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A study to evaluate the safety and effectiveness of MB-001 in adults with moderate to severe ulcerative colitis

Investigational

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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 individuals living with Ulcerative Colitis, a condition involving long-lasting inflammation and sores in the lining of the large intestine. The purpose of the study is to evaluate the safety and effectiveness of an experimental medication called MB-001. Participants will be given either the active MB-001 drug in a capsule form taken by mouth or a placebo.

During the study, researchers will monitor how the body handles the medication and how well it works to reduce symptoms. The process involves regular check-ups to track changes in physical health, laboratory results, and signs of healing in the intestinal lining. The study will observe participants over a period of time to see if they reach clinical remission, which is a state where symptoms like blood in the stool and frequent bowel movements are significantly reduced or gone.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Participation in the study
After joining the study, an oral capsule is taken. this capsule contains either the test drug, named mb-001, or a placebo. a placebo is a substance that looks exactly like the test drug but contains no active ingredient.
Step 2
Monitoring through week 12
During the first 12 weeks, safety and effects are monitored. this includes tracking adverse events, which are any side effects or unexpected health changes, as well as checking vital signs and laboratory parameters, such as blood tests.
The effectiveness of the treatment is assessed at week 12 by checking for clinical remission. clinical remission means the ulcerative colitis symptoms are significantly reduced or absent, specifically looking at stool frequency, rectal bleeding, and the appearance of the colon during an endoscopy (a procedure where a camera is used to look inside the bowel).

Who can join the trial?

11 criteria

You must be an adult between 18 and 75 years old.
You cannot be pregnant or currently breastfeeding.
You must have a diagnosis of ulcerative colitis, which is a type of long-term inflammation in the large intestine, that has lasted for at least 3 months before the study begins.
Your ulcerative colitis must affect a significant portion of your colon, specifically extending at least 15 centimeters from the opening of the rectum.
The diagnosis must be confirmed through histology, which means a doctor has examined your tissue samples under a microscope, and through endoscopy, which is a procedure where a doctor uses a thin tube with a camera to look inside your body.
You must have moderate to severe active disease, which is measured by specific scoring systems (mMS, MES, and RB subscore) that track the level of inflammation and damage in your colon.
Depending on how long you have had your condition, you may need a colonoscopy (a full exam of the large intestine) or a flexible sigmoidoscopy (an exam of just the lower part of the colon) to check your status.
You must have already tried at least one standard treatment for ulcerative colitis that did not work well enough, or you must have been unable to take that treatment due to side effects or medical reasons. These treatments may include 5-aminosalicylic acid, corticosteroids (steroid medications used to reduce swelling), immunosuppressants (medicines that lower your immune system activity), or various biologic therapies (targeted medicines).
You are not eligible if you have already failed to respond to more than one advanced therapy, which refers to specialized, high-level medications like anti-integrin antibodies or S1PR modulators.
You may continue taking certain medications, such as 5-ASA, sulfasalazine, or specific low doses of corticosteroids, as long as your dose has been stable for at least 2 weeks or has been stopped for at least 2 weeks before your examination.
If you are taking immunosuppressants, your dose must have been stable for at least 8 weeks or stopped for at least 8 weeks before your examination.

Who cannot join the trial?

9 criteria

Having acute severe ulcerative colitis, which means having 6 or more bloody bowel movements per day along with signs like a fast heart rate, a high temperature, low hemoglobin (a protein in red blood cells that carries oxygen), a high erythrocyte sedimentation rate or C-reactive protein (both are markers that show inflammation in the body), or if a doctor believes you may need to go to the hospital soon.
A history of having a large part or all of the colon (the large intestine) surgically removed.
Having short bowel syndrome, which is a condition where the small intestine is too short to absorb enough nutrients.
Having an ileostomy, colostomy, or ileoanal pouch (surgical openings or bags used to divert waste), fistulae (abnormal tunnels connecting organs), or a known permanent narrowing of the intestine called stenosis.
Having toxic megacolon (a dangerous swelling of the colon) or a bowel perforation (a hole in the wall of the intestine) within the last 6 months.
Being diagnosed with Crohn’s disease, indeterminate colitis, ischemic colitis (damage due to low blood flow), nonsteroidal anti-inflammatory drug induced colitis (inflammation caused by certain pain relievers), radiation colitis, microscopic colitis, or infectious colitis.
Having colonic mucosal dysplasia (abnormal cell growth in the lining of the colon) or untreated bile acid malabsorption (when the body cannot properly absorb bile acids).
Having not responded well enough to more than one of the following treatments: vedolizumab, ustekinumab, anti-IL-23 p19 antibodies, or S1PR modulators.
Having not responded well enough to, or having lost the effectiveness of, TNF inhibitors or Janus kinase inhibitors.

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Investigated drugs

MB-001 is an oral capsule being tested to see if it is safe and effective for people living with moderately to severely active ulcerative colitis, which is a type of inflammatory bowel disease.

MB-001

What is already known about the treatment

MB-001
This medication is taken by mouth in the form of a capsule and is currently being studied in clinical trials to treat moderately to severely active ulcerative colitis. As an experimental drug, its exact way of working at a molecular level is still being investigated, but it is classified as a new therapeutic agent for digestive system diseases. It is designed to target the underlying causes of inflammation in the colon to help patients manage their symptoms.
Placebo
This is an inactive substance administered orally in a capsule form that contains no active medicine. It is used in clinical research as a control to compare against the experimental drug to ensure that the results are due to the medication itself. In this study, it serves as a benchmark to help researchers evaluate the safety and effectiveness of MB-001 in patients with ulcerative colitis.

Investigated diseases

Ulcerative Colitis - This is a condition that causes inflammation and sores in the inner lining of the large intestine. The inflammation typically occurs in a continuous pattern within the colon or rectum. As the disease progresses, the lining of the intestine may become swollen and develop small ulcers. This can lead to frequent changes in bowel habits and bleeding. The severity of the inflammation can vary from mild to severe.