A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
NCT ID: NCT03926169
Last Updated: 2022-08-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
243 participants
INTERVENTIONAL
2019-06-03
2021-08-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Risankizumab 180 mg
In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
Risankizumab
Risankizumab is administered as a SC injection in pre-filled syringe (PFS)
Risankizumab 360 mg
In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
Risankizumab
Risankizumab is administered as a SC injection in pre-filled syringe (PFS)
Placebo
In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
Placebo for risankizumab
Placebo for risankizumab is administered as a SC injection in PFS
Risankizumab 180 mg / Risankizumab 360 mg
In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.
Risankizumab
Risankizumab is administered as a SC injection in pre-filled syringe (PFS)
Placebo for risankizumab
Placebo for risankizumab is administered as a SC injection in PFS
Risankizumab 360 mg / Risankizumab 360 mg
In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
Risankizumab
Risankizumab is administered as a SC injection in pre-filled syringe (PFS)
Placebo for risankizumab
Placebo for risankizumab is administered as a SC injection in PFS
Placebo / Risankizumab 360 mg
In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants receive blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
Risankizumab
Risankizumab is administered as a SC injection in pre-filled syringe (PFS)
Placebo for risankizumab
Placebo for risankizumab is administered as a SC injection in PFS
Interventions
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Risankizumab
Risankizumab is administered as a SC injection in pre-filled syringe (PFS)
Placebo for risankizumab
Placebo for risankizumab is administered as a SC injection in PFS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HS lesions present in at least two distinct anatomical areas.
* Draining fistula count of ≤ 20 at Baseline visit.
* Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline visit.
* Participants are required to use a daily antiseptic wash on their HS lesions.
* Participant must have a history of inadequate response or intolerance to an adequate trial of oral antibiotics for treatment of HS.
Exclusion Criteria
* Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection.
* Participant has prior exposure to anti-interleukin-1 (anti-IL-1) treatment within 3 months or 5 half-lives, whichever is longer, prior to baseline.
* Participant has received prescription topical therapies (including topical antibiotics) within 14 days prior to the Baseline visit.
* Participant has received systemic non-biologic therapies that can also be used to treat HS within 4 weeks prior to the Baseline visit.
* Participant has received any systemic (including oral) antibiotic treatment within 4 weeks prior to the Baseline visit.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Burke Pharmaceutical Research /ID# 211671
Hot Springs, Arkansas, United States
Bakersfield Derma & Skin Cance /ID# 211684
Bakersfield, California, United States
Wallace Medical Group /ID# 215958
Los Angeles, California, United States
Integrative Skin Science and Research /ID# 212550
Sacramento, California, United States
UC Davis Health /ID# 211436
Sacramento, California, United States
California Dermatology Institute /ID# 211786
Thousand Oaks, California, United States
CCD Research, PLLC /ID# 214479
Cromwell, Connecticut, United States
Advanced Medical Research /ID# 215203
Sandy Springs, Georgia, United States
Arlington Dermatology /ID# 219096
Rolling Meadows, Illinois, United States
Tufts Medical Center /ID# 212680
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center /ID# 211794
Boston, Massachusetts, United States
Hamzavi Dermatology /ID# 212318
Fort Gratiot, Michigan, United States
University of Minnesota /ID# 212319
Minneapolis, Minnesota, United States
Minnesota Clinical Study Center /ID# 211979
