Study on Bowel Urgency in Adults with Moderate to Severe Ulcerative Colitis Treated with Mirikizumab

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What is this study about?

This clinical trial is focused on studying ulcerative colitis, a condition that causes inflammation and sores in the digestive tract, specifically affecting the colon and rectum. The study is investigating the effects of a treatment called Mirikizumab, which is administered as a solution for injection. Mirikizumab is a type of protein-based medication developed by Eli Lilly and Company.

The purpose of the study is to assess how well Mirikizumab can improve the severity of bowel urgency, which is a common and distressing symptom for people with moderately to severely active ulcerative colitis. Participants in the study will receive Mirikizumab and will be monitored over a period of 12 weeks to observe any changes in their symptoms.

This study is designed to provide valuable insights into the relationship between bowel urgency and other health outcomes in adults with ulcerative colitis. By the end of the study, researchers aim to better understand how Mirikizumab can help manage this condition and improve the quality of life for those affected.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. This study aims to investigate the improvement in bowel urgency in adults with moderately to severely active ulcerative colitis using mirikizumab.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying your diagnosis of ulcerative colitis and ensuring you meet the criteria for participation.

3 treatment administration

You will receive mirikizumab as a solution for injection. The dosage and frequency will be explained to you by the medical team. The treatment will continue for a specified duration, with regular monitoring.

4 regular monitoring

Throughout the study, you will have regular check-ups to monitor your condition and any changes in bowel urgency. These assessments will help track your progress and any side effects.

5 final assessment

At the end of the study period, a final assessment will be conducted to evaluate the change in bowel urgency severity. This will help determine the effectiveness of the treatment.

Who Can Join the Study?

  • Have an established diagnosis of Ulcerative Colitis (UC) for at least 3 months.
  • Have a confirmed diagnosis of moderately to severely active Ulcerative Colitis.
  • Have current bowel urgency (a strong need to have a bowel movement).
  • Have shown an inadequate response to, a loss of response to, or an intolerance to conventional treatments or to biologic/Janus Kinase (JAK) inhibitor/sphingosine-1-phosphate (S1P) receptor modulator therapy for Ulcerative Colitis.
  • Be within the age range of 18 to 65 years old.
  • Both male and female participants are eligible.

Who Cannot Join the Study?

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had recent surgery related to the digestive system.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of not following medical advice or treatment plans.
  • Patients with a known allergy to the study medication or its ingredients.
  • Patients with a history of alcohol or drug abuse.
  • Patients who have been diagnosed with certain infections that could affect the study.
  • Patients who have received certain treatments that could interfere with the study results.
  • Patients with a history of certain types of cancer.

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
Bekes Varmegyei Koezponti Korhaz Bekescsaba Hungary
Amicare Sp. z o.o. S.K. Lodz Poland
Ospedale San Raffaele S.r.l. Milan Italy
Centre Hospitalier Universitaire De Nice Nice France
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Cliniq s.r.o. Bratislava Slovakia
Javorszky Odon Korhaz Vac Hungary
KM Management spol. s r.o. Nitra Slovakia
Semmelweis University Budapest Hungary
University Of Debrecen Debrecen Hungary
Clinexpert Kft. Budapest Hungary
Clinfan Kft. Szekszard Hungary
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Hepato-Gastroenterologie HK s.r.o. Hradec Kralove Czechia
Centre Hospitalier Universitaire De Nantes Nantes France
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
PreventaMed s.r.o. Olomouc Czechia
Universitair Ziekenhuis Gent Gent Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Centrum Medyczne Kuba-Med 2 Sp. z o.o. Zamosc Poland
National Institute Of Gastroenterology Saverio De Bellis Research Hospital Castellana Grotte Italy
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j. Bydgoszcz Poland
Sonomed Sp. z o.o. Szczecin Poland
Hamburgisches Forschungsinstitut fuer chronisch entzuendliche Darmerkrankungen HaFCED e.K. Hamburg Germany
Nowe Zdrowie-Ck Kieltucki I Wspolnicy Sp. j. Staszow Poland
Centrum Medyczne Oporow Wroclaw Poland
Centrum Medyczne Med-Gastr Sp. z o.o. Lodz Poland
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Mz Badania Slowik Zymla Sp. j. Knurow Poland
Nzoz For Med Sp. z o.o. Wadowice Poland
Topolowa Medicenter Ryszawa & Wspolnicy Sp. j. Cracow Poland
Planetmed Sp. z o.o. Wroclaw Poland
SurGal Clinic s.r.o. Brno-Sever Czechia
Accout Center s.r.o. Sahy Slovakia
Endomed s.r.o. Kosice Slovakia
Hopital Saint Eloi Montpellier France
University Hospital Ostrava Ostrava Czechia
Centre Hospitalier De Pau Pau France
Hôpital Pontchaillou-CHU Rennes Rennes France
Uniklinikum Salzburg Salzburg Austria
Clinique Jules Verne Nantes France
Pannonia Maganorvosi Centrum Kft. Budapest Hungary
Gastro Jeka s.r.o. Klatovy Czechia
Economicus Sp. z o.o. Katowice Poland
Gastroenterologische Spezialpraxis Berlin Germany
Cpxv Dd Nojbz Vandoeuvre Les Nancy France
Btxpdwbe Ulmghprvmb Hzoevjaq Cnbybf Besançon France
Cywxat Hiwohjezuwi Ubawabfvkyhfg Rwbgn Reims France
Mftqzpjanclaascqahydrbnsyi Htwolyfhizkimdwx Halle (Saale) Germany
Iwdhahni dv Cfhdronrckve Huqntjdrvxo Uuljqhiqalexx dc Sirwl Ekflsnj (vizpnsl Saint Priest En Jarez France
Komzuhs Dyr Btfbbxfbzcce Btwomww Linz Austria

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
30.07.2023
Belgium Belgium
Not recruiting
30.07.2023
Czechia Czechia
Not recruiting
30.07.2023
France France
Not recruiting
30.07.2023
Germany Germany
Not recruiting
30.07.2023
Hungary Hungary
Not recruiting
30.07.2023
Italy Italy
Not recruiting
30.07.2023
Poland Poland
Not recruiting
30.07.2023
Slovakia Slovakia
Not recruiting
30.07.2023

Trial locations

Investigated drugs:

Mirikizumab is a medication being studied for its effects on ulcerative colitis, which is a condition that causes inflammation and sores in the colon and rectum. This medication works by targeting a specific protein in the body that is involved in the inflammatory process. By blocking this protein, Mirikizumab aims to reduce inflammation and help improve symptoms such as bowel urgency, which is a sudden and strong need to have a bowel movement. The goal of using Mirikizumab in this trial is to see if it can help people with moderately to severely active ulcerative colitis feel better by reducing the severity of their symptoms.

Investigated diseases:

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon, also known as the large intestine. It is characterized by inflammation and ulceration of the innermost lining of the colon, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease typically begins in the rectum and may extend continuously to involve the entire colon. The inflammation causes the colon to empty frequently, resulting in urgent bowel movements. Over time, the persistent inflammation can lead to the formation of ulcers, which are small open sores that can bleed and produce pus. The severity of symptoms can vary, with periods of active disease followed by times of remission.

Trial ID:
2022-502393-16-00
Protocol code:
I6T-MC-AMBZ
NCT ID:
NCT05767021
Trial Phase:
Therapeutic confirmatory (Phase III)

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