Clinical trial NCT03535194: A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Interleukin-23 (IL-23)
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-05-24
Enrollment: 1484
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Participant must have chronic plaque psoriasis for at least 6 months.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline
timeFrame: Week 16
measure: Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving a 75% Improvement in PASI 75
timeFrame: Week 16
measure: Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement
timeFrame: Week 16
measure: Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 in Those With PSS Symptom Score of ≥1 at Baseline
timeFrame: Week 16
measure: 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
timeFrame: Week 16
measure: Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline
timeFrame: Baseline, Week 16
measure: Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline
timeFrame: Baseline, Week 16
measure: Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline
timeFrame: Baseline, Week 16
measure: Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
timeFrame: Baseline, Week 16
measure: Change From Baseline on the SF-36 Mental Component Summary (MCS)
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving Patient's Global Assessment (PatGA) of Disease Severity of (0,1) With at Least a 2-point Improvement From Baseline in Patients With a Baseline PatGA ≥2
timeFrame: Week 16
measure: Change From Baseline for the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO) Scores
timeFrame: Baseline, Week 16
measure: Change From Baseline in Quick Inventory of Depressive Symptomatology (QIDS-SR16) Total Score in Those With a Baseline QIDS-SR16 Total Score ≥11.
timeFrame: Baseline, Week 16
measure: Pharmacokinetics: Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab
timeFrame: Week 16
measure: Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline (Non-inferiority)
timeFrame: Week 16
measure: Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline (Non-inferiority)
timeFrame: Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Bakersfield
country: United States
facility: Bakersfield Dermatology and Skin Cancer Medical Group
state: California
city: Beverly Hills
country: United States
facility: David Stoll, M.D.
state: California
city: Encinitas
country: United States
facility: California Dermatology and Clinical Research Institute
state: California
city: Fountain Valley
country: United States
facility: Tien Q. Nguyen, MD inc. DBA First OC Dermatology
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine University of Southern California
state: California
city: Newport Beach
country: United States
facility: Dermatology Clinical Trials
state: California
city: San Luis Obispo
country: United States
facility: San Luis Dermatology & Laser Clinic, Inc
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Macon
country: United States
facility: Dermatologic Surgery Specialists, PC
state: Georgia
city: Newnan
country: United States
facility: Medaphase Inc
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Dermatology
state: Idaho
city: Darien
country: United States
facility: University Dermatology
state: Illinois
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: South Bend
country: United States
facility: The South Bend Clinic
state: Indiana
city: Louisville
country: United States
facility: Dermatology Specialist
state: Kentucky
city: Baton Rouge
country: United States
facility: DelRicht Research
state: Louisiana
city: Rockville
country: United States
facility: Dermatology and Skin Cancer Specialists
state: Maryland
city: Rockville
country: United States
facility: Lawrence J Green, M.D, LLC
state: Maryland
city: Andover
country: United States
facility: ORA, Inc
state: Massachusetts
city: Saint Louis
country: United States
facility: Central Dermatology PC
state: Missouri
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: New York
country: United States
facility: Mount Sinai School of Medicine Dermatology Clinical Trials
state: New York
city: Cary
country: United States
facility: PMG Research of Cary, LLC
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina Dermatology and Skin Cancer Cen
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Bexley
country: United States
facility: Bexley Dermatology Research
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Fairborn
country: United States
facility: Wright State Physicians Dermatology
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Johnston
country: United States
facility: Clinical Partners LLC
state: Rhode Island
city: Dallas
country: United States
facility: Modern Research Associates PLLC
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: West Jordan
country: United States
facility: Jordan Valley Dermatology Center
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates
state: Washington
city: Caba
country: Argentina
facility: CEDIC-Centro de Investigaciones Clinicas
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Buenos Aires Skin
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Instituto de Neumonología y Dermatología
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Psoriahue Medicina Interdisciplinaria
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Clinica Adventista de Belgrano
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Halitus Instituto Médico
city: Mendoza
country: Argentina
facility: Parra Dermatología
city: Phillip
country: Australia
facility: Woden Dermatology
state: Australian Capital Territory
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research Pty Ltd
state: Queensland
city: Adelaide
country: Australia
facility: Clinical Trials SA Pty Ltd
state: South Australia
city: Carlton
country: Australia
facility: Skin and Cancer Foundation Inc.
state: Victoria
city: Perth
country: Australia
facility: Fremantle Dermatology
state: Western Australia
city: Edmonton
country: Canada
facility: Stratica Medical
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc.
state: British Columbia
city: Halifax
country: Canada
facility: Eastern Canada Cutaneous Research Assoicates Ltd
state: Nova Scotia
city: London
country: Canada
facility: The Guenther Dermatology Research Centre
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research Inc
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc
state: Quebec
city: Praha 10
country: Czechia
facility: Clintrial, s.r.o.
state: Hl. M. Praha
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
state: Hl. M. Praha
city: Brno
country: Czechia
facility: Fakultni Nemocnice U svate Anny
state: Jihomoravský Kraj
city: Kutna Hora
country: Czechia
facility: Kozni ambulance Kutna Hora, s.r.o.
