A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)

March 17, 2023 updated by: Eli Lilly and Company

A Multicenter, Long-Term Extension to Evaluate the Long-term Safety and Maintenance of Treatment Effect of LY3074828 in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-3

The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of mirikizumab in participants with moderate-to-severe plaque psoriasis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1936

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1027AAP
        • Centro de Investigaciones Metabólicas (CINME)
      • Ciudad Autonoma de Buenos Aire, Argentina, C1122AAF
        • Halitus Instituto Médico
      • Mendoza, Argentina, 5500
        • Parra Dermatología
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1060ABN
        • Dermatology
      • Capital Federal, Buenos Aires, Argentina, 1425
        • Instituto de Neumonologia Y Dermatologia
      • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1425DKG
        • Psoriahue
    • Ciudad Autónoma De Buenos Aire
      • Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina, 1055
        • Buenos Aires Skin
      • Caba, Ciudad Autónoma De Buenos Aire, Argentina, C1430EGF
        • Clinica Adventista Belgrano
  • Australia
    • Australian Capital Territory
      • Phillip, Australian Capital Territory, Australia, 2606
        • Woden Dermatology
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Veracity Clinical Research Pty Ltd
    • South Australia
      • Adelaide, South Australia, Australia, 5073
        • Clinical Trials SA Pty Ltd
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • Skin Health Institute Inc.
    • Western Australia
      • Perth, Western Australia, Australia, 6160
        • Fremantle Dermatology
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2G 1B1
        • Kirk Barber Research
      • Edmonton, Alberta, Canada, T6G 1C3
        • Alberta Dermasurgery Centre
    • British Columbia
      • Surrey, British Columbia, Canada, V3R 6A7
        • Dr. Chih-ho Hong Medical Inc.
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H1Z2
        • Eastern Canada Cutaneous Research Assoicates Ltd
    • Ontario
      • London, Ontario, Canada, N6A 3H7
        • Guenther Research Inc.
      • Markham, Ontario, Canada, L3P1X2
        • Lynderm Research Inc.
      • Peterborough, Ontario, Canada, K9J 5K2
        • Skin Centre for Dermatology
      • Waterloo, Ontario, Canada, N2J 1C4
        • K. Papp Clinical Research
    • Quebec
      • Montreal, Quebec, Canada, H2X 2V1
        • Innovaderm Research Inc
  • Czechia
    • Hl. M. Praha
      • Praha 10, Hl. M. Praha, Czechia, 100 34
        • Fakultní Nemocnice Královské Vinohrady
    • Jihomoravský Kraj
      • Brno, Jihomoravský Kraj, Czechia, 656 91
        • Fakultni Nemocnice U svate Anny
    • Moravskoslezsky Kraj
      • Novy Jicin, Moravskoslezsky Kraj, Czechia, 741 01
        • Nemocnice AGEL Nový Jičín a.s.
    • Praha 10
      • Praha, Praha 10, Czechia, 100 00
        • CLINTRIAL s.r.o.
    • Středočeský Kraj
      • Kutna Hora, Středočeský Kraj, Czechia, 28401
        • Kozni ambulance Kutna Hora, s.r.o.
    • Ustecký Kraj
      • Usti nad Labem, Ustecký Kraj, Czechia, 40113
        • Etická komise Krajské zdravotní, a.s. - Masarykovy nemocnice v Ústí nad Labem, o.z.
  • France
      • Le Mans Cedex 1, France, 72037
        • CH du Mans - Pavillon Claude Monet
      • Martigues, France, 13500
        • Cabinet Medical
      • Montpellier, France, 34295
        • Hopital Saint Eloi
      • Nice cedex 3, France, 06202
        • Chu de Nice Hopital de L'Archet
      • Rouen cedex, France, 76036
        • CHU Charles Nicolle in Rouen
      • Toulouse cedex 9, France, 31059
        • Hôpital Larrey
    • Cedex
      • Limoges, Cedex, France, 87042
        • CHU Dupuytren 2
    • Gironde
      • Bordeaux, Gironde, France, 33075
        • CHU de Bordeaux Hop St ANDRE
  • Germany
      • Berlin, Germany, 10789
        • ISA GmbH
      • Berlin, Germany, 10117
        • Charité Campus Virchow-Klinikum
      • Berlin, Germany, 10117
        • Klin. Forschung Berlin-Mitte GmbH
      • Berlin, Germany, 10783
        • Rothhaar Studien
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf
      • Hamburg, Germany, 20537
        • TFS Trial Form Support GmbH
      • Hamburg, Germany, 22143
        • Clinical Research Hamburg GmbH
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Universitätsklinikum Heidelberg
      • Stuttgart, Baden-Württemberg, Germany, 70178
        • Hautarztpraxis Dr. Leitz
      • Tübingen, Baden-Württemberg, Germany, 72076
        • Universitätsklinikum Tübingen
    • Brandenburg
      • Mahlow, Brandenburg, Germany, 15831
        • Dermatologische Gemeinschaftspraxis Mahlow
    • Hessen
      • Darmstadt, Hessen, Germany, 64283
        • Rosenpark Research GmbH
      • Frankfurt am Main, Hessen, Germany, 60590
        • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
    • Niedersachsen
      • Bad Bentheim, Niedersachsen, Germany, 48455
        • Fachklinik Bad Bentheim
      • Bramsche, Niedersachsen, Germany, 49565
        • Dermatologisches Zentrum Osnabrück Nord
