This trial is active, not recruiting.

Condition ulcerative colitis
Treatment rhumab beta7
Phase phase 2
Sponsor Genentech, Inc.
Start date November 2011
End date February 2015
Trial size 116 participants
Trial identifier NCT01461317, GA27927


This study is an open-label extension (OLE) trial to evaluate the safety and tolerability of rhuMAb Beta7 in patients with moderate to severe ulcerative colitis (UC) who were enrolled in the Phase II Study ABS4986g and meet the eligibility criteria for entry in the OLE study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
rhumab beta7
Repeating subcutaneous injection

Primary Outcomes

Incidence of adverse events
time frame: up to 104 weeks
Incidence of serious adverse events
time frame: up to 104 weeks

Secondary Outcomes

Clinically significant changes in vital signs and safety laboratory measures
time frame: up to 104 weeks
Study discontinuation due to adverse events
time frame: up to 104 weeks
Incidence and nature of injection-site reactions and hypersensitivity
time frame: up to 104 weeks
Incidence of infectious complications
time frame: up to 104 weeks
Immunogenicity as measured by the incidence of anti-therapeutic antibodies (ATAs)
time frame: up to 104 weeks
Clinical signs and symptoms of allergic reaction to rhuMAb Beta7
time frame: up to 104 weeks

Eligibility Criteria

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

Inclusion Criteria: All patients (placebo or active) who were previously enrolled in the Phase II study (ABS4986g) and fulfill any of the following criteria: - Patients 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 - Patients 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 - Ability and willingness to provide written informed consent and comply with the requirements of the OLE protocol - 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) Patients at study sites in the United States must meet the following additional inclusion requirements for OLE study entry: - Concomitant immunosuppressive therapy must be discontinued before entry into this OLE study - Patients must have tapered completely off oral corticosteroids within 24 weeks of enrollment to this OLE study Exclusion Criteria: - Patients 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 GI disorders - Any new clinically significant signs or symptoms of infection as judged by the investigator - Any abnormal lab 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 Rhumab Beta7 in Patients With Moderate to Severe Ulcerative Colitis
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Genentech, Inc..