Study on the Long-Term Effects and Safety of Mirikizumab for Patients with Crohn’s Disease

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What is this study about?

This clinical trial is focused on studying the long-term effects of a medication called Mirikizumab in individuals with Crohn’s Disease. Crohn’s Disease is a chronic inflammatory condition that affects the digestive tract, causing symptoms like abdominal pain, diarrhea, and weight loss. The medication being tested, Mirikizumab, is administered as a solution for injection and is designed to help manage the symptoms of this disease.

The purpose of this study is to evaluate how effective and safe Mirikizumab is over an extended period. Participants in the study will receive Mirikizumab and will be monitored to see how well the medication works in reducing the symptoms of Crohn’s Disease. The study will also assess the safety of the medication to ensure it is well-tolerated by those taking it.

Throughout the study, participants will receive regular injections of Mirikizumab and will have scheduled visits with healthcare professionals to track their progress. The study aims to provide valuable information on the long-term use of Mirikizumab for managing Crohn’s Disease, helping to improve treatment options for those affected by this condition.

1 joining the study

Participation begins after completing a previous study related to Crohn’s disease. Eligibility is confirmed based on prior study completion and specific criteria, such as contraception requirements for female participants.

2 initial treatment phase

The treatment involves the administration of mirikizumab, a solution for injection. The medication is provided in a pre-filled syringe for ease of use.

3 ongoing treatment and monitoring

Participants continue to receive mirikizumab as a solution for injection or infusion. Regular monitoring is conducted to assess the long-term efficacy and safety of the treatment.

4 evaluation of treatment response

The primary goal is to evaluate the percentage of participants achieving an endoscopic response and clinical remission by week 52. Endoscopic response is measured using the Simple Endoscopic Score for Crohn’s Disease (SES-CD), and clinical remission is assessed based on the Crohn’s Disease Activity Index (CDAI).

5 completion of the study

The study is estimated to conclude by December 20, 2026. Participants will have contributed to understanding the long-term effects of mirikizumab in managing Crohn’s disease.

Who Can Join the Study?

  • Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130).
  • If the participant is female, she must meet the requirements for using birth control.
  • Both male and female participants are eligible to join the study.
  • The study includes participants from vulnerable populations, which means people who might need extra care or protection.

Who Cannot Join the Study?

