Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of RO7790121 Compared to Placebo for Treatment of Adults with Moderate to Severe Ulcerative Colitis

Verified siteInvestigational
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 study focuses on Ulcerative Colitis, specifically the moderately to severely active form. This is a chronic inflammatory condition affecting the large intestine, causing inflammation and ulcers in the digestive tract. The study will test a new medication called RO7790121 as an induction therapy, which means it is used to bring about initial improvement in the disease symptoms.

The research aims to determine if RO7790121 is effective and safe compared to placebo in helping patients achieve clinical remission. During the study, participants will receive either the study medication or placebo over a 12-week period. The medication is being investigated for patients who have not responded well enough to previous treatments or have lost response to them.

Throughout the study, various aspects of the disease will be monitored, including bowel movements, bleeding symptoms, and the appearance of the intestinal lining through medical examinations. The study will also track other important factors such as abdominal pain, fatigue, and overall quality of life. Participants will be monitored for any side effects or complications that may occur during the treatment period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your eligibility for the study will be evaluated based on specific criteria, including age (between 18 and 80 years) and weight (minimum 40 kg)

    A confirmation of active ulcerative colitis diagnosis will be required

    A colorectal cancer screening will be performed according to local standards

  2. Step 2

    Treatment phase

    You will receive either RO7790121 or a placebo (inactive substance) for 12 weeks

    Neither you nor your doctor will know which treatment you are receiving (this is called 'double-blind')

    Your condition will be monitored throughout the treatment period

  3. Step 3

    Regular assessments

    Your symptoms will be evaluated at week 2 and week 12

    Assessments will include monitoring of bowel movements, bleeding, and internal examination of the colon

    You will be asked to complete questionnaires about your symptoms, fatigue levels, and quality of life

    Any side effects or health changes will be recorded throughout the study

  4. Step 4

    Final evaluation

    At week 12, a final comprehensive assessment will be conducted

    This will include an examination of your colon and tissue samples

    Your overall response to the treatment will be evaluated

    All side effects and health changes will be documented

Who can join the trial?

6 criteria

  • You must be between 18 and 80 years old and weigh at least 40 kilograms (88 pounds)
  • You must have a confirmed diagnosis of active ulcerative colitis (UC) that is moderate to severe in nature
  • You must have completed a colorectal cancer screening (an examination to check for signs of cancer in the colon and rectum) according to your local medical standards
  • You must meet ONE of these previous treatment conditions:
    • Had an inadequate response to, lost response to, or could not tolerate standard treatments (such as aminosalicylates, corticosteroids, or immunosuppressants) AND have never used advanced therapies
    • OR had an inadequate response to, lost response to, or could not tolerate advanced therapies (such as biological medications or targeted treatments)
    • Both men and women can participate in this study

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Pregnant or breastfeeding women
  • History of severe allergic reactions to medications
  • Active or chronic infections, including tuberculosis or hepatitis B or C
  • Current treatment with other biological medications for ulcerative colitis
  • Major surgery within the last 3 months
  • History of cancer in the past 5 years (except successfully treated skin cancer)
  • Severe heart, liver, or kidney disease
  • Uncontrolled diabetes (high blood sugar levels)
  • Current mental health conditions that could interfere with the study
  • Use of prohibited medications within specified timeframes
  • Participation in another clinical trial within the last 30 days
  • Substance abuse or alcohol dependency within the past year
  • Unable to provide informed consent
  • Conditions that could interfere with study procedures or evaluation
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 treating moderate to severe ulcerative colitis, which is an inflammatory bowel disease. This medication is being tested to see if it can help patients achieve remission (reduction or disappearance) of their disease symptoms. The way this medication works in treating ulcerative colitis is being evaluated through this clinical trial.

What is already known about the treatment

RO7790121 – An investigational medication being studied in Phase III clinical trials for the treatment of moderately to severely active Ulcerative Colitis (UC). This drug is being evaluated through a multicenter, double-blind, placebo-controlled study to assess its efficacy in inducing clinical remission in UC patients. While specific details about its molecular mechanism of action are not provided in the source data, it is being investigated as a potential therapeutic option for inflammatory bowel disease management. The medication's administration method and specific pharmacological classification are not specified in the provided clinical trial information, though it is being studied in comparison to placebo for its effectiveness in treating UC.

Investigated diseases

Ulcerative Colitis - A chronic inflammatory bowel disease that affects the large intestine (colon) and rectum. The condition causes inflammation and ulcers in the digestive tract, leading to the development of tiny sores in the lining of the colon. The inflammation typically begins in the rectum and extends continuously up into the colon. Common symptoms include diarrhea with blood or mucus, abdominal pain, urgency to defecate, weight loss, and fatigue. The disease usually develops gradually over time and can range from mild to severe, with periods of active disease alternating with periods of remission.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513015-27-00Protocol codeGA45330Estimated enrolment350 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.