A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled (Entyvio), Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of A Study Drug in Participants with Moderately to Severely Active UC...
Published: 01/25/2019
General Information:
Full Study Title: A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled (Entyvio), Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of A Study Drug in Participants with Moderately to Severely Active Ulcerative Colitis [Expedition]
The primary objective of this study is to evaluate the efficacy and safety of a study drug versus placebo in patients with moderately to severely active Ulcerative Colitis.
Eligibility:
Inclusion criteria:
- Diagnosis of Ulcerative Colitis (UC) for at least 3 months
- Inadequate response or intolerance to conventional therapy for the treatment of UC
- Evidence of active UC based on the modified Mayo score
- No known history of active TB (certain conditions withstanding)
- Agree to practice abstinence or adhere to specific birth control requirements
Exclusion criteria:
- Participant has UC limited to the rectum
- History of fulminant colitis, a diagnosis of Crohn's disease or indeterminate colitis
- Previous intolerance or non-response to Entyvio (vedolizumab)
- Participants receiving exclusionary treatment within specified time periods
- History of cancer, except for basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
- Clinically significant infections
- Clinically significant cardiovascular conditions
- Celiac disease
- Bile acid malabsorption
- History of surgery for UC
- Breast-feeding or planning to become pregnant
- Clinically significant kidney disease
Study Details:
Study Description
- Patients will be randomly assigned to 1 of 5 study groups: three groups of active investigational study intervention at differing doses, one group of the active comparator Entyvio (Vedolizumab), and one group of placebo.
- The study duration will consist of a 4-week screening period, a 54-week treatment period and an 18-week safety follow-up period.
- The total study period will last up to 72 weeks.
- The study doctor and study staff will not know if a participant is receiving study drug, Entyvio (vedolizumab) or placebo.
- Patients will have an 80% chance of getting an active drug.
Description of Treatment or Intervention (Mechanism of Action)
- The investigational study intervention is believed to reduce inflammation in the colon and could possibly decrease the signs and symptoms of ulcerative colitis.
- The investigational study intervention will be given to patients who have failed prior treatment, have had good response or have never had treatment with a biologic to see how well the drug works in different UC populations as compared to the active comparator.
Patient Participation Requirements
- Patients will have a total of 19 study visits over the 72-week period.
- After screening, study intervention will be given through a needle in a vein (intravenously) for the first three visits.
- At all other study visits, the study intervention will be given both intravenously and as an injection under your skin (subcutaneous) every four weeks.
- Patients will also be asked to complete an electronic diary to record their general health information and UC symptoms from screening until you exit the study.
- Diaries will be completed at specific intervals from screening until you exit the study.
- At scheduled clinic visits, patients will also fill out questionnaires.
- Colonoscopy will be performed at screening and two additional flexible sigmoidosopies will be performed thereafter.
- Blood and stool samples will also be taken at screening and at specific times during the study.
Possible Risks & Side Effects
The study doctor will review all the possible risks and side effects of the experimental study intervention and active control at screening.