  • Participants who have a different condition than Crohn’s Disease cannot join. Crohn’s Disease is a condition that affects the digestive system.
  • Participants who are not within the specified age range cannot join. The age range for this study is not specified here, but it is important for eligibility.
  • Participants who are not part of the specified clinical trial groups cannot join. This means the study is looking for specific types of participants.
  • Participants who are not male or female cannot join. The study is open to both males and females.
  • Participants who are considered part of a vulnerable population cannot join. Vulnerable populations may include groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Endomed s.r.o. Kosice Slovakia
SYNEXUS Magyarorszag Kft. Budapest Hungary
Pauls Stradins Clinical University Hospital Riga Latvia
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Centre Hospitalier Universitaire De Poitiers Poitiers France
PreventaMed s.r.o. Olomouc Czechia
Iscare a.s. Prague Czechia
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Delta Health Care S.R.L. Bucharest Romania
Synexus Czech s.r.o. Prague Czechia
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
Sonomed Sp. z o.o. Szczecin Poland
DRC Kft. Balatonfured Hungary
Nzoz For Med Sp. z o.o. Wadowice Poland
Endoskopia Sp. z o.o. Sopot Poland
Krajska Nemocnice T Bati a.s. Zlin Czechia
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH Oldenburg In Holstein Germany
Siloah St Trudpert Klinikum Pforzheim Germany
Dc-Med Michal Kowalski sp.k. Swidnica Poland
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p. Bialystok Poland
Gastro LM s.r.o. Presov Slovakia
KBC Zagreb Zagreb Croatia
Clinfan Kft. Szekszard Hungary
Melita Medical sp. z o.o. Wroclaw Poland
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
IRCCS Policlinico San Donato San Donato Milanese Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Synexus Polska Sp. z o.o. Poznan Poland
Hepato-Gastroenterologie HK s.r.o. Hradec Kralove Czechia
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Cliniq s.r.o. Bratislava Slovakia
Javorszky Odon Korhaz Vac Hungary
Reumatop Grzegorz Rozumek Karin Pistorius Sp. j. Wroclaw Poland
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Krajska zdravotni a.s. Teplice Czechia
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Topolowa Medicenter Ryszawa & Wspolnicy Sp. j. Cracow Poland
Cabinet Particular Policlinic Algomed S.R.L. Timisoara Romania
Fakultni Thomayerova nemocnice Prague Czechia
Synexus Clinical Research GmbH Frankfurt Germany
Uniklinikum Salzburg Salzburg Austria
Centrum Zdrowia MDM Warsaw Poland
Pannonia Maganorvosi Centrum Kft. Budapest Hungary
Gastromed ZOZ Lublin Poland
Agsj Cjcphdfa szfnna Prague Czechia
Isvamcqcd Fgw Caneutsd Aww Ejuakqeintbz Mcrhjtih Prague Czechia
Iuygnw Bonheiden Belgium
Tgagbrmxaaff Nyuceuzjdyxalp Gqvj Nordhausen Germany
Sxitkxnlcjrgbumyiut Jfyadjce Uh Wipperfuerth Germany
Gzekpgjsufk sisybx Nove Zamky Slovakia
Egs Zcpqcm Zamosc Poland
Nhxlryargweo Zaeuwz Ovfxdg Zulgwrydfd Tirow Zgzzknd Eo Sml z ojuy Elblag Poland
Egumcrj serafg Slezska Ostrava Czechia
Oqdbyqan Nxgdoqblo Nharrr axmt Nachod Czechia
Mheliwgmay Slebma Bucharest Romania
Mglpmwao Sv z onnd Bydgoszcz Poland
Fnfvkzcf nicmsxxvv Muswq a Hjkxylg Prague Czechia
Abmjqhhgb Uje Amsterdam The Netherlands
Sbp Eefkgqtii Hqrjpkwt Thhhblg Tilburg The Netherlands
Czve Dd Nnhmu Vandoeuvre Les Nancy France
Uoymblzmpqgiavxvliuov Wwpzviqlq Ako Wuerzburg Germany
Wyr Wuklyb Ixt Pczum Ptxnmbmu Kfxeqsw Warsaw Poland
Adazqor Sbdpi Smbzygaww Twcvgbrpqhwz Rxqgaije Rho Italy
Scpzfbwaiisnkhfebcb Bvo Ui (rxflgzcrebsqhsgtumob Halle (Saale) Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
16.09.2020
Belgium Belgium
Not recruiting
16.09.2020
Croatia Croatia
Not recruiting
16.09.2020
Czechia Czechia
Not recruiting
16.09.2020
France France
Not recruiting
16.09.2020
Germany Germany
Not recruiting
16.09.2020
Hungary Hungary
Not recruiting
16.09.2020
Italy Italy
Not recruiting
16.09.2020
Latvia Latvia
Not recruiting
16.09.2020
Lithuania Lithuania
Not recruiting
16.09.2020
Poland Poland
Recruiting
16.09.2020
Romania Romania
Not recruiting
16.09.2020
Slovakia Slovakia
Not recruiting
16.09.2020
The Netherlands The Netherlands
Not recruiting
16.09.2020

Trial locations

Investigated drugs:

Mirikizumab is a medication being studied for its long-term effectiveness and safety in treating patients with Crohn’s disease. It is designed to help reduce inflammation in the intestines, which is a common problem in people with Crohn’s disease. The goal of using Mirikizumab in this trial is to see how well it works over an extended period and to monitor any potential side effects.

Investigated diseases:

Crohn’s Disease – Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of flare-ups and remission, where symptoms can vary in intensity. Common symptoms include abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The exact cause of Crohn’s disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors. The disease can affect any part of the digestive tract, from the mouth to the anus, but most commonly affects the end of the small intestine.

Trial ID:
2022-502841-91-00
Protocol code:
I6T-MC-AMAX
Trial Phase:
Therapeutic confirmatory (Phase III)

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