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Study on the Safety and Effects of Tulisokibart for Patients with Moderate to Severe Crohn's Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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 PRA023, which is being tested to see how safe and effective it is for people with moderate to severe Crohn's disease. The treatment involves using a medication that is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of the study is to assess the safety and tolerability of PRA023 over a 12-week period. Participants will receive the treatment and be monitored for any side effects or improvements in their condition. The study will also look at how well the treatment works by checking for improvements in the inflammation of the digestive tract using a procedure called endoscopy, which allows doctors to see inside the digestive tract with a camera. The goal is to see if there is a significant reduction in inflammation after 12 weeks of treatment.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their symptoms. The study aims to provide valuable information about the potential benefits and risks of PRA023 for treating Crohn's disease, which could lead to new treatment options for patients in the future. Participants will be closely observed to ensure their safety and to gather data on how the treatment affects their condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participation is confirmed through written consent. Understanding and compliance with study requirements are necessary.
Step 2
Initial assessment
An initial assessment is conducted to confirm the diagnosis of Crohn's disease. This may involve endoscopy and histology to ensure eligibility.
Step 3
Treatment initiation
The treatment involves the administration of tulisokibart, a concentrate for solution for infusion. This is given through an intravenous infusion.
The treatment period lasts for 12 weeks, during which the safety and effectiveness of the medication are evaluated.
Step 4
Monitoring and evaluation
Throughout the 12-week period, regular monitoring is conducted to assess the response to treatment. This includes checking for any side effects and measuring improvement in symptoms.
Endoscopic improvement is evaluated by a decrease in the simple endoscopy score for Crohn's disease by at least 50% from the baseline.
Step 5
Completion of treatment
At the end of the 12-week treatment period, a final assessment is conducted to determine the overall effectiveness and safety of the treatment.
The study aims to achieve clinical remission and improvement in both endoscopic and clinical symptoms.

Who can join the trial?

11 criteria

Must be a male or female who is at least 18 years old.
Must have been diagnosed with Crohn's disease at least 3 months before joining the study. This diagnosis should be confirmed by a procedure called an endoscopy and a tissue examination called histology. If there is no previous confirmation, it must be confirmed during a screening procedure called a colonoscopy.
Must have moderately to severely active Crohn's disease, which is determined by a specific score called the Crohn's Disease Activity Index (CDAI) that should be between 220 and 450.
Must have a Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 6 if the disease affects both the small and large intestines or just the large intestine, or at least 4 if it affects only the small intestine.
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Must meet at least one of the following treatment criteria:
- In the past, did not respond well to certain treatments like oral steroids, immunosuppressants, or specific biologic drugs.
- Had side effects that made it hard to continue with the treatments mentioned above.
- Currently taking certain medications like oral steroids or immunosuppressants for a specified period.
- Women who can become pregnant must use two highly effective birth control methods for at least 4 weeks before starting the study and continue using them until 12 weeks after the last dose of the study drug.
- Men must use two highly effective birth control methods with their female partners who can become pregnant and must not donate sperm from the start of the study until 12 weeks after the last dose of the study drug.
- Must have stable doses of certain medications, such as oral corticosteroids, aminosalicylates, azathioprine, 6-mercaptopurine, and methotrexate, for a specified period before starting the study.
- Must be able to provide written consent and understand and follow the study requirements.

Who cannot join the trial?

8 criteria

Patients who have other serious health conditions that could interfere with the study.
Patients who are currently participating in another clinical trial.
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 severe allergic reactions to medications.
Patients who have an active infection that requires treatment.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to follow the study procedures or attend study visits.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Institut de Cancérologie Hématologie Universitaire de Saint Etienne (iCHUSE)
Saint Priest En Jarez, France
Responsive
Krakowskie Centrum Medyczne Sp. z o.o.
Cracow, Poland

Trial locations

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Investigated drugs

PRA023 is a medication being studied for its potential to help people with moderately to severely active Crohn's Disease. The trial aims to see how safe and tolerable this medication is when used over a 12-week period. Researchers are also looking to see if it can improve the condition of the intestines, as observed through a special type of examination called an endoscopy. The goal is to find out if PRA023 can reduce the severity of Crohn's Disease symptoms and improve the quality of life for patients.

Tulisokibart

What is already known about the treatment

PRA023 – This medication is administered through injection and is currently being studied in clinical trials for its effectiveness in treating Crohn's disease. It is in the investigational stage, with ongoing research to determine its safety and efficacy. The main therapeutic indication for PRA023 is to manage moderately to severely active Crohn's disease. At the molecular level, it works by targeting specific pathways involved in inflammation, aiming to reduce the symptoms associated with the disease. PRA023 is classified under immunomodulatory agents, which are designed to modify the immune response to achieve therapeutic effects.

Investigated diseases

Crohn's disease – Crohn's disease is a chronic inflammatory condition that primarily affects the gastrointestinal tract, particularly the small intestine and colon. It is characterized by periods of active disease, known as flare-ups, and periods of remission. During flare-ups, individuals may experience symptoms such as abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications like strictures or fistulas. The exact cause of Crohn's disease is not fully understood, but it is believed to involve a combination of genetic, environmental, and immune system factors. The progression of the disease varies among individuals, with some experiencing mild symptoms and others having more severe manifestations.