Acute haemorrhagic ulcerative colitis Trials in Disease

Study Comparing AVT16 and Vedolizumab for Adults with Moderate to Severe Ulcerative Colitis

This clinical trial is investigating two treatments for moderate to severe ulcerative colitis, a condition that causes inflammation and sores in the large intestine and rectum. The study lasts approximately 52 weeks and involves regular check-ups to monitor participants' health and treatment response.

Main focus: The trial aims to compare the effectiveness, safety, and immune response of AVT16, a proposed biosimilar medication, with Entyvio (vedolizumab), an established treatment. Both medications are given through an intravenous infusion directly into the bloodstream. Researchers will assess whether AVT16 works as well as Entyvio in managing symptoms, promoting healing of the colon lining, and maintaining safety.

Investigational drugs: The trial tests two medications:

• AVT16 is a biosimilar medication being developed as an alternative treatment. A biosimilar is a drug that is very similar to an already approved medication and is expected to have the same therapeutic effects. AVT16 is a monoclonal antibody that targets specific proteins involved in the inflammatory process to reduce inflammation in the colon.
• Entyvio (vedolizumab) is the reference medication used for comparison. It is an established treatment that works by targeting specific proteins in the body to reduce inflammation and help manage symptoms of ulcerative colitis.

Who can participate:

• Adults aged 18 to 80 years with a diagnosis of moderate to severe active ulcerative colitis
• Individuals who are able to provide consent to participate
• Patients who have not responded well to, lost response to, or could not tolerate at least one previous treatment for ulcerative colitis within the past 5 years
• Women must not be pregnant or breastfeeding and must agree to use reliable birth control during the study and for 18 weeks after the last treatment
• Men with partners who can become pregnant must use appropriate contraception methods and agree not to donate sperm during the study and for 18 weeks afterward
• Patients with certain types or durations of colitis must have had recent colonoscopy examinations and be up to date with colorectal cancer screenings if they have risk factors
• Current use of certain medications such as oral 5-aminosalicylic acid, oral corticosteroids, probiotics, antidiarrheals, azathioprine, or 6-mercaptopurine is permitted

Who cannot participate:

• Individuals who do not have moderate to severe active ulcerative colitis
• People outside the specified age range of 18 to 80 years
• Members of vulnerable populations who may be at higher risk of harm or exploitation, such as certain groups with disabilities

Treatment timeline: Participants receive their first infusion at the beginning of the study, with additional infusions at Week 2 and Week 6. After an initial assessment at Week 6 to evaluate symptom reduction, treatment continues with infusions at Weeks 14, 22, 30, 38, and 46. Throughout the study, regular monitoring includes checking vital signs, conducting laboratory tests, and watching for any adverse reactions. A comprehensive final assessment occurs at Week 52 to evaluate clinical remission and healing of the colon lining.