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

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2011-003409-36-CZ
• Date of registration: 18/11/2011
• Prospective Registration: Yes
• Primary sponsor: Genentech, Inc.
• Public title: A study to evaluate the long term safety of etrolizumab in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease)
• Scientific title: A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients with Moderate to Severe Ulcerative Colitis
• Date of first enrolment: 11/01/2012
• Target sample size: 120
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003409-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Canada, Czech Republic, Germany, Hungary, Israel, New Zealand, Spain, United Kingdom, United States

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: Genentech Inc. c/o F. Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: Genentech Inc. c/o F. Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

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)



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Ulcerative colitis
MedDRA version: 20.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000016670

Intervention(s)

Product Name: Etrolizumab
Product Code: RO5490261/F02
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETROLIZUMAB
CAS Number: 1044758-60-2
Current Sponsor code: RO5490261
Other descriptive name: rhuMAb Beta7; Anti Beta7; PRO145223
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

Secondary Objective: To obtain long-term data on the effectiveness, immunogenicity and exposure of etrolizumab

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)

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

Secondary Outcome(s)

Secondary end point(s): N/A

Timepoint(s) of evaluation of this end point: N/A

Secondary ID(s)

2011-003409-36-BE

GA27927

NCT01461317

Source(s) of Monetary Support

Genentech Inc. c/o F. Hoffmann-La Roche Ltd