      • Buxtehude, Niedersachsen, Germany, 21614
        • Elbe Klinikum Buxtehude
    • Nordrhein-Westfalen
      • Münster, Nordrhein-Westfalen, Germany, 48149
        • Universitätsklinikum Münster
    • Sachsen
      • Dresden, Sachsen, Germany, 01097
        • Hautarztpraxis Dr. Gerlach
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein
  • Hungary
      • Budapest, Hungary, 1152
        • UNO Medical Trials Kft.
      • Budapest, Hungary, 1238
        • Ambrozia Kft.
    • Bekes
      • Oroshaza, Bekes, Hungary, 5900
        • Oroshaza Varosi Onkormanyzat Korhaza
    • Bács-Kiskun
      • Kecskemét, Bács-Kiskun, Hungary, 6000
        • Bacs-Kiskun Megyei Korhaz
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
    • Jasz-Nagykun-Szolnok
      • Szolnok, Jasz-Nagykun-Szolnok, Hungary, 5000
        • Allergo-Derm Bakos Kft
    • Veszprém City
      • Veszprém, Veszprém City, Hungary, 8200
        • Medmare Bt
  • Israel
      • Afula, Israel, 1834111
        • Haemek Medical Center- Dermatology
      • Beer Sheva, Israel, 8410101
        • Soroka Medical Center
      • Haifa, Israel, 3525408
        • Rambam Medical Center
      • Petach Tikva, Israel, 4941492
        • Rabin Medical Center
      • Ramat Gan, Israel, 5265601
        • Sheba Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Firenze, Italy, 50125
        • Presidio Ospedaliero Firenze Centro Piero Palagi
      • Roma, Italy, 00133
        • Policlinico Di Tor Vergata
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Policlinico Gemelli - Università Cattolica del Sacro Cuore
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas
  • Japan
      • Gifu, Japan, 501-1194
        • Gifu University Hospital
      • Kyoto, Japan, 602-8566
        • Kyoto Furitsu Medical University Hospital
      • Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital
      • Osaka, Japan, 545-8586
        • Osaka City University Hospital
      • Osaka, Japan, 550-0006
        • Nippon Life Hospital
      • Tokushima, Japan, 770-8503
        • Tokushima University Hospital
      • Tokyo, Japan, 104-8560
        • St. Luke's International Hospital
      • Wakayama, Japan, 641-0012
        • Wakayama Medical University Hospital
    • Aichi
      • Nagoya, Aichi, Japan, 467-8602
        • Nagoya City University Hospital
    • Chiba
      • Sakura, Chiba, Japan, 285-8741
        • Toho University School of Medicine, Sakura Hospital
      • Urayasu, Chiba, Japan, 279-0021
        • Juntendo Urayasu Hospital
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Kurume University Hospital
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
        • Gunma University Hosptial
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 078-8510
        • Asahikawa Medical College Hospital
      • Obihiro, Hokkaido, Japan, 080-0013
        • Takagi Dermatology
    • Ibaraki
      • Inashiki, Ibaraki, Japan, 300-0332
        • Tokyo Medical University Ibaraki Medical Center
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1143
        • Tokai University Hospital- Isehara Campus
      • Kawasaki, Kanagawa, Japan, 211-8510
        • Kanto Rosai Hospital
      • Yokohama, Kanagawa, Japan, 236-0004
        • Yokohama City University Hospital
    • Mie
      • Tsu, Mie, Japan, 514-8507
        • Mie University Hospital
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
    • Nagano
      • Matsumoto, Nagano, Japan, 390-8621
        • Shinshu University Hospital
    • Okinawa
      • Nakagami-gun, Okinawa, Japan, 903-0215
        • Ryukyu University Hospital
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital
      • Nishi-ku Sakai-shi, Osaka, Japan, 593 8324
        • Kume Clinic
    • Shiga
      • Ōtsu, Shiga, Japan, 520-2192
        • Shiga University of Medical Science Hosptial
    • Shimane
      • Izumo, Shimane, Japan, 693-0021
        • Shimane University Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8655
        • The University of Tokyo Hospital
      • Hachioji, Tokyo, Japan, 193-0998
        • Tokyo Medical University Hachioji Medical Center
      • Itabashi-ku, Tokyo, Japan, 173-8610
        • Nihon University Itabashi Hospital
      • Itabashi-ku, Tokyo, Japan, 173 8606
        • Teikyo University Hospital
      • Shinagawa, Tokyo, Japan, 142-8555
        • Showa University Hospital
      • Shinagawa-KU, Tokyo, Japan, 141-8625
        • NTT Medical Center Tokyo
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital
      • Shinjuku-ku, Tokyo, Japan, 161-8521
        • Seibo Hospital
    • Toyama
      • Takaoka, Toyama, Japan, 933-0871
        • Takaokashi Shirasaki Dermatology Clinic
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-8505
        • Yamaguchi University Hospital
    • Yamanashi
      • Kofu, Yamanashi, Japan, 400-8506
        • Yamanashi Prefectural Central Hospital
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05030
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of, 06973
        • Chungang University Hospital
    • Gyeonggi-do
      • Bucheon,, Gyeonggi-do, Korea, Republic of, 14647
        • Bucheon St. Mary's Hospital
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10380
