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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

October 12, 2011
November 2, 2016
November 2011
August 2016   (final data collection date for primary outcome measure)
  • Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to approximately Week 246 ] [ Designated as safety issue: No ]
  • 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]) ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: up to 104 weeks ] [ Designated as safety issue: No ]
  • Incidence of serious adverse events [ Time Frame: up to 104 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01461317 on ClinicalTrials.gov Archive Site
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) ] [ Designated as safety issue: No ]
  • Clinically significant changes in vital signs and safety laboratory measures [ Time Frame: up to 104 weeks ] [ Designated as safety issue: No ]
  • Study discontinuation due to adverse events [ Time Frame: up to 104 weeks ] [ Designated as safety issue: No ]
  • Incidence and nature of injection-site reactions and hypersensitivity [ Time Frame: up to 104 weeks ] [ Designated as safety issue: No ]
  • Incidence of infectious complications [ Time Frame: up to 104 weeks ] [ Designated as safety issue: No ]
  • Immunogenicity as measured by the incidence of anti-therapeutic antibodies (ATAs) [ Time Frame: up to 104 weeks ] [ Designated as safety issue: No ]
  • Clinical signs and symptoms of allergic reaction to rhuMAb Beta7 [ Time Frame: up to 104 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis
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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ulcerative Colitis
Drug: Etrolizumab
Participants will receive etrolizumab at a dose of 100 mg.
Experimental: Etrolizumab
Etrolizumab 100 milligrams (mg) subcutaneous (SC) administration every 4 weeks during the treatment period of up to 240 weeks.
Intervention: Drug: Etrolizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
121
August 2016
August 2016   (final data collection date for primary outcome measure)

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)
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Czech Republic,   Germany,   Hungary,   Israel,   New Zealand,   Spain,   United Kingdom
 
NCT01461317
GA27927, 2011-003409-36
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP