A Study to Assess Whether Etrolizumab is a Safe and Effective Treatment for Participants With Moderately to Severely Active Crohn's Disease (CD)

  • Interventional
  • Recruiting
  • NCT02394028
Eligibility Details Visit Clinicaltrials.gov

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction And Maintenance Treatment For Patients With Moderately to Severely Active Crohn's Disease

This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderate to severely active CD in participants who are refractory or intolerant to corticosteroids (CS), immunosuppressants (IS), or anti-tumor necrosis factors (anti-TNFs) or have inadequate response to anti-tumor necrosis factor (TNF-IR). Participants who enroll on the basis of refractory or intolerance to CS and/or IS may have been previously exposed to anti-TNFs or be naïve to anti-TNFs. The study period will consist of Screening Phase (up to 35 days) plus (+) 14-week Induction Phase + 52-week Maintenance Phase + 12-week Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving decrease of 70 points in Crohn's Disease Activity Index (CDAI) from baseline (CDAI-70 response) without the use of rescue therapy will continue to the Maintenance Phase.

Gender
All

Age Group
18 Years to 80 Years

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Moderately to severely active CD as determined by the CDAI, patient reported outcomes and endoscopically defined disease activity in the ileum and/or colon

         - Intolerance, refractory disease, or no response to CS, IS, or anti-TNF therapy within 5 years from screening. Participants who have not previously demonstrated inadequate response or intolerance to one or more anti-TNF therapies are eligible to participate in the study provided they are intolerant or refractory to CS or IS therapy

         - Use of effective contraception as defined by the protocol

        Exclusion Criteria:

         - A history of, or current conditions affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome

         - Planned surgery for CD

         - Ileostomy or colostomy

         - Has received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab, as stated in the protocol)

         - Any prior treatment with ustekinumab within 14 weeks prior to randomization

         - Chronic hepatitis B or C infection, human immunodeficiency virus (HIV), active or latent tuberculosis (participants with prior history of Bacillus Calmette-Guérin [BCG] vaccination must pass protocol-defined screening criteria)

         - Sinus tract with evidence for infection (e.g., purulent discharge) in the clinical judgment of the investigator. Fistulas related to CD are not exclusionary

         - Any prior treatment with anti-adhesion molecules (e.g., anti-mucosal addressin cell adhesion molecule [anti-MAdCAM-1])

         - Any major episode of infection requiring treatment with intravenous antibiotics </=8 weeks prior to screening or oral antibiotics </=4 weeks prior to screening. Treatment with antibiotics as adjunctive therapy for CD in the absence of documented infection is not exclusionary

         - Hospitalization (other than for elective reasons) within 4 weeks prior to randomization

At a Glance

National Government IDNCT02394028

IRB#IRB15-0149

Lead SponsorHoffmann-La Roche

Lead PhysicianDavid T. Rubin

Collaborator(s)N/A

EligibilityAll
18 Years to 80 Years
Recruiting