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Completed

NCT Number: NCT01461317

Study to Evaluate the Long-term Safety of Etrolizumab in Participants 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Canberra Hospital, Garran, Australian Capital Territory, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Etrolizumab

Drug

Participants will receive etrolizumab at a dose of 100 mg.

Primary outcomes

  1. Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

    Time frame: Baseline up to approximately Week 246

  2. 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 outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Oct 28, 2011
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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