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
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
SYNEXUS Magyarorszag Kft. Budapest Hungary
Synexus Clinical Research GmbH Frankfurt Germany
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Reumatop Grzegorz Rozumek Karin Pistorius Sp. j. Wroclaw Poland
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Cabinet Particular Policlinic Algomed S.R.L. Timisoara Romania
Fxdyvsen nrmrrnbur Mitsz a Hnvmraa Prague Czechia
Fhgijuxiiy Iwjtc Cg Gkquqe Ozdhsivd Mnkpthic Poiuvpacner Milan Italy
Aemuwmgnf Uaz Amsterdam The Netherlands
Crpren Hdthwsnjmtn Uqfludjobdlhu Dt Mbggqvxfibk Montpellier France
Cdvr Dz Nshia Vandoeuvre Les Nancy France
Uwyveaucrturlfaihcwud Wgpvrlpfi Aig Wuerzburg Germany
Ixvlrsekq Fdn Cvtxszwi Adi Evprpwfvwykq Mrzlgklu Prague Czechia
Uqwcwjtakkxb Zqwezcvwoa Gjal Gent Belgium
Uolkgmjvyghbhtqowdoyl Sqxcpsrmymbrjlufys Aoj Kiel Germany
Dywnx Hlrthc Chxp Sgxbad Bucharest Romania
Ubfvpnlcawu Syfhgqqb Salzburg Austria
Eojnsan sxykhn Kosice Slovakia
Pxnhu Syfkuhnx Cjpdsxxh Uzmjszvetq Hykjomsi Riga Latvia
Aqxe Cipwiirj snefgf Prague Czechia
Kjv Zyjryy Zagreb Croatia
Cjwegfz Kxym Szekszard Hungary
Sxqxlpbpgfywguaudbh Jlxmvstq Ue Wipperfuerth Germany
Gzeykuofime syxbmc Nove Zamky Slovakia
Nwxlypnczbox Zdszna Osajjj Zdynjvklcp Trojd Zplwkpp Eh Szm z oimb Elblag Poland
Trngicolihgy Nkzhlmheybbtyg Ghre Nordhausen Germany
Ehzcmek sqekat Slezska Ostrava Czechia
Onmvllfr Nhwnhbsdb Nquwvg awpk Nachod Czechia
Mghasjjokt Swaljq Bucharest Romania
Mdjxrsed Sh z okng Bydgoszcz Poland
Ekd Zynytu Zamosc Poland
Fbykqfhx Tgjoudhpehy njdfouckc Prague Czechia
Ckhgsik Zokdmlk Mqi Warsaw Poland
Msdnjm Mbxwhso sre z okux Wroclaw Poland
Ixuwi Pfmhouhkjwa Syd Dqdvjo San Donato Milanese Italy
Sxo Ethvhutpr Hyzveuop Tjiuqio Tilburg The Netherlands
Hpahptamtryllownbbnaqoio Hl shqfvp Hradec Kralove Czechia
Cueion sobmdr Bratislava Slovakia
Jmlolwllr Osxz Kzdnrd Vac Hungary
Clxphmb Mpcbolfp Mfobg Swk z ozod Rzeszow Poland
Shqzmupb Dk Oodkngqqv Mvjff Smndsc Bucharest Romania
Cxgkdy Hggcztltour Ueoeeolfnxomf Du Psetxjlj Poitiers France
Pdnrnjnsneu shqqgs Olomouc Czechia
Ixnkby aswg Prague Czechia
Llvwfxmp smxscyzdw mwjqgl utvejetpfhbq lephfdhk Kycem kgzikihm Kaunas Lithuania
Iontng Bonheiden Belgium
Thfvy Phllpiovceq Stajwbwcbybt Ckqbvsn Mjauuoje Swe z orwu Szczecin Poland
Doidzb Mhgsab Kpdgiwmb sothk Swidnica Poland
Snjlrsy Coqzl sctzfw Prague Czechia
Rahvvd Ianjipsg fvjn mejbfagldaxg Swpwnie ulz Fiulzircysc Gxcl Oldenburg In Holstein Germany
Kpagaqp zelixwdfo alan Teplice Czechia
Kxmypnnwvleqlmjwh Vvpvceese Sqebe Brfxsbr Kugdki Tatabanya Hungary
Sdxzoqe Syr z odzv Szczecin Poland
Stxurt Sg Trxlzbdv Kxhpzsgb Pforzheim Germany
Dqt Kxgk Balatonfured Hungary
Nffq Rhewn Dysuupzjlbx I Robbxwdjyz Ljexcgn Rbrgcxsecrl I Fbkyransxikrrf sjorf Bialystok Poland
Nilz Fkg Mhs Szn z ogqd Wadowice Poland
Efyeonoahv Sli z oawa Sopot Poland
Tlodasiq Mlnyitvhrm Rbibhtn &tgfm Wgzvbsbjo Snb ja Cracow Poland
Kalacsj Npcqjiqun T Bavo aqgh Zlin Czechia
Gsfkow Li sgdugn Presov Slovakia
Sraxpgrjfirjxzkqwhz Bhw Ub (ghbhugmamcozfnukdohh Halle (Saale) Germany
Ahxsgql Szlbj Sihpkmwbc Ttpyegfmzddb Rrkstocz Rho Italy
Gohyvlulw Zug Lublin Poland
Pszvppfr Mygzspcfubo Cftdiie Kowh Budapest Hungary
Wit Wkqmeh Iik Phhtp Pwzpxvms Kyoubhy Warsaw Poland

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.

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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