A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)
NCT ID: NCT03535194
Last Updated: 2021-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1484 participants
INTERVENTIONAL
2018-06-26
2020-06-03
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
DOUBLE
Study Groups
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250mg Q4W/250mg Q8W Mirikizumab
Participants received 250 Milligrams (mg) Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.
Mirikizumab
Administered SC
250mg Q4W/125mg Q8W Mirikizumab
Participants received 250mg Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 125mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.
Mirikizumab
Administered SC
Placebo/250mg Mirikizumab
Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 in maintenance period. Participants received matching placebo to blind Secukinumab.
Mirikizumab
Administered SC
Placebo
Administered SC
300mg Secukinumab
Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period followed by 300mg Secukinumab Q4W from week 16 to 52 in maintenance period.
Secukinumab
Administered SC
Japan GPP/EP
Participants received 250mg Mirikizumab Q4W in induction period followed by 250mg Q8W in maintenance period by subcutaneous injection.
Mirikizumab
Administered SC
Interventions
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Mirikizumab
Administered SC
Placebo
Administered SC
Secukinumab
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Participant must not have had serious, opportunistic, or chronic/recurring infection within 3 months.
* Participant must not have received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or received live vaccine(s) (including attenuated live vaccines) within 12 weeks of baseline or intend to receive either during the study.
* Participant must not have any other skin conditions (excluding psoriasis).
* Participant must not have previous exposure to Cosentyx and any other biologic therapy targeting IL-17 (including Taltz).
* Participant must not have received anti-tumor necrosis factor (TNF) biologics within 8 weeks.
* Participant must not have previous exposure to any biologic therapy targeting IL-23 (including Stelara).
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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all 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, United States
David Stoll, M.D.
Beverly Hills, California, United States
California Dermatology and Clinical Research Institute
Encinitas, California, United States
Tien Q. Nguyen, MD inc. DBA First OC Dermatology
Fountain Valley, California, United States
Keck School of Medicine University of Southern California
Los Angeles, California, United States
Dermatology Clinical Trials
Newport Beach, California, United States
San Luis Dermatology & Laser Clinic, Inc
San Luis Obispo, California, United States
Clinical Science Institute
Santa Monica, California, United States
Park Avenue Dermatology
Orange Park, Florida, United States
Dermatologic Surgery Specialists, PC
Macon, Georgia, United States
Medaphase Inc
Newnan, Georgia, United States
Meridian Clinical Research
Savannah, Georgia, United States
Treasure Valley Dermatology
Boise, Idaho, United States
University Dermatology
Darien, Illinois, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
Dawes Fretzin Clinical Research
Indianapolis, Indiana, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
The South Bend Clinic
South Bend, Indiana, United States
Dermatology Specialist
Louisville, Kentucky, United States
DelRicht Research
Baton Rouge, Louisiana, United States
Dermatology and Skin Cancer Specialists
Rockville, Maryland, United States
Lawrence J Green, M.D, LLC
Rockville, Maryland, United States
ORA, Inc
Andover, Massachusetts, United States
Central Dermatology PC
St Louis, Missouri, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
Mount Sinai School of Medicine Dermatology Clinical Trials
New York, New York, United States
PMG Research of Cary, LLC
Cary, North Carolina, United States
University of North Carolina Dermatology and Skin Cancer Cen
Chapel Hill, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Bexley Dermatology Research
Bexley, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Wright State Physicians Dermatology
Fairborn, Ohio, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Clinical Partners LLC
Johnston, Rhode Island, United States
Modern Research Associates PLLC
Dallas, Texas, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Jordan Valley Dermatology Center
West Jordan, Utah, United States
Virginia Clinical Research
Norfolk, Virginia, United States
Dermatology Associates
Seattle, Washington, United States
CEDIC-Centro de Investigaciones Clinicas
Caba, Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, , Argentina
Buenos Aires Skin
Ciudad Autonoma Buenos Aires, , Argentina
Instituto de Neumonología y Dermatología
Ciudad Autonoma Buenos Aires, , Argentina
Psoriahue Medicina Interdisciplinaria
Ciudad Autonoma Buenos Aires, , Argentina
Clinica Adventista de Belgrano
Ciudad Autonoma Buenos Aires, , Argentina
Halitus Instituto Médico
Ciudad Autonoma de Buenos Aire, , Argentina
Parra Dermatología
Mendoza, , Argentina
Woden Dermatology
Phillip, Australian Capital Territory, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, Australia
Clinical Trials SA Pty Ltd
Adelaide, South Australia, Australia
Skin and Cancer Foundation Inc.
