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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01461317




Registration number
NCT01461317
Ethics application status
Date submitted
12/10/2011
Date registered
28/10/2011
Date last updated
10/02/2020

Titles & IDs
Public title
Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis
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
Secondary ID [1] 0 0
2011-003409-36
Secondary ID [2] 0 0
GA27927
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Etrolizumab

Experimental: Etrolizumab - Etrolizumab 100 milligrams (mg) subcutaneous (SC) administration every 4 weeks during the treatment period of up to 240 weeks.


Treatment: Drugs: Etrolizumab
Participants will receive etrolizumab at a dose of 100 mg.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Baseline up to approximately Week 246
Primary outcome [2] 0 0
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
Timepoint [2] 0 0
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 outcome [1] 0 0
Serum Concentrations of Etrolizumab
Timepoint [1] 0 0
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
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/08/2016
Sample size
Target
Accrual to date
Final
121
Recruitment in Australia
Recruitment state(s)
ACT,VIC
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
St Vincent's Hospital Melbourne; Department of Gastroenterology - Fitzroy
Recruitment hospital [3] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Royal Melbourne Hospital; Gastroenterology - Parkville
Recruitment postcode(s) [1] 0 0
2065 - Garran
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
Belgium
State/province [6] 0 0
Bonheiden
Country [7] 0 0
Belgium
State/province [7] 0 0
Gent
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Canada
State/province [9] 0 0
British Columbia
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Czechia
State/province [11] 0 0
Hradec Kralove
Country [12] 0 0
Czechia
State/province [12] 0 0
Nachod
Country [13] 0 0
Czechia
State/province [13] 0 0
Ostrava - Poruba
Country [14] 0 0
Czechia
State/province [14] 0 0
Zlin
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Hannover
Country [17] 0 0
Germany
State/province [17] 0 0
Kiel
Country [18] 0 0
Germany
State/province [18] 0 0
Minden
Country [19] 0 0
Germany
State/province [19] 0 0
Ulm
Country [20] 0 0
Hungary
State/province [20] 0 0
Budapest
Country [21] 0 0
Hungary
State/province [21] 0 0
Gyor
Country [22] 0 0
Israel
State/province [22] 0 0
Haifa
Country [23] 0 0
Israel
State/province [23] 0 0
Jerusalem
Country [24] 0 0
Israel
State/province [24] 0 0
Ramat-Gan
Country [25] 0 0
Israel
State/province [25] 0 0
Tel Aviv
Country [26] 0 0
New Zealand
State/province [26] 0 0
Auckland
Country [27] 0 0
New Zealand
State/province [27] 0 0
Christchurch
Country [28] 0 0
New Zealand
State/province [28] 0 0
Dunedin
Country [29] 0 0
New Zealand
State/province [29] 0 0
Takapuna
Country [30] 0 0
Spain
State/province [30] 0 0
Barcelona
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Harrow
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT01461317
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Genentech, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01461317