A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis
A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Risankizumab in Adult and Adolescent Subjects With Moderate to Severe Atopic Dermatitis
2 other identifiers
interventional
172
5 countries
65
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2018
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2018
CompletedFirst Posted
Study publicly available on registry
October 15, 2018
CompletedStudy Start
First participant enrolled
December 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2021
CompletedResults Posted
Study results publicly available
November 18, 2021
CompletedNovember 18, 2021
October 1, 2021
1.8 years
October 11, 2018
October 20, 2021
October 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline and Week 16
Secondary Outcomes (31)
Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 16
Baseline and Week 16
Percentage of Participants Who Achieved a Reduction of ≥ 4 Points in Worst Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
Baseline and Week 16
Percent Change From Baseline in EASI Score at Week 16
Baseline and Week 16
Percent Change From Baseline in EASI Score at Week 28 and Week 52
Baseline and Weeks 28 and 52
Percentage of Participants Who Achieved an EASI 75 Response at Week 28 and Week 52
Baseline and Weeks 28 and 52
- +26 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORParticipants 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.
Risankizumab 150 mg
EXPERIMENTALParticipants randomized to receive risankizumab 150 mg for 16 weeks in Period A followed by risankizumab 150 mg for 36 weeks in Period B.
Risankizumab 300 mg
EXPERIMENTALParticipants randomized to receive risankizumab 300 mg for 16 weeks in Period A followed by risankizumab 300 mg for 36 weeks in Period B.
Interventions
subcutaneous (SC) injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (65)
UAB Department of Dermatology /ID# 211561
Birmingham, Alabama, 35233, United States
Cognitive Clinical Trials /ID# 208895
Scottsdale, Arizona, 85258-4446, United States
Cosmetic Dermatology of Orange County /ID# 205801
Anaheim, California, 92807-4780, United States
Center for Dermatology Clinical Research /ID# 204950
Fremont, California, 94538, United States
Integrative Skin Science and Research /ID# 212486
Sacramento, California, 95815-4500, United States
Cosmetic Laser Dermatology /ID# 210560
San Diego, California, 92121-2119, United States
Therapeutics Clinical Research /ID# 203422
San Diego, California, 92123, United States
Colorado Center for Dermatology, PLLC /ID# 216260
Centennial, Colorado, 80111-1724, United States
Park Avenue Dermatology, PA /ID# 203378
Orange Park, Florida, 32073, United States
MetroDerm ACC Research /ID# 205958
Atlanta, Georgia, 30342-1418, United States
Skin Care Physicians of Georgia /ID# 213188
Macon, Georgia, 31217, United States
University Dermatology and Vein Clinic, LLC /ID# 210702
Darien, Illinois, 60561, United States
The Indiana Clinical Trials Center /ID# 211618
Plainfield, Indiana, 46168, United States
Tulane University /ID# 203214
New Orleans, Louisiana, 70112-2699, United States
DermAssociates /ID# 206189
Rockville, Maryland, 20850, United States
Oakland Hills Dermatology /ID# 217453
Auburn Hills, Michigan, 48326-4600, United States
Duplicate_Great Lakes Research, Inc. /ID# 206447
Bay City, Michigan, 48602, United States
Grekin Skin Institute /ID# 210485
Warren, Michigan, 48088, United States
Skin Cancer and Dermatology Institute (SCDI) /ID# 213041
Reno, Nevada, 89052, United States
Psoriasis Treatment Center of Central New Jersey /ID# 203203
East Windsor, New Jersey, 08520, United States
Darst Dermatology /ID# 215100
Charlotte, North Carolina, 28277, United States
Dermatologists of Southwest Ohio, Inc /ID# 215104
Mason, Ohio, 45040-4520, United States
Unity Clinical Research /ID# 217461
Oklahoma City, Oklahoma, 73118, United States
Oregon Derm & Res. Ctr /ID# 202880
Portland, Oregon, 97210, United States
Dermatologic SurgiCenter /ID# 208972
