Abbvie M25-540: Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who are Nave to Targeted Therapies
| Sponsor: |
AbbVie |
| Enrolling: |
Male and Female Patients |
| Study Length: |
68 Weeks |
| Clinic Visits: |
12 |
| IRB Number: |
AAAV8334 |
| U.S. Govt. ID: |
NCT06880744 |
| Contact: |
Claudia Musat: 212-342-4102 / surgcoreresearch@cumc.columbia.edu |
The purpose of this study is to compare the efficacy and safety of two standard-of-care drugs, Risankizumab (Skyrizi) versus Vedolizumab (Entyvio), over 48 weeks to compare how well these drugs work in patients with moderate to severe Ulcerative Colitis (UC). This study is being conducted at approximately 285 research centers worldwide and is expected to enroll approximately 530 patients in total with moderately to severely active UC. Your study participation could be up to approximately 69 weeks if you are assigned to the risankizumab group or up to 71 weeks if you are assigned to the vedolizumab group. This includes up to a 35-day screening period followed by a primary treatment period of 44 weeks for risankizumab and 46 weeks for vedolizumab, and a 140-day follow-up call after the last dose of study drug. The only difference in this study is that you will be randomly assigned (like flipping a coin) to receive either risankizumab or vedolizumab. The dose you get will be the same as what you would receive if your doctor prescribed the medication outside of the study.
Investigator
Le-Chu Su, MD
| Are you between 18 and 80 years old? |
Yes |
No |
| Have you had active ulcerative colitis for at least 3 months (a condition that causes inflammation in the colon)? |
Yes |
No |
| Have you not gotten enough relief from, or could not tolerate, common medications designed to treat ulcerative colitis? |
Yes |
No |
| Have you ever taken any advanced or targeted treatments for ulcerative colitis such as infliximab, etanercept, adalimumab, etc? |
Yes |
No |