A Phase 4 Open-Label Study to Evaluate Vedolizumab IV Dose Optimization on Treatment Outcomes in Non-Responders with Moderately to Severely Active Ulcerative Colitis (ENTERPRET)

Phase

Condition

Ulcerative Colitis

Treatment

N/A

Clinical Study ID

TX155009

Ages 18-85
All Genders

Study Summary

This is a phase 4, open-label, multicenter study to investigate the efficacy and safety of dose optimization of vedolizumab IV, compared with standard dosing of vedolizumab IV, over a 30-week treatment period. This study will enroll adult subjects with moderately to severely active ulcerative colitis (UC) who are eligible for treatment with vedolizumab IV.

There will be up to 12 study visits, across the 30 weeks of treatment, along with a follow-up visit at Week 48, and a long-term follow-up phone call at 6 months from the last study visit.

Patients will receive up to $810 for completing the study, and Takeda has agreed to assist subjects who have finished the trial with obtaining free or lower-cost Entyvio (infusion cost will NOT be included).

Eligibility Criteria

Inclusion

Inclusion:

• Male or Female, 18 to 85 years of age

• Have had UC diagnosed at least 1 month prior to Screening, and evidence that the UC extends ≥ 15 cm from the anal verge

• Subject has demonstrated an inadequate response with, loss of response to, or intolerance to:

o Immunomodulators

o Corticosteroids

o TNF-α Antagonists

• Subjects who are naive to TNF-α antagonist therapy or who have previously failed TNF-α antagonist therapy (including primary and secondary non- responders or intolerant) may be included

Exclusion:

• Diagnosis of Crohn's or indeterminate colitis, ischemic colitis or microscopic colitis

• Extensive colonic resection, subtotal or total colectomy

• Subject has had prior exposure to Vedolizumab

• The subject has any evidence of an active infection

• History of drug or alcohol abuse within 1 year prior to the Screening visit