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

3 1 1

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

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Azienda Sanitaria Locale Roma 2 Rome Italy
PreventaMed s.r.o. Olomouc Czechia
Iscare a.s. Prague Czechia
Centre Hospitalier Lyon Sud Pierre Benite France
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Hospital De Sagunto Sagunto Spain
Sonomed Sp. z o.o. Szczecin Poland
Eb Group Sp. z o.o. Warsaw Poland
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Hospital Universitario De Fuenlabrada Fuenlabrada Spain
Szpital Miejski Sw. Jana Pawla II W Elblagu Elblag Poland
Nzoz For Med Sp. z o.o. Wadowice Poland
Pelican Impex S.R.L. Oradea Romania
Endoskopia Sp. z o.o. Sopot Poland
Planetmed Sp. z o.o. Wroclaw Poland
centre Hospitalier de Wallonie Picarde Tournai Belgium
Wojewodzki Szpital Specjalistyczny W Olsztynie Olsztyn Poland
Policlinica CCBR S.R.L. Bucharest Romania
Endomed s.r.o. Kosice Slovakia
Eszak-Budai Szent Janos Centrumkorhaz Budapest Hungary
Spitalul Clinic Colentina Bucuresti Bucharest Romania
A-Shine s.r.o. Plzen Czechia
Clinfan Kft. Szekszard Hungary
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Semmelweis University Budapest Hungary
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
IRCCS Ospedale Policlinico San Martino Genoa Italy
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Hepato-Gastroenterologie HK s.r.o. Hradec Kralove Czechia
Centre Hospitalier Universitaire De Nice Nice France
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Cliniq s.r.o. Bratislava Slovakia
Javorszky Odon Korhaz Vac Hungary
Gastromed Sp. z o.o. Torun Poland
KM Management spol. s r.o. Nitra Slovakia
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Medico Chirurgical Ambroise Pare Hartmann Neuilly-Sur-Seine France
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Topolowa Medicenter Ryszawa & Wspolnicy Sp. j. Cracow Poland
University Of Szeged Szeged Hungary
Region Sjaelland Holbæk Denmark
Hopital Saint Eloi Montpellier France
Centre Hospitalier De Pau Pau France
Uniklinikum Salzburg Salzburg Austria
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Economicus Sp. z o.o. Katowice Poland
Azienda Ospedaliera Universitaria Mater Domini Catanzaro Italy
Gastromed ZOZ Lublin Poland
NZOZ Medica Warsaw Poland
Endomedix Kft. Budapest Hungary
Hrkfavjt Ukblhmklmwovt Mymqwgm Dx Vgkquewbjd Santander Spain
Goghdne Eikxqyacdr Pvtnlqdh Pkvcmffhedh Cracow Poland
Ciopgev Mososgbf Lpt Mdu Rzeszow Poland
Knlerxucg Mvyxhk phlwwdxahud Klaipeda Lithuania
Mepdyujxmi Sefmpd Bucharest Romania
Pdsoqbr Mabopr Sph z Olly Eip Pcaxhivlg Poniatowa Poland
Musigvja Sj z ohpx Bydgoszcz Poland
Hejksd Htnnkqya Herlev Denmark
Apastqgfwf Pxqnceuw Hnfpbdyj Db Pezco Paris France
Clabkd Hfnjfqcnbmi Rvxufxds Uaijbuniptmol Dx Tplnu Tours France
Spv Eulysvuye Hmedifvg Todnhwn Tilburg The Netherlands
Aoyryihvp Uyo Amsterdam The Netherlands
Goygyodtnnsvtvqhj Vyxarqiyf Pgty Aqlytt Egsxrbmh Oayjph Kkcgab Gyor Hungary
Fzaegbamx Plql Lg Ijckmvqubzlhh Bsoyrrxqy Dls Hkiymjmp Unvkzbrshexkf Lw Paa Madrid Spain
Ixhatoyd dc Chenpglxqbxo Hcqfdybyvmp Uzlheoiylwkhl da Sxult Egpovvs (blekrhr Saint Priest En Jarez France
Aiaenwv Sutyv Shnyldoss Trgugshyuvuw Rsfzgzfw Rho 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

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.

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)

Other Trials to Consider

  • A study to evaluate the safety and effectiveness of MB-001 in adults with moderate to severe ulcerative colitis

    Recruiting

    1 1
    Investigated drugs:
    Poland
  • Study of mirikizumab and tirzepatide in adults with moderate to severe ulcerative colitis who are overweight or obese

    Recruiting

    3 1
    Austria Belgium Bulgaria Czechia Denmark France +9