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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01461317
First received: October 12, 2011
Last updated: November 2, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Ulcerative Colitis
Drug: Etrolizumab
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients With Moderate to Severe Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: 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]) ]

Secondary Outcome Measures:
  • 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) ]

Enrollment: 121
Study Start Date: November 2011
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461317

  Hide Study Locations
Locations
United States, California
La Jolla, California, United States, 92037
United States, Georgia
Atlanta, Georgia, United States, 30342
United States, Michigan
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, New York
Great Neck, New York, United States, 11021
United States, Ohio
Cincinnati, Ohio, United States, 45219
Australia, Australian Capital Territory
Garran, Australian Capital Territory, Australia, 2065
Australia, Victoria
Fitzroy, Victoria, Australia, 3065
Melbourne, Victoria, Australia, 3004
Parkville, Victoria, Australia, 3050
Belgium
Bonheiden, Belgium, 2820
Gent, Belgium, 9000
Leuven, Belgium, 3000
Canada, British Columbia
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Ontario
London, Ontario, Canada, N6A 4L6
London, Ontario, Canada, N6A 5W9
Woodbridge, Ontario, Canada, L4L 4Y7
Czech Republic
Hradec Kralove, Czech Republic, 500 12
Nachod, Czech Republic, 547 01
Ostrava - Poruba, Czech Republic, 708 52
Zlin, Czech Republic, 762 75
Germany
Berlin, Germany, 13353
Hannover, Germany, 30625
Lübeck, Germany, 23538
Minden, Germany, 32423
Ulm, Germany, 89081
Hungary
Budapest, Hungary, 1073
Budapest, Hungary, 1136
Gyor, Hungary, 9024
Israel
Beer Sheva, Israel, 84105
Haifa, Israel, 31096
Jerusalem, Israel, 91031
Ramat-Gan, Israel, 52621
Tel Aviv, Israel, 64239
New Zealand
Auckland, New Zealand
Christchurch, New Zealand, 8011
Dunedin, New Zealand, 9054
Takapuna, New Zealand, 0620
Spain
Barcelona, Spain, 08036
United Kingdom
Harrow, United Kingdom, HA1 3UJ
Newcastle upon Tyne, United Kingdom, NE1 4LP
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01461317     History of Changes
Other Study ID Numbers: GA27927  2011-003409-36 
Study First Received: October 12, 2011
Last Updated: November 2, 2016

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

ClinicalTrials.gov processed this record on January 19, 2017