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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms Accepts Healthy Volunteers	No
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. Study Type	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

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

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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. Trial ID:	NCT02394028
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. Phase	Phase 3
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. Lead Sponsor	Hoffmann-La Roche
The person who is responsible for the scientific and technical direction of the entire clinical study. Principal Investigator	Clinical Trials
Principal Investigator Affiliation	Hoffmann-La Roche
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. Agency Class	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czechia, Estonia, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States
The disease, disorder, syndrome, illness, or injury that is being studied. Conditions	Crohn Disease

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Moore Clinical Trials, LLC, Sherwood, Arkansas

Status

Terminated

Address

Moore Clinical Trials, LLC

Sherwood, Arkansas, 72120

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