A study to evaluate the long term safety of etrolizumab in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 108

Inclusion Criteria

• All patients (placebo or active) who were previously enrolled in the Phase II study (ABS4986g) and who have completed this study or who fulfill any of the criteria specified in the protocol regarding clinical response.
• 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 (e.g., hormonal contraceptive [oral or patch], vaginal ring, intrauterine device, physical barrier, or vasectomized partner) from study start to a minimum of 4 months (approximately 5 half lives)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 114
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

• Pregnancy or lactation
• Any new malignancy within the past 6 months
• Any new, significant, uncontrolled co morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or GI disorders (since enrolling in the Phase II study [ABS4986g])
• 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) as follows:
Moderate to severe anemia (hemoglobin less than 9 g/dL)
Impaired renal function (serum creatinine greater than 1.5 x upper limit of normal [ULN])
Impaired hepatic function in the absence of a diagnosis of primary sclerosing cholangitis (serum transaminases greater than 2.5 x ULN, alkaline phosphatase greater than 2.5 x ULN, total bilirubin greater than 1.5 x ULN, or abnormalities in synthetic liver function tests judged by the investigator to be clinically significant). If the patient has a diagnosis of primary sclerosing cholangitis, serum transaminases grater than 3 x ULN, alkaline phosphatase greater than 3 x ULN, total bilirubin greater than 2.5 x ULN, or abnormalities in synthetic liver function tests judged by the investigator to be clinically significant.
Thrombocytopenia (platelet count less than 75,000/microL)
Neutropenia (absolute neutrophil count less than 1500/microL)
Lymphopenia (absolute lymphocyte count less than 500/microL)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To obtain long-term data on the effectiveness, immunogenicity and exposure of etrolizumab;Primary end point(s): The primary endpoints are safety endpoints, including the adverse event incidence, serious adverse event incidence, changes in safety laboratory tests, analytes (ie, serum chemistry), physical examination and vital signs, and specific evaluations for immunogenicity, allergic reaction, injection site reactions and progressive multifocal leukoencephalopathy (PML).;Timepoint(s) of evaluation of this end point: N/A;Main Objective: To assess the long-term safety and tolerability of etrolizumab, as measured by adverse events, immunogenicity and safety laboratory parameters, over an extended treatment period of up to 240 weeks (July 2016)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A

Updated 10/16/2023

A study to evaluate the long term safety of etrolizumab in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease)

Recruitment & Eligibility

Study & Design

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