state: Středočeský Kraj
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
state: Ustecký Kraj
city: Novy Jicin
country: Czechia
facility: Kozni oddeleni
city: Limoges
country: France
facility: CHU Dupuytren 2
state: Cedex
city: Bordeaux Cedex
country: France
facility: CHU de Bordeaux Hopital Saint Andre
city: Le Mans Cedex 1
country: France
facility: CH du Mans - Pavillon Claude Monet
city: Martigues
country: France
facility: Cabinet Médical
city: Montpellier
country: France
facility: Hopital Saint Eloi
city: Nice cedex 3
country: France
facility: CHU de Nice Hopital de L'Archet
city: Rouen cedex
country: France
facility: Chu de Rouen Hopital Charles Nicolle
city: Toulouse cedex 9
country: France
facility: Hopital Larrey
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
state: Baden-Württemberg
city: Stuttgart
country: Germany
facility: Hautarztpraxis Dr. Leitz und Kollegen
state: Baden-Württemberg
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
state: Baden-Württemberg
city: Darmstadt
country: Germany
facility: Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
state: Hessen
city: Bramsche
country: Germany
facility: Dermatologisches Zentrum Osnabrück Nord
state: Niedersachsen
city: Buxtehude
country: Germany
facility: Elbe Kliniken Stade Buxtehude GmbH Klinikum Buxtehude
state: Niedersachsen
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
state: Nordrhein-Westfalen
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Klin. Forschung Berlin-Mitte GmbH
city: Berlin
country: Germany
facility: Rothhaar Studien GmbH
city: Hamburg
country: Germany
facility: TFS Trial Form Support GmbH
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz
state: Bacs-Kiskun
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
state: Hajdu-Bihar
city: Puspokladany
country: Hungary
facility: Trial Pharma Kft.
state: Hajdu-Bihar
city: Szolnok
country: Hungary
facility: Allergo-Derm Bakos Kft
state: Jasz-Nagykun-Szolnok
city: Budapest
country: Hungary
facility: UNO Medical Trials Kft.
city: Budapest
country: Hungary
facility: Ambrozia Kft.
city: Oroshaza
country: Hungary
facility: Oroshaza Varosi Onkormanyzat Korhaza
city: Veszprem
country: Hungary
facility: MedMare Bt
city: Afula
country: Israel
facility: Haemek Medical Center- Dermatology
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Roma
country: Italy
facility: Policlinico Univ. Agostino Gemelli
state: Rome
city: Firenze
country: Italy
facility: Presidio Ospedaliero Firenze Centro Piero Palagi
city: Roma
country: Italy
facility: Policlinico di Tor Vergata
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Urayasu
country: Japan
facility: Juntendo Urayasu Hospital
state: Chiba
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Maebashi
country: Japan
facility: Gunma University Hosptial
state: Gunma
city: Asahikawa
country: Japan
facility: Asahikawa Medical College Hospital
state: Hokkaido
city: Inashiki-gun
country: Japan
facility: Tokyo Medical University Ibaraki Medical Center
state: Ibaraki
city: Isehara
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Kyoto Prefectural University of Medicine
state: Kyoto
city: Tsu
country: Japan
facility: Mie University Hospital
state: Mie
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
state: Nagano
city: Nakagami-gun
country: Japan
facility: Ryukyu University Hospital
state: Okinawa
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Ohtsu-shi
country: Japan
facility: Shiga University of Medical Science Hosptial
state: Shiga
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital
state: Tokyo
city: Chuo-Ku
country: Japan
facility: St. Lukes International Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Showa University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Ube
country: Japan
facility: Yamaguchi University Hospital
state: Yamaguchi
city: Kofu
country: Japan
facility: Yamanashi Prefectural Central Hospital
state: Yamanashi
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Nagaski
country: Japan
facility: Nagasaki University Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Osaka
country: Japan
facility: Nippon Life Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Wakayama
country: Japan
facility: Wakayama MedicaL University Hospital
city: IlsanSeo-gu
country: Korea, Republic of
facility: Ilsan Paik Hospital
state: Goyang-si
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Korea
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Korea
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Korea
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Korea
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Chungang University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Wroclaw
country: Poland
facility: DermMEDICA Sp. z o.o.
state: Dolnoslaskie
city: Osielsko
country: Poland
facility: DermoDent, Centrum Medyczne Czajkowscy
state: Kujawsko-pomorskie
city: Lodz
country: Poland
facility: Dermed Centrum Medyczne Sp. z o.o.
state: Lodzkie
city: Swidnik
country: Poland
facility: Lubelskie Centrum Diagnostyczne
state: Lubelskie
city: Krakow
country: Poland
facility: Barbara Rewerska DIAMOND CLINIC
state: Malopolskie
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSW Klinika Dermatologii
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centrum Medyczne Evimed
state: Mazowieckie
city: Bialystok
country: Poland
facility: NZOZ ZDROWIE Osteo-Medic
state: Podlaskie
city: Bialystok
country: Poland
facility: NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm
state: Podlaskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych, PI House
state: Pomorskie
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
state: Slaskie
city: Szczecin
country: Poland
facility: LASER CLINIC Specjalistyczne Gabinety Lekarskie
state: Zachodniopomorskie
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
city: Poznan
country: Poland
facility: AI Centrum Medyczne
city: Bayamón
country: Puerto Rico
facility: Santa Cruz Behavioral PSC
city: Caguas
country: Puerto Rico
facility: Office of Dr. Samuel Sanchez PSC
city: Carolina
country: Puerto Rico
facility: Office of Dr. Alma M. Cruz
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine CAIMED Center
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC
city: Villajoyosa
country: Spain
facility: Hospital Marina Baixa
state: Alicante
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Badalona
city: Manises
country: Spain
facility: Hospital de Manises
state: Valencia
city: Bilbao
country: Spain
facility: Hospital De Basurto
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Cordoba
country: Spain
facility: Hospital Reina Sofia
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Pontevedra
country: Spain
facility: Centro de Especialidades Mollabao
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Universitario La Fe de Valencia
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
state: Greater Manchester
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: