A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of Mirikizumab to Secukinumab and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-2
Status: Completed
Location: See all (172) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for moderate to severe plaque psoriasis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participant must have chronic plaque psoriasis for at least 6 months.
Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
California
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield
David Stoll, M.D.
Beverly Hills
California Dermatology and Clinical Research Institute
Encinitas
Tien Q. Nguyen, MD inc. DBA First OC Dermatology
Fountain Valley
Keck School of Medicine University of Southern California
Los Angeles
Dermatology Clinical Trials
Newport Beach
San Luis Dermatology & Laser Clinic, Inc
San Luis Obispo
Clinical Science Institute
Santa Monica
Florida
Park Avenue Dermatology
Orange Park
Georgia
Dermatologic Surgery Specialists, PC
Macon
Medaphase Inc
Newnan
Meridian Clinical Research
Savannah
Idaho
Treasure Valley Dermatology
Boise
Illinois
University Dermatology
Darien
Arlington Dermatology
Rolling Meadows
Indiana
Dawes Fretzin Clinical Research
Indianapolis
The Indiana Clinical Trials Center, PC
Plainfield
The South Bend Clinic
South Bend
Kentucky
Dermatology Specialist
Louisville
Louisiana
DelRicht Research
Baton Rouge
Massachusetts
ORA, Inc
Andover
Maryland
Dermatology and Skin Cancer Specialists
Rockville
Lawrence J Green, M.D, LLC
Rockville
Missouri
Central Dermatology PC
Saint Louis
North Carolina
PMG Research of Cary, LLC
Cary
University of North Carolina Dermatology and Skin Cancer Cen
Chapel Hill
PMG Research of Wilmington, LLC
Wilmington
New Jersey
Psoriasis Treatment Center of Central New Jersey
East Windsor
New York
Mount Sinai School of Medicine Dermatology Clinical Trials
New York
Ohio
Bexley Dermatology Research
Bexley
University Hospitals Cleveland Medical Center
Cleveland
Wright State Physicians Dermatology
Fairborn
Oregon
Oregon Dermatology and Research Center
Portland
Oregon Health and Science University
Portland
Rhode Island
Clinical Partners LLC
Johnston
Texas
Modern Research Associates PLLC
Dallas
Austin Institute for Clinical Research, Inc.
Pflugerville
Texas Dermatology and Laser Specialists
San Antonio
Utah
Jordan Valley Dermatology Center
West Jordan
Virginia
Virginia Clinical Research
Norfolk
Washington
Dermatology Associates
Seattle
Other Locations
Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires
CEDIC-Centro de Investigaciones Clinicas
Caba
Buenos Aires Skin
Ciudad Autonoma Buenos Aires
Clinica Adventista de Belgrano
Ciudad Autonoma Buenos Aires
Instituto de Neumonología y Dermatología
Ciudad Autonoma Buenos Aires
Psoriahue Medicina Interdisciplinaria
Ciudad Autonoma Buenos Aires
Halitus Instituto Médico
Ciudad Autonoma De Buenos Aire
Parra Dermatología
Mendoza
Australia
Clinical Trials SA Pty Ltd
Adelaide
Skin and Cancer Foundation Inc.
Carlton
Fremantle Dermatology
Perth
Woden Dermatology
Phillip
Veracity Clinical Research Pty Ltd
Woolloongabba
Canada
Stratica Medical
Edmonton
Eastern Canada Cutaneous Research Assoicates Ltd
Halifax
The Guenther Dermatology Research Centre
London
Lynderm Research Inc
Markham
Innovaderm Research Inc
Montreal
SKiN Centre for Dermatology
Peterborough
Dr. Chih-ho Hong Medical Inc.
Surrey
K. Papp Clinical Research Inc
Waterloo
France
CHU de Bordeaux Hopital Saint Andre
Bordeaux Cedex
CH du Mans - Pavillon Claude Monet
Le Mans Cedex 1
CHU Dupuytren 2
Limoges
Cabinet Médical
Martigues
Hopital Saint Eloi
Montpellier
CHU de Nice Hopital de L'Archet
Nice Cedex 3
Chu de Rouen Hopital Charles Nicolle
Rouen Cedex
Hopital Larrey
Toulouse Cedex 9
Germany
Fachklinik Bad Bentheim
Bad Bentheim
Klin. Forschung Berlin-Mitte GmbH
Berlin
Rothhaar Studien GmbH
Berlin
Dermatologisches Zentrum Osnabrück Nord
Bramsche
Elbe Kliniken Stade Buxtehude GmbH Klinikum Buxtehude
Buxtehude
Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH
Darmstadt
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt Am Main
TFS Trial Form Support GmbH
Hamburg
Universitätsklinikum Heidelberg
Heidelberg
Universitätsklinikum Schleswig-Holstein
Kiel
Universitätsklinikum Schleswig-Holstein
Lübeck
Hautarztpraxis Dr. Leitz und Kollegen
Stuttgart
Universitätsklinikum Tübingen
Tübingen
Hungary
Ambrozia Kft.