Carlton, Victoria, Australia
Fremantle Dermatology
Perth, Western Australia, Australia
Stratica Medical
Edmonton, Alberta, Canada
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, Canada
Eastern Canada Cutaneous Research Assoicates Ltd
Halifax, Nova Scotia, Canada
The Guenther Dermatology Research Centre
London, Ontario, Canada
Lynderm Research Inc
Markham, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
K. Papp Clinical Research Inc
Waterloo, Ontario, Canada
Innovaderm Research Inc
Montreal, Quebec, Canada
Kozni ambulance Kutna Hora, s.r.o.
Kutná Hora, Central Bohemia, Czechia
Clintrial, s.r.o.
Prague, Hl. M. Praha, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Hl. M. Praha, Czechia
Fakultni Nemocnice U svate Anny
Brno, South Moravian, Czechia
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
Ústí nad Labem, Ustecký Kraj, Czechia
Kozni oddeleni
Nový Jičín, , Czechia
CHU Dupuytren 2
Limoges, Cedex, France
CHU de Bordeaux Hopital Saint Andre
Bordeaux, , France
CH du Mans - Pavillon Claude Monet
Le Mans, , France
Cabinet Médical
Martigues, , France
Hopital Saint Eloi
Montpellier, , France
CHU de Nice Hopital de L'Archet
Nice, , France
Chu de Rouen Hopital Charles Nicolle
Rouen, , France
Hopital Larrey
Toulouse, , France
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Hautarztpraxis Dr. Leitz und Kollegen
Stuttgart, Baden-Wurttemberg, Germany
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany
Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH
Darmstadt, Hesse, Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, Hesse, Germany
Dermatologisches Zentrum Osnabrück Nord
Bramsche, Lower Saxony, Germany
Elbe Kliniken Stade Buxtehude GmbH Klinikum Buxtehude
Buxtehude, Lower Saxony, Germany
Fachklinik Bad Bentheim
Bad Bentheim, North Rhine-Westphalia, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
Klin. Forschung Berlin-Mitte GmbH
Berlin, , Germany
Rothhaar Studien GmbH
Berlin, , Germany
TFS Trial Form Support GmbH
Hamburg, , Germany
Bacs-Kiskun Megyei Korhaz
Kecskemét, Bács-Kiskun county, Hungary
Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
Debrecen, Hajdú-Bihar, Hungary
Trial Pharma Kft.
Püspökladány, Hajdú-Bihar, Hungary
Allergo-Derm Bakos Kft
Szolnok, Jász-Nagykun-Szolnok, Hungary
UNO Medical Trials Kft.
Budapest, , Hungary
Ambrozia Kft.
Budapest, , Hungary
Oroshaza Varosi Onkormanyzat Korhaza
Orosháza, , Hungary
MedMare Bt
Veszprém, , Hungary
Haemek Medical Center- Dermatology
Afula, , Israel
Soroka Medical Center
Beersheba, , Israel
Rambam Medical Center
Haifa, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Policlinico Univ. Agostino Gemelli
Roma, Rome, Italy
Presidio Ospedaliero Firenze Centro Piero Palagi
Florence, , Italy
Policlinico di Tor Vergata
Roma, , Italy
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Juntendo Urayasu Hospital
Urayasu, Chiba, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Gunma University Hosptial
Maebashi, Gunma, Japan
Asahikawa Medical College Hospital
Asahikawa, Hokkaido, Japan
Tokyo Medical University Ibaraki Medical Center
Inashiki-gun, Ibaraki, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
Kyoto Prefectural University of Medicine
Kyoto, Kyoto, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Shinshu University Hospital
Matsumoto, Nagano, Japan
Nagasaki University Hospital
Nagaski, Nagaski, Japan
Ryukyu University Hospital
Nakagami-gun, Okinawa, Japan
Kansai Medical University Hospital
Hirakata, Osaka, Japan
Shiga University of Medical Science Hosptial
Ohtsu-shi, Shiga, Japan
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, Japan
St. Lukes International Hospital
Chuo-Ku, Tokyo, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan
Showa University Hospital
Shinagawa-ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan
Gifu University Hospital
Gifu, , Japan
Osaka City University Hospital
Osaka, , Japan
Nippon Life Hospital
Osaka, , Japan
Tokushima University Hospital
Tokushima, , Japan
Wakayama MedicaL University Hospital
Wakayama, , Japan
DermoDent, Centrum Medyczne Czajkowscy
Osielsko, Kuyavian-Pomeranian Voivodeship, Poland
Barbara Rewerska DIAMOND CLINIC
Krakow, Lesser Poland Voivodeship, Poland
DermMEDICA Sp. z o.o.
Wroclaw, Lower Silesian Voivodeship, Poland
Lubelskie Centrum Diagnostyczne
Świdnik, Lublin Voivodeship, Poland
Centralny Szpital Kliniczny MSW Klinika Dermatologii
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne Evimed
Warsaw, Masovian Voivodeship, Poland
NZOZ ZDROWIE Osteo-Medic
Bialystok, Podlaskie Voivodeship, Poland
NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm
Bialystok, Podlaskie Voivodeship, Poland
Centrum Badan Klinicznych, PI House
Gdansk, Pomeranian Voivodeship, Poland
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, Poland
LASER CLINIC Specjalistyczne Gabinety Lekarskie
Szczecin, West Pomeranian Voivodeship, Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Lodz, , Poland
AI Centrum Medyczne
Poznan, , Poland
Dermed Centrum Medyczne Sp. z o.o.
Lodz, Łódź Voivodeship, Poland
Office of Dr. Samuel Sanchez PSC
Caguas, PR, Puerto Rico
Office of Dr. Alma M. Cruz
Carolina, PR, Puerto Rico
Ponce School of Medicine CAIMED Center
Ponce, PR, Puerto Rico
GCM Medical Group PSC
San Juan, PR, Puerto Rico
Santa Cruz Behavioral PSC
Bayamón, , Puerto Rico
Ilsan Paik Hospital
IlsanSeo-gu, Goyang-si, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Pusan National University Hospital
Busan, Korea, South Korea
Gachon University Gil Medical Center
Incheon, Korea, South Korea
Samsung Medical Center
Seoul, Korea, South Korea
Korea University Guro Hospital
Seoul, Korea, South Korea
Konkuk University Medical Center
Seoul, , South Korea
Seoul St. Mary's Hospital
Seoul, , South Korea
Chungang University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Hospital Marina Baixa
Villajoyosa, Alicante, Spain
Hospital Germans Trias i Pujol
Barcelona, Badalona, Spain
Hospital de Manises
Manises, Valencia, Spain
Hospital De Basurto
Bilbao, Vizcaya, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Reina Sofia
Córdoba, , Spain
Hospital Infanta Leonor
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Centro de Especialidades Mollabao
Pontevedra, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario La Fe de Valencia
Valencia, , Spain
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, United Kingdom
Countries
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References
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Papp K, Warren RB, Green L, Reich K, Langley RG, Paul C, Asahina A, Johnson L, Arora V, Osuntokun O, Lebwohl M. Safety and efficacy of mirikizumab versus secukinumab and placebo in the treatment of moderate-to-severe plaque psoriasis (OASIS-2): a phase 3, multicentre, randomised, double-blind study. Lancet Rheumatol. 2023 Sep;5(9):e542-e552. doi: 10.1016/S2665-9913(23)00120-0. Epub 2023 Aug 21.
Provided Documents
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Document Type: Study Protocol: Final Protocol
Document Type: Statistical Analysis Plan
Document Type: Study Protocol: Protocol addendum
Related Links
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A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)
Other Identifiers
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I6T-MC-AMAJ
Identifier Type: OTHER
Identifier Source: secondary_id
2017-003286-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16504
Identifier Type: -
Identifier Source: org_study_id
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