RAVAMP UC
Summary
The purpose of this study is to compare the efficacy and safety of risankizumab versus vedolizumab over 48 weeks to compare how well these drugs work in patients with moderate to severe Ulcerative Colitis (UC).
Both study drugs risankizumab and vedolizumab are currently approved in multiple countries for the treatment of adults with moderate to severe Ulcerative Colitis (UC) and Crohn’s disease(CD).
You have been diagnosed with UC disease and are experiencing symptoms such as diarrhea with or without blood, abdominal pain and/or a sudden and constant feeling that you have to move your bowels. Additionally, you have been never treated with some medications that help reduce the inflammation associated with your disease that are referred to as targeted therapies.
Risankizumab is made in the laboratory and is a monoclonal antibody which means that it is the same as a protein in your body, called an antibody. It works by blocking the actions of a protein known as Interleukin 23. Interleukin 23 is involved in the immune response and plays an important role in the development of chronic inflammation. Risankizumab is currently approved in multiple countries for the treatment of adults with moderate to severe UC and CD.
Vedolizumab is a monoclonal antibody which is directed against the α4β7 heterodimer which is expressed on most leucocytes (a type of blood cell that is made in the bone marrow and found in the blood and lymph tissue) and is important for migration of leucocytes to gut-associated lymphoid tissues. Vedolizumab is approved in multiple countries for both moderately to severely active UC and CD.
Eligibility
Eligible ages: 18 to 80
Inclusion criteria:
Inclusion Criteria:
Participant has confirmed diagnosis of Ulcerative Colitis (UC) for at least 3 months prior to Baseline.
Participant has active UC with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader).
Participant has demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates, oral locally acting steroids, systemic steroids (prednisone or equivalent), and immunomodulators.
Exclusion Criteria:
Participant has received any targeted therapies (TaTs) for UC, including but not limited to infliximab, etanercept, adalimumab, natalizumab, golimumab, ozanimod, ustekinumab, etrolizumab, vedolizumab, tofacitinib, filgotinib, etrasimod, guselkumab, mirikizumab, upadacitinib, and risankizumab.
Participant with a current diagnosis of Crohn's disease (CD) or Irritable Bowel Disease (IBD)-unclassified or a history of radiation colitis or ischemic colitis.
Currently known complications of UC such as: fulminant colitis and/or toxic megacolon, acute severe UC, previous colectomy (total or subtotal), or any other manifestation that might require surgery while in the study
Active systemic infection/clinically important infection during the last 2 weeks prior to Baseline Visit as assessed by the investigator.
Exclusion criteria:
Participant has received any targeted therapies (TaTs) for UC, including but not limited to infliximab, etanercept, adalimumab, natalizumab, golimumab, ozanimod, ustekinumab, etrolizumab, vedolizumab, tofacitinib, filgotinib, etrasimod, guselkumab, mirikizumab, upadacitinib, and risankizumab.
Participant with a current diagnosis of Crohn's disease (CD) or Irritable Bowel Disease (IBD)-unclassified or a history of radiation colitis or ischemic colitis.
Currently known complications of UC such as: fulminant colitis and/or toxic megacolon, acute severe UC, previous colectomy (total or subtotal), or any other manifestation that might require surgery while in the study
Active systemic infection/clinically important infection during the last 2 weeks prior to Baseline Visit as assessed by the investigator.
Participate
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Additional information
Contact information
Karen Graham
Principal investigator:
Remo Panaccione
Clinical trial:
Yes
REB-ID:
REB25-0155
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