A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors (Study #1)

  • Interventional
  • Recruiting
  • NCT02163759
Eligibility Details Visit Clinicaltrials.gov

Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF Inhibitors

This Phase III, double blind, placebo and active comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active UC who are naIve to TNF inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.

Gender
All

Age Group
18 Years to 80 Years

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Diagnosis of UC established at least 3 months prior to randomization (Day 1)

         - Moderately to severely active UC as determined by the MCS

         - Naive to treatment with TNF inhibitor therapy

         - An inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment

         - Background UC therapy may include oral 5-aminosalisylate (ASA), oral corticosteroids, budesonide, probiotics, azathioprine (AZA), 6-mercaptopurine (MP), or methotrexate (MTX) if doses have been stable for the 8 weeks immediately prior to randomization

         - Use of highly effective contraception method as defined by the protocol

         - Have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening

        Exclusion Criteria:

         - A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic, radiation or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, stricture (stenosis) of the colon, toxic megacolon, or unremoved adenomatous colonic polyps

         - Prior or planned surgery for UC

         - Past or present ileostomy or colostomy

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

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

         - Congenital or acquired immune deficiency, chronic hepatitis B or C infection, HIV positive

         - Evidence of or treatment for Clostridium difficile within 60 days prior to randomization or other intestinal pathogens within 30 days prior to randomization

         - History of active or latent tuberculosis (TB), recurrent opportunistic infections, severe disseminated viral infections and organ transplant

         - Any major episode of infection requiring treatment with intravenous (IV) antibiotics within 8 weeks prior to screening or oral antibiotics within 4 weeks prior to screening

         - Received a live attenuated vaccine within 4 weeks prior to randomization

At a Glance

National Government IDNCT02163759

IRB#IRB14-1257

Lead SponsorHoffmann-La Roche

Lead PhysicianDavid T. Rubin

Collaborator(s)N/A

EligibilityAll
18 Years to 80 Years
Recruiting