Clinical trials on Crohn’s Disease

Understanding Crohn’s Disease

Crohn’s Disease is a chronic inflammatory condition that primarily affects the gastrointestinal tract, but it can impact any part from the mouth to the anus. It is a type of Inflammatory Bowel Disease (IBD) that can lead to severe symptoms and complications if not managed properly. The exact cause of Crohn’s Disease remains unknown; however, it is believed to result from a combination of genetic, environmental, and immune system factors. This condition is characterized by periods of remission, where symptoms may subside, interspersed with flare-ups, where symptoms intensify.

Symptoms and Management

The symptoms of Crohn’s Disease can vary significantly from person to person but commonly include abdominal pain, diarrhea, fatigue, weight loss, and malnutrition. The severity of these symptoms can range from mild to debilitating, affecting the quality of life and the ability to perform daily activities. Diagnosis typically involves a combination of blood tests, stool tests, endoscopy, and imaging studies to assess the extent of inflammation and the areas affected.

Management of Crohn’s Disease focuses on reducing inflammation, controlling symptoms, and maintaining remission. Treatment strategies may include medication, such as anti-inflammatory drugs, immune system suppressors, and antibiotics, as well as lifestyle modifications, including diet changes and stress management. In severe cases, surgery may be necessary to remove damaged portions of the gastrointestinal tract. With appropriate treatment and care, many individuals with Crohn’s Disease can lead active, fulfilling lives.

  • CT-EU-00084134

    Studying ustekinumab treatment for Crohn’s perianal fistula

    This is a medical study being conducted to examine how effective a certain medication, called Ustekinumab, can be for people suffering from Crohn’s disease, specifically a subset called perianal Crohn’s. A group of people suffering from moderate to severe forms of this disease will be randomly assigned to receive either the actual medication or a placebo. Their symptoms will then be tracked for a period of 48 weeks to see if the medication helps lessen their symptoms. The end goal is to see whether the drug is useful in stopping all abnormal openings (fistulas) from draining. The study also aims to ensure that the drug doesn’t cause any buildup of more than 2 cm.

    • Ustekinumab
  • Comparison of treatment with vedolizumab and adalimumab in the treatment of Crohn’s disease

    This trial is about finding better treatment options for people who have Crohn’s disease and no longer respond to their current medication, specifically Infliximab or Adalimumab. The objective is to determine the optimal course of action in such cases, whether it involves administering a higher dose of the same medication, transitioning to an alternative version, or exploring an entirely new treatment approach. The study also seeks to identify potential indicators in the body’s biological markers that could predict treatment response. A comparative evaluation is being established between the new treatment, Vedolizumab, and the conventional approach of intensified Adalimumab dosing. The goal is to assess which intervention proves more effective in managing Crohn’s disease under these particular circumstances.

    • Vedolizumab
    • Adalimumab
  • Testing the effect of the new drug on Crohn’s Disease

    This study is exploring a new medication for Crohn’s disease, an ailment of the gut. The medication, known as BI 706321, is given alongside another medication called Ustekinumab that is already used to treat Crohn’s. The trial is conducted to see if this combination helps to manage the disease better. Participants will be split into two groups. One group will be given the new medication and the other will receive a placebo, alongside Ustekinumab. Participating in this study will last for 1 year. During this time, participants will have about 13 visits to the clinic. Some visits will involve a colonoscopy where doctors look at the intestine’s condition. Their findings will help doctors understand if the new treatment is working.

    • BI 706321- new potential medication for Crohn’s disease
    • ustekinumab
  • Testing oral ozanimod for active Crohn’s Disease treatment

    This trial is for a medicine called Ozanimod, that’s taken by mouth. It’s a Phase 3 trial, meaning it’s been tested in smaller trials before and looks promising. The disease we’re looking at is Crohn’s Disease, which can be quite severe. The goal of this trial is to see if Ozanimod can help get the disease under control, this is called an ‘induction therapy’. To make sure the results are accurate, some people will get the real medication while others will get a ‘placebo’, which looks the same but doesn’t have any medicine in it. Everything is double-checked to make sure it’s fair and unbiased.

