AzTrials
AzTrials

PsoriasisPhase 3NCT03556202

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

A Phase 3 study testing Mirikizumab in people with Psoriasis, run by Eli Lilly and Company at 229 sites in 19 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
Mirikizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,936 participants
Where
229 sitesin 19 countries
Study dates
3 Sep 2018to 7 Feb 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

229 sites in 19 countries.

229 sites in 19 countries

United States47 sites

  • ORA, Inc

    Andover, Massachusetts, 01810

  • DelRicht Research

    Baton Rouge, Louisiana, 70809

  • Zenith Research, Inc.

    Beverly Hills, California, 90212

  • Bexley Dermatology Research

    Bexley, Ohio, 43209

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • PMG Research of Cary, LLC

    Cary, North Carolina, 27518

  • University of North Carolina Dermatology and Skin Cancer Cen

    Chapel Hill, North Carolina, 27516

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Florida Academic Centers Research and Education, LLC

    Coral Gables, Florida, 33134

  • Modern Research Associates

    Dallas, Texas, 75231

  • University Dermatology

    Darien, Illinois, 60561

  • Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey, 08520

  • California Dermatology & Clinical Research Institute

    Encinitas, California, 92024

  • The Pennsylvania Centre for Dermatology, LLC

    Exton, Pennsylvania, 19341

  • Wright State Univ School of Medicine

    Fairborn, Ohio, 45324

  • Univ of Connecticut

    Farmington, Connecticut, 06030-2840

  • First OC Dermatology

    Fountain Valley, California, 92708

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

  • Clinical Partners, LLC

    Johnston, Rhode Island, 02919

  • Keck School of Medicine University of Southern California

    Los Angeles, California, 90033

  • Forefront Research

    Louisville, Kentucky, 40241

  • Dermatologic Surgery Specialists, PC

    Macon, Georgia, 31217

  • Advanced Clinical Research LLC

    Meridian, Idaho, 83642

  • University of Utah

    Murray, Utah, 84107

  • Mount Sinai School of Medicine Dermatology Clinical Trials

    New York, New York, 10029

  • Dermatology Clinical Trials

    Newport Beach, California, 92660-7831

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia, 23502

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Park Avenue Dermatology

    Orange Park, Florida, 32073

  • Austin Institute for Clinical Research

    Pflugerville, Texas, 78660

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168

  • Oregon Dermatology and Research Center

    Portland, Oregon, 97210

  • Oregon Medical Research Center

    Portland, Oregon, 97223

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Dermatology and Skin Cancer Specialists

    Rockville, Maryland, 20850

  • Lawrence J Green, M.D, LLC

    Rockville, Maryland, 20850

  • Arlington Dermatology

    Rolling Meadows, Illinois, 60008

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

  • San Luis Dermatology & Laser Clinic

    San Luis Obispo, California, 93405

  • Clinical Science Institute

    Santa Monica, California, 90404

  • Meridian Clinical Research

    Savannah, Georgia, 31406

  • Dermatology Associates

    Seattle, Washington, 98101

  • The South Bend Clinic Center for Research

    South Bend, Indiana, 46617

  • Central Dermatology PC

    St Louis, Missouri, 63117

  • MultiCare Good Samaritan Hospital

    Tacoma, Washington, 98405

  • ForCare Clinical Research

    Tampa, Florida, 33613-1244

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28411

Other trials in United States

Japan38 sites

  • Asahikawa Medical College Hospital

    Asahikawa, Hokkaido, 078-8510

  • The University of Tokyo Hospital

    Bunkyo-ku, Tokyo, 113-8655

  • Gifu University Hospital

    Gifu, 501-1194

  • Tokyo Medical University Hachioji Medical Center

    Hachiōji, Tokyo, 193-0998

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191

  • Tokyo Medical University Ibaraki Medical Center

    Inashiki, Ibaraki, 300-0332

  • Tokai University Hospital- Isehara Campus

    Isehara, Kanagawa, 259-1143

  • Teikyo University Hospital

    Itabashi-ku, Tokyo, 173 8606

  • Nihon University Itabashi Hospital

    Itabashi-ku, Tokyo, 173-8610

  • Shimane University Hospital

    Izumo, Shimane, 693-0021

  • Kanto Rosai Hospital

    Kawasaki, Kanagawa, 211-8510

  • Yamanashi Prefectural Central Hospital

    Kofu, Yamanashi, 400-8506

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

  • Kyoto Furitsu Medical University Hospital

    Kyoto, 602-8566

  • Gunma University Hosptial

    Maebashi, Gunma, 371-8511

  • Shinshu University Hospital

    Matsumoto, Nagano, 390-8621

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Ryukyu University Hospital

    Nakagami-gun, Okinawa, 903-0215

  • Kume Clinic

    Nishi-ku Sakai-shi, Osaka, 593 8324

  • Takagi Dermatology

    Obihiro, Hokkaido, 080-0013

  • Osaka City University Hospital

    Osaka, 545-8586

  • Nippon Life Hospital

    Osaka, 550-0006

  • Shiga University of Medical Science Hosptial

    Ōtsu, Shiga, 520-2192

  • Toho University School of Medicine, Sakura Hospital

    Sakura, Chiba, 285-8741

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Showa University Hospital

    Shinagawa, Tokyo, 142-8555

  • NTT Medical Center Tokyo

    Shinagawa-KU, Tokyo, 141-8625

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo, 160-0023

  • Seibo Hospital

    Shinjuku-ku, Tokyo, 161-8521

  • Takaokashi Shirasaki Dermatology Clinic

    Takaoka, Toyama, 933-0871

  • Tokushima University Hospital

    Tokushima, 770-8503

  • St. Luke's International Hospital

    Tokyo, 104-8560

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507

  • Yamaguchi University Hospital

    Ube, Yamaguchi, 755-8505

  • Juntendo Urayasu Hospital

    Urayasu, Chiba, 279-0021

  • Wakayama Medical University Hospital

    Wakayama, 641-0012

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

Germany20 sites

  • Fachklinik Bad Bentheim

    Bad Bentheim, Lower Saxony, 48455

  • Charité Campus Virchow-Klinikum

    Berlin, 10117

  • Klin. Forschung Berlin-Mitte GmbH

    Berlin, 10117

  • Rothhaar Studien

    Berlin, 10783

  • ISA GmbH

    Berlin, 10789

  • Dermatologisches Zentrum Osnabrück Nord

    Bramsche, Lower Saxony, 49565

  • Elbe Klinikum Buxtehude

    Buxtehude, Lower Saxony, 21614

  • Rosenpark Research GmbH

    Darmstadt, Hesse, 64283

  • Hautarztpraxis Dr. Gerlach

    Dresden, Saxony, 01097

  • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

    Frankfurt am Main, Hesse, 60590

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • TFS Trial Form Support GmbH

    Hamburg, 20537

  • Clinical Research Hamburg GmbH

    Hamburg, 22143

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitätsklinikum Schleswig-Holstein

    Kiel, Schleswig-Holstein, 24105

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein, 23538

  • Dermatologische Gemeinschaftspraxis Mahlow

    Mahlow, Brandenburg, 15831

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

  • Hautarztpraxis Dr. Leitz

    Stuttgart, Baden-Wurttemberg, 70178

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

South Korea18 sites

  • Bucheon St. Mary's Hospital

    Bucheon-si, Gyeonggi-do, 14647

  • Pusan National University Hospital

    Busan, Korea, 49241

  • Chungnam National University Hospital

    Daejeon, Korea, 35015

  • Ilsan Paik Hospital

    Goyang-si, Gyeonggi-do, 10380

  • Chonnam National University Hospital

    Gwangju, Korea, 61469

  • Gachon University Gil Hospital

    Incheon, Korea, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Kyung Hee University Hospital

    Seoul, Korea, 02447

  • Hanyang University Medical Center

    Seoul, Korea, 04763

  • Seoul St. Mary's Hospital

    Seoul, Korea, 06591

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 6351

  • Korea University Guro Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 8308

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Konkuk University Medical Center

    Seoul, 05030

  • Chungang University Hospital

    Seoul, 06973

  • CHA Bundang Medical Center, CHA University

    Sungnam-si, Gyeonggi-do, 13496

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

  • Ulsan University Hospital

    Ulsan, Ulsan-Kwangyǒkshi, 44033

Other trials in South Korea

Poland15 sites

  • NZOZ ZDROWIE Osteo-Medic

    Bialystok, Podlaskie Voivodeship, 15-351

  • NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm

    Bialystok, Podlaskie Voivodeship, 15-375

  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk, Pomeranian Voivodeship, 80-546

  • Centrum Medyczne Angelius Provita

    Katowice, Silesian Voivodeship, 40-611

  • Diamond Clinic

    Krakow, Lesser Poland Voivodeship, 31-559

  • Dermed Centrum Medyczne Sp. z o.o.

    Lodz, Łódź Voivodeship, 90-265

  • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

    Lodz, Łódź Voivodeship

  • DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.

    Osielsko, Kuyavian-Pomeranian Voivodeship, 86-031

  • Ai Centrum Medyczne Sp. Z O.O. Sp.K.

    Poznan, Greater Poland Voivodeship, 61-113

  • Lubelskie Centrum Diagnostyczne

    Świdnik, Lublin Voivodeship, 21-040

  • LASER CLINIC Specjalistyczne Gabinety Lekarskie

    Szczecin, West Pomeranian Voivodeship, 70-332

  • Centrum Medyczne AMED

    Warsaw, Masovian Voivodeship, 01-518

  • Centrum Medyczne Evimed

    Warsaw, Masovian Voivodeship, 02-625

  • Centralny Szpital Kliniczny MSW Klinika Dermatologii

    Warsaw, 02-507

  • dermMedica Sp. z o.o.

    Wroclaw, Lower Silesian Voivodeship, 51-318

Other trials in Poland

Spain12 sites

  • Hospital Germans Trias i Pujol

    Barcelona, Badalona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital De Basurto

    Bilbao, Vizcaya, 48013

  • Hospital Reina Sofia

    Córdoba, 14004

  • Hospital Infanta Leonor

    Madrid, 28031

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital de Manises

    Manises, Valencia, 46940

  • Centro de Especialidades Mollabao

    Pontevedra, 36001

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario La Fe de Valencia

    Valencia, 46026

  • Hospital Marina Baixa

    Villajoyosa, Alicante, 03570

Other trials in Spain

Canada9 sites

  • Kirk Barber Research

    Calgary, Alberta, T2G 1B1

  • Alberta DermaSurgery Centre

    Edmonton, Alberta, T6G 1C3

  • Eastern Canada Cutaneous Research Assoicates Ltd

    Halifax, Nova Scotia, B3H1Z2

  • Guenther Research Inc.

    London, Ontario, N6A 3H7

  • Lynderm Research Inc.

    Markham, Ontario, L3P1X2

  • Innovaderm Research Inc

    Montreal, Quebec, H2X 2V1

  • SKiN Centre for Dermatology

    Peterborough, Ontario, K9J 5K2

  • Dr. Chih-ho Hong Medical Inc.

    Surrey, British Columbia, V3R 6A7

  • K. Papp Clinical Research

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

Argentina8 sites

  • Buenos Aires Skin

    Buenos Aires, Ciudad Autónoma de Buenos Aire, 1055

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1027AAP

  • Dermatology

    CABA, Buenos Aires, C1060ABN

  • Clinica Adventista Belgrano

    CABA, Ciudad Autónoma de Buenos Aire, C1430EGF

  • Instituto de Neumonología Y Dermatología

    Capital Federal, Buenos Aires, 1425

  • Psoriahue

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1425DKG

  • Halitus Instituto Médico

    Ciudad Autonoma de Buenos Aire, C1122AAF

  • Parra Dermatología

    Mendoza, 5500

Other trials in Argentina

France8 sites

  • CHU de Bordeaux Hop St ANDRE

    Bordeaux, Gironde, 33075

  • CH du Mans - Pavillon Claude Monet

    Le Mans, 72037

  • CHU Dupuytren 2

    Limoges, Cedex, 87042

  • Cabinet Médical

    Martigues, 13500

  • Hopital Saint Eloi

    Montpellier, 34295

  • CHU de Nice Hopital de L'Archet

    Nice, 06202

  • CHU Charles Nicolle in Rouen

    Rouen, 76036

  • Hopital Larrey

    Toulouse, 31059

Other trials in France

Mexico8 sites

  • RM Pharma Specialists S.A. de C.V.

    Distrito Federal, 3100

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C

    Durango, 34000

  • Grupo Clinico CATEI Sociedad Civil

    Guadalajara, Jalisco, 44657

  • B&B Investigaciones Medicas, SC

    Mazatlán, Sinaloa, 82140

  • Köhler & Milstein Research

    Mérida, Yucatán, 97070

  • Centro Medico del Angel

    Mexicali, Estado de Baja California, 21100

  • Hospital de Jesus I.A.P.

    Mexico City, Mexico City, 06090

  • Clinica De Enfermedades Cronicas y Procedimientos Especiales

    Morelia, Michoacán, 58249

Other trials in Mexico

Hungary7 sites

  • Uno Medical Trials Kft.

    Budapest, 1152

  • Ambrozia Kft.

    Budapest, 1238

  • Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

    Debrecen, Hajdú-Bihar, 4032

  • Bacs-Kiskun Megyei Korhaz

    Kecskemét, Bács-Kiskun county, 6000

  • Oroshaza Varosi Onkormanyzat Korhaza

    Orosháza, Bekes County, 5900

  • Allergo-Derm Bakos Kft

    Szolnok, Jász-Nagykun-Szolnok, 5000

  • Medmare Bt

    Veszprém, Veszprém City, 8200

Other trials in Hungary

Taiwan7 sites

  • National Taiwan University Hospital - Hsinchu branch

    Hsinchu, 300

  • Chang Gung Memorial Hospital - Kaohsiung Branch

    Kaohsiung City, 83301

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561

  • Chung Shan Medical University Hospital

    Taichung, 40201

  • National Cheng-Kung Uni. Hosp.

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 10048

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan Hsien, 10508

Other trials in Taiwan

Czechia6 sites

  • Fakultni Nemocnice U svate Anny

    Brno, South Moravian, 656 91

  • Kožní ambulance Kutná Hora, s.r.o.

    Kutná Hora, Central Bohemia, 28401

  • Nemocnice AGEL Novy Jicin a.s.

    Nový Jičín, Moravian-Silesian Region, 741 01

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, Hl. M. Praha, 100 34

  • Clintrial s.r.o.

    Prague, Praha 10, 100 00

  • Etická komise Krajské zdravotní, a.s. - Masarykovy nemocnice v Ústí nad Labem, o.z.

    Ústí nad Labem, Ustecký Kraj, 40113

Other trials in Czechia

Israel6 sites

  • Haemek Medical Center- Dermatology

    Afula, 1834111

  • Soroka Medical Center

    Beersheba, 8410101

  • Rambam Medical Center

    Haifa, 3525408

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Sheba Medical Center

    Ramat Gan, 5265601

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Australia5 sites

  • Clinical Trials SA Pty Ltd

    Adelaide, South Australia, 5073

  • Skin Health Institute Inc.

    Carlton, Victoria, 3053

  • Fremantle Dermatology

    Perth, Western Australia, 6160

  • Woden Dermatology

    Phillip, Australian Capital Territory, 2606

  • Veracity Clinical Research Pty Ltd

    Woolloongabba, Queensland, 4102

Other trials in Australia

Puerto Rico5 sites

  • Santa Cruz Behavioral PSC

    Bayamón, 00961-6911

  • Dr. Samuel Sanchez PSC

    Caguas, PR, 00727

  • Office of Dr. Alma M. Cruz

    Carolina, PR, 00985

  • Ponce School of Medicine CAIMED Center

    Ponce, PR, 00716

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, PR, 00917

Other trials in Puerto Rico

Russia5 sites

  • GBUZ Clinical dermatology and venereological dispensary

    Krasnodar, Krasnodarskiy Kray, 350020

  • State scientific centre for dermatovenerology and cosmetolog

    Moscow, 107076

  • SPb SBHI Skin-venerologic dispensary #10

    Saint Petersburg, 194021

  • GOU VPO 'Smolensk State Medical Academy of Ministry of Health and Social Development of Russian Federation'

    Smolensk, 214000

  • Tver State Medical University

    Tver', 170100

Other trials in Russia

Italy4 sites

  • Presidio Ospedaliero Firenze Centro Piero Palagi

    Florence, 50125

  • Policlinico di Tor Vergata

    Roma, 00133

  • Policlinico Gemelli - Università Cattolica del Sacro Cuore

    Rome, Lazio, 00168

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

Other trials in Italy

United Kingdom1 site

  • Salford Royal NHS Foundation Trust

    Salford, Greater Manchester, M6 8HD

Other trials in United Kingdom

About this study

Official title: 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.

Conditions
Psoriasis
Being tested
Mirikizumab
Keywords
IL-23, Interleukin-23, Psoriasis
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MirikizumabDrug

    Also called LY3074828

    Administered SC

Study groups in NCT03556202
Study groupRoleWhat they receive
125 Milligram (mg) Mirikizumab Q8WExperimentalParticipants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).
Receives: Drug: Mirikizumab
250 mg Mirikizumab Q8W Excluding SecukinumabExperimentalParticipants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ)
Receives: Drug: Mirikizumab
Secukinumab/250 mg Mirikizumab Q8WExperimentalParticipants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.
Receives: Drug: Mirikizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 104

  2. 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).

    Measured: Week 104

Secondary outcomes (6)

  1. 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).

    Measured: Week 104

  2. 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.

    Measured: Week 104

  3. 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.

    Measured: Week 104

  4. 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.

    Measured: Baseline, Week 104

  5. 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).

    Measured: Baseline, Week 104

  6. 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).

    Measured: Baseline, Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2018
  2. Study start3 Sep 2018
  3. Primary completion7 Feb 2022
  4. Study completion7 Feb 2022

Why it stopped: The study was terminated due to a strategic business decision made by the Sponsor.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,936 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03556202
Sponsor's protocol ID
16491
Other IDs
I6T-MC-AMAH, 2017-003299-30, 2017
Status last verified
Mar 2023
First submitted
4 Jun 2018
Last updated
21 Mar 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Hsieh CY, Hsu FL, Tsai TF. Comparison of Drug-Free Remission after the End of Phase III Trials of Three Different Anti-IL-23 Inhibitors in Psoriasis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2607-2620. doi: 10.1007/s13555-024-01229-6. Epub 2024 Jul 29.

    PubMed 39073712

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mirikizumab in people with Psoriasis, run by Eli Lilly and Company at 229 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 229 sites in United States, Japan, Germany, South Korea, Poland and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03556202, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.

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