        • Ilsan Paik Hospital
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Sungnam-si, Gyeonggi-do, Korea, Republic of, 13496
        • Cha Bundang Medical Center, Cha University
      • Suwon, Gyeonggi-do, Korea, Republic of, 16499
        • Ajou University Hospital
    • Korea
      • Busan, Korea, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Daejeon, Korea, Korea, Republic of, 35015
        • Chungnam National University Hospital
      • Gwangju, Korea, Korea, Republic of, 61469
        • Chonnam National University Hospital
      • Incheon, Korea, Korea, Republic of, 21565
        • Gachon University Gil Hospital
      • Seoul, Korea, Korea, Republic of, 06591
        • Seoul St. Mary'S Hospital
      • Seoul, Korea, Korea, Republic of, 04763
        • Hanyang University Medical Center
      • Seoul, Korea, Korea, Republic of, 02447
        • Kyung Hee University Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 6351
        • Samsung Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 8308
        • Korea University Guro Hospital
    • Ulsan-Kwangyǒkshi
      • Ulsan, Ulsan-Kwangyǒkshi, Korea, Republic of, 44033
        • Ulsan University Hospital
  • Mexico
      • Distrito Federal, Mexico, 3100
        • RM Pharma Specialists S.A. de C.V.
      • Durango, Mexico, 34000
        • Instituto de Investigaciones Aplicadas a la Neurociencia A.C
    • Baja California
      • Mexicali, Baja California, Mexico, 21100
        • Centro Medico del Angel
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 06090
        • Hospital de Jesus I.A.P.
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44657
        • Grupo Clinico CATEI Sociedad Civil
    • Michoacan
      • Morelia, Michoacan, Mexico, 58249
        • Clinica De Enfermedades Cronicas y Procedimientos Especiales
    • Sinaloa
      • Mazatlan, Sinaloa, Mexico, 82140
        • B&B Investigaciones Medicas, SC
    • Yucatan
      • Mérida, Yucatan, Mexico, 97070
        • Köhler & Milstein Research
  • Poland
      • Warszawa, Poland, 02-507
        • Centralny Szpital Kliniczny MSW Klinika Dermatologii
    • Dolnośląskie
      • Wrocław, Dolnośląskie, Poland, 51-318
        • Dermmedica Sp. Z O.O.
    • Kujawsko-pomorskie
      • Osielsko, Kujawsko-pomorskie, Poland, 86-031
        • DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
    • Lodzkie
      • Lodz, Lodzkie, Poland, 90-265
        • DERMED Centrum Medyczne Sp. z o.o.
    • Lubelskie
      • Swidnik, Lubelskie, Poland, 21-040
        • Lubelskie Centrum Diagnostyczne
    • Malopolskie
      • Krakow, Malopolskie, Poland, 31-559
        • Diamond Clinic
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 02-625
        • Centrum Medyczne Evimed
      • Warsaw, Mazowieckie, Poland, 01-518
        • Centrum Medyczne AMED
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-351
        • Nzoz Zdrowie Osteo-Medic
      • Bialystok, Podlaskie, Poland, 15-375
        • NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o.
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 61-113
        • Ai Centrum Medyczne Sp. Z O.O. Sp.K.
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 70-332
        • LASER CLINIC Specjalistyczne Gabinety Lekarskie
    • Łódzkie
      • Lodz, Łódzkie, Poland
        • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
    • Śląskie
      • Katowice, Śląskie, Poland, 40-611
        • Centrum Medyczne Angelius Provita
  • Puerto Rico
      • Bayamón, Puerto Rico, 00961-6911
        • Santa Cruz Behavioral PSC
      • Caguas, Puerto Rico, 00727
        • Dr. Samuel Sanchez PSC
      • Carolina, Puerto Rico, 00985
        • Office of Dr. Alma M. Cruz
      • Ponce, Puerto Rico, 00716
        • Ponce School of Medicine CAIMED Center
      • San Juan, Puerto Rico, 00917
        • GCM Medical Group, PSC - Hato Rey Site
  • Russian Federation
      • Moscow, Russian Federation, 107076
        • State scientific centre for dermatovenerology and cosmetolog
      • Smolensk, Russian Federation, 214000
        • GOU VPO 'Smolensk State Medical Academy of Ministry of Health and Social Development of Russian Federation'
      • St. Petersburg, Russian Federation, 194021
        • SPb SBHI Skin-venerologic dispensary #10
      • Tver, Russian Federation, 170100
        • Tver State Medical University
    • Krasnodarskiy Kray
      • Krasnodar, Krasnodarskiy Kray, Russian Federation, 350020
        • GBUZ Clinical dermatology and venereological dispensary
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Cordoba, Spain, 14004
        • Hospital Reina Sofia
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28031
        • Hospital Infanta Leonor
      • Pontevedra, Spain, 36001
        • Centro de Especialidades Mollabao
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain, 46026
        • Hospital Universitario La Fe de Valencia
    • Alicante
      • Villajoyosa, Alicante, Spain, 03570
        • Hospital Marina Baixa
    • Badalona
      • Barcelona, Badalona, Spain, 08916
        • Hospital Germans Trias i Pujol
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Hospital de Manises
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital de Basurto
  • Taiwan
      • Hsinchu, Taiwan, 300
        • National Taiwan University Hospital - Hsinchu branch
      • Kaohsiung, Taiwan, 83301
        • Chang Gung Memorial Hospital - Kaohsiung Branch
      • New Taipei City, Taiwan, 23561
        • Taipei Medical University Shuang Ho Hospital
      • Taichung City, Taiwan, 40201
        • Chung Shan Medical University Hospital
      • Tainan, Taiwan, 70403
        • National Cheng-Kung Uni. Hosp.
      • Taipei City, Taiwan, 10048
        • National Taiwan University Hospital
      • Taoyuan Hsien, Taiwan, 10508
        • Chang Gung Memorial Hospital - Linkou
  • United Kingdom
    • Greater Manchester
      • Salford, Greater Manchester, United Kingdom, M6 8HD
        • Salford Royal NHS Foundation Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • California
      • Beverly Hills, California, United States, 90212
        • Zenith Research, Inc.
      • Encinitas, California, United States, 92024
        • California Dermatology & Clinical Research Institute
      • Fountain Valley, California, United States, 92708
        • First OC Dermatology
      • Los Angeles, California, United States, 90033
        • Keck School of Medicine University of Southern California
      • Newport Beach, California, United States, 92660-7831
        • Dermatology Clinical Trials
      • San Luis Obispo, California, United States, 93405
        • San Luis Dermatology & Laser Clinic
      • Santa Monica, California, United States, 90404
        • Clinical Science Institute
    • Connecticut
      • Farmington, Connecticut, United States, 06030-2840
        • Univ of Connecticut
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Florida Academic Centers Research and Education, LLC
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research
      • Orange Park, Florida, United States, 32073
        • Park Avenue Dermatology
      • Tampa, Florida, United States, 33613-1244
        • ForCare Clinical Research
    • Georgia
      • Macon, Georgia, United States, 31217
        • Dermatologic Surgery Specialists, PC
      • Savannah, Georgia, United States, 31406
        • Meridian Clinical Research
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research LLC
    • Illinois
      • Darien, Illinois, United States, 60561
        • University Dermatology
      • Rolling Meadows, Illinois, United States, 60008
        • Arlington Dermatology
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Clinical Research Group, LLC
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center
      • South Bend, Indiana, United States, 46617
        • The South Bend Clinic Center for Research
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Forefront Research
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • DelRicht Research
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Dermatology and Skin Cancer Specialists
      • Rockville, Maryland, United States, 20850
        • Lawrence J Green, M.D, LLC
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • ORA, Inc
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Central Dermatology PC
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Psoriasis Treatment Center of Central New Jersey
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine Dermatology Clinical Trials
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • PMG Research of Cary, LLC
      • Chapel Hill, North Carolina, United States, 27516
        • University of North Carolina Dermatology and Skin Cancer Cen
      • Wilmington, North Carolina, United States, 28411
        • PMG Research of Wilmington
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Bexley Dermatology Research
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Fairborn, Ohio, United States, 45324
        • Wright State Univ School of Medicine
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
      • Portland, Oregon, United States, 97210
        • Oregon Dermatology and Research Center
      • Portland, Oregon, United States, 97223
        • Oregon Medical Research Center
    • Pennsylvania
      • Exton, Pennsylvania, United States, 19341
        • The Pennsylvania Centre for Dermatology, LLC
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Clinical Partners, LLC
    • Texas
      • Dallas, Texas, United States, 75231
        • Modern Research Associates
      • Pflugerville, Texas, United States, 78660
        • Austin Institute for Clinical Research
      • San Antonio, Texas, United States, 78218
        • Texas Dermatology and Laser Specialists
    • Utah
      • Murray, Utah, United States, 84107
        • University of Utah
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Clinical Research, Inc.
    • Washington
      • Seattle, Washington, United States, 98101
        • Dermatology Associates
      • Tacoma, Washington, United States, 98405
        • MultiCare Good Samaritan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant must have completed the last visit of an eligible study period of originating study.
  • Participant must be willing to follow the birth control measures during and after study treatment if woman of childbearing potential.

