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 Austria, Hungary, Italy
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.

International Sites

Medizinische Universität Innsbruck, Innsbruck, Austria

Status

Address

Medizinische Universität Innsbruck

Innsbruck, , 6020

Wien, Austria

Status

Address

KH der Barmherzigen Schwestern Wien BetriebsGesmbH

Wien, , 1060

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

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

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