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Study of RO7837195 injection compared to placebo to treat moderate to severe ulcerative colitis

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 clinical trial focuses on patients with Ulcerative Colitis, a chronic inflammatory condition affecting the large intestine. The study specifically targets individuals with moderately to severely active disease. The investigational medication being tested is RO7837195, which is a recombinant bispecific antibody given as a solution for injection under the skin (subcutaneous use).

The purpose of this study is to determine if RO7837195 is effective in inducing remission in people with moderately to severely active Ulcerative Colitis when compared to placebo. The study is designed as a double-blind trial, meaning neither the participants nor the doctors know who receives which treatment during the study. The medication will be tested over a 12-week period, followed by an additional treatment phase.

During the study, participants will receive either RO7837195 or placebo through injections under the skin. The study will monitor various aspects of the disease activity, including symptoms such as stool frequency and bleeding. The researchers will also track how the body processes the medication and check for any potential side effects throughout the study 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.

Step 1
Initial screening
Your ulcerative colitis (UC) diagnosis must be confirmed by clinical and endoscopic examination
A colonoscopy or flexible sigmoidoscopy will be performed to verify that your UC extends at least 15 cm from the anal area
Your disease activity will be assessed using a modified Mayo Score to confirm moderate to severe UC
Step 2
Treatment phase - first 12 weeks
You will receive either RO7837195 or a placebo through subcutaneous injection (injection under the skin)
Regular assessments will monitor your response to treatment
Your stool frequency and any rectal bleeding will be tracked
Blood tests will be conducted to measure drug levels in your body
Your vital signs and laboratory test results will be monitored throughout the study
Step 3
Week 12 evaluation
An endoscopic examination will be performed to assess your response to treatment
Your disease activity will be measured using the modified Mayo Score
The effectiveness of the treatment will be evaluated based on improvements in your symptoms
Blood tests will check for the presence of antibodies to the study medication
Step 4
Active treatment extension
Following the initial 12-week period, you may continue in an extended treatment phase
Regular monitoring of your condition will continue
Safety assessments and blood tests will be performed periodically
The study will continue until approximately June 2028

Who can join the trial?

8 criteria

Must be diagnosed with Ulcerative Colitis (UC) for at least 3 months before screening, confirmed by clinical examination and internal viewing of the colon during screening
The inflammation in your colon must extend at least 15 centimeters from the anus, as shown by examination with a flexible tube with a camera (endoscopy) during screening
Must have had a complete colon examination (colonoscopy) within the past 2 years, or be willing to have one during screening instead of a partial examination
Must have moderate to severe active UC, as measured by a special scoring system called the modified Mayo Score of 5-9, including signs of inflammation seen during the internal examination
Must agree to follow the study's requirements for birth control and pregnancy prevention
Must have previously tried and not responded adequately to standard UC treatments or advanced therapies
Must be an adult (18 years or older)
Can be either male or female

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
Current or recent participation in other clinical trials (within last 30 days)
Major surgery within the past 3 months
Active or chronic infections, including tuberculosis or hepatitis (liver inflammation)
History of cancer in the past 5 years (except successfully treated skin cancer)
Severe heart, liver, or kidney disease
Current substance abuse or alcohol dependence
Mental health conditions that could interfere with study participation
Use of prohibited medications, including immunosuppressants (medications that weaken the immune system)
History of gastrointestinal perforation (hole in the digestive tract)
Severe, uncontrolled inflammatory bowel disease (severe gut inflammation)
Blood disorders or significant abnormal blood test results
Unable to provide informed consent

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Verified sites

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Responsive
Azienda Ospedaliera Ordine Mauriziano Di Torino
Turin, Italy
Verified
Centre Hospitalier Lyon Sud
Pierre Benite, France
Verified
Centre Medico Chirurgical Ambroise Pare Hartmann
Neuilly-Sur-Seine, France

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Investigated drugs

RO7837195 is an investigational medication being studied for treating ulcerative colitis, which is a condition that causes inflammation in the large intestine. The medication is being tested to see if it can help reduce inflammation and symptoms in patients with moderate to severe forms of the disease. This is a new drug that is still known by its development code name since it hasn't yet been given an official generic or brand name.

RO7837195

What is already known about the treatment

RO7837195 - An investigational medication currently being studied in Phase IIb clinical trials for the treatment of moderately to severely active Ulcerative Colitis (UC). This experimental drug is being evaluated for its efficacy in inducing remission in UC patients, with the trial designed as a multicenter, double-blind, placebo-controlled study that includes an active treatment extension phase. The medication is being assessed not only for its effectiveness but also for its safety profile and pharmacokinetic properties in patients with inflammatory bowel conditions. Since this is an investigational drug still in clinical trials, its specific mechanism of action and final form of administration are yet to be fully established in medical literature.

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 over time, with symptoms that can include diarrhea, abdominal pain, and rectal bleeding. The inflammation usually begins in the rectum and lower colon but may spread continuously to involve other parts of the colon. Patients experience periods of active disease (flares) alternating with periods of remission. The disease can cause changes in bowel habits and frequent urgency to empty the bowels.