A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

Study Purpose

The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130) - If female, participant must meet the contraception requirements

Exclusion Criteria:

- Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM) - Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study - Participants may not have received surgery for Crohn's disease in the originator study or are likely to require surgery for treatment of Crohn's disease during the study - Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04232553
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Call 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)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries Argentina, Australia, Austria, Belgium, Canada, Czechia, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Romania, Russian Federation, Turkey, Ukraine, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn's Disease
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Mirikizumab SC

Mirikizumab given subcutaneously (SC).

Experimental: Mirikizumab IV and SC

Mirikizumab given intravenously (IV) and SC.

Interventions

Drug: - Mirikizumab

Administered IV

Drug: - Mirikizumab

Administered SC

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

California Medical Research Group, Fresno, California

Status

Address

California Medical Research Group

Fresno, California, 91324

Clinical Research of West Florida, Clearwater, Florida

Status

Address

Clinical Research of West Florida

Clearwater, Florida, 33765

SIH Research, LLC, Kissimmee, Florida

Status

Address

SIH Research, LLC

Kissimmee, Florida, 34741

Wellness Clinical Research, Lehigh Acres, Florida

Status

Address

Wellness Clinical Research

Lehigh Acres, Florida, 33936

Care Access Research - Orlando, Orlando, Florida

Status

Address

Care Access Research - Orlando

Orlando, Florida, 32825

Indiana University Health, Indianapolis, Indiana

Status

Address

Indiana University Health

Indianapolis, Indiana, 46202

Delta Research Partners LLC, Bastrop, Louisiana

Status

Address

Delta Research Partners LLC

Bastrop, Louisiana, 71720

Robert Ferguson, MD PC, West Bloomfield, Michigan

Status

Address

Robert Ferguson, MD PC

West Bloomfield, Michigan, 48323

Minnesota Gastroenterology, P.A., Plymouth, Minnesota

Status

Address

Minnesota Gastroenterology, P.A.