Budapest
UNO Medical Trials Kft.
Budapest
Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
Debrecen
Bacs-Kiskun Megyei Korhaz
Kecskemet
Oroshaza Varosi Onkormanyzat Korhaza
Oroshaza
Trial Pharma Kft.
Puspokladany
Allergo-Derm Bakos Kft
Szolnok
MedMare Bt
Veszprem
Israel
Haemek Medical Center- Dermatology
Afula
Soroka Medical Center
Beer Sheva
Rambam Medical Center
Haifa
Rabin Medical Center
Petach Tikva
Sheba Medical Center
Ramat Gan
Tel Aviv Sourasky Medical Center
Tel Aviv
Italy
Presidio Ospedaliero Firenze Centro Piero Palagi
Firenze
Policlinico di Tor Vergata
Roma
Policlinico Univ. Agostino Gemelli
Roma
Istituto Clinico Humanitas
Rozzano
Japan
Asahikawa Medical College Hospital
Asahikawa
The University of Tokyo Hospital
Bunkyo-ku
St. Lukes International Hospital
Chuo-ku
Gifu University Hospital
Gifu
Kansai Medical University Hospital
Hirakata
Tokyo Medical University Ibaraki Medical Center
Inashiki-gun
Tokai University Hospital
Isehara
Nihon University Itabashi Hospital
Itabashi-ku
Teikyo University Hospital
Itabashi-ku
Yamanashi Prefectural Central Hospital
Kofu
Kurume University Hospital
Kurume
Kyoto Prefectural University of Medicine
Kyoto-shi
Gunma University Hosptial
Maebashi
Shinshu University Hospital
Matsumoto
Nagasaki University Hospital
Nagaski
Nagoya City University Hospital
Nagoya
Ryukyu University Hospital
Nakagami-gun
Shiga University of Medical Science Hosptial
Ohtsu-shi
Nippon Life Hospital
Osaka
Osaka City University Hospital
Osaka
Tohoku University Hospital
Sendai
Showa University Hospital
Shinagawa-ku
Tokyo Medical University Hospital
Shinjuku-ku
Tokushima University Hospital
Tokushima
Mie University Hospital
Tsu
Yamaguchi University Hospital
Ube
Juntendo Urayasu Hospital
Urayasu
Wakayama MedicaL University Hospital
Wakayama
Poland
NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm
Bialystok
NZOZ ZDROWIE Osteo-Medic
Bialystok
Centrum Badan Klinicznych, PI House
Gdansk
Centrum Medyczne Angelius Provita
Katowice
Barbara Rewerska DIAMOND CLINIC
Krakow
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Lodz
Dermed Centrum Medyczne Sp. z o.o.
Lodz
DermoDent, Centrum Medyczne Czajkowscy
Osielsko
AI Centrum Medyczne
Poznan
Lubelskie Centrum Diagnostyczne
Swidnik
LASER CLINIC Specjalistyczne Gabinety Lekarskie
Szczecin
Centralny Szpital Kliniczny MSW Klinika Dermatologii
Warszawa
Centrum Medyczne Evimed
Warszawa
DermMEDICA Sp. z o.o.
Wroclaw
Puerto Rico
Santa Cruz Behavioral PSC
Bayamón
Office of Dr. Samuel Sanchez PSC
Caguas
Office of Dr. Alma M. Cruz
Carolina
Ponce School of Medicine CAIMED Center
Ponce
GCM Medical Group PSC
San Juan
Republic of Korea
Pusan National University Hospital
Busan
Ilsan Paik Hospital
Ilsanseo-gu
Gachon University Gil Medical Center
Incheon
Seoul National University Bundang Hospital
Seongnam-si
Chungang University Hospital
Seoul
Konkuk University Medical Center
Seoul
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul St. Mary's Hospital
Seoul
Severance Hospital Yonsei University Health System
Seoul
Spain
Hospital del Mar
Barcelona
Hospital Germans Trias i Pujol
Barcelona
Hospital De Basurto
Bilbao
Hospital Reina Sofia
Cordoba
Hospital Infanta Leonor
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Ramon y Cajal
Madrid
Hospital de Manises
Manises
Centro de Especialidades Mollabao
Pontevedra
Hospital Universitario Virgen Macarena
Sevilla
Hospital Universitario La Fe de Valencia
Valencia
Hospital Marina Baixa
Villajoyosa
United Kingdom
Salford Royal NHS Foundation Trust
Salford
Time Frame
Start Date: 2018-06-26
Completion Date: 2020-06-03
Participants
Target number of participants: 1484
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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.
Active_comparator: 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.
Experimental: Japan GPP/EP
Participants received 250mg Mirikizumab Q4W in induction period followed by 250mg Q8W in maintenance period by subcutaneous injection.
Authors
Marie Selerova, Cindy E Owen, Peter J Jenkin, Jeffrey James Crowley, Ira Hughes Thorla, James Krell, Corinne Howington, Sunil S Dhawan, George Schmieder, Ellen H Frankel, David M Stoll, Stefani Takahashi, Phoebe Rich, Craig L Leonardi, David M Pariser, Boni Elizabeth Elewski, Todd Schlesinger, Scott A Fretzin, Paul S Yamauchi, Mark G. Lebwohl, Navid Nami, Michael Bukhalo, Ryan Harris, Jose Gonzalez-Chavez, Jamie Debra Weisman, Aron Jeffrey Gewirtzman, Vivian Laquer, William Cragun, Lawrence Green, Edward Lain, Benjamin N. Lockshin, Douglass W Forsha, Jennifer Soung, Michael Heffernan, John C. Browning, Stacy R. Smith, Aida Lugo-Somolinos, Samuel Sanchez-Rivera, Patricia C. Lee, Mark R Ling, Jeffrey M Sobell, Brenda LaTowsky, James E Appel, Vassilios A Dimitropoulos, Steven R Feldman, Neil J Korman, Eneida de la Torre, Lena Gonser, Sascha Gerdes, Christophe BEDANE, Carle Paul, Diamant Thaci, Andreas Pinter, Richard Graham Ballentyne Langley, Knut Schäkel, Kamran Ghoreschi, Marie Beylot-Barry, Athanasios Tsianakas, Ansgar Weyergraf, Celine Girard, Andreas Kleinheinz, Catherine Hren, Howard L Sofen, Jerry Bagel, Jeffrey Travers, David J Cohen, Artis P Truett, Craig Teller, Laura K Ferris, Katsuhiko Tsukamoto, Joo-Heung Lee, Sang-Woong Youn, Anne-Benedicte Duval-Modeste, Kazuya Teramura, Eisaku Ogawa, Jean-Philippe Lacour, Norman R. Wasel, Nathalie BENETON, Michal Ramon, Mariko Seishima, Andrzej Kaszuba, Hagit Matz, Ignacio Dei-Cas, Vladimir Vasku, Hirohiko Sueki, Annalisa Patrizi, Kenshi Yamasaki, Shireen Kaur Sidhu, Alex Zvulunov, Barbara Rewerska, Chika Ohata, Yoshiaki Kubo, Tomotaka Mabuchi, Yong Beom Choe, Michael Ziv, Eva Remenyik, Catherine Maari, Chiharu Tateishi, Masatoshi Jinnin, Charles W. Lynde, Piergiorgio Malagoli, Koji Masuda, Sabatino Pallotta, Hiroyuki Okamoto, Joo Young Roh, Lynda Jane Spelman, Peter Foley, Masaru Honma, Yoshihide Asano, Mari Higashiyama, Yasushi Suga, Yasuhiro Kawachi, Antonio Costanzo, Ramon Marla Pujol, Ketty Peris, Noriki Fujimoto, Luca Bianchi, Richard Warren, Tae Yoon Kim, Lev Pavlovsky, Tadashi Terui, Yayoi Tada, Maria Laura Galimberti, Paula Luna, Yutaka Shimomura, Yukari Okubo, Rosa Izu Belloso, Akimichi Morita, Lyn Guenther, Felix Pavlotsky, Petr Arenberger, Chih-Ho H Hong, Antonio Richetta, Keiichi Yamanaka, Melinda J Gooderham, Lajos Kemeny
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company