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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)

This study is currently recruiting participants.
Verified November 2017 by Hoffmann-La Roche
Sponsor:
ClinicalTrials.gov Identifier:
NCT02163759
First Posted: June 16, 2014
Last Update Posted: November 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention Phase
Ulcerative Colitis Drug: Adalimumab Other: Adalimumab Placebo Drug: Etrolizumab Other: Etrolizumab Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Induction of Remission Compared With Placebo as Determined by the Mayo Clinic Score (MCS) [ Time Frame: Week 10 ]

Secondary Outcome Measures:
  • Percentage of Participants With Induction of Remission Compared With Adalimumab as Determined by the MCS [ Time Frame: Week 10 ]
  • Percentage of Participants With Induction of Clinical Remission as Determined by the MCS [ Time Frame: Week 10 ]
  • Percentage of Participants With Clinical Response as Determined by the MCS [ Time Frame: Week 10 ]
  • Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa as Determined by the Mayo Endoscopic Subscore [ Time Frame: Week 10 ]
  • Percentage of Participants With Endoscopic Remission as Determined by the Mayo Endoscopic Subscore [ Time Frame: Week 10 ]
  • Percentage of Participants who Achieve Remission at Week 10 and who Maintained Remission to Week 14 as Determined by MCS [ Time Frame: Week 10 and 14 ]
  • Percentage of Participants With Histological Remission as Determined by the Geboes Histological Subscore [ Time Frame: Week 10 ]
  • Percentage of Participants With Remission, Among Alpha E Integrin High Participants as Determined by the MCS [ Time Frame: Week 10 ]
  • Change From Baseline to Week 10 in UC Bowel Movement Signs and Symptoms, as Assessed by UC-Participant-Reported Outcome Signs and Symptoms (PRO/SS) [ Time Frame: Baseline, Week 10 ]
  • Change From Baseline to Week 10 in UC Abdominal Symptoms, as Assessed by UC-PRO/SS [ Time Frame: Baseline, Week 10 ]
  • Change From Baseline to Week 10 in Health-Related Quality of Life (QOL), as Assessed by Overall Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline, Week 10 ]
  • Pharmacokinetics of Etrolizumab: Serum Concentration [ Time Frame: Pre-dose (0 hour) on Day 1, Week 10, Week 14, early termination/end of safety follow-up (up to Week 26) ]
  • Percentage of Participants With Adverse Events [ Time Frame: Baseline up to end of study (up to Week 26) ]
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Etrolizumab [ Time Frame: Pre-dose (0 hour) on Day 1, Week 4, Week 10, Week 14, early termination/end of safety follow-up (up to Week 26) ]

Estimated Enrollment: 350
Actual Study Start Date: November 4, 2014
Estimated Study Completion Date: October 30, 2020
Estimated Primary Completion Date: October 30, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Adalimumab + Etrolizumab Placebo
Participants will receive adalimumab up to Week 8 and placebo matching to etrolizumab up to Week 12.
Drug: Adalimumab
Adalimumab 160 milligrams (mg) will be administered subcutaneously (SC) at Week 0; 80 mg SC at Week 2; 40 mg SC at Weeks 4, 6 and 8.
Other Name: Humira
Other: Etrolizumab Placebo
Placebo matching to etrolizumab will be administered SC Q4W.
Experimental: Etrolizumab + Adalimumab Placebo
Participants will receive etrolizumab up to Week 12 and placebo matching to adalimumab up to Week 8.
Other: Adalimumab Placebo
Placebo matching to adalimumab will be administered SC at Weeks 0, 2, 4, 6 and 8.
Drug: Etrolizumab
Etrolizumab 105 mg will be administered SC every 4 weeks (Q4W).
Placebo Comparator: Etrolizumab Placebo + Adalimumab Placebo
Participants will receive placebo matching to etrolizumab up to Week 12 and placebo matching to adalimumab up to Week 8.
Other: Adalimumab Placebo
Placebo matching to adalimumab will be administered SC at Weeks 0, 2, 4, 6 and 8.
Other: Etrolizumab Placebo
Placebo matching to etrolizumab will be administered SC Q4W.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163759


Contacts
Contact: Reference Study ID Number: GA28948 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Show 135 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02163759     History of Changes
Other Study ID Numbers: GA28948
2013-004279-11 ( EudraCT Number )
First Submitted: June 12, 2014
First Posted: June 16, 2014
Last Update Posted: November 27, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents