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Study of RO7790121 Treatment for Adults with Moderate to Severe Ulcerative Colitis: Testing Effectiveness and Safety in Initial and Long-term Therapy

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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 Ulcerative Colitis, a chronic inflammatory bowel disease that causes inflammation and sores in the digestive tract. The condition being studied specifically involves moderately to severely active form of this disease. The study will test a new medication called RO7790121 to see how well it works compared to a placebo for both initial treatment (induction) and long-term treatment (maintenance) of the disease.

The purpose of this research is to determine if RO7790121 is effective in helping patients achieve and maintain remission of their disease symptoms. Remission means that the symptoms of ulcerative colitis have significantly improved or disappeared. The study will last for 52 weeks, during which participants will receive either the study medication or a placebo.

Throughout the study, doctors will monitor various aspects of the disease, including improvements in the intestinal lining (viewed through an endoscopy), changes in bowel movements, and the presence of rectal bleeding. They will also track other symptoms such as bowel urgency, abdominal pain, and fatigue. The study will evaluate how well the medication works and monitor its safety by checking for any side effects that may occur during treatment.

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 evaluation

    You will undergo an endoscopy (examination of the colon using a small camera) to confirm active ulcerative colitis

    Your medical history will be reviewed to confirm previous treatments and their outcomes

    Basic health measurements will be taken, including weight (minimum 40 kg required)

  2. Step 2

    Treatment phase 1 - Induction

    Duration: 12 weeks

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

    Neither you nor your doctor will know which treatment you are receiving

    Regular assessments of your symptoms will be conducted, including stool frequency and presence of blood

  3. Step 3

    Week 12 evaluation

    An endoscopy will be performed to assess your colon

    Tissue samples will be taken to examine healing at the microscopic level

    Your symptoms will be evaluated using specific scoring systems

    Quality of life questionnaires will be completed

  4. Step 4

    Treatment phase 2 - Maintenance

    Duration: 40 weeks (until week 52)

    Continuation of assigned treatment (RO7790121 or placebo)

    Regular monitoring of symptoms and side effects

    Assessment of fatigue levels and overall well-being

  5. Step 5

    Final evaluation at week 52

    Final endoscopy examination

    Complete assessment of disease activity

    Final tissue sampling

    Evaluation of treatment effectiveness and safety

    Completion of quality of life assessments

Who can join the trial?

6 criteria

  • Must be between 18 and 80 years old and weigh at least 40 kilograms
  • Must have a confirmed diagnosis of Ulcerative Colitis (UC) that is moderately to severely active, proven by internal examination of the colon (endoscopy)
  • Must undergo colorectal cancer screening before participating in the study
  • Must meet one of these previous treatment conditions:
    • Had poor results or side effects from standard treatments (such as aminosalicylates - anti-inflammatory drugs, corticosteroids - medications that reduce inflammation, or immunosuppressants - drugs that lower immune system activity) and have never used advanced therapies
    • OR had poor results or side effects from advanced treatments (such as biological medications or targeted therapies)
    • Can be either male or female

Who cannot join the trial?

14 criteria

  • Previous unsuccessful treatment with any anti-TNF therapy (medications that reduce inflammation)
  • History of inflammatory bowel conditions other than Ulcerative Colitis, such as Crohn's Disease
  • Active or chronic infection, including tuberculosis (TB), hepatitis B, or hepatitis C
  • History of cancer within the past 5 years (except for successfully treated non-melanoma skin cancer)
  • Significant heart conditions or uncontrolled high blood pressure
  • Current or recent serious infections requiring hospitalization or intravenous antibiotics
  • Received live vaccines within 4 weeks before starting the study
  • Pregnancy or breastfeeding
  • History of severe allergic reactions to similar medications
  • Current participation in other clinical trials or use of investigational drugs
  • Severe liver disease or abnormal liver function tests
  • Significant kidney problems or abnormal kidney function
  • History of blood disorders or significant abnormal blood test results
  • Unable to discontinue certain medications that might interfere with the study drug
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Investigated drugs

RO7790121 is an investigational medication being studied for treating ulcerative colitis, which is a condition that causes inflammation in the large intestine. This medication is being tested to see if it can help reduce inflammation and symptoms in people with moderate to severe ulcerative colitis. The medication is being evaluated both for its ability to initially improve symptoms (induction therapy) and to keep symptoms under control over time (maintenance therapy).

What is already known about the treatment

RO7790121 - An investigational medication currently undergoing Phase III clinical trials for the treatment of moderately to severely active Ulcerative Colitis (UC). This drug is being studied in a double-blind, placebo-controlled trial to evaluate its effectiveness in both inducing and maintaining clinical remission in UC patients. While the specific mechanism of action and form of administration are not detailed in the source data, this experimental treatment is being investigated as a potential therapeutic option for inflammatory bowel disease management. The study is being conducted across multiple medical centers to thoroughly assess both the efficacy and safety profile of the medication.

Investigated diseases

Ulcerative Colitis - A chronic inflammatory bowel disease that causes inflammation and ulcers in the digestive tract, specifically affecting the innermost lining of the large intestine and rectum. The condition typically develops gradually and can become worse over time, causing recurring episodes of abdominal pain, diarrhea, and bloody stools. The inflammation usually begins in the rectum and lower colon but may spread continuously to involve the entire colon. During periods of active disease, symptoms can include frequent bowel movements, urgency to defecate, and fatigue.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513014-35-00Protocol codeGA45329Estimated enrolment400 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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