This clinical trial is focused on studying the effects of two treatments for ulcerative colitis, a condition that causes inflammation and sores in the digestive tract. The study involves two medications: AVT16, a proposed biosimilar, and Entyvio (also known as vedolizumab). Both medications are given as a solution through an intravenous infusion, which means they are administered directly into the bloodstream through a vein.
The purpose of the study is to compare the effectiveness, safety, and immune response of AVT16 and Entyvio in people aged 18 to 80 who have moderate to severe active ulcerative colitis. Participants will receive either AVT16 or Entyvio, and some may receive a placebo. The study will last for about 46 weeks, during which participants will have regular check-ups to monitor their health and the effects of the treatment.
Throughout the study, participants will be assessed at various intervals to see how well the treatment is working. This includes checking for clinical responses, which are improvements in symptoms, and clinical remission, which is when symptoms are reduced or disappear. The study will also look at mucosal healing, which is the healing of the lining of the colon, and other health markers like albumin and CRP levels. Safety will be monitored by looking at any side effects or reactions to the infusion. The goal is to determine if AVT16 is as effective and safe as Entyvio for treating ulcerative colitis.
1initial treatment phase
The study involves the administration of two medications: AVT16 and Entyvio. Both are given as a solution for infusion, which means they are administered directly into the bloodstream through a vein.
The initial phase of the treatment involves receiving the infusion at specific intervals. The first infusion is given at the start of the study, followed by additional infusions at Week 2 and Week 6.
2assessment at week 6
At Week 6, an assessment is conducted to evaluate the response to the treatment. This includes measuring the reduction in symptoms related to ulcerative colitis, such as rectal bleeding.
The primary goal is to observe a clinical response, which is defined by a reduction in the severity of symptoms.
3continued treatment and monitoring
After the initial assessment, the treatment continues with infusions at Weeks 14, 22, 30, 38, and 46.
Throughout this period, regular monitoring is conducted to assess the effectiveness and safety of the treatment. This includes checking vital signs, conducting laboratory tests, and monitoring for any adverse reactions.
4final assessment at week 52
At Week 52, a comprehensive assessment is performed to evaluate the overall response to the treatment.
This includes checking for clinical remission, which means the absence of symptoms, and mucosal healing, which refers to the healing of the lining of the colon.
5end of study procedures
After the final assessment, the study concludes with end-of-study procedures. These may include a final physical examination and laboratory tests to ensure the participant’s health and safety.
Participants are provided with information about the results of the study and any necessary follow-up care.
Who Can Join the Study?
Participants must be men or women aged 18 to 80 years old.
Participants must be able to give their consent to join the study.
Women can join if they are not pregnant or breastfeeding and meet one of the following conditions:
They are not able to have children, which means they have had surgery to remove certain reproductive organs or have not had a menstrual period for 12 months without another medical reason.
If they can have children, they must agree to use a reliable form of birth control during the study and for 18 weeks after the last treatment.
Men who have partners that can have children can join if they agree to:
Not have sexual intercourse as their usual lifestyle choice.
Use a condom with spermicide and ensure their partner uses a reliable form of birth control.
If their partner is pregnant or breastfeeding, they must use a condom with spermicide or not have sexual intercourse.
Not donate sperm during the study and for 18 weeks after the last treatment.
Participants must have a diagnosis of Ulcerative Colitis (UC), which is a condition that causes inflammation in the colon.
The UC must be moderate to severe in activity.
Participants must have evidence of UC.
Participants with extensive colitis or pancolitis for more than 8 years, or left-sided colitis for more than 12 years, must have had a colonoscopy within 12 months before the study starts.
Participants with a family history of colorectal cancer, personal history of increased risk, age over 50, or other risk factors must be up to date with colorectal cancer checks.
Participants must have shown in the past 5 years that they did not respond well, lost response, or could not tolerate at least one treatment for UC.
Participants may be taking certain medications like oral 5-aminosalicylic acid (5-ASA), oral corticosteroids, probiotics, antidiarrheals, azathioprine, or 6-mercaptopurine.
Who Cannot Join the Study?
Patients who do not have Moderate to Severe Active Ulcerative Colitis cannot participate. This is a condition where the inner lining of the large intestine and rectum becomes inflamed and develops sores.
Patients who are not within the specified age range cannot participate. The age range includes adults and older children.
Both males and females can participate, so gender is not a reason for exclusion.
Patients who are considered part of a vulnerable population may be excluded. This term refers to groups of people who might be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.
AVT16 is a medication being tested as a potential biosimilar to another drug used for treating ulcerative colitis. A biosimilar is a drug that is very similar to an already approved medication, known as the reference product, and is expected to have the same therapeutic effects. In this trial, AVT16 is being compared to see if it works just as well as the reference medication in treating moderate to severe active ulcerative colitis.
Entyvio is the reference medication in this study. It is an established treatment for ulcerative colitis, a condition that causes inflammation and sores in the digestive tract. Entyvio works by targeting specific proteins in the body to reduce inflammation and help manage symptoms of the disease. The trial aims to compare the effects of AVT16 to those of Entyvio to ensure that the new medication is just as effective and safe for patients.
Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the colon, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease often progresses with periods of exacerbation and remission. During flare-ups, individuals may experience increased urgency to defecate and fatigue. Over time, the inflammation can lead to complications such as strictures or increased risk of colon cancer. The severity of symptoms can vary, with some individuals experiencing mild discomfort and others facing more severe challenges.
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