Study on Risankizumab for Patients 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 trial will evaluate a treatment called risankizumab, which is administered as a solution for injection using a pre-filled syringe. Risankizumab is being compared to a placebo to determine its effectiveness and safety for individuals with moderately to severely active Crohn’s disease.

The purpose of the study is to assess how well risankizumab works and how safe it is for patients. Participants in the study will receive either risankizumab or a placebo through subcutaneous injections, which means the medication is injected under the skin. The study will monitor participants over a period of time to see if there is an improvement in their symptoms and overall health. The trial aims to find out if risankizumab can help achieve clinical remission, which means a significant reduction in disease activity, and if it can lead to an endoscopic response, indicating healing of the intestinal lining.

Throughout the study, participants will be closely observed to ensure their safety and to gather information on how the treatment affects their condition. The trial will also look at secondary outcomes, such as changes in fatigue levels and other symptoms related to Crohn’s disease. The findings from this study could provide valuable insights into the potential benefits of risankizumab for people living with Crohn’s disease.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility for the trial will be confirmed based on specific criteria, such as age, diagnosis of Crohn’s disease, and previous treatment history.

You will undergo a series of assessments, including a review of your medical history and a physical examination. This is to ensure that you meet all the necessary requirements to participate in the trial.

2 baseline assessments

Baseline assessments will be conducted to evaluate the current state of your Crohn’s disease. This includes measuring your Crohn’s Disease Activity Index (CDAI) and performing an endoscopy to assess mucosal inflammation.

These assessments help establish a starting point for your condition, which will be used to measure the effectiveness of the treatment.

3 treatment administration

You will be randomly assigned to receive either the study medication, risankizumab, or a placebo. The medication is administered as a subcutaneous injection, which means it is injected under the skin.

The treatment will be given according to a specific schedule over a period of 12 weeks. The exact dosage and frequency will be explained to you by the study team.

4 regular follow-up visits

Throughout the 12-week treatment period, you will have regular follow-up visits. These visits are important for monitoring your health and the effects of the treatment.

During these visits, you will undergo various assessments, including physical examinations, blood tests, and questionnaires about your symptoms and overall well-being.

5 end of treatment assessments

At the end of the 12-week treatment period, you will have a final set of assessments. These will include another measurement of your CDAI and an endoscopy to evaluate any changes in mucosal inflammation.

The results of these assessments will help determine the effectiveness of the treatment in managing your Crohn’s disease.

6 post-trial follow-up

After completing the treatment phase, you may be asked to participate in follow-up visits. These visits are designed to monitor your long-term health and any lasting effects of the treatment.

The study team will provide you with detailed information about the schedule and nature of these follow-up visits.

Who Can Join the Study?

Must be a male or female adult who is at least 18 years old.
Must have a confirmed diagnosis of Crohn’s disease for at least 3 months before starting the study.
Must have moderately to severely active Crohn’s disease. This means having a Crohn’s Disease Activity Index (CDAI) score between 220 to 450 and visible signs of inflammation in the intestines as shown by a test called SES-CD.
Must have shown intolerance or inadequate response to standard treatments or advanced therapies for Crohn’s disease.
If female, must follow the contraception recommendations provided by the study.

Who Cannot Join the Study?

Patients with any other significant health conditions that might interfere with the study.
Patients who have had a recent infection or are currently experiencing an infection.
Patients who have a history of cancer, except for certain types of skin cancer that have been treated.
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 are currently participating in another clinical trial.
Patients who have received certain medications that might interfere with the study treatment.
Patients with known allergies to the study medication or its ingredients.
Patients who have a history of certain heart conditions.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Wsd Medi Clinical Sp. z o.o.	Warsaw	Poland
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
Clinfan Kft.	Szekszard	Hungary
Vilniaus universiteto ligonine Santaros klinikos VšĮ	Vilnius	Lithuania
Semmelweis University	Budapest	Hungary
Fakultni Thomayerova nemocnice	Prague	Czechia
Nemocnice Ceske Budejovice a.s.	Ceske Budejovice	Czechia
Centermed Krakow Sp. z o.o.	Cracow	Poland
Acle Crndpauz sunsxb	Prague	Czechia
Pibracrjh Iwzayawc Mmyzamux Muoounjzvnvt Sjpdu Wfruxifxtumc I Amobzxccipfsk	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	01.12.2024
Hungary	Not recruiting	01.12.2024
Lithuania	Not recruiting	01.12.2024
Poland	Not recruiting	01.12.2024

Trial locations

Investigated drugs:

Risankizumab

Risankizumab is a medication used in this clinical trial to help people with Crohn’s Disease, which is a condition that causes inflammation in the digestive tract. This medication is given as an injection under the skin. It works by targeting a specific part of the immune system that is involved in causing inflammation. By doing this, Risankizumab aims to reduce the symptoms of Crohn’s Disease, such as abdominal pain and diarrhea, and help patients feel better. The trial is designed to see how effective and safe Risankizumab is for people with moderate to severe Crohn’s Disease.

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 flares, and periods of remission. During flares, individuals may experience symptoms such as abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can lead to complications like strictures, fistulas, and abscesses. The disease can affect any part of the gastrointestinal tract from the mouth to the anus, and the inflammation can penetrate through the entire thickness of the bowel wall. The exact cause of Crohn’s disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors.

Trial ID:

2024-516023-13-00

Protocol code:

M23-784

NCT ID:

NCT06063967

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Risankizumab for Patients with Moderate to Severe Crohn’s Disease

What is this study about?

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