Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis
NCT ID: NCT03478787
Last Updated: 2021-07-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
327 participants
INTERVENTIONAL
2018-05-08
2020-07-08
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
SINGLE
Study Groups
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Risankizumab
Participants randomized to risankizumab receive 2 injections of active risankizumab (150 mg total dosage) subcutaneously (SC) at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
risankizumab
Subcutaneous (SC) injection
Secukinumab
Participants randomized to secukinumab receive 2 injections of active secukinumab (300 mg total dosage) SC at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.
secukinumab
Subcutaneous (SC) injection
Interventions
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risankizumab
Subcutaneous (SC) injection
secukinumab
Subcutaneous (SC) injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis
* Subject must be a candidate for systemic therapy as assessed by the investigator;
* Subject must be an acceptable candidate to receive secukinumab according to the local label for this compound.
Exclusion Criteria
* Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), and/ or active tuberculosis. Subjects with a positive QuantiFERON®-TB/purified protein derivative (PPD) test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines.
* Active systemic infection during the last 2 weeks prior to Baseline Visit (exception: common cold)
* History of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix
* Previous exposure to risankizumab
* Previous exposure to secukinumab
18 Years
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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Advanced Research Associates - Glendale /ID# 204335
Glendale, Arizona, United States
Alliance Dermatology and MOHs /ID# 204336
Phoenix, Arizona, United States
Bakersfield Derma & Skin Cance /ID# 202115
Bakersfield, California, United States
Center for Dermatology Clin Res /ID# 202116
Fremont, California, United States
Dermatology Res. Assoc., CA /ID# 202170
Los Angeles, California, United States
UC Davis Health /ID# 202263
Sacramento, California, United States
Medderm Associates /ID# 202162
San Diego, California, United States
UConn Health Main /ID# 201745
Farmington, Connecticut, United States
Tory P Sullivan, MD PA /ID# 202177
North Miami Beach, Florida, United States
Renstar Medical Research /ID# 202113
Ocala, Florida, United States
Progressive Medical Research /ID# 202183
Port Orange, Florida, United States
Integrated Clinical Research LLC /ID# 202152
West Palm Beach, Florida, United States
Dermatology Specialists Resear /ID# 202145
Louisville, Kentucky, United States
Dermatology and Skin Cancer Specialists, LLC /ID# 203938
Rockville, Maryland, United States
ORA, Inc. /ID# 204342
Andover, Massachusetts, United States
Beth Israel Deaconess Medical Center /ID# 204340
Boston, Massachusetts, United States
Minnesota Clinical Study Center /ID# 202369
New Brighton, Minnesota, United States
Central Dermatology, PC /ID# 202156
St Louis, Missouri, United States
Psoriasis Treatment Ctr of Central NJ /ID# 202107
East Windsor, New Jersey, United States
Synexus Research Cincinnati /ID# 202161
Cincinnati, Ohio, United States
Oregon Derm & Res. Ctr /ID# 201652
Portland, Oregon, United States
Oregon Medical Res Center PC /ID# 201651
Portland, Oregon, United States
Clinical Partners, LLC /ID# 201736
Johnston, Rhode Island, United States
Center for Clinical Studies - Houston (Binz) /ID# 202178
Houston, Texas, United States
Progressive Clinical Research /ID# 202155
San Antonio, Texas, United States
Center for Clinical Studies - Webster TX /ID# 202154
Webster, Texas, United States
University of Utah /ID# 204035
Salt Lake City, Utah, United States
Froedtert Mem Lutheran Hosp /ID# 204896
Milwaukee, Wisconsin, United States
Beacon Dermatology Inc /ID# 203054
Calgary, Alberta, Canada
Enverus Medical Research /ID# 203043
Surrey, British Columbia, Canada
Dr. Irina Turchin PC Inc. /ID# 203052
Fredericton, New Brunswick, Canada
Eastern Canada Cutaneous Resea /ID# 203045
Halifax, Nova Scotia, Canada
Dermatrials Research /ID# 203051
Hamilton, Ontario, Canada
Dre Angelique Gagne-Henley M.D. inc. /ID# 203053
Saint-Jérôme, Quebec, Canada
Dermatologique du Quebec /ID# 203050
Québec, , Canada
Charles Nicolle CHU Rouen /ID# 203590
Rouen, Seine-Maritime, France
Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 203591
Nice, , France
Hopital Saint-Louis /ID# 203586
Paris, , France
Polyclinique Courlancy /ID# 203588
Reims, , France
Hopital Larrey - CHU de Toulouse /ID# 203587
Toulouse, , France
TU Uniklinik Munchen /ID# 203919
Munich, , Germany
Policlinico A. Gemelli /ID# 203009
Rome, Lazio, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 204982
Milan, Lombardy, Italy
Radboud Universitair Medisch Centrum /ID# 202560
Nijmegen, Gelderland, Netherlands
Bravis Ziekenhuis /ID# 205232
Bergen op Zoom, North Brabant, Netherlands
Academisch Medical center Amsterdam /ID# 202556
Amsterdam, North Holland, Netherlands
Klinika Dermatologii Pod Fortem /ID# 204180
Krakow, Lesser Poland Voivodeship, Poland
Przychodnia Specjalistyczna High-Med /ID# 203183
Warsaw, Masovian Voivodeship, Poland
Klinika Ambroziak Sp. z o.o. /ID# 203928
Warsaw, Masovian Voivodeship, Poland
KSW nr1 w Rzeszowie /ID# 203776
Rzeszów, Podkarpackie Voivodeship, Poland
Osteo-Medic S.C. /ID# 203742
Bialystok, Podlaskie Voivodeship, Poland
Dermed Centrum Medyczne Sp. z o.o /ID# 203171
Lodz, Łódź Voivodeship, Poland
Hospital de Manises /ID# 203757
Manises, Valencia, Spain
Hospital General Universitario Alicante /ID# 203764
Alicante, , Spain
Hospital Universitario Clinico San Cecilio /ID# 203760
Granada, , Spain
Hospital Universitario de la Princesa /ID# 203754
Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 203756
Madrid, , Spain
Hospital Universitario Arnau Vilanova /ID# 203763
Valencia, , Spain
Whipps Cross Univ Hospital /ID# 204723
London, London, City of, United Kingdom
Guy's and St Thomas' NHS Found /ID# 204721
London, London, City of, United Kingdom
The University of Manchester /ID# 204720
Salford, , United Kingdom
Countries
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References
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Crowley JJ, Langley RG, Gordon KB, Pinter A, Ferris LK, Rubant S, Photowala H, Xue Z, Wu T, Zhan T, Beeck S, Shah M, Warren RB. Efficacy of Risankizumab versus Secukinumab in Patients with Moderate-to-Severe Psoriasis: Subgroup Analysis from the IMMerge Study. Dermatol Ther (Heidelb). 2022 Feb;12(2):561-575. doi: 10.1007/s13555-021-00679-6. Epub 2022 Jan 20.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-004932-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M16-766
Identifier Type: -
Identifier Source: org_study_id
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