Drexel Hill, Pennsylvania, 19026-1101, United States
Dermdox Dermatology Centers, PC /ID# 212259
Hazleton, Pennsylvania, 18201, United States
University of Pittsburgh MC /ID# 203296
Pittsburgh, Pennsylvania, 15260, United States
Derm Assoc of Plymouth Meeting /ID# 208925
Plymouth Meeting, Pennsylvania, 19462, United States
RI SkinDoc /ID# 203417
Johnston, Rhode Island, 02910-4423, United States
Omega Medical Research /ID# 216022
Warwick, Rhode Island, 02886, United States
Health Concepts /ID# 203205
Rapid City, South Dakota, 57702, United States
Rivergate Dermatology & Skin Care Center /ID# 203372
Goodlettsville, Tennessee, 37072-2301, United States
Arlington Research Center, Inc /ID# 215899
Arlington, Texas, 76011, United States
Tekton Research, Inc. /ID# 211558
Austin, Texas, 78745, United States
Center for Clinical Studies - Houston (Binz) /ID# 203383
Houston, Texas, 77004-8097, United States
Acclaim Dermatology /ID# 213026
Sugar Land, Texas, 77479-2645, United States
Virginia Dermatology & Skin Cancer Center /ID# 210154
Norfolk, Virginia, 23502-2233, United States
Dominion Medical Associates /ID# 212986
Richmond, Virginia, 23219, United States
The Vancouver Clinic, INC. PS /ID# 202930
Vancouver, Washington, 98664, United States
Woden Dermatology /ID# 204778
Phillip, Australian Capital Territory, 2606, Australia
St George Hospital /ID# 204780
Kogarah, New South Wales, 2217, Australia
Veracity Clinical Research /ID# 204786
Woolloongabba, Queensland, 4102, Australia
North Eastern Health Specialists /ID# 204785
Hectorville, South Australia, 5073, Australia
Skin Health Institute Inc /ID# 204779
Carlton, Victoria, 3053, Australia
Fremantle Dermatology /ID# 204784
Fremantle, Western Australia, 6160, Australia
Kirk Barber Research, CA /ID# 201046
Calgary, Alberta, T2G 1B1, Canada
Beacon Dermatology Inc /ID# 213003
Calgary, Alberta, T3E 0B2, Canada
University of Alberta Hospital - Division of Hematology /ID# 213008
Edmonton, Alberta, T6G 2B7, Canada
Medicor Research Inc /ID# 211274
Greater Sudbury, Ontario, P3A 1W8, Canada
Dr. Wei Jing Loo Medicine Prof /ID# 208849
London, Ontario, N6H 5L5, Canada
Lynderm Research Inc. /ID# 201050
Markham, Ontario, L3P 1X2, Canada
Dre Angelique Gagne-Henley M.D. inc. /ID# 208189
Saint-Jérôme, Quebec, J7Z 7E2, Canada
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 213667
Nagoya, Aichi-ken, 455-8530, Japan
Kurume University Hospital /ID# 203139
Kurume-shi, Fukuoka, 830-0011, Japan
Nippon Medical School Musashi Kosugi Hospital /ID# 213961
Kawasaki-shi, Kanagawa, 211-8533, Japan
Nagaoka Red Cross Hospital /ID# 214140
Nagaoka-shi, Niigata, 940-2085, Japan
University of the Ryukyus Hospital /ID# 203974
Nakagami-gun, Okinawa, 903-0215, Japan
Osaka City University Hospital /ID# 203410
Osaka, Osaka, 545-8586, Japan
Hamamatsu University Hospital /ID# 203270
Hamamatsu, Shizuoka, 431-3192, Japan
Teikyo University Hospital /ID# 202884
Itabashi-ku, Tokyo, 173-8606, Japan
Tokyo Medical University Hospital /ID# 203647
Shinjuku-ku, Tokyo, 160-0023, Japan
Tokyo Medical University Hospital /ID# 204101
Shinjuku-ku, Tokyo, 160-0023, Japan
Dr. Samuel Sanchez PSC /ID# 213117
Caguas, 00727, Puerto Rico
Cruz-Santana, Carolina, PR /ID# 213229
Carolina, 00985, Puerto Rico
Clinical Research Puerto Rico /ID# 213118
San Juan, 00909, Puerto Rico
Related Publications (1)
Tyring SK, Rich P, Tada Y, Beeck S, Messina I, Liu J, Huang X, Shumack S. Risankizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study. Dermatol Ther (Heidelb). 2023 Feb;13(2):595-608. doi: 10.1007/s13555-022-00876-x. Epub 2023 Jan 2.
PMID: 36588137DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2018
First Posted
October 15, 2018
Study Start
December 27, 2018
Primary Completion
October 28, 2020
Study Completion
April 26, 2021
Last Updated
November 18, 2021
Results First Posted
November 18, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing, please refer to the link below.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
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.