Study of Mirikizumab for Children with Moderate to Severe Crohn’s Disease

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What is this study about?

This clinical trial is focused on studying Crohn’s Disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The study will evaluate a treatment called Mirikizumab, which is a solution for injection. Mirikizumab is being tested to see if it can help children with moderate to severe Crohn’s Disease achieve clinical remission, which means a reduction or disappearance of symptoms, and an endoscopic response, which is an improvement seen during an examination of the digestive tract.

The purpose of the study is to determine if treatment with Mirikizumab is more effective than a placebo in achieving these improvements over a period of 52 weeks. Participants in the study will receive Mirikizumab through injections, and their progress will be monitored to see if there is a clinical response by Week 12 and a clinical remission by Week 52. The study will also look at the endoscopic response by Week 52 to assess the effectiveness of the treatment.

Throughout the study, participants will undergo regular check-ups and assessments to monitor their health and the effects of the treatment. The study aims to provide valuable information on the potential benefits of Mirikizumab for children with Crohn’s Disease, helping to improve treatment options for this challenging condition.

1 joining the study

Upon joining the study, the participant is confirmed to have a diagnosis of Crohn’s Disease (CD) or fistulizing CD with active colitis, ileitis, or ileocolitis. This is verified through clinical, endoscopic, and histologic criteria.

The participant must have moderately to severely active CD, indicated by a baseline Pediatric Crohn’s Disease Activity Index (PCDAI) score greater than 30.

2 screening and baseline assessment

An endoscopy is performed to confirm active CD, defined by a Simple Endoscopic Score for CD (SES-CD) score of 6 or more, or 4 or more for participants with isolated ileal disease.

The participant’s medical history is reviewed to ensure they have experienced inadequate response, loss of response, or intolerance to previous treatments, including immunomodulators, corticosteroids, biologic therapy, or JAK inhibitors.

3 treatment initiation

The participant begins treatment with mirikizumab, administered as a solution for injection.

The initial administration is through intravenous use.

4 ongoing treatment

Following the initial intravenous administration, mirikizumab is administered through subcutaneous use.

The treatment continues with regular monitoring to assess the participant’s response.

5 evaluation at week 12

At week 12, the participant’s clinical response is evaluated using the PCDAI.

The goal is to determine the percentage of participants achieving a clinical response.

6 evaluation at week 52

At week 52, the participant’s endoscopic response is assessed using the SES-CD.

The study aims to evaluate the percentage of participants achieving clinical remission and endoscopic response.

7 completion of study

The study is estimated to conclude by August 4, 2028.

The participant’s overall response to the treatment is documented and analyzed.

Who Can Join the Study?

Participants must have a diagnosis of Crohn’s Disease (CD) or fistulizing CD, which means they have inflammation in the digestive tract, confirmed by medical tests in the past.
Participants must have moderately to severely active CD, which is determined by a specific score called the PCDAI score being greater than 30.
Participants must have had an endoscopy, a procedure where a doctor looks inside the digestive tract, showing active CD with a specific score called SES-CD being 6 or more (or 4 or more for those with disease only in the ileum, a part of the small intestine) during the study screening.
Participants must have a history of using CD medications, including immunomodulators or corticosteroids, and either did not respond well, stopped responding, or could not tolerate these treatments. They may also have used biologic therapy or JAK inhibitors for CD and have a history of not responding well, losing response, or not tolerating these treatments.
Participants can be both male and female.
Participants must be part of a vulnerable population, which means they may need special protection or consideration in the study.

Who Cannot Join the Study?

Participants who have a different condition than Crohn’s Disease cannot join the study.
Participants who are not within the specified age range for the study cannot participate.
Participants who need changes in their current treatment plan or require additional therapies that are not part of the study cannot take part.
Participants who are not able to follow the study procedures or attend required visits cannot be included.
Participants who have other health conditions that might interfere with the study or put them at risk cannot join.
Participants who are pregnant or breastfeeding cannot participate in the study.
Participants who have used certain medications recently that might affect the study results cannot take part.
Participants who have a history of not following medical advice or treatment plans cannot be included.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal
Medical University Of Vienna	Vienna	Austria
Centre Hospitalier Universitaire De Lille	Lille	France
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
Katholieke Universiteit te Leuven	Leuven	Belgium
Oslo Universitetssykehus HF	Oslo	Norway
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Hopital Beaujon	Clichy	France
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Instytut Pomnik Centrum Zdrowia Dziecka	Warsaw	Poland
Cdekawhbv Unhrondejnmrcl Slfjhbfts	Woluwe-Saint-Lambert	Belgium
Uvfljttvbvooiitwtvmnt Njzkdpboif Hb	Tromsø	Norway
Acgzdeow Ubvcxdvwih Hnwssjih	Lorenskog	Norway
Evrmfym Unygdvwybocu Mjcbhhi Coqfxya Regficfcn (axntxzs Mba	Rotterdam	The Netherlands
Cwgcua Htczzvkycuf Udugiboqldzbn Abttca Pexoxqvn	Amiens	France
Apkehih Osnplzewabk Pwyv Gwavkanj Xsydh	Bergamo	Italy
Uyixsmefom Djluc Srnpc Di Rmha Lz Suoaokxn	Rome	Italy
Uufvhzyygoja Zxymjizpuy Goka	Gent	Belgium
Vskrl Uyialcmlaifz Boeopad	Jette	Belgium
Cgnm Cagvsn Cakgxpe Antbzmenf Bzoxj Aqdaonglph	Braga	Portugal
Obfmehqi Pfclwgzszd Boodndw Gsctrqujuxf	Rome	Italy
Pffn Ttvbw Hiuhuysy Ubzrnrnqnmuy	Sabadell	Spain
Adfpkxe Oyzhszlbuds Nroverzdc Sw Awlapwn E Bpcpqh E C Avrgyl Acvrjjyyvhd	Alexandria	Italy
Anye Fsgkufzcxlvzvgkm Slzzb	Milan	Italy
Anrlmmc Ocynjclrqar Usqexovpgkevn Merrd Imgdf	Florence	Italy
Stj Osktd Hayjqlod Hd	Trondheim	Norway
Chsgvsp Miegozjr Ojeabw	Wroclaw	Poland
Mp Kfjqrpfekm Bioufxx Gfjddfv Lwtdgfhn	Rzeszow	Poland
Wfx Wthhyv Itb Pfauc Pothlcld Klchpin	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	12.02.2024
Belgium	Recruiting	12.02.2024
France	Not recruiting	12.02.2024
Italy	Recruiting	12.02.2024
Norway	Recruiting	12.02.2024
Poland	Recruiting	12.02.2024
Portugal	Recruiting	12.02.2024
Spain	Recruiting	12.02.2024
The Netherlands	Recruiting	12.02.2024

Trial locations

Investigated Drugs:

Mirikizumab

Mirikizumab is a medication being studied for its potential to help children with Crohn’s disease. It works by targeting a specific part of the immune system called IL-23, which is involved in inflammation. The goal of using Mirikizumab in this trial is to see if it can help reduce the symptoms of Crohn’s disease and improve the condition of the intestines over time.

Investigated Diseases:

Crohn's disease

Crohn’s Disease – Crohn’s Disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of active disease, known as flare-ups, and periods of remission. Symptoms often include abdominal pain, diarrhea, weight loss, and fatigue. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The exact cause of Crohn’s Disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors. The disease can vary greatly in severity and may affect different parts of the digestive tract in different individuals.

Trial ID:

2024-511472-32-00

Protocol code:

I6T-MC-AMAY

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Mirikizumab for Children with Moderate to Severe Crohn’s Disease

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