This study focuses on Ulcerative Colitis, a chronic inflammatory condition affecting the large intestine. The research compares the effectiveness and safety of two medications: risankizumab and vedolizumab in adults with moderate to severe ulcerative colitis who have not previously received targeted therapies. Both medications are designed to reduce inflammation in the digestive tract but work through different mechanisms in the immune system.
The purpose of this study is to determine whether risankizumab is as effective as or more effective than vedolizumab for treating ulcerative colitis over a 48-week period. Participants in this study will have already tried other conventional treatments such as aminosalicylates (anti-inflammatory drugs), steroids, or immunomodulators without adequate relief of their symptoms.
During the study, participants will be randomly assigned to receive either risankizumab or vedolizumab. The study will monitor improvements in the intestinal lining through endoscopy (a procedure where a small camera is used to examine the inside of the colon) and track symptom improvement including stool frequency and rectal bleeding. This is an open-label study, meaning both the healthcare providers and participants will know which medication is being administered.
1Screening and Enrollment
You will be enrolled in this study if you have been diagnosed with Ulcerative Colitis for at least 3 months. Ulcerative Colitis is a condition where the lining of the large intestine (colon) becomes inflamed and develops ulcers.
To qualify, you must have active Ulcerative Colitis with a modified Mayo Score of 5 to 9 points and an endoscopic subscore of 2 to 3, as confirmed by a central reader.
You must have shown intolerance or inadequate response to previous treatments such as aminosalicylates, oral locally acting steroids, systemic steroids (prednisone or equivalent), or immunomodulators.
2Random Assignment to Treatment Group
You will be randomly assigned to receive either risankizumab or vedolizumab (also known as Entyvio).
This is an open-label study, which means both you and your doctor will know which medication you are receiving.
3Treatment Period (48 Weeks)
If assigned to the risankizumab (ABBV-066) group, you will receive this medication as a solution for injection in a pre-filled syringe.
If assigned to the vedolizumab (Entyvio) group, you will receive 300 mg as a solution for infusion. An infusion means the medication is given directly into your vein.
You will continue treatment for 48 weeks (approximately 11 months).
Throughout this period, your condition will be regularly monitored to assess how well the treatment is working.
4Assessment at Week 48
At the end of the 48-week treatment period, you will undergo an endoscopy (a procedure where a small camera is inserted into the colon to examine the lining).
The doctors will assess whether you have achieved endoscopic improvement, defined as an endoscopy subscore of 0 or 1 (excluding friability, which means bleeding when touched).
They will also determine if you have achieved clinical remission, which includes improvements in stool frequency, rectal bleeding, and endoscopy results.
5Study Completion
After completing the 48-week treatment period and final assessments, your participation in the study will end.
The overall study is expected to run until July 2025, with final data collection completed by October 2028.
Who Can Join the Study?
You have been diagnosed with Ulcerative Colitis (a chronic inflammatory disease affecting the colon) for at least 3 months before starting the study.
You have active Ulcerative Colitis with a modified Mayo Score (a scale measuring disease activity) of 5 to 9 points.
You have an endoscopic subscore (a rating of how your colon looks during examination) of 2 to 3, which indicates moderate to severe inflammation as confirmed by a central reader.
You have tried one or more of these medications but either couldn’t tolerate them or they didn’t work well enough for you:
Aminosalicylates (anti-inflammatory drugs like mesalamine)
Oral locally acting steroids (steroids that work mainly in the gut like budesonide)
Systemic steroids (like prednisone that affect the whole body)
Immunomodulators (medications that modify your immune system like azathioprine)
You have not previously received targeted therapies (newer medications like biologics that target specific parts of the immune system) for your Ulcerative Colitis.
Who Cannot Join the Study?
Previous use of targeted therapies (specific medications designed to target certain processes in the body related to ulcerative colitis)
Having Crohn’s disease (another type of inflammatory bowel disease) instead of ulcerative colitis
History of intestinal surgery related to ulcerative colitis, such as removal of part of the intestine
Current intestinal infections that could worsen symptoms
Active or latent tuberculosis (TB) infection
Recent serious infections requiring hospitalization or intravenous antibiotics
History of cancer (except for successfully treated non-melanoma skin cancer)
Severe liver disease or abnormal liver function tests
Serious heart conditions or uncontrolled high blood pressure
Pregnant or breastfeeding women, or those planning pregnancy during the study
Current participation in another clinical trial
Known allergies to the study medications or their ingredients
Unwillingness to follow study procedures or attend required visits
Risankizumab is a medication that works by blocking a specific protein in the body called interleukin-23 (IL-23). By blocking this protein, risankizumab helps reduce inflammation in the digestive tract. It is being studied as a treatment for moderate to severe ulcerative colitis, which is a condition that causes inflammation and sores in the lining of the large intestine.
Vedolizumab is a medication that works by preventing certain white blood cells from entering the intestinal tissue. This helps reduce inflammation in the digestive tract. It is already approved for treating ulcerative colitis and is being used as a comparison treatment in this study.
Ulcerative Colitis – A chronic inflammatory bowel disease that causes inflammation and ulcers in the innermost lining of the large intestine (colon) and rectum. The disease typically begins in the rectum and lower colon but may spread continuously to involve the entire colon. Ulcerative colitis is characterized by recurring episodes of abdominal pain, diarrhea, and rectal bleeding. The condition often progresses gradually over time, with symptoms ranging from mild to severe depending on the extent of inflammation and the amount of the colon affected. Patients may experience periods of active disease (flares) alternating with periods of remission when symptoms subside.
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