Study on Long-Term Effects of Mirikizumab for Patients with Moderate to Severe Ulcerative Colitis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called mirikizumab in patients with ulcerative colitis. Ulcerative colitis is a chronic condition that causes inflammation and sores in the lining of the large intestine, leading to symptoms like abdominal pain and diarrhea. The treatment being tested, mirikizumab, is a type of medication known as a monoclonal antibody. It works by targeting a specific part of the immune system to help reduce inflammation.

The purpose of this study is to determine if long-term treatment with mirikizumab can help manage symptoms in patients with moderately to severely active ulcerative colitis. Participants in this study will receive mirikizumab as a solution for injection. The study will monitor the participants over time to assess the medication’s effectiveness and safety. This includes observing how many participants achieve clinical remission, which means a significant reduction or disappearance of symptoms.

Throughout the study, researchers will also look at other factors, such as the percentage of participants who achieve endoscopic remission, which is a reduction in visible inflammation during a medical examination of the colon. Additionally, the study will track the number of hospitalizations and surgeries related to ulcerative colitis, as well as changes in quality of life scores. The study aims to provide valuable information on the long-term benefits and safety of mirikizumab for individuals living with ulcerative colitis.

1 joining the study

Participation begins after joining the study, which is an extension of previous studies AMAC or AMBG. Participants must have received at least one dose of the study drug in these prior studies and not have discontinued early.

2 medication administration

The study involves the administration of mirikizumab, a solution for injection. This medication is intended to evaluate its long-term effectiveness and safety in treating moderately to severely active ulcerative colitis.

3 treatment duration

The study is designed to continue until July 15, 2025, allowing for long-term observation of the medication’s effects.

4 monitoring and assessments

Participants will be monitored for clinical remission, which is assessed using the modified Mayo Score (MMS).

Secondary assessments include endoscopic remission based on the Mayo Endoscopic Score (ES), hospitalization rates due to ulcerative colitis, surgeries related to ulcerative colitis, and quality of life scores measured by the IBDQ.

Who Can Join the Study?

  • Participants must have been part of a previous study called AMAC or AMBG and received at least one dose of the study medication without stopping the medication early.
  • Female participants must agree to use birth control methods as required by the study.
  • Both male and female participants are eligible to join the study.
  • The study includes individuals from certain age groups, specifically adults and older adults.
  • The study may include individuals who are considered part of a vulnerable population, meaning they might need extra care or protection.

Who Cannot Join the Study?

  • Patients who have a history of severe allergic reactions to the study medication or similar medications.
  • Patients who have other serious health conditions that might interfere with the study, such as certain heart, liver, or kidney diseases.
  • Patients who are currently participating in another clinical trial or have recently participated in one.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have an active infection that requires treatment.
  • Patients who have been diagnosed with certain types of cancer.
  • Patients who have received certain treatments that might affect the study results, such as other investigational drugs.
  • Patients who have a condition called immunodeficiency, which means their immune system is not working properly.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.

