Study on Mirikizumab for Children and Teens with Moderate to Severe Ulcerative Colitis

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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 colon and rectum. The study is specifically for children and teenagers aged 2 to less than 18 years who have moderately to severely active ulcerative colitis. The treatment being tested is called mirikizumab, which is also known by its code name LY-3074828. Mirikizumab is available in two forms for this study: a 100 mg solution for injection in a pre-filled syringe and a 300 mg concentrate for solution for infusion. The purpose of the study is to evaluate how effective and safe mirikizumab is for treating ulcerative colitis in young patients.

Participants in the study will receive either mirikizumab or a placebo. The study will observe the participants over a period of time to see if their condition improves. The main goal is to see if mirikizumab can help achieve clinical remission, which means reducing the symptoms of ulcerative colitis, by the end of the study period. The study will also look at how the body processes the medication and monitor any side effects that may occur.

The study is designed to last until 2026, with the recruitment of participants expected to start in December 2023. During the study, participants will receive regular check-ups and assessments to track their progress and ensure their safety. The results of this study will help determine if mirikizumab is a beneficial treatment option for young people with ulcerative colitis.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes reviewing medical history and current health status.

Participants must be between 2 and less than 18 years old, weigh more than 10 kg, and have moderately to severely active ulcerative colitis.

2 treatment initiation

The treatment begins with the administration of mirikizumab. This medication is provided in two forms: a 100 mg solution for injection in a pre-filled syringe and a 300 mg concentrate for solution for infusion.

The initial dose is given through an intravenous infusion, which means the medication is delivered directly into a vein.

3 subsequent doses

Following the initial infusion, subsequent doses of mirikizumab are administered as a subcutaneous injection, which means the medication is injected under the skin.

The frequency and dosage of these injections will be determined by the study protocol and communicated by the healthcare team.

4 regular monitoring

Throughout the study, regular monitoring will be conducted to assess the effectiveness and safety of the treatment.

This includes scheduled visits for health evaluations, blood tests, and other necessary assessments.

5 evaluation at week 12

At week 12, an evaluation will be performed to determine the response to the treatment.

Participants who show a clinical response will continue with the treatment regimen.

6 final assessment

The study concludes with a final assessment at week 52 to evaluate the overall effectiveness of the treatment.

The primary goal is to achieve clinical remission, which means a significant reduction or disappearance of symptoms.

Who Can Join the Study?

Participants must be males or females who weigh more than 10 kg.
Participants must be 2 to 18 years old.
Participants must have moderate to severe ulcerative colitis (UC). This means their condition is more than mild but not the most severe form.
Participants must have tried and not responded to treatments such as corticosteroids (a type of medication that reduces inflammation), biologics (medicines made from living organisms), anti-TNF antibodies (medicines that block a protein involved in inflammation), anti-integrin antibodies (medicines that block certain proteins on the surface of cells), or Janus Kinase (JAK) inhibitors (medicines that block certain enzymes involved in inflammation).
Participants must have had UC for at least 3 months before starting the study. This includes having evidence of UC from an endoscopy (a procedure where a doctor looks inside the colon) and a histopathology report (a detailed examination of tissue samples).

Who Cannot Join the Study?

Patients with any other significant health condition that might interfere with the study.
Patients who have had a recent infection that required treatment with antibiotics or antiviral medications.
Patients who have a history of cancer, except for certain types of skin cancer that have been treated.
Patients who have a history of certain diseases affecting the immune system, such as HIV.
Patients who are currently using other medications that might interfere with the study treatment.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have participated in another clinical trial recently.
Patients who have a known allergy to the study medication or its ingredients.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Helios Universitaetsklinikum Wuppertal	Wuppertal	Germany
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Centrum Medyczne Oporow	Wroclaw	Poland
Instytut Pomnik Centrum Zdrowia Dziecka	Warsaw	Poland
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Azienda Ospedaliera Universitaria Meyer IRCCS	Florence	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.	Szczecin	Poland
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
MD Korczowski Bartosz Gabinet Lekarski	Rzeszow	Poland
Anmpxqdhu Upy	Amsterdam	The Netherlands
Ehsyclr Ubdlkgpbgmjm Mhpjiss Cdlxoeu Rnzflqmvj (tkgopba Mrz	Rotterdam	The Netherlands
Lszzqk Mlujbcgayo Ufyaqppzsy Ow Mjsueg	Munich	Germany
Umahyvrjhu Oe Adxefnp	Edegem	Belgium
Uqbkhdmmty Daxck Sfkwt Dm Rxxo Lg Swvuecvu	Rome	Italy
Wai Wmitvw Ilo Peknl Pcoqnjsa Kqpvfur	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	15.12.2023
France	Not recruiting	15.12.2023
Germany	Not recruiting	15.12.2023
Italy	Not recruiting	15.12.2023
Poland	Not recruiting	15.12.2023
Portugal	Not recruiting	15.12.2023
The Netherlands	Not recruiting	15.12.2023

Trial locations

Investigated drugs:

Mirikizumab

Mirikizumab is a medication being studied for its potential to help people with ulcerative colitis, a condition that causes inflammation and sores in the colon. This medication works by targeting specific proteins in the body that are involved in the inflammatory process. By doing so, it aims to reduce inflammation and help achieve remission, which means reducing or eliminating the symptoms of ulcerative colitis. The study is focused on understanding how well mirikizumab works, how it moves through the body, and its safety for children and teenagers aged 2 to less than 18 years who have moderate to severe ulcerative colitis.

Investigated diseases:

Colitis ulcerative

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 diarrhea. Over time, the inflammation can lead to the formation of ulcers, which are small open sores that can produce pus and mucus. The progression of ulcerative colitis can vary, with periods of active symptoms followed by times of remission.

Trial ID:

2022-502183-20-00

Protocol code:

I6T-MC-AMBA

NCT ID:

NCT05784246

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Mirikizumab for Children and Teens with Moderate to Severe Ulcerative Colitis

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