Exclusion Criteria:

  • Participant must not have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disease or abnormal lab results, that the study investigator thinks makes it unsafe or inappropriate for the participant to participate in this study.
  • Participant must not have stopped taking mirikizumab during a previous study or if the study investigator thinks restarting mirikizumab would create an unacceptable risk to the participant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 125 Milligram (mg) Mirikizumab Q8W
Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).
Drug: Mirikizumab
Administered SC
Other Names:
  • LY3074828
Experimental: 250 mg Mirikizumab Q8W Excluding Secukinumab
Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ)
Drug: Mirikizumab
Administered SC
Other Names:
  • LY3074828
Experimental: Secukinumab/250 mg Mirikizumab Q8W
Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.
Drug: Mirikizumab
Administered SC
Other Names:
  • LY3074828

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Static Physician's Global Assessment Among Those Who Entered the Study With a sPGA of 0,1
Time Frame: Week 104
The sPGA is the physician's determination of the participant's psoriasis (PsO) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO 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. Participants who did not meet the clinical response criteria or had missing data at Week 104 were considered non-responders for non-responder Imputation (NRI) analysis.
Week 104
Percentage of Participants Who Maintained a ≥90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those Who Entered the Study With a PASI 90
Time Frame: Week 104
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. 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 104

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
Time Frame: Week 104
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. 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 104
Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 (Free of Itch, Pain, Stinging, and Burning) in Those With a PSS Symptoms Score ≥1 at Baseline
Time Frame: Week 104
PSS is a patient-administered assessment of 4 symptoms (itch, pain, stinging, and burning); 3 signs (redness, scaling, and cracking); and 1 item on the discomfort related to symptoms/signs. The overall severity for each individual symptom/sign from the patient's psoriasis is indicated by selecting the number from a numeric rating scale (NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign. In addition, a symptoms score ranging from 0 (no symptoms) to 40 (worst imaginable symptoms), and a sign score of 0 (no signs) to 30 (worst imaginable signs) will be reported.
Week 104
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
Time Frame: Week 104
The DLQI is a patient-reported, 10-question, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Totals range from 0 to 30 (less to more impairment). A DLQI total score of 0 to 1 is considered as having no effect on a patient's health-related quality of life (HRQoL), and a 5-point change from baseline is considered as the minimal clinically important difference (MCID) threshold.
Week 104
Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline
Time Frame: Baseline, Week 104
The PPASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline.
Baseline, Week 104
Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline
Time Frame: Baseline, Week 104
The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity).
Baseline, Week 104
Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline
Time Frame: Baseline, Week 104
The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix PsO by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed PsO 0 (none) to 4 (PsO in 4 quadrants of the fingernail) and fingernail matrix PsO 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix PsO in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis).
Baseline, Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 1-877-CTLILLY (1-877-285-4559) or Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2018

Primary Completion (Actual)

February 7, 2022

Study Completion (Actual)

February 7, 2022

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

June 4, 2018

First Posted (Actual)

June 14, 2018

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16491
  • I6T-MC-AMAH (Other Identifier: Eli Lilly and Company)
  • 2017-003299-30 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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