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
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland
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F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Nice Nice France
A-Shine s.r.o. Plzen Czechia
Hopital Saint Eloi Montpellier France
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Hospital Universitario De Fuenlabrada Fuenlabrada Spain
Rywzsi Smbrqafrt Holbæk Denmark
Hxdvpl Hehkzwyl Herlev Denmark
Uwdftwqphsib Mqteiab Cjrkivx Ulhswby Utrecht The Netherlands
Ceoogu Hudiudpeibf Rtxvznam Uslodhpfxvrxg Do Tolqq Tours France
Fcexncum Nlvcpnlxg Kryjaswqi Vgvzhkdwl Prague Czechia
Ivyvr Oyuujjrv Pumnhfgspds Ssd Mgkyzah Genoa Italy
Ueqhbaponw Op Sdzrry Szeged Hungary
Cfmbyx Hnnyugzvsyw Umlqrnflzteib Anstjk Pktxopji Amiens France
Cdusjn Hapjvsilkjl Lmps Syg Pierre Benite France
Hziyabfi Ueflmktetdhrg Mvjcwjy Dt Vuvsrvgicu Santander Spain
Fefezscdo Pzng Lu Iietvanuwztlo Bwailkdyu Diz Hsscdkqj Ujnqpitvkdylb Lz Pdd Madrid Spain
Uhrczbkjenz Stmrbadn Salzburg Austria
Ahlqkjc Oxdyaaawqql Uerzcmwvvhinw Pqtxim Pisa Italy
Egmqiqr sclejb Kosice Slovakia
Phifl Slymxusr Coemcosv Usjwzgzkyc Hndvztdh Riga Latvia
Evukhtmgbze Smsye Jppiz Cfzwpuhgacqxg Budapest Hungary
Szvuyrln Cghzbv Cfbigbebh Byakkndjf Bucharest Romania
Cehaivy Kdxo Szekszard Hungary
Pizuwxu Msqbed Sur z Oubz Efl Pfqjopfog Poniatowa Poland
Agxzeug Sezfottqg Lqyjbe Rkod 2 Rome Italy
Gjapmfh Ehjfwzrmxp Pvrtxtvw Pcvyiakbwoc Cracow Poland
Igtjqgmr du Czgfodtlettq Hklbgxiyaks Unpsihdgymqlf di Sgohu Etkfotq (lrhbytu Saint Priest En Jarez France
Kilimdqhq Mortpf pisbuvqupio Klaipeda Lithuania
Cctxwsa Mpeiosgq Lwu Mmf Rzeszow Poland
Mwbspaajkf Sgnidv Bucharest Romania
Mrrmwwxc Sj z oarn Bydgoszcz Poland
Euqkfqtii Krwy Budapest Hungary
Ctcbxw Hwhqbmrzwzi Dx Pul Pau France
Atqunrftoe Prngtcfs Hvajuzdb Dl Pmxlr Paris France
Sek Eronyrddu Hieqdyyf Taskjye Tilburg The Netherlands
Fwzlmako Naqyhpydb U Sf Awvj V Bbzu Brno-Stred Czechia
Aqnxdowmx Uug Amsterdam The Netherlands
Gfxlnxwhaavzrftmr Vjwrdwday Pkmr Aekucf Etmskjlr Ocvsgx Kwoxtc Gyor Hungary
Hszdmhxasuszdiubkcqtgkmj Hi stmvnp Hradec Kralove Czechia
Cgessq smvkrb Bratislava Slovakia
Jsdruoevv Orps Kiwwla Vac Hungary
Gfloztnac Sja z oicn Torun Poland
Kg Mpfkveoose slatd s rzdh Nitra Slovakia
Czgiev Mkmtib Cwvixddtrgu Aljdgmsc Pfbe Hoqewrda Neuilly-Sur-Seine France
Slovlajz Db Otsihbbmi Mjszt Svhydl Bucharest Romania
Plrpwkyrqag skgqsq Olomouc Czechia
Ivbaig arhu Prague Czechia
Letojvrn suewwhsdd mnezbe uymnkyfzukhe lmhibwql Ktbqk klfuosam Kaunas Lithuania
Tkdry Puvjsoyywzw Sqzwuzlvecee Coxxzmf Mblgsaqt Smb z otdb Szczecin Poland
cjwayw Hwvcgublecu du Wyedbweo Pfiowxq Tournai Belgium
Hwgqkbjk Dc Sofuysa Sagunto Spain
Suxboqn Sal z oykg Szczecin Poland
Pqkmryrodcp Cbgz Sauset Bucharest Romania
Eo Gmzbz Sri z obxq Warsaw Poland
Ew Hzyiwniv Uuwlflaanqmww Dz Gwsw Cqhqrzz Dig Nosvox Las Palmas De Gran Canaria Spain
Ajjcwah Ozvcukpovou Opdbsh Mkulksdccu Dq Tsrrym Turin Italy
Sdsgssj Mriolky Snb Jcaw Pizsu Io W Exlraew Elblag Poland
Nwmr Fcy Mhx Sry z ojly Wadowice Poland
Pslpdql Iaqru Sdejog Oradea Romania
Esisoruqzb Snm z oycz Sopot Poland
Ttzsijsg Msujaetapx Rnsgzba &iefa Wrzpxfixm Swi jf Cracow Poland
Pcjtibgcp Sed z ogbb Wroclaw Poland
Wjgmgtyucx Svwltyt Ssnyqwivysuhxtr W Oedycxcgq Olsztyn Poland
Eocouxjafe Sqx z obig Katowice Poland
Axhgsuz Sdgdv Sdxsubnqw Tvtoxnskcesz Rmpdxexg Rho Italy
Gajaiklqu Zls Lublin Poland
Nryv Mkuane Warsaw Poland
Aoyhfxe Ofmtvlatnsx Uneqwfgbplivb Mdjhx Detvox Catanzaro Italy

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
04.10.2018
Belgium Belgium
Not recruiting
04.10.2018
Czechia Czechia
Not recruiting
04.10.2018
Denmark Denmark
Not recruiting
04.10.2018
France France
Not recruiting
04.10.2018
Hungary Hungary
Not recruiting
04.10.2018
Italy Italy
Not recruiting
04.10.2018
Latvia Latvia
Not recruiting
04.10.2018
Lithuania Lithuania
Not recruiting
04.10.2018
Poland Poland
Not recruiting
04.10.2018
Romania Romania
Not recruiting
04.10.2018
Slovakia Slovakia
Not recruiting
04.10.2018
Spain Spain
Not recruiting
04.10.2018
The Netherlands The Netherlands
Not recruiting
04.10.2018

Trial locations

Investigated Drugs:

Mirikizumab is a medication being studied for its potential to help patients with ulcerative colitis, a condition that causes inflammation and sores in the digestive tract. This study aims to evaluate the long-term effectiveness and safety of mirikizumab in treating patients with moderately to severely active ulcerative colitis.

Investigated Diseases:

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of exacerbation and remission. Over time, the inflammation can lead to complications such as strictures or increased risk of colon cancer. The exact cause is unknown, but it is believed to involve an abnormal immune response in the gut.

Trial ID:
2023-507657-15-00
Protocol code:
I6T-MC-AMAP
NCT ID:
NCT03519945
Trial Phase:
Therapeutic confirmatory (Phase III)

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