New Brighton, Minnesota, United States
Skin Specialists, PC /ID# 211675
Omaha, Nebraska, United States
Montefiore Medical Center - Moses Campus /ID# 211800
The Bronx, New York, United States
Oregon Medical Res Center PC /ID# 211796
Portland, Oregon, United States
Penn State Hershey Medical Ctr /ID# 211659
Hershey, Pennsylvania, United States
Rhode Island Hospital /ID# 211807
Providence, Rhode Island, United States
Modern Research Associates, PL /ID# 215202
Dallas, Texas, United States
Virginia Clinical Research, Inc. /ID# 215959
Norfolk, Virginia, United States
Premier Clinical Research /ID# 211799
Spokane, Washington, United States
Woden Dermatology /ID# 212437
Phillip, Australian Capital Territory, Australia
Westmead Hospital /ID# 212438
Westmead, New South Wales, Australia
Veracity Clinical Research /ID# 212432
Woolloongabba, Queensland, Australia
Skin Health Institute Inc /ID# 212433
Carlton, Victoria, Australia
Sinclair Dermatology /ID# 215548
East Melbourne, Victoria, Australia
The Royal Melbourne Hospital /ID# 212436
Parkville, Victoria, Australia
Fremantle Dermatology /ID# 212434
Fremantle, Western Australia, Australia
Wiseman Dermatology Research /ID# 212243
Winnipeg, Manitoba, Canada
Dr. Irina Turchin PC Inc. /ID# 212248
Fredericton, New Brunswick, Canada
Dr. S.K. Siddha Medicine Professional Corporation /ID# 219043
Newmarket, Ontario, Canada
K. Papp Clinical Research /ID# 212166
Waterloo, Ontario, Canada
Dre Angelique Gagne-Henley M.D. inc. /ID# 212249
Saint-Jérôme, Quebec, Canada
Chu de Nice-Hopital L'Archet Ii /Id# 212563
Nice, Alpes-Maritimes, France
CHU de SAINT ETIENNE - Hopital Nord /ID# 212564
Saint Priest EN Jarez, Pays de la Loire Region, France
HCL - Hopital Edouard Herriot /ID# 218408
Lyon, , France
Polyclinique Courlancy /ID# 212567
Reims, , France
CHU Toulouse - Hopital Larrey /ID# 213581
Toulouse, , France
Hopital Prive d'Antony /ID# 212566
Antony, Île-de-France Region, France
Universitaetsklinikum Frankfurt /ID# 211913
Frankfurt am Main, Hesse, Germany
Klinikum Ruhr Univ Bochum /ID# 211910
Bochum, , Germany
Staedtisches Klinikum Dessau /ID# 211914
Dessau, , Germany
Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 211912
Hamburg, , Germany
Nagoya City University Hospital /ID# 211155
Nagoya, Aichi-ken, Japan
Fukuoka University Hospital /ID# 211303
Fukuoka, Fukuoka, Japan
Tohoku University Hospital /ID# 212214
Sendai, Miyagi, Japan
University of the Ryukyus Hospital /ID# 211373
Nakagami-gun, Okinawa, Japan
Toranomon Hospital /ID# 211742
Minato-ku, Tokyo, Japan
Bravis Ziekenhuis /ID# 212536
Bergen op Zoom, North Brabant, Netherlands
Erasmus Medisch Centrum /ID# 212535
Rotterdam, South Holland, Netherlands
Amphia Ziekenhuis /ID# 212538
Breda, , Netherlands
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212015
Sabadell, Barcelona, Spain
Hospital de Manises /ID# 211541
Manises, Valencia, Spain
Hospital General Universitario Alicante /ID# 212010
Alicante, , Spain
Hospital Santa Creu i Sant Pau /ID# 212009
Barcelona, , Spain
Hospital Universitario Virgen de las Nieves /ID# 212014
Granada, , Spain
Hospital General Universitario Gregorio Maranon /ID# 212011
Madrid, , Spain
Hospital Universitario Virgen de la Victoria /ID# 212013
Málaga, , Spain
Countries
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References
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Kimball AB, Prens EP, Passeron T, Maverakis E, Turchin I, Beeck S, Drogaris L, Geng Z, Zhan T, Messina I, Bechara FG. Efficacy and Safety of Risankizumab for the Treatment of Hidradenitis Suppurativa: A Phase 2, Randomized, Placebo-Controlled Trial. Dermatol Ther (Heidelb). 2023 May;13(5):1099-1111. doi: 10.1007/s13555-023-00913-3. Epub 2023 Mar 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Other Identifiers
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2019-000122-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M16-833
Identifier Type: -
Identifier Source: org_study_id
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