Plymouth, Minnesota, 55446

Chapel Hill, North Carolina

Status

Address

University of North Carolina Center for Inflammatory Bowel Disease

Chapel Hill, North Carolina, 27599

Carolina Digestive Diseases, Greenville, North Carolina

Status

Address

Carolina Digestive Diseases

Greenville, North Carolina, 27834

Cleveland, Ohio

Status

Address

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

Paramount Medical Research, Middleburg Heights, Ohio

Status

Address

Paramount Medical Research

Middleburg Heights, Ohio, 44130

Oklahoma City, Oklahoma

Status

Address

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

Gastro One, Germantown, Tennessee

Status

Address

Gastro One

Germantown, Tennessee, 38138

HD Research, Houston, Texas

Status

Address

HD Research

Houston, Texas, 77047

Southern Star Research Institute, LLC, San Antonio, Texas

Status

Address

Southern Star Research Institute, LLC

San Antonio, Texas, 78229

Care Access Research - Salt Lake City, Salt Lake City, Utah

Status

Address

Care Access Research - Salt Lake City

Salt Lake City, Utah, 84124

Virginia Mason Medical Center, Seattle, Washington

Status

Address

Virginia Mason Medical Center

Seattle, Washington, 98111

International Sites

DOM- Centro de Reumatologia, Caba, Buenos Aires, Argentina

Status

Address

DOM- Centro de Reumatologia

Caba, Buenos Aires, 1111

Royal Adelaide Hospital, Adelaide, South Australia, Australia

Status

Address

Royal Adelaide Hospital

Adelaide, South Australia, 5000

Wien, Vienna, Austria

Status

Address

AKH - Gastroenterologie und Hepatologie - Interne Medizin III

Wien, Vienna, 1090

Medizinische Universität Innsbruck, Innsbruck, Austria

Status

Address

Medizinische Universität Innsbruck

Innsbruck, , 6020

Universitätsklinikum Salzburg, Salzburg, Austria

Status

Address

Universitätsklinikum Salzburg

Salzburg, , 5020

Wien, Austria

Status

Address

KH der Barmherzigen Schwestern Wien BetriebsGesmbH

Wien, , 1060

Hospital Universitaire Erasme Brussel, Brussel, Belgium

Status

Address

Hospital Universitaire Erasme Brussel

Brussel, , 1070

Universitair Ziekenhuis Gent, Gent, Belgium

Status

Address

Universitair Ziekenhuis Gent

Gent, , 9000

Victoria Hospital, London, Ontario, Canada

Status

Address

Victoria Hospital

London, Ontario, N6A 5W9

Vojenska nemocnice Brno, Brno, Czechia

Status

Address

Vojenska nemocnice Brno

Brno, , 636 00

Fakultni nemocnice u sv. Anny v Brne, Brno, Czechia

Status

Address

Fakultni nemocnice u sv. Anny v Brne

Brno, , 65691

Hepato-gastroenterologie HK, s.r.o., Hradec Kralove, Czechia

Status

Address

Hepato-gastroenterologie HK, s.r.o.

Hradec Kralove, , 50012

Gregar s.r.o., Olomouc, Czechia

Status

Address

Gregar s.r.o.

Olomouc, , 779 00

PreventaMed, s.r.o., Olomouc, Czechia

Status

Address

PreventaMed, s.r.o.

Olomouc, , 779 00

A-Shine s.r.o., Plzen, Czechia

Status

Address

A-Shine s.r.o.

Plzen, , 31200

Thomayerova Nemocnice, Praha 4 - Krc, Czechia

Status

Address

Thomayerova Nemocnice

Praha 4 - Krc, , 140 59

Fakultni Nemocnice v Motole, Praha 5, Czechia

Status

Address

Fakultni Nemocnice v Motole

Praha 5, , 150 06

Mediendo s.r.o., Praha 8 - Karlin, Czechia

Status

Address

Mediendo s.r.o.

Praha 8 - Karlin, , 18600

Krajska nemocnice T. Bati a.s., Zlin, Czechia

Status

Address

Krajska nemocnice T. Bati a.s.

Zlin, , 76275

Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany

Status

Address

Medizinische Hochschule Hannover

Hannover, Niedersachsen, 30625

Magen-Darm-Zentrum Remscheid, Remscheid, North Rhine-Westphalia, Germany

Status

Address

Magen-Darm-Zentrum Remscheid

Remscheid, North Rhine-Westphalia, 42859

Friedrichsthal, Saarland, Germany

Status

Address

Gemeinschaftspraxis Dres. Denger&Pfitzner

Friedrichsthal, Saarland, 66299

Halle (Saale),, Sachsen Anhalt, Germany

Status

Address

Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt

Halle (Saale),, Sachsen Anhalt, 06108

Leipzig, Sachsen, Germany

Status

Address

Universität Leipzig - Universitätsklinikum

Leipzig, Sachsen, 04103

Charité Universitätsmedizin Berlin, Berlin, Germany

Status

Address

Charité Universitätsmedizin Berlin

Berlin, , 12200

Dr. Rethy Pal Korhaz es Rendelointezet, Bekescsaba, Bekes, Hungary

Status

Address

Dr. Rethy Pal Korhaz es Rendelointezet

Bekescsaba, Bekes, 5600

DRC Gyogyszervizsgalo Rendelointezet Kft, Balatonfüred, EU, Hungary

Status

Address

DRC Gyogyszervizsgalo Rendelointezet Kft

Balatonfüred, EU, 8230

Tatabanya, Komarom-Esztergom, Hungary

Status

Address

Komarom-Eszetergom Megyei Onkormanyzat Szent Borbala Korhaza

Tatabanya, Komarom-Esztergom, 2800

Clinexpert SMO, Budapest, Hungary

Status

Address

Clinexpert SMO

Budapest, , 1033

Obudai Egeszsegugyi Centrum Kft, Budapest, Hungary

Status

Address

Obudai Egeszsegugyi Centrum Kft

Budapest, , 1036

Bugat Pal Korhaz, Gyongyos, Hungary

Status

Address

Bugat Pal Korhaz

Gyongyos, , 3200

Endomedix Diagnosztikai Kozpont, Miskolc, Hungary

Status

Address

Endomedix Diagnosztikai Kozpont

Miskolc, , 3525

SZTE I. sz. Belgyogyaszati Klinika, Szeged, Hungary

Status

Address

SZTE I. sz. Belgyogyaszati Klinika

Szeged, , 6720

Clinfan Szolgaltato Kft., Szekszard, Hungary

Status

Address

Clinfan Szolgaltato Kft.

Szekszard, , 7100

Javorszky Odon Hospital, Vac, Hungary

Status

Address

Javorszky Odon Hospital

Vac, , 2600

Soroka Medical Center, Beer Sheva, Israel

Status

Address

Soroka Medical Center

Beer Sheva, , 8410101

Shaare Zedek Medical Center, Jerusalem, Israel

Status

Address

Shaare Zedek Medical Center

Jerusalem, , 91031

Nahariya, Israel

Status

Address

Galilee Medical Center Department of Internal Medicine A

Nahariya, , 22100

Kaplan Medical Center, Rehovot, Israel

Status

Address

Kaplan Medical Center

Rehovot, , 7610001

Assaf Harofeh Medical Center, Zerifin 70300, Israel

Status

Address

Assaf Harofeh Medical Center

Zerifin 70300, , 6093000

Ospedale di Rho, Rho, Milano, Italy

Status

Address

Ospedale di Rho

Rho, Milano, 20017

Istituto Clinico Humanitas, Rozzano, Milano, Italy

Status

Address

Istituto Clinico Humanitas

Rozzano, Milano, 20089

Policlinico Mater Domini, Catanzaro, Italy

Status

Address

Policlinico Mater Domini

Catanzaro, , 88100

Kitakyushu Municipal Medical Center, Kitakyusyu-shi, Fukoka, Japan

Status

Address

Kitakyushu Municipal Medical Center

Kitakyusyu-shi, Fukoka, 802-0077

Fukuoka University Chikushi Hospital, Chikushino-shi, Fukuoka-Ken, Japan

Status

Address

Fukuoka University Chikushi Hospital

Chikushino-shi, Fukuoka-Ken, 818 8502

Sameshima Hospital, Kagoshima-shi, Kagoshima, Japan

Status

Address

Sameshima Hospital

Kagoshima-shi, Kagoshima, 892-0846

Gokeikai Ofuna Chuo Hospital, Kamakura-shi, Kanagawa, Japan

Status

Address

Gokeikai Ofuna Chuo Hospital

Kamakura-shi, Kanagawa, 247-0056

Takagi Clinic, Sendai-shi, Miyagi-Ken, Japan

Status

Address

Takagi Clinic

Sendai-shi, Miyagi-Ken, 981 3213

Bunkyo-ku, Tokyo, Japan

Status

Address

Tokyo Medical And Dental University Hospital

Bunkyo-ku, Tokyo, 113-8519

Kyorin University Hospital, Mitaka, Tokyo, Japan

Status

Address

Kyorin University Hospital

Mitaka, Tokyo, 181-8611

JHCO Tokyo Yamate Medical Center, Shinjuku-ku, Tokyo, Japan

Status

Address

JHCO Tokyo Yamate Medical Center

Shinjuku-ku, Tokyo, 169-0073

Yeungnam Univeristy Medical Center, Daegu, Korea, Korea, Republic of

Status

Address

Yeungnam Univeristy Medical Center

Daegu, Korea, 42415

ETZ Elisabeth Tilburg, Tilburg, North Brabant, Netherlands

Status

Address

ETZ Elisabeth Tilburg

Tilburg, North Brabant, 5022 GC

Academisch Medisch Centrum, Amsterdam, Netherlands

Status

Address

Academisch Medisch Centrum

Amsterdam, , 1105 AZ

Korczowski Bartosz, Gabinet Lekarski, Rzeszow, Poland

Status

Address

Korczowski Bartosz, Gabinet Lekarski

Rzeszow, , 35-302

Szczecin, Poland

Status

Address

Twoja Przychodnia-Szczecinskie Centrum Medyczne

Szczecin, , 71-434

SC Pelican SRL, Oradea, Bihor, Romania

Status

Address

SC Pelican SRL

Oradea, Bihor, 410469

Sc Tvm Med Serv, Cluj-Napoca, Cluj, Romania

Status

Address

Sc Tvm Med Serv

Cluj-Napoca, Cluj, 400132

Bucharest, Romania

Status

Address

Arensia Exploratory Medicine Colentina Clinical Hospital

Bucharest, , 020125

SC Med Life SA, Bucuresti, Romania

Status

Address

SC Med Life SA

Bucuresti, , 010719

Institutul Clinic Fundeni, Bucuresti, Romania

Status

Address

Institutul Clinic Fundeni

Bucuresti, , 022328

Centrul Medical Unirea SRL, Bucuresti, Romania

Status

Address

Centrul Medical Unirea SRL

Bucuresti, , 040055

Policlinica CCBR S.R.L., Bucuresti, Romania

Status

Address

Policlinica CCBR S.R.L.

Bucuresti, , 30463

Policlinica Algomed, Timisoara, Romania

Status

Address

Policlinica Algomed

Timisoara, , 300002

LLC "Medicine Center SibNovoMed", Novosibirsk, Russian Federation

Status

Address

LLC "Medicine Center SibNovoMed"

Novosibirsk, , 630005

Clinical Diagnostic Center Ultramed, Omsk, Russian Federation

Status

Address

Clinical Diagnostic Center Ultramed

Omsk, , 644024

Samara, Russian Federation

Status

Address

NonState Healthcare Institution Central Clinical Hospital

Samara, , 443029

Antalya Training and Research Hospital, Muratpasa, Antayla, Turkey

Status

Address

Antalya Training and Research Hospital

Muratpasa, Antayla, 7100

Izmit, Kocaeli, Turkey

Status

Address

Kocaeli University Medical Faculty Hospital

Izmit, Kocaeli, 41380

Mersin University Medical Faculty, Yenişehir, Mersin, Turkey

Status

Address

Mersin University Medical Faculty

Yenişehir, Mersin, 33110

Hacettepe University Faculty of Medicine, Ankara, Turkey

Status

Address

Hacettepe University Faculty of Medicine

Ankara, , 06100

Gazi University Faculty of Medicine, Ankara, Turkey

Status

Address

Gazi University Faculty of Medicine

Ankara, , 6500

Uludag University Medical Faculty, Bursa, Turkey

Status

Address

Uludag University Medical Faculty

Bursa, , 16059

Gaziantep University Medical Faculty, Gaziantep, Turkey

Status

Address

Gaziantep University Medical Faculty

Gaziantep, , 27310

Acibadem Fulya Hospital, Istanbuk, Turkey

Status

Address

Acibadem Fulya Hospital

Istanbuk, , 34349

Istanbul, Turkey

Status

Address

Haydarpasa Numune Egitim Arastirma Hastanesi

Istanbul, , 34662

İstanbul, Turkey

Status

Address

Marmara University Pendik Research and Training Hospital

İstanbul, , 34899

Dokuz Eylul University Hospital, Izmir, Turkey

Status

Address

Dokuz Eylul University Hospital

Izmir, ,

Erciyes University Hospital, Kayseri, Turkey

Status

Address

Erciyes University Hospital

Kayseri, , 38039

Kyiv Municipal Clinical Hospital #1, Kyiv, Ukraine

Status

Address

Kyiv Municipal Clinical Hospital #1

Kyiv, , 02091

Odesa, Ukraine

Status

Address

Communal Enterprise "Odesa Regional Clinical Hospital"

Odesa, , 65117

Uzhgorod, Ukraine

Status

Address

A. Novak Transcarpathian Regional Clinical Hospital

Uzhgorod, , 88018

Vinnytsia, Ukraine

Status

Address

Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU

Vinnytsia, , 21005

Zaporizhzhia, Ukraine

Status

Address

Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2

Zaporizhzhia, , 69104

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