital /ID# 203410
state: Osaka
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu University Hospital /ID# 203270
state: Shizuoka
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital /ID# 202884
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital /ID# 203647
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital /ID# 204101
state: Tokyo
city: Caguas
country: Puerto Rico
facility: Dr. Samuel Sanchez PSC /ID# 213117
city: Carolina
country: Puerto Rico
facility: Cruz-Santana, Carolina, PR /ID# 213229
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico /ID# 213118
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: