A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)
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
3 other identifiers
interventional
1,484
16 countries
178
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2018
178 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
May 14, 2018
CompletedFirst Posted
Study publicly available on registry
May 24, 2018
CompletedStudy Start
First participant enrolled
June 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2020
CompletedResults Posted
Study results publicly available
March 30, 2021
CompletedMarch 30, 2021
August 1, 2020
1.7 years
May 14, 2018
March 3, 2021
March 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline
The sPGA is the physician's determination of the participant's psoriasis lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's psoriasis was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
Week 16
Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).
Week 16
Secondary Outcomes (15)
Percentage of Participants Achieving a 75% Improvement in PASI 75
Week 16
Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement
Week 16
Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 in Those With PSS Symptom Score of ≥1 at Baseline
Week 16
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) With at Least a 5-Point Improvement (Reduction) From Baseline in Participants With a Baseline DLQI Total Score ≥5
Week 16
Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline
Baseline, Week 16
- +10 more secondary outcomes
Study Arms (5)
250mg Q4W/250mg Q8W Mirikizumab
EXPERIMENTALParticipants 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.
250mg Q4W/125mg Q8W Mirikizumab
EXPERIMENTALParticipants 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.
Placebo/250mg Mirikizumab
EXPERIMENTALParticipants 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.
300mg Secukinumab
ACTIVE COMPARATORParticipants 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.
Japan GPP/EP
EXPERIMENTALParticipants received 250mg Mirikizumab Q4W in induction period followed by 250mg Q8W in maintenance period by subcutaneous injection.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- Participant must have chronic plaque psoriasis for at least 6 months.
You may not qualify if:
- Participant must not be breastfeeding or nursing woman.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (178)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, 93309, United States
David Stoll, M.D.
Beverly Hills, California, 90212, United States
California Dermatology and Clinical Research Institute
Encinitas, California, 92024, United States
Tien Q. Nguyen, MD inc. DBA First OC Dermatology
Fountain Valley, California, 92708, United States
Keck School of Medicine University of Southern California
Los Angeles, California, 90033, United States
Dermatology Clinical Trials
Newport Beach, California, 92660, United States
San Luis Dermatology & Laser Clinic, Inc
San Luis Obispo, California, 93405, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Park Avenue Dermatology
Orange Park, Florida, 32073, United States
Dermatologic Surgery Specialists, PC
Macon, Georgia, 31217, United States
Medaphase Inc
Newnan, Georgia, 30263, United States
Meridian Clinical Research
Savannah, Georgia, 31406, United States
Treasure Valley Dermatology
Boise, Idaho, 83713, United States
University Dermatology
Darien, Illinois, 60561, United States
Arlington Dermatology
Rolling Meadows, Illinois, 60008, United States
Dawes Fretzin Clinical Research
Indianapolis, Indiana, 46250, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168, United States
The South Bend Clinic
South Bend, Indiana, 46617, United States
Dermatology Specialist
Louisville, Kentucky, 40241, United States
DelRicht Research
Baton Rouge, Louisiana, 70809, United States
Dermatology and Skin Cancer Specialists
Rockville, Maryland, 20850, United States
Lawrence J Green, M.D, LLC
Rockville, Maryland, 20850, United States
ORA, Inc
Andover, Massachusetts, 01810, United States
Central Dermatology PC
St Louis, Missouri, 63117, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520, United States
Mount Sinai School of Medicine Dermatology Clinical Trials
New York, New York, 10029, United States
PMG Research of Cary, LLC
Cary, North Carolina, 27511, United States
University of North Carolina Dermatology and Skin Cancer Cen
Chapel Hill, North Carolina, 27516, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Bexley Dermatology Research
Bexley, Ohio, 43209, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Wright State Physicians Dermatology
Fairborn, Ohio, 46435, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Clinical Partners LLC
Johnston, Rhode Island, 02919, United States
Modern Research Associates PLLC
Dallas, Texas, 75231, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218, United States
Jordan Valley Dermatology Center
West Jordan, Utah, 84088, United States
Virginia Clinical Research
Norfolk, Virginia, 23502, United States
Dermatology Associates
Seattle, Washington, 98101, United States
CEDIC-Centro de Investigaciones Clinicas
Caba, Buenos Aires, C1425DES, Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1027AAP, Argentina
Buenos Aires Skin
Ciudad Autonoma Buenos Aires, C1055AA0, Argentina
Instituto de Neumonología y Dermatología
Ciudad Autonoma Buenos Aires, C1425BEA, Argentina
Psoriahue Medicina Interdisciplinaria
Ciudad Autonoma Buenos Aires, C1425DKG, Argentina
Clinica Adventista de Belgrano
Ciudad Autonoma Buenos Aires, C1430EGF, Argentina
Halitus Instituto Médico
Ciudad Autonoma de Buenos Aire, C1122AAF, Argentina
Parra Dermatología
Mendoza, 5500, Argentina
Woden Dermatology
Phillip, Australian Capital Territory, 2606, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, 4102, Australia
Clinical Trials SA Pty Ltd
Adelaide, South Australia, 5073, Australia
Skin and Cancer Foundation Inc.
Carlton, Victoria, 3053, Australia
Fremantle Dermatology
Perth, Western Australia, 6160, Australia
Stratica Medical
Edmonton, Alberta, T5K 1X3, Canada
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, V3R 6A7, Canada
Eastern Canada Cutaneous Research Assoicates Ltd
Halifax, Nova Scotia, B3H1Z2, Canada
The Guenther Dermatology Research Centre
London, Ontario, N6A 3H7, Canada
Lynderm Research Inc
Markham, Ontario, L3P1X2, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
K. Papp Clinical Research Inc
Waterloo, Ontario, N2J 1C4, Canada
Innovaderm Research Inc
Montreal, Quebec, H2X 2V1, Canada
Kozni ambulance Kutna Hora, s.r.o.
Kutná Hora, Central Bohemia, 28430, Czechia
Clintrial, s.r.o.
Prague, Hl. M. Praha, 100 00, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Hl. M. Praha, 100 34, Czechia
Fakultni Nemocnice U svate Anny
Brno, South Moravian, 656 91, Czechia
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
Ústí nad Labem, Ustecký Kraj, 40113, Czechia
Kozni oddeleni
Nový Jičín, 741 01, Czechia
CHU Dupuytren 2
Limoges, Cedex, 87042, France
CHU de Bordeaux Hopital Saint Andre
Bordeaux, 33075, France
CH du Mans - Pavillon Claude Monet
Le Mans, 72037, France
Cabinet Médical
Martigues, 13500, France
Hopital Saint Eloi
Montpellier, 34295, France
CHU de Nice Hopital de L'Archet
Nice, 06202, France
Chu de Rouen Hopital Charles Nicolle
Rouen, 76036, France
Hopital Larrey
Toulouse, 31059, France
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Hautarztpraxis Dr. Leitz und Kollegen
Stuttgart, Baden-Wurttemberg, 70178, Germany
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH
Darmstadt, Hesse, 64283, Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, Hesse, 60590, Germany
Dermatologisches Zentrum Osnabrück Nord
Bramsche, Lower Saxony, 49565, Germany
Elbe Kliniken Stade Buxtehude GmbH Klinikum Buxtehude
Buxtehude, Lower Saxony, 21614, Germany
Fachklinik Bad Bentheim
Bad Bentheim, North Rhine-Westphalia, 48455, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538, Germany
Klin. Forschung Berlin-Mitte GmbH
Berlin, 10117, Germany
Rothhaar Studien GmbH
Berlin, 10783, Germany
TFS Trial Form Support GmbH
Hamburg, 20537, Germany
Bacs-Kiskun Megyei Korhaz
Kecskemét, Bács-Kiskun county, 6000, Hungary
Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
Debrecen, Hajdú-Bihar, 4032, Hungary
Trial Pharma Kft.
Püspökladány, Hajdú-Bihar, 4150, Hungary
Allergo-Derm Bakos Kft
Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary
UNO Medical Trials Kft.
Budapest, 1135, Hungary
Ambrozia Kft.
Budapest, 1238, Hungary
Oroshaza Varosi Onkormanyzat Korhaza
Orosháza, 5900, Hungary
MedMare Bt
Veszprém, 8200, Hungary
Haemek Medical Center- Dermatology
Afula, 1834111, Israel
Soroka Medical Center
Beersheba, 8410101, Israel
Rambam Medical Center
Haifa, 3525408, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 5265601, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
Policlinico Univ. Agostino Gemelli
Roma, Rome, 00168, Italy
Presidio Ospedaliero Firenze Centro Piero Palagi
Florence, 50125, Italy
Policlinico di Tor Vergata
Roma, 00133, Italy
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602, Japan
Juntendo Urayasu Hospital
Urayasu, Chiba, 279-0021, Japan
Kurume University Hospital
Kurume, Fukuoka, 830 0011, Japan
Gunma University Hosptial
Maebashi, Gunma, 371-8511, Japan
Asahikawa Medical College Hospital
Asahikawa, Hokkaido, 078-8510, Japan
Tokyo Medical University Ibaraki Medical Center
Inashiki-gun, Ibaraki, 300-0395, Japan
Tokai University Hospital
Isehara, Kanagawa, 259-1193, Japan
Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566, Japan
Mie University Hospital
Tsu, Mie-ken, 514-8507, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Shinshu University Hospital
Matsumoto, Nagano, 390-8621, Japan
Nagasaki University Hospital
Nagaski, Nagaski, 852-8501, Japan
Ryukyu University Hospital
Nakagami-gun, Okinawa, 903-0215, Japan
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191, Japan
Shiga University of Medical Science Hosptial
Ohtsu-shi, Shiga, 520-2192, Japan
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, 113-8655, Japan
St. Lukes International Hospital
Chuo-Ku, Tokyo, 104 8560, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo, 173 8606, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, 173-8610, Japan
Showa University Hospital
Shinagawa-ku, Tokyo, 142-8666, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, 400-8506, Japan
Gifu University Hospital
Gifu, 501-1194, Japan
Osaka City University Hospital
Osaka, 545-8586, Japan
Nippon Life Hospital
Osaka, 550-0006, Japan
Tokushima University Hospital
Tokushima, 770-8503, Japan
Wakayama MedicaL University Hospital
Wakayama, 641-8510, Japan
DermoDent, Centrum Medyczne Czajkowscy
Osielsko, Kuyavian-Pomeranian Voivodeship, 86-031, Poland
Barbara Rewerska DIAMOND CLINIC
Krakow, Lesser Poland Voivodeship, 31-559, Poland
DermMEDICA Sp. z o.o.
Wroclaw, Lower Silesian Voivodeship, 51-318, Poland
Lubelskie Centrum Diagnostyczne
Świdnik, Lublin Voivodeship, 21-040, Poland
Centralny Szpital Kliniczny MSW Klinika Dermatologii
Warsaw, Masovian Voivodeship, 02-507, Poland
Centrum Medyczne Evimed
Warsaw, Masovian Voivodeship, 02-625, Poland
NZOZ ZDROWIE Osteo-Medic
Bialystok, Podlaskie Voivodeship, 15-351, Poland
NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm
Bialystok, Podlaskie Voivodeship, 15-375, Poland
Centrum Badan Klinicznych, PI House
Gdansk, Pomeranian Voivodeship, 80-546, Poland
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, 40-611, Poland
LASER CLINIC Specjalistyczne Gabinety Lekarskie
Szczecin, West Pomeranian Voivodeship, 70-332, Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Lodz, 90-242, Poland
AI Centrum Medyczne
Poznan, 61-113, Poland
Dermed Centrum Medyczne Sp. z o.o.
Lodz, Łódź Voivodeship, 90-265, Poland
Office of Dr. Samuel Sanchez PSC
Caguas, PR, 00727, Puerto Rico
Office of Dr. Alma M. Cruz
Carolina, PR, 00985, Puerto Rico
Ponce School of Medicine CAIMED Center
Ponce, PR, 00716, Puerto Rico
GCM Medical Group PSC
San Juan, PR, 00917, Puerto Rico
Santa Cruz Behavioral PSC
Bayamón, 00961-6911, Puerto Rico
Ilsan Paik Hospital
IlsanSeo-gu, Goyang-si, 10380, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Pusan National University Hospital
Busan, Korea, 49241, South Korea
Gachon University Gil Medical Center
Incheon, Korea, 21565, South Korea
Samsung Medical Center
Seoul, Korea, 06351, South Korea
Korea University Guro Hospital
Seoul, Korea, 08308, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Chungang University Hospital
Seoul, 06973, South Korea
Severance Hospital Yonsei University Health System
Seoul, 120-792, South Korea
Hospital Marina Baixa
Villajoyosa, Alicante, 03570, Spain
Hospital Germans Trias i Pujol
Barcelona, Badalona, 08916, Spain
Hospital de Manises
Manises, Valencia, 46940, Spain
Hospital De Basurto
Bilbao, Vizcaya, 48013, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Reina Sofia
Córdoba, 14004, Spain
Hospital Infanta Leonor
Madrid, 28031, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Centro de Especialidades Mollabao
Pontevedra, 36001, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitario La Fe de Valencia
Valencia, 46026, Spain
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, M6 8HD, United Kingdom
Related Publications (1)
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.
PMID: 38251498DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2018
First Posted
May 24, 2018
Study Start
June 26, 2018
Primary Completion
March 5, 2020
Study Completion
June 3, 2020
Last Updated
March 30, 2021
Results First Posted
March 30, 2021
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.