Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of RVT-3101 for Treating Moderate to Severe Crohn's Disease in Patients

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 treatment being tested in this study is a medication known as RO7790121, which is administered as a solution for injection under the skin. The purpose of the study is to evaluate the safety and tolerability of this medication in individuals with moderate to severe active Crohn's disease.

Participants in the study will receive either the medication RO7790121 or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased. The study will take place over a period of time, with regular check-ups to monitor the participants' health and any side effects they may experience. The goal is to see how well the medication works in reducing the symptoms of Crohn's disease and to gather information on any potential side effects.

Throughout the study, participants will be closely monitored for any adverse effects, and their progress will be assessed using various measures, such as endoscopic examinations and clinical evaluations. The study aims to provide valuable information on the effectiveness and safety of RO7790121 as a potential treatment for Crohn's disease, which could lead to improved management of this challenging condition in the future.

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

    Initial visit

    Upon joining the study, the initial visit involves a comprehensive assessment to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure a confirmed diagnosis of Crohn's disease.

    The Crohn's Disease Activity Index (CDAI) score is determined to assess the severity of the condition. This score must be between 220 and 450.

  2. Step 2

    Baseline visit

    The baseline visit marks the official start of the trial. During this visit, the first dose of the study medication, RO7790121, is administered as a solution for injection.

    Participants receive instructions on how to monitor and report any side effects or changes in their condition.

  3. Step 3

    Treatment phase

    Throughout the treatment phase, RO7790121 is administered subcutaneously. The frequency and dosage are determined by the study protocol and are closely monitored by the research team.

    Participants are required to attend regular follow-up visits to assess the medication's effects and to ensure safety and tolerability.

  4. Step 4

    Mid-study assessment

    At week 14, a mid-study assessment is conducted to evaluate the response to the treatment. This includes an endoscopic examination to measure any decrease in the Simple Endoscopic Score for Crohn's Disease (SES-CD).

    Clinical remission is assessed by checking if the CDAI score is below 150.

  5. Step 5

    End of treatment phase

    The treatment phase concludes with a final assessment to evaluate the overall effectiveness and safety of RO7790121.

    Participants are monitored for any adverse events, and the study team collects data on the proportion of participants achieving clinical remission.

  6. Step 6

    Follow-up period

    After the treatment phase, a follow-up period is conducted to monitor long-term effects and any delayed side effects of the medication.

    Participants may be required to attend additional visits or provide information on their health status.

Who can join the trial?

4 criteria

  • Participants must provide a signed and dated written consent form before any study-related activities begin. This means they agree to take part in the study after being informed about it.
  • Participants can be of any gender and must be between 18 and 75 years old. If local rules allow, participants can be younger than 18 if they are at the age of consent.
  • Participants must have a confirmed diagnosis of **Crohn's disease** affecting the ileum, ileocolon, or colon for at least 12 weeks (about 3 months) before the first visit of the study. This diagnosis should be supported by a biopsy, which is a small sample of tissue taken for testing.
  • Participants need to have a **CDAI score** between 220 and 450 at the screening. **CDAI** stands for Crohn's Disease Activity Index, which is a way to measure the severity of Crohn's disease. This score should be determined before a screening colonoscopy, which is a procedure to look inside the colon.

Who cannot join the trial?

10 criteria

  • Patients who have any 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 allergic reactions to similar medications.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have a history of substance abuse or alcohol dependency.
  • Patients who have an active infection that requires treatment.
  • Patients who have been diagnosed with cancer within the last five years, except for certain types of skin cancer.
  • Patients who have a history of heart problems, such as heart attack or heart failure.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

RO7790121 is an investigational medication being studied for its potential to treat moderate to severe active Crohn's disease. It is administered through an injection under the skin. The main goal of the study is to assess how safe and well-tolerated this medication is for patients with this condition.

What is already known about the treatment

RO7790121 – This medication is administered subcutaneously, meaning it is injected under the skin. It is currently in Phase 2 clinical trials, focusing on its safety and tolerability for treating moderate to severe active Crohn's disease. The main therapeutic indication for RO7790121 is to manage symptoms and inflammation associated with Crohn's disease. At the molecular level, it works by targeting specific pathways involved in the inflammatory process, although the exact mechanism is still under investigation. It is classified pharmacologically as an investigational drug, as it is still being studied and not yet approved for general medical use.

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 flare-ups and remission, where symptoms can vary in intensity. During flare-ups, individuals may experience 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 exact cause of Crohn's disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors. The progression of the disease is unpredictable, with some people experiencing long periods of remission and others having frequent flare-ups.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504265-23-00Protocol codeGA45392/RVT-3101-201Estimated enrolment77 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.