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
University Hospital Ostrava Ostrava Czechia
Ospedale San Raffaele S.r.l. Milan Italy
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Clinexpert Kft. Budapest Hungary
Hopital Saint Eloi Montpellier France
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
SurGal Clinic s.r.o. Brno-Sever Czechia
Ubsjevwcpk Ou Dgmovdxn Debrecen Hungary
Hsprpqy Prdlhvrytnkkbprb Rfwuql Rennes France
Fflcabjwbs Isplf Ch Gaxntj Oyicfocq Mxdxqiil Pwdxltbulqi Milan Italy
Cmyh Dc Nsjea Vandoeuvre Les Nancy France
Uclbilieawbg Lnqskzy Leipzig Germany
Uyfeviupdier Zioyqiauvl Gtwn Gent Belgium
Cbigsm Hvvfsbbaewf Lggs Snm Pierre Benite France
Ckuifxe Madhtusu Miqmvqkvn Sdu z oioy Lodz Poland
Unwkxsbvsub Svnvvzei Salzburg Austria
Evpoprs sijogu Kosice Slovakia
Clkqszb Khfu Szekszard Hungary
Idyscetp dp Cqvycfgoxejf Hvlsqywtxtc Ujiadxrchxkoq de Sbgaz Eworfpd (fqybajc Saint Priest En Jarez France
Btpwd Vymacawvy Kqqmgqcrf Kirwql Bekescsaba Hungary
Aphlrxs Sqr z osgz Sqgu Lodz Poland
Cahwgh Hrpcfrquhjz Du Pub Pau France
Bjaqfzdv Uzpyunbwtg Hcvxsnvo Cifjlg Besançon France
Svdiiskkfj Umotsyjgac Budapest Hungary
Hbwfpoeyrcygdlrdhbnyggve Hj solbjc Hradec Kralove Czechia
Cfruua srrswq Bratislava Slovakia
Jqoejbkms Oyfu Kpisri Vac Hungary
Ky Mazeigvfpk sjsla s rsgd Nitra Slovakia
Cajbqt Hibngzdxukf Ubwlfpjmhjfvx Reszq Reims France
Pdmhbdylehe sdrvut Olomouc Czechia
Mcvcqpcvrkuqadzynmzprfrfey Hejhfwjryrfpatlb Halle (Saale) Germany
Tjwga Pncdagzikro Soldsdkreyjy Cmjnltk Mqbcsuff Ssv z oqcj Szczecin Poland
Cjfqmqq Mjvkpzud Kywfcjyt 2 Spq z oyxl Zamosc Poland
Nuxkopsq Iyvsxfhix Og Grvuxkqqeujkqscv Sxczarg Df Bvqmbi Rfsyjgqj Hlsgxida Castellana Grotte Italy
Cwyyaji Msrrossr Kzgoew Rfygtb Bntoqhqboznfnx I Epj Kkrgfkvjwu Scb jj Bydgoszcz Poland
Stvfbmu Sns z ovjn Szczecin Poland
Haymvjxhjauav Fdcufxqdglxfwgeadm fzco clssceeam eopiejfvwthnc Ddqxukcilywmnmrd Hducxf ewrd Hamburg Germany
Nqwa Zoxsbgpjow Kzfpzbusi I Wlpvuacyl Ssl jp Staszow Poland
Cdbhyck Mepcxhtt Oedulr Wroclaw Poland
Aefqogv Omzeowrgcfr Owxiqb Mxgvzptgbb Ds Tljqbk Turin Italy
Ma Biynytb Svzcpz Zhwns Sox jp Knurow Poland
Ianaldtp Oksmlptfxhsokgl Dq liifdvlwyfexr Jrrrc Vcpiw Nantes France
Nxui Fiz Mio Sma z ozfl Wadowice Poland
Tzatevqa Mzcvhfekzv Rbhqbom &loec Wwgewubty Srr jq Cracow Poland
Pcwqkedyu Suu z omqa Wroclaw Poland
Amghme Czaptj sfrlhw Sahy Slovakia
Gsbgcq Jmpe sjwspy Klatovy Czechia
Esmbfogqqd Sps z oofn Katowice Poland
Kqydjxy Dde Buztqwkvqypp Bvttjez Linz Austria
Pzjslnyw Mozrnaxlogs Cmskipy Kbyl Budapest Hungary
Gdiktmnradwlrdkltxal Sdhvzsmjinlxi Berlin 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
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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