Study of Mirikizumab for Children and Teens with Moderate-to-Severe Ulcerative Colitis or Crohn’s Disease

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Mirikizumab on children and adolescents who have either Ulcerative Colitis or Crohn’s Disease. These are types of Inflammatory Bowel Diseases, which cause inflammation in the digestive tract, leading to symptoms like abdominal pain, diarrhea, and fatigue. The medication being tested, Mirikizumab, is given as a solution for injection and is being evaluated for its long-term safety and effectiveness in managing these conditions.

The purpose of the study is to assess how well Mirikizumab works in treating these diseases over an extended period. Participants in the study will receive the medication and be monitored to see how their symptoms change over time. The study will look at whether the medication helps achieve clinical remission, which means a significant reduction or disappearance of symptoms, in participants with either Ulcerative Colitis or Crohn’s Disease.

Throughout the study, participants will receive regular injections of Mirikizumab and will have follow-up visits to track their progress. The study aims to provide valuable information on the long-term use of Mirikizumab in young patients with these chronic conditions, helping to determine its potential benefits and any side effects that may occur during treatment.

1 joining the study

Upon joining the study, participation is confirmed if the individual has completed assessments and procedures from previous related studies and continues to receive the study medication.

Female participants must adhere to specific contraception requirements during the study period.

2 treatment with mirikizumab

The treatment involves the administration of mirikizumab, which is provided as a solution for injection or infusion.

The medication is intended for children and adolescents with moderate-to-severe ulcerative colitis or Crohn’s disease.

3 monitoring and evaluation

The primary goal is to evaluate the effectiveness of mirikizumab in achieving clinical remission in participants with ulcerative colitis or Crohn’s disease.

For ulcerative colitis, the Modified Mayo Score (MMS) is used to assess clinical remission at Week 52.

For Crohn’s disease, the Pediatric Crohn’s Disease Activity Index (PCDAI) is used to assess clinical remission at Week 52.

4 long-term extension

The study is designed as a long-term extension to evaluate the ongoing safety and effectiveness of mirikizumab over an extended period.

The estimated end date for the study is July 30, 2030.

Who Can Join the Study?

  • The study is for children with certain conditions like Ulcerative Colitis and Crohn’s Disease, which are types of Inflammatory Bowel Diseases. These are conditions that cause swelling and irritation in the digestive tract.
  • Participants must have been part of previous related studies and, in the opinion of the study doctor, would benefit from continuing treatment with the study medication, mirikizumab.
  • Participants must have completed all necessary check-ups and procedures in the previous study and still be taking the study medication.
  • Female participants must agree to follow specific birth control guidelines during the study.
  • The study is open to both boys and girls.
  • The study includes children who are considered a vulnerable group, meaning they may need extra protection or care.

Who Cannot Join the Study?

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
Instytut Pomnik Centrum Zdrowia Dziecka Warsaw Poland
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
Universitair Ziekenhuis Gent Gent Belgium
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Centrum Medyczne Oporow Wroclaw Poland
Hospital Universitario Reina Sofía Cordoba Spain
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Hopital Beaujon Clichy France
Vrije Universiteit Brussel Jette Belgium
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Universitetssykehuset Nord-Norge HF Tromsø Norway
St. Olavs Hospital HF Trondheim Norway
MD Korczowski Bartosz Gabinet Lekarski Rzeszow Poland
ASST FBF-Sacco Ospedale dei Bambini “V.Buzzi” Milan Italy
Ccknrgmfh Uloopphlxajhlz Saceplpmb Woluwe-Saint-Lambert Belgium
Pmca Tmsem Hknyigrk Utyxyqwdttbc Sabadell Spain
Efacnsw Utvxhlmtieqv Mjsmfdh Cevyodz Rbiopquvl (lnrdktx Myn Rotterdam The Netherlands
Kfneuocp duy Usgddvrfkijr Mcgjccsp Axp Munich Germany
Undupoeskz Oq Aevjvom Edegem Belgium
Algvauu Ooddfgblars Pgfb Gxnleobu Xqwyv Bergamo Italy
Upkjdrfcmo Dhbju Swzrc Dj Rwos Lg Sqeondjd Rome Italy
Aodutgsd Uwkapnehmc Hgcehkok Lorenskog Norway
Wfs Wxbnez Ibs Pjvqg Pwpkrina Kzoowdy 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 yet recruiting
01.01.2025
Belgium Belgium
Recruiting
01.01.2025
France France
Not yet recruiting
01.01.2025
Germany Germany
Recruiting
01.01.2025
Italy Italy
Recruiting
01.01.2025
Norway Norway
Not yet recruiting
01.01.2025
Poland Poland
Recruiting
01.01.2025
Portugal Portugal
Recruiting
01.01.2025
Spain Spain
Recruiting
01.01.2025
The Netherlands The Netherlands
Not yet recruiting
01.01.2025

Trial locations

Investigated drugs:

Mirikizumab is a medication being studied for its effectiveness in treating children and adolescents with moderate-to-severe ulcerative colitis or Crohn’s disease. This trial aims to understand how well mirikizumab works over a long period and to ensure it is safe for young patients with these conditions.

Ulcerative Colitis Chronic – A long-term condition affecting the colon, characterized by inflammation and ulcers on the inner lining of the large intestine. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of flare-ups and remission. Over time, the inflammation can lead to complications such as narrowing of the colon or increased risk of colon cancer.

Inflammatory Bowel Diseases – A group of disorders that cause chronic inflammation in the digestive tract. The two main types are Crohn’s disease and ulcerative colitis. Symptoms can include persistent diarrhea, abdominal pain, and weight loss. The inflammation can affect different parts of the digestive tract, leading to various complications over time.

Crohn’s Disease – A chronic inflammatory condition that can affect any part of the gastrointestinal tract, from the mouth to the anus. It often causes abdominal pain, severe diarrhea, fatigue, and malnutrition. The inflammation can spread deep into the layers of affected bowel tissue. The disease can lead to complications such as strictures or fistulas.

Ulcerative Colitis – A chronic inflammatory condition specifically affecting the colon and rectum. It is characterized by continuous inflammation of the colon lining, leading to ulcers. Symptoms include frequent diarrhea, abdominal pain, and rectal bleeding. The disease progresses with alternating periods of active symptoms and remission.

Trial ID:
2023-506239-14-00
Protocol code:
I6T-MC-AMAZ
NCT ID:
NCT04844606
Trial Phase:
Therapeutic confirmatory (Phase III)

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