    • Ozanimod
  • Continued study of ozanimod for severe Crohn’s Disease

    This research is about an extended study on the use of an oral medication named Ozanimod for people suffering from Crohn’s disease. Crohn’s disease can make the stomach and intestines really uncomfortable, causing swellings and pain. The main aim of this study is to check if this medicine, Ozanimod, is safe for intake and how effective it is in easing these uncomfortable feelings in the stomach. The researchers will rate patients’ illnesses using the Crohn’s Disease Activity Index (a measurement tool).

    • Ozanimod
  • Study of mirikizumab in participants with Crohn’s Disease

    This study involves pediatric participants with Crohn’s disease and aims to assess the effectiveness, safety, and tolerability of a drug called mirikizumab. Participants will be randomly assigned to receive mirikizumab or another intervention, and the study will last approximately 74 weeks with up to 19 visits.

    • Mirikizumab
  • Long-term study on the effectiveness of mirikizumab for Crohn’s Disease

    This research study is about a long-term test of a medicine called Mirikizumab for people who have Crohn’s disease. The main aim of this study is to know if the medicine is effective and safe for those people eventually. The effect of the medicine will be checked using different tests and scores like the Simple Endoscopic Score for Crohn’s Disease, the Crohn’s Disease Activity Index, and patient-reported outcomes. Researchers will also be checking changes in certain markers in the blood and stool that can show inflammation.

    • Mirikizumab
  • Studying ozanimod as ongoing treatment for Severe Crohn’s Disease

    This trial is to test a medication called Ozanimod on people who have a serious type of Crohn’s Disease. Crohn’s Disease can make the stomach hurt a lot and sometimes makes difficulty eating.  The researchers want to see if the medication helps to calm the disease, so patients feel better. Some patients will get the Ozanimod and others will get a placebo.  The researchers use  ‘Crohn’s Disease Activity Index’ to see how the disease is doing.

    • Ozanimod
  • Long-term monitoring of Crohn’s disease treatment with Ustekinumab

    This research is an extension of a previous study (REScUE), focusing on ustekinumab, a medication used to treat Crohn’s disease. The primary goal is to evaluate the long-term effectiveness and safety of a modified ustekinumab treatment plan.

    In the initial REScUE study, some patients experienced a reduced response to the standard ustekinumab regimen given every 8 weeks. To address this, the extension study aims to assess whether adjusting the dose to every 4 weeks provides better and sustained results.

    Patients from the REScUE study are eligible for this extension. The study involves regular check-ups to monitor the patients’ health, including disease activity, medication effectiveness, and any potential side effects. The objective is to gather valuable insights into the extended use of ustekinumab, contributing to our understanding of optimal treatment strategies for Crohn’s disease.

    • ustekinumab
  • Vedolizumab treatment for kids and teens with severe Crohn’s disease

    This research study is on a medicine named vedolizumab, which helps reduce pain and swelling in the digestive system caused by Crohn’s Disease. This sickness affects the digestive system and more children and teenagers are getting it. The goal of the study is to check if vedolizumab helps them feel better and makes the symptoms go away. Participants will get three vedolizumab doses over six weeks. Based on how they feel after this, patients will get either a high or low dose of vedolizumab every 8 weeks. Around 120 kids and teenagers will participate in the study.

    • Vedolizumab
  • Combination therapy trial for moderately to severely active Crohn’s disease

    The study examines a combination therapy using guselkumab and golimumab in individuals with active Crohn’s Disease. It aims to compare the effectiveness of this dual approach to individual treatments, focusing on reducing disease symptoms and improving patients’ quality of life. The study’s goal is to offer new hope and better management strategies for those battling this challenging condition.

    • JNJ-78934804 (guselkumab, golimumab)
    • Golimumab
    • Guselkumab
  • Understanding new medicine in moderate to severe ulcerative colitis or Crohn’s disease

    This is a study about a medicine called TEV-48574, used to treat serious bowel diseases called ulcerative colitis and Crohn’s disease. The main purpose of this study is to see how well the medicine works and how much of it should be given to patients, specifically, every 4 weeks. The study aims to test two different doses of TEV-48574 while assessing its safety and the ease with which patients can manage it. Additionally, the research aims to analyze the long-term reactions of the body to the medication. Each participant will be observed for up to 66 weeks, and the entire study is expected to span approximately 37 months. The success of the treatment will be gauged through various tests, including the Mayo score, which considers symptoms such as rectal bleeding, stool frequency, and inflammation within the gut.

    • TEV-48574
  • Study on new drug treatment for patients with Crohn’s disease

    This study looks at a drug called MBF-118 used to treat Crohn’s disease. The research team wants to check how safe and effective this drug is and understand how it behaves in the body. The medicine is taken orally every day for 28 days as an addition to regular treatment. Some patients will receive 100 mg of the drug daily and others will receive 200 mg. The first five people to join the study will receive 100 mg of the drug per day, and the next five people will receive 200 mg per day. The study will last approximately 14–16 weeks for each person and includes a screening process, 4 weeks of treatment, and then 8 weeks of follow-up.

    • MBF-018
  • Study on the use of new medication for severe Crohn’s disease

    The study focuses on evaluating a new medication, RVT-3101, for its potential to alleviate symptoms in adults suffering from Crohn’s disease, a condition characterized by severe abdominal pain and difficulties in nutrient absorption. The primary aims are to determine the efficacy of RVT-3101 in improving these symptoms and to assess its safety, ensuring it does not cause additional problems. A notable aspect of this study is the administration of RVT-3101 through subcutaneous injections rather than oral pills. To maintain objectivity in the results, the study is conducted in a double-blind manner. This means that neither the participants receiving the treatment nor the doctors administering it know who is receiving the actual medication and who is receiving a placebo. This approach is critical in validating the study’s findings.
    A notable aspect of this study is the administration of RVT-3101 through subcutaneous injections rather than oral pills. To maintain objectivity in the results, the study is conducted in a double-blind manner. This means that neither the participants receiving the treatment nor the doctors administering it know who is receiving the actual medication and who is receiving a placebo. This approach is critical in validating the study’s findings.

    • RVT-3101- new potential medication for ulcerative colitis
  • Looking into the impact of the new drug on Crohn’s disease

    The research study ‘STENOVA’ is aimed at evaluating the safety and effect of a new medication, AGMB-129, on patients with Fibrostenotic Crohn’s Disease, a specific type of digestive illness. The study has three primary objectives: first, to assess the safety of AGMB-129 for patient consumption; second, to investigate the pharmacokinetics, which is how the body processes the drug; and third, to explore the pharmacodynamics, or the effect of the drug on the body. Participants in the study are required to commit to a duration of approximately 19 weeks. During this period, they will receive either a high dose, a low dose, or a placebo of AGMB-129. The placebo is a harmless substance that has no effect on the body. The study is structured to blind participants to the specific treatment they receive, to maintain unbiased results. In addition to taking the medication, participants will undergo various checkups and tests. These procedures are designed for continuous monitoring and evaluation of the drug’s effects and the participants’ health throughout the study.

    • AGMB-129- new potential medication for Fibrostenosing Crohn’s Disease
  • Evaluating etrasimod for treating Crohn’s disease

    This study evaluates the usefulness and safety of the oral medication, etrasimod, for the treatment of adults with moderately to severely active Crohn’s disease. The study is made up of five substudies to assess the efficacy, safety, and tolerability of the therapy. It offers a unique research pathway to adults suffering from Crohn’s disease who has not seen improvements from their current therapies. The research spans a long timeline of up to 282 weeks, accounting for a screening period, varying treatment periods, and a 4-week follow-up for safety assessment. This ensures a comprehensive and detailed evaluation of etrasimod’s effects and potential benefits.

    • Etrasimod