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, Austria, Belgium, Czechia, Germany, Hungary, Israel, Italy, Japan, Netherlands, Romania, Russian Federation, 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.

Clinical Research of West Florida, Clearwater, Florida

Status

Address

Clinical Research of West Florida

Clearwater, Florida, 33765

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

Washington University, Saint Louis, Missouri

Status

Address

Washington University

Saint Louis, Missouri, 63110

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

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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

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

Wien, Austria

Status

Address

KH der Barmherzigen Schwestern Wien BetriebsGesmbH

Wien, , 1060

Universitair Ziekenhuis Gent, Gent, Belgium

Status

Address

Universitair Ziekenhuis Gent

Gent, , 9000

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

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

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

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

Kaplan Medical Center, Rehovot, Israel

Status

Address

Kaplan Medical Center

Rehovot, , 7610001

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

Bunkyo-ku, Tokyo, Japan

Status

Address

Tokyo Medical And Dental University Hospital

Bunkyo-ku, Tokyo, 113-8519

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

Status

Address

JHCO Tokyo Yamate Medical Center

Shinjuku-ku, Tokyo, 169-0073

ETZ Elisabeth, Tilburg, North Brabant, Netherlands

Status

Address

ETZ Elisabeth

Tilburg, North Brabant, 5022 GC

Academisch Medisch Centrum, Amsterdam, Netherlands

Status

Address

Academisch Medisch Centrum

Amsterdam, , 1105 AZ

SC Med Life SA, Bucuresti, Romania

Status

Address

SC Med Life SA

Bucuresti, , 010719

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

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