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Study on the Effectiveness and Safety of RO7790121 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 RO7790121, which is being tested to see if it can help reduce the symptoms and inflammation associated with moderately to severely active Crohn's Disease. The trial will compare the effects of RO7790121 with a placebo to determine its effectiveness and safety.

The purpose of the study is to assess whether RO7790121 can help patients achieve clinical remission, which means a significant reduction in disease activity, and an endoscopic response, which refers to visible improvements in the digestive tract as seen through an endoscope. Participants in the study will receive either the treatment or a placebo, and their progress will be monitored over time to see how well the treatment works in reducing symptoms and improving their condition.

Throughout the study, researchers will track various outcomes, such as the overall change in symptoms, the severity of symptoms, and the general well-being of participants. They will also monitor any adverse events, which are unwanted effects that might occur during the trial. The study aims to provide valuable information on the potential benefits and risks of using RO7790121 for treating Crohn's Disease, helping to improve future treatment options for those affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to sign an informed consent form. This form confirms your understanding of the study and your willingness to participate.

    If you are between 16 and 18 years old, you may also need to sign an assent form, depending on local guidelines.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your diagnosis of moderately to severely active Crohn's disease. This includes reviewing your medical history and conducting necessary tests.

    Your body weight will be measured to ensure it is at least 40 kg, as this is a requirement for participation.

  3. Step 3

    Baseline evaluation

    A baseline evaluation will be performed to assess the current state of your Crohn's disease. This involves measuring the Crohn's Disease Activity Index (CDAI) and the Simple Endoscopic Score for Crohn's Disease (SES-CD).

    The CDAI score should be between 220 and 450, and the SES-CD should be at least 6, or 4 for isolated ileal disease.

  4. Step 4

    Treatment phase

    During the treatment phase, you will receive either the study medication RO7790121 or a placebo. This is a double-blind study, meaning neither you nor the study team will know which treatment you are receiving.

    The medication will be administered according to the study protocol, which will be explained to you in detail by the study team.

  5. Step 5

    Regular monitoring

    You will undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes clinical evaluations and endoscopic assessments.

    Your symptoms and any side effects will be closely monitored throughout the study.

  6. Step 6

    End of study evaluation

    At the end of the study, a final evaluation will be conducted to determine the overall response to the treatment.

    The primary goals are to achieve clinical remission and an endoscopic response, which will be measured by improvements in your CDAI and SES-CD scores.

Who can join the trial?

7 criteria

  • Sign a form to show you agree to participate. If you are younger, you might need to sign a special form called an Assent Form, depending on your age and local rules.
  • Be between the ages of 18 and 80 years old. If you are between 16 and 18 years old, you might still be able to join if local rules allow it.
  • Weigh at least 40 kg (about 88 pounds).
  • Have a confirmed diagnosis of Crohn's Disease (CD), which means your doctor has used tests like looking inside your intestines with a camera (endoscopy) and examining tissue samples (histopathology) to confirm it.
  • Have moderately to severely active Crohn's Disease. This means:
    • A score of 6 or more on a test called SES-CD, or 4 or more if the disease is only in the ileum (a part of the small intestine).
    • A score between 220 and 450 on a test called CDAI, which measures the severity of your symptoms.
    • The disease must affect the ileum (part of the small intestine) and/or the colon (large intestine). At least four parts of the colon should be reachable by a camera used in an endoscopy, or three parts if you have had surgery to remove part of your bowel.

Who cannot join the trial?

10 criteria

  • Patients with any other significant health condition that could interfere with the study.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have a history of cancer, except for certain types of skin cancer that have been treated.
  • Patients who have had a major surgery within the last 12 weeks.
  • Patients who are currently pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse within the last year.
  • Patients who are currently participating in another clinical trial.
  • Patients who have received certain medications that could affect the study results.
  • Patients with a known allergy to any of the study medications.
  • Patients who have a history of certain heart conditions.
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Investigated drugs

RO7790121 is a medication being tested in this clinical trial for its ability to help people with Crohn's Disease, which is a condition that causes inflammation in the digestive tract. This medication is being studied to see if it can help reduce the symptoms of Crohn's Disease and improve the health of the digestive system. The trial aims to find out if this medication can help patients achieve clinical remission, which means that the symptoms of the disease are reduced or disappear, and also to see if it can improve the appearance of the digestive tract when viewed with a special camera. The goal is to determine if this medication can be a safe and effective treatment option for people with moderately to severely active Crohn's Disease.

What is already known about the treatment

RO7790121 – This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating moderately to severely active Crohn's Disease. It is not yet widely available in medical practice, as it is still under investigation. The main goal of this medication is to help patients achieve clinical remission and improve their intestinal health by reducing inflammation. RO7790121 works by targeting specific molecules in the immune system that contribute to inflammation, helping to calm the immune response. It is classified as an immunosuppressive agent, which means it helps to reduce the activity of the immune system to prevent excessive inflammation.

Investigated diseases

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 active phases, symptoms may include abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The disease can progress unpredictably, with varying severity and frequency of symptoms. Over time, the inflammation can cause damage to the digestive tract, potentially leading to further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513054-30-00Protocol codeGA45332Estimated enrolment429 patientsSponsorF. Hoffmann-La Roche AG

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