Overview

This trial has been completed.

Condition ulcerative colitis
Treatment etrolizumab
Phase phase 2
Sponsor Genentech, Inc.
Start date November 2011
End date August 2016
Trial size 121 participants
Trial identifier NCT01461317, 2011-003409-36, GA27927

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Etrolizumab 100 milligrams (mg) subcutaneous (SC) administration every 4 weeks during the treatment period of up to 240 weeks.
etrolizumab
Participants will receive etrolizumab at a dose of 100 mg.

Primary Outcomes

Measure
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 Outcomes

Measure
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)

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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)

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Genentech, Inc..