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Study of RO7790121 (afimkibart) for Treatment and Long-term Management in Adults with Moderate to Severe Crohn's Disease

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This study focuses on patients with Crohn's Disease, specifically those with moderate to severe forms of this chronic inflammatory bowel condition that causes inflammation in the digestive tract. The study will test a new medication called RO7790121, which is given as a solution through subcutaneous injection under the skin.

The purpose of this research is to determine how well RO7790121 works compared to placebo in helping patients maintain improvement of their Crohn's Disease symptoms. The study involves two phases - an initial treatment phase (induction) followed by a longer maintenance phase where patients continue receiving either the study medication or placebo.

During the study, participants will receive regular doses of either RO7790121 or placebo through injections under the skin. The study is "double-blind," which means neither the patients nor their doctors will know which treatment is being given. The effectiveness of the treatment will be measured by checking if patients achieve reduced disease activity and healing of the intestinal lining.

The research process

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

  1. Step 1

    Initial phase

    You will participate in a study testing a medication called RO7790121 for Crohn's disease.

    The study will evaluate if the medication is effective in maintaining improvement in patients with moderate to severe Crohn's disease.

    The medication will be given as an injection under the skin (subcutaneous injection).

  2. Step 2

    Treatment groups

    You will be randomly assigned to receive either the study medication (RO7790121) or a placebo (a substance with no active medication).

    Neither you nor your doctor will know which treatment you are receiving during the study.

  3. Step 3

    Treatment phases

    The study consists of two main phases: induction (initial treatment) and maintenance (continued treatment).

    Your progress will be monitored through regular assessments of your symptoms and intestinal healing.

  4. Step 4

    Monitoring and assessments

    Your condition will be evaluated using several measures:

    - Assessment of disease activity using a scoring system (CDAI)

    - Examination of your intestines through endoscopy (SES-CD score)

    - Monitoring of symptoms such as bowel urgency and fatigue

    - Quality of life assessments

  5. Step 5

    Study duration

    The study is expected to run from March 2025 to December 2030.

    Regular follow-up visits will be required throughout the study period to monitor your progress and any side effects.

Who can join the trial?

10 criteria

  • Must be between 18 and 80 years old when signing the consent form
  • Body weight must be at least 40 kg
  • Must have a confirmed diagnosis of Crohn's Disease supported by clinical tests, internal examination (endoscopy), and tissue examination
  • Must have moderately to severely active Crohn's Disease with:
    • A CDAI score between 220 and 450 (CDAI is a measure of disease activity)
    • A SES-CD score of 6 or higher (or 4 or higher for disease affecting only the ileum - last part of small intestine)
    • Must have disease affecting the ileum and/or colon with either:
      • At least 4 colon segments that can be examined by endoscope, or
      • At least 3 segments in patients who have had previous bowel surgery
      • Must complete colorectal cancer screening:
        • If at high risk: must have had examination within 12 months before screening
        • All others: must be up-to-date with regular cancer screening
        • Any polyps (abnormal growths) must be removed before starting the study medication

Who cannot join the trial?

14 criteria

  • Current or past diagnosis of ulcerative colitis (a type of inflammatory bowel disease different from Crohn's disease)
  • Previous surgery that removed a significant portion of the intestines (bowel resection)
  • Active infections, including but not limited to:
    • Tuberculosis (TB)
    • Hepatitis B or C
    • HIV
    • History of cancer within the past 5 years (except successfully treated non-melanoma skin cancer)
    • Heart failure or other serious heart conditions
    • Pregnant or breastfeeding women
    • Current participation in other clinical trials or use of investigational drugs within 30 days
    • Known allergies to similar medications or their components
    • Serious mental health conditions that could interfere with study compliance
    • Immunodeficiency conditions (weakened immune system) or use of medications that severely suppress the immune system
    • History of substance abuse within the past year
    • Inability to comply with study procedures or follow-up visits
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Investigated drugs

Afimkibart (RO7790121) is a new investigational medication being studied for treating Crohn's disease, which is a type of inflammatory bowel disease. This medication is being tested to see if it can help control symptoms and maintain improvement in patients with moderate to severe Crohn's disease. The medication is being compared to placebo to determine how well it works both in initially treating symptoms (induction phase) and in keeping symptoms under control over time (maintenance phase).

What is already known about the treatment

Afimkibart – A novel investigational medication administered through injection that is currently being studied in Phase III clinical trials for the treatment of moderately to severely active Crohn's Disease. This drug belongs to the class of biological medications designed to reduce inflammation in the digestive tract. While its exact molecular mechanism of action is still being investigated in clinical trials, it is being evaluated for its ability to maintain response in patients with Crohn's Disease by targeting specific inflammatory pathways in the immune system. The medication represents a potential new treatment option for patients who have not responded adequately to conventional therapies.

Investigated diseases

Crohn's Disease - A chronic inflammatory bowel disease that can affect any part of the digestive tract, from mouth to anus, but most commonly involves the small intestine and colon. The inflammation can penetrate deep into the layers of the bowel wall, causing pain, severe diarrhea, fatigue, and weight loss. The disease typically develops in patches, with healthy sections in between affected areas. Symptoms can vary from mild to severe and may come and go with periods of active disease followed by periods of remission. The condition can lead to complications such as narrowing of the intestine, fistulas (abnormal connections between organs), and nutritional deficiencies.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513053-69-00Protocol codeGA45331Estimated enrolment604 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).