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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03556202
Other study ID # 16491
Secondary ID I6T-MC-AMAH2017-
Status Terminated
Phase Phase 3
First received
Last updated
Start date September 3, 2018
Est. completion date February 7, 2022

Study information

Verified date March 2023
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 1936
Est. completion date February 7, 2022
Est. primary completion date February 7, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Mirikizumab
Administered SC

Locations

Country Name City State
Argentina Buenos Aires Skin Buenos Aires Ciudad Autónoma De Buenos Aire
Argentina Centro de Investigaciones Metabólicas (CINME) Buenos Aires
Argentina Clinica Adventista Belgrano Caba Ciudad Autónoma De Buenos Aire
Argentina Dermatology Caba Buenos Aires
Argentina Instituto de Neumonología Y Dermatología Capital Federal Buenos Aires
Argentina Halitus Instituto Médico Ciudad Autonoma de Buenos Aire
Argentina Psoriahue Ciudad Autonoma de Buenos Aire Buenos Aires
Argentina Parra Dermatología Mendoza
Australia Clinical Trials SA Pty Ltd Adelaide South Australia
Australia Skin Health Institute Inc. Carlton Victoria
Australia Fremantle Dermatology Perth Western Australia
Australia Woden Dermatology Phillip Australian Capital Territory
Australia Veracity Clinical Research Pty Ltd Woolloongabba Queensland
Canada Kirk Barber Research Calgary Alberta
Canada Alberta DermaSurgery Centre Edmonton Alberta
Canada Eastern Canada Cutaneous Research Assoicates Ltd Halifax Nova Scotia
Canada Guenther Research Inc. London Ontario
Canada Lynderm Research Inc. Markham Ontario
Canada Innovaderm Research Inc Montreal Quebec
Canada SKiN Centre for Dermatology Peterborough Ontario
Canada Dr. Chih-ho Hong Medical Inc. Surrey British Columbia
Canada K. Papp Clinical Research Waterloo Ontario
Czechia Fakultni Nemocnice U svate Anny Brno Jihomoravský Kraj
Czechia Kožní ambulance Kutná Hora, s.r.o. Kutna Hora Stredoceský Kraj
Czechia Nemocnice AGEL Novy Jicin a.s. Novy Jicin Moravskoslezsky Kraj
Czechia Clintrial s.r.o. Praha Praha 10
Czechia Fakultni nemocnice Kralovske Vinohrady Praha 10 Hl. M. Praha
Czechia Etická komise Krajské zdravotní, a.s. - Masarykovy nemocnice v Ústí nad Labem, o.z. Usti nad Labem Ustecký Kraj
France CHU de Bordeaux Hop St ANDRE Bordeaux Gironde
France CH du Mans - Pavillon Claude Monet Le Mans Cedex 1
France CHU Dupuytren 2 Limoges Cedex
France Cabinet Médical Martigues
France Hopital Saint Eloi Montpellier
France CHU de Nice Hopital de L'Archet Nice cedex 3
France CHU Charles Nicolle in Rouen Rouen cedex
France Hopital Larrey Toulouse cedex 9
Germany Fachklinik Bad Bentheim Bad Bentheim Niedersachsen
Germany Charité Campus Virchow-Klinikum Berlin
Germany ISA GmbH Berlin
Germany Klin. Forschung Berlin-Mitte GmbH Berlin
Germany Rothhaar Studien Berlin
Germany Dermatologisches Zentrum Osnabrück Nord Bramsche Niedersachsen
Germany Elbe Klinikum Buxtehude Buxtehude Niedersachsen
Germany Rosenpark Research GmbH Darmstadt Hessen
Germany Hautarztpraxis Dr. Gerlach Dresden Sachsen
Germany Klinikum der Johann Wolfgang Goethe-Universität Frankfurt Frankfurt am Main Hessen
Germany Clinical Research Hamburg GmbH Hamburg
Germany TFS Trial Form Support GmbH Hamburg
Germany Universitaetsklinikum Hamburg-Eppendorf Hamburg
Germany Universitätsklinikum Heidelberg Heidelberg Baden-Württemberg
Germany Universitätsklinikum Schleswig-Holstein Kiel Schleswig-Holstein
Germany Universitätsklinikum Schleswig-Holstein Lübeck Schleswig-Holstein
Germany Dermatologische Gemeinschaftspraxis Mahlow Mahlow Brandenburg
Germany Universitätsklinikum Münster Münster Nordrhein-Westfalen
Germany Hautarztpraxis Dr. Leitz Stuttgart Baden-Württemberg
Germany Universitätsklinikum Tübingen Tübingen Baden-Württemberg
Hungary Ambrozia Kft. Budapest
Hungary Uno Medical Trials Kft. Budapest
Hungary Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika Debrecen Hajdu-Bihar
Hungary Bacs-Kiskun Megyei Korhaz Kecskemét Bács-Kiskun
Hungary Oroshaza Varosi Onkormanyzat Korhaza Oroshaza Bekes
Hungary Allergo-Derm Bakos Kft Szolnok Jasz-Nagykun-Szolnok
Hungary Medmare Bt Veszprém Veszprém City
Israel Haemek Medical Center- Dermatology Afula
Israel Soroka Medical Center Beer Sheva
Israel Rambam Medical Center Haifa
Israel Rabin Medical Center Petach Tikva
Israel Sheba Medical Center Ramat Gan
Israel Tel Aviv Sourasky Medical Center Tel Aviv
Italy Presidio Ospedaliero Firenze Centro Piero Palagi Firenze
Italy Policlinico di Tor Vergata Roma
Italy Policlinico Gemelli - Università Cattolica del Sacro Cuore Roma Lazio
Italy Istituto Clinico Humanitas Rozzano Milano
Japan Asahikawa Medical College Hospital Asahikawa Hokkaido
Japan The University of Tokyo Hospital Bunkyo-ku Tokyo
Japan Gifu University Hospital Gifu
Japan Tokyo Medical University Hachioji Medical Center Hachioji Tokyo
Japan Kansai Medical University Hospital Hirakata Osaka
Japan Tokyo Medical University Ibaraki Medical Center Inashiki Ibaraki
Japan Tokai University Hospital- Isehara Campus Isehara Kanagawa
Japan Nihon University Itabashi Hospital Itabashi-ku Tokyo
Japan Teikyo University Hospital Itabashi-ku Tokyo
Japan Shimane University Hospital Izumo Shimane
Japan Kanto Rosai Hospital Kawasaki Kanagawa
Japan Yamanashi Prefectural Central Hospital Kofu Yamanashi
Japan Kurume University Hospital Kurume Fukuoka
Japan Kyoto Furitsu Medical University Hospital Kyoto
Japan Gunma University Hosptial Maebashi Gunma
Japan Shinshu University Hospital Matsumoto Nagano
Japan Nagasaki University Hospital Nagasaki
Japan Nagoya City University Hospital Nagoya Aichi
Japan Ryukyu University Hospital Nakagami-gun Okinawa
Japan Kume Clinic Nishi-ku Sakai-shi Osaka
Japan Takagi Dermatology Obihiro Hokkaido
Japan Nippon Life Hospital Osaka
Japan Osaka City University Hospital Osaka
Japan Shiga University of Medical Science Hosptial Otsu Shiga
Japan Toho University School of Medicine, Sakura Hospital Sakura Chiba
Japan Tohoku University Hospital Sendai-shi Miyagi
Japan Showa University Hospital Shinagawa Tokyo
Japan NTT Medical Center Tokyo Shinagawa-KU Tokyo
Japan Seibo Hospital Shinjuku-ku Tokyo
Japan Tokyo Medical University Hospital Shinjuku-ku Tokyo
Japan Takaokashi Shirasaki Dermatology Clinic Takaoka Toyama
Japan Tokushima University Hospital Tokushima
Japan St. Luke's International Hospital Tokyo
Japan Mie University Hospital Tsu Mie
Japan Yamaguchi University Hospital Ube Yamaguchi
Japan Juntendo Urayasu Hospital Urayasu Chiba
Japan Wakayama Medical University Hospital Wakayama
Japan Yokohama City University Hospital Yokohama Kanagawa
Korea, Republic of Bucheon St. Mary's Hospital Bucheon, Gyeonggi-do
Korea, Republic of Pusan National University Hospital Busan Korea
Korea, Republic of Chungnam National University Hospital Daejeon Korea
Korea, Republic of Ilsan Paik Hospital Goyang-si Gyeonggi-do
Korea, Republic of Chonnam National University Hospital Gwangju Korea
Korea, Republic of Gachon University Gil Hospital Incheon Korea
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do
Korea, Republic of Chungang University Hospital Seoul
Korea, Republic of Hanyang University Medical Center Seoul Korea
Korea, Republic of Konkuk University Medical Center Seoul
Korea, Republic of Korea University Guro Hospital Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Kyung Hee University Hospital Seoul Korea
Korea, Republic of Samsung Medical Center Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Seoul St. Mary's Hospital Seoul Korea
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of CHA Bundang Medical Center, CHA University Sungnam-si Gyeonggi-do
Korea, Republic of Ajou University Hospital Suwon Gyeonggi-do
Korea, Republic of Ulsan University Hospital Ulsan Ulsan-Kwangyokshi
Mexico RM Pharma Specialists S.A. de C.V. Distrito Federal
Mexico Instituto de Investigaciones Aplicadas a la Neurociencia A.C Durango
Mexico Grupo Clinico CATEI Sociedad Civil Guadalajara Jalisco
Mexico B&B Investigaciones Medicas, SC Mazatlan Sinaloa
Mexico Köhler & Milstein Research Mérida Yucatan
Mexico Centro Medico del Angel Mexicali Baja California
Mexico Hospital de Jesus I.A.P. Mexico City Distrito Federal
Mexico Clinica De Enfermedades Cronicas y Procedimientos Especiales Morelia Michoacan
Poland NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm Bialystok Podlaskie
Poland NZOZ ZDROWIE Osteo-Medic Bialystok Podlaskie
Poland Centrum Badan Klinicznych PI-House sp. z o.o. Gdansk Pomorskie
Poland Centrum Medyczne Angelius Provita Katowice Slaskie
Poland Diamond Clinic Krakow Malopolskie
Poland Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna Lodz Lódzkie
Poland Dermed Centrum Medyczne Sp. z o.o. Lodz Lodzkie
Poland DermoDent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski s.c. Osielsko Kujawsko-pomorskie
Poland Ai Centrum Medyczne Sp. Z O.O. Sp.K. Poznan Wielkopolskie
Poland Lubelskie Centrum Diagnostyczne Swidnik Lubelskie
Poland LASER CLINIC Specjalistyczne Gabinety Lekarskie Szczecin Zachodniopomorskie
Poland Centrum Medyczne AMED Warsaw Mazowieckie
Poland Centrum Medyczne Evimed Warsaw Mazowieckie
Poland Centralny Szpital Kliniczny MSW Klinika Dermatologii Warszawa
Poland dermMedica Sp. z o.o. Wroclaw Dolnoslaskie
Puerto Rico Santa Cruz Behavioral PSC Bayamón
Puerto Rico Dr. Samuel Sanchez PSC Caguas
Puerto Rico Office of Dr. Alma M. Cruz Carolina
Puerto Rico Ponce School of Medicine CAIMED Center Ponce
Puerto Rico GCM Medical Group, PSC - Hato Rey Site San Juan
Russian Federation GBUZ Clinical dermatology and venereological dispensary Krasnodar Krasnodarskiy Kray
Russian Federation State scientific centre for dermatovenerology and cosmetolog Moscow
Russian Federation GOU VPO 'Smolensk State Medical Academy of Ministry of Health and Social Development of Russian Federation' Smolensk
Russian Federation SPb SBHI Skin-venerologic dispensary #10 St. Petersburg
Russian Federation Tver State Medical University Tver
Spain Hospital del Mar Barcelona
Spain Hospital Germans Trias i Pujol Barcelona Badalona
Spain Hospital De Basurto Bilbao Vizcaya
Spain Hospital Reina Sofia Cordoba
Spain Hospital Infanta Leonor Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Ramón y Cajal Madrid
Spain Hospital de Manises Manises Valencia
Spain Centro de Especialidades Mollabao Pontevedra
Spain Hospital Universitario Virgen Macarena Sevilla
Spain Hospital Universitario La Fe de Valencia Valencia
Spain Hospital Marina Baixa Villajoyosa Alicante
Taiwan National Taiwan University Hospital - Hsinchu branch Hsinchu
Taiwan Chang Gung Memorial Hospital - Kaohsiung Branch Kaohsiung
Taiwan Taipei Medical University Shuang Ho Hospital New Taipei City
Taiwan Chung Shan Medical University Hospital Taichung City
Taiwan National Cheng-Kung Uni. Hosp. Tainan
Taiwan National Taiwan University Hospital Taipei City
Taiwan Chang Gung Memorial Hospital - Linkou Taoyuan Hsien
United Kingdom Salford Royal NHS Foundation Trust Salford Greater Manchester
United States ORA, Inc Andover Massachusetts
United States DelRicht Research Baton Rouge Louisiana
United States Zenith Research, Inc. Beverly Hills California
United States Bexley Dermatology Research Bexley Ohio
United States University of Alabama at Birmingham Birmingham Alabama
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 University Hospitals Cleveland Medical Center Cleveland Ohio
United States Florida Academic Centers Research and Education, LLC Coral Gables Florida
United States Modern Research Associates Dallas Texas
United States University Dermatology Darien Illinois
United States Psoriasis Treatment Center of Central New Jersey East Windsor New Jersey
United States California Dermatology & Clinical Research Institute Encinitas California
United States The Pennsylvania Centre for Dermatology, LLC Exton Pennsylvania
United States Wright State Univ School of Medicine Fairborn Ohio
United States Univ of Connecticut Farmington Connecticut
United States First OC Dermatology Fountain Valley California
United States Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana
United States Clinical Partners, LLC Johnston Rhode Island
United States Keck School of Medicine University of Southern California Los Angeles California
United States Forefront Research Louisville Kentucky
United States Dermatologic Surgery Specialists, PC Macon Georgia
United States Advanced Clinical Research LLC Meridian Idaho
United States University of Utah Murray Utah
United States Mount Sinai School of Medicine Dermatology Clinical Trials New York New York
United States Dermatology Clinical Trials Newport Beach California
United States Virginia Clinical Research, Inc. Norfolk Virginia
United States Renstar Medical Research Ocala Florida
United States Park Avenue Dermatology Orange Park Florida
United States Austin Institute for Clinical Research Pflugerville Texas
United States The Indiana Clinical Trials Center Plainfield Indiana
United States Oregon Dermatology and Research Center Portland Oregon
United States Oregon Health and Science University Portland Oregon
United States Oregon Medical Research Center Portland Oregon
United States Dermatology and Skin Cancer Specialists Rockville Maryland
United States Lawrence J Green, M.D, LLC Rockville Maryland
United States Arlington Dermatology Rolling Meadows Illinois
United States Central Dermatology PC Saint Louis Missouri
United States Texas Dermatology and Laser Specialists San Antonio Texas
United States San Luis Dermatology & Laser Clinic San Luis Obispo California
United States Clinical Science Institute Santa Monica California
United States Meridian Clinical Research Savannah Georgia
United States Dermatology Associates Seattle Washington
United States The South Bend Clinic Center for Research South Bend Indiana
United States MultiCare Good Samaritan Hospital Tacoma Washington
United States ForCare Clinical Research Tampa Florida
United States PMG Research of Wilmington Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Poland,  Puerto Rico,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With a Static Physician's Global Assessment Among Those Who Entered the Study With a sPGA of 0,1 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
Primary 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 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 Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) 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 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 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
Secondary 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 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
Secondary Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline 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
Secondary Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline 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
Secondary Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline 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
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