Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis

February 3, 2020 updated by: Genentech, Inc.

A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients With Moderate to Severe Ulcerative Colitis

This study is an open-label extension (OLE) trial to evaluate the safety and tolerability of etrolizumab in participants with moderate to severe ulcerative colitis (UC) who were enrolled in the Phase II Study ABS4986g (NCT01336465) and meet the eligibility criteria for entry in the OLE study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2065
        • The Canberra Hospital
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's Hospital Melbourne; Department of Gastroenterology
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital; Gastroenterology
  • Belgium
      • Bonheiden, Belgium, 2820
        • Imeldaziekenhuis
      • Gent, Belgium, 9000
        • UZ Gent
      • Leuven, Belgium, 3000
        • UZ Leuven Gasthuisberg
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • GI Research Institute
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • London Health Sciences Centre; Victoria Hospital
      • London, Ontario, Canada, N6A 4L6
        • London Health Sciences Centre
      • Woodbridge, Ontario, Canada, L4L 4Y7
        • Toronto Digest. Disease Asso.
  • Czechia
      • Hradec Kralove, Czechia, 500 12
        • Poliklinika Iii, Hk; Hepatogatroenterolgy
      • Nachod, Czechia, 547 69
        • Oblastni nemocnice Nachod a.s.; Endoskopicke centrum
      • Ostrava - Poruba, Czechia, 708 52
        • Fakultni Nemocnice Ostrava
      • Zlin, Czechia, 762 75
        • Krajska Nemocnice Tomase Bati
  • Germany
      • Berlin, Germany, 13353
        • CAMPUS VIRCHOW-KLINIKUM; Charité Centrum 13; Med. Klinik Abt. Hepatologie u. Gastroenterologie
      • Hannover, Germany, 30625
        • Med. Hochschule Hannover; Gastroenterologie
      • Kiel, Germany, 24105
        • Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin
      • Minden, Germany, 32423
        • Facharzt für Gastroenterologie
      • Ulm, Germany, 89081
        • Univ klinikum Ulm; Medizin Zentrum Innere Medizin I
  • Hungary
      • Budapest, Hungary, 1073
        • ENDOMEDIX Kft; Gasztroenterológia Budapest
      • Budapest, Hungary, 1136
        • Pannónia Klinika Magánorvosi
      • Gyor, Hungary, 9024
        • Petz Aladar County Hosp; 1St Dept. of Internal Med.
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Medical Center
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Ctr; Dept. of Gastroenterology
      • Ramat-Gan, Israel, 5262100
        • The Chaim Sheba Medical Center; Multiple Sclerosis Center
      • Tel Aviv, Israel, 6423900
        • Tel Aviv Sourasky Medical Ctr; Gastroenterology Department
  • New Zealand
      • Auckland, New Zealand
        • Middlemore Hospital
      • Christchurch, New Zealand, 8011
        • University of Otago, Christchurch
      • Dunedin, New Zealand, 9054
        • Dunedin Hospital; Otago District Health Board
      • Takapuna, New Zealand, 0620
        • Shakespeare Specialist Group
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic i Provincial
  • United Kingdom
      • Harrow, United Kingdom, HA1 3UJ
        • St. Mark's Hospital; Inflammatory Bowel Disease Unit
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
  • United States
    • California
      • La Jolla, California, United States, 92037
        • University of California, San Diego
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastroenterology Associates
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Clin Rsch Asc, LLP
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clin. Rsrch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All participants (placebo or active) who were previously enrolled in the Phase II study (ABS4986g) and fulfill any of the following criteria:
  • Participants who have not obtained a clinical response in the Phase II study (ABS4986g) by Week 10 (the end of the Phase II treatment phase) may enter this OLE trial at any time after Week 10 and up to and including Week 28
  • Participants who have a clinical response in the Phase II study (ABS4986g) at Week 10 but have had a flare of UC between Week 10 and Week 28
  • Males and females with reproductive potential must be willing to use a highly effective method of contraception, vaginal ring, intrauterine device, physical barrier, or vasectomized partner) from study start to a minimum of 4 months (approximately 5 half-lives)
  • Concomitant immunosuppressive therapy must be tapered within 6 weeks after enrollment in this OLE study
  • Participants must have tapered completely off oral corticosteroids within 24 weeks of enrollment to this OLE study

Exclusion Criteria:

  • Participants who did not complete through Week 10 of the Phase II study (ABS4986g)
  • Pregnancy or lactation
  • Any new malignancy within the past 6 months
  • Any new (since enrolling in the Phase II study [ABS4986g]), significant, uncontrolled, co- morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal (GI) disorders
  • Any new clinically significant signs or symptoms of infection as judged by the investigator
  • Any abnormal laboratory values recorded at the last visit completed in the Phase II study (ABS4986g)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Etrolizumab
Etrolizumab 100 milligrams (mg) subcutaneous (SC) administration every 4 weeks during the treatment period of up to 240 weeks.
Drug: Etrolizumab
Participants will receive etrolizumab at a dose of 100 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time Frame: Baseline up to approximately Week 246
Baseline up to approximately Week 246
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
Time Frame: Baseline up to approximately Week 246 (assessed at predose (Hour 0) at baseline, Weeks 4, 8, 12, and every 12 weeks thereafter up to Week 252, 12 weeks after last dose [up to approximately Week 246])
Baseline up to approximately Week 246 (assessed at predose (Hour 0) at baseline, Weeks 4, 8, 12, and every 12 weeks thereafter up to Week 252, 12 weeks after last dose [up to approximately Week 246])

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum Concentrations of Etrolizumab
Time Frame: Predose (Hour 0) at baseline, Weeks 4, 8, 12, and every 12 weeks thereafter up to approximately Week 246; 12 weeks after last dose (up to approximately Week 246)
Predose (Hour 0) at baseline, Weeks 4, 8, 12, and every 12 weeks thereafter up to approximately Week 246; 12 weeks after last dose (up to approximately Week 246)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2011

Primary Completion (Actual)

August 7, 2016

Study Completion (Actual)

August 7, 2016

Study Registration Dates

First Submitted

October 12, 2011

First Submitted That Met QC Criteria

October 27, 2011

First Posted (Estimate)

October 28, 2011

Study Record Updates

Last Update Posted (Actual)

February 10, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA27927
  • 2011-003409-36 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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