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Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Etrolizumab
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of California, San Diego
  • Atlanta Gastroenterology Associates
  • Mayo Clinic Cancer Center
  • Long Island Clin Rsch Asc, LLP
  • Consultants for Clin. Rsrch
  • The Canberra Hospital
  • St Vincent's Hospital Melbourne; Department of Gastroenterology
  • Alfred Hospital
  • Royal Melbourne Hospital; Gastroenterology
  • Imeldaziekenhuis
  • UZ Gent
  • UZ Leuven Gasthuisberg
  • GI Research Institute
  • London Health Sciences Centre; Victoria Hospital
  • London Health Sciences Centre
  • Toronto Digest. Disease Asso.
  • Poliklinika Iii, Hk; Hepatogatroenterolgy
  • Oblastni nemocnice Nachod a.s.; Endoskopicke centrum
  • Fakultni nemocnice Ostrava
  • Krajska nemocnice Tomase Bati
  • CAMPUS VIRCHOW-KLINIKUM; Charité Centrum 13; Med. Klinik Abt. Hepatologie u. Gastroenterologie
  • Med. Hochschule Hannover; Gastroenterologie
  • Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin
  • Facharzt für Gastroenterologie
  • Univ klinikum Ulm; Medizin Zentrum Innere Medizin I
  • ENDOMEDIX Kft; Gasztroenterológia Budapest
  • Pannónia Klinika Magánorvosi
  • Petz Aladar County Hosp; 1St Dept. of Internal Med.
  • Rambam Medical Center
  • Shaare Zedek Medical Center
  • Shaare Zedek Medical Ctr; Dept. of Gastroenterology
  • The Chaim Sheba Medical Center; Multiple Sclerosis Center
  • Tel Aviv Sourasky Medical Ctr; Gastroenterology Department
  • Middlemore Hospital
  • University of Otago, Christchurch
  • Dunedin Hospital; Otago District Health Board
  • Shakespeare Specialist Group
  • Hospital Clinic I Provincial
  • St. Mark's Hospital; Inflammatory Bowel Disease Unit
  • Royal Victoria Infirmary

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Etrolizumab

Arm Description

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

Outcomes

Primary Outcome Measures

Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab

Secondary Outcome Measures

Serum Concentrations of Etrolizumab

Full Information

First Posted
October 12, 2011
Last Updated
February 3, 2020
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01461317
Brief Title
Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 29, 2011 (Actual)
Primary Completion Date
August 7, 2016 (Actual)
Study Completion Date
August 7, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Etrolizumab
Arm Type
Experimental
Arm Description
Etrolizumab 100 milligrams (mg) subcutaneous (SC) administration every 4 weeks during the treatment period of up to 240 weeks.
Intervention Type
Drug
Intervention Name(s)
Etrolizumab
Intervention Description
Participants will receive etrolizumab at a dose of 100 mg.
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time Frame
Baseline up to approximately Week 246
Title
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 Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Long Island Clin Rsch Asc, LLP
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Consultants for Clin. Rsrch
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2065
Country
Australia
Facility Name
St Vincent's Hospital Melbourne; Department of Gastroenterology
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Royal Melbourne Hospital; Gastroenterology
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Imeldaziekenhuis
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
GI Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
London Health Sciences Centre; Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Toronto Digest. Disease Asso.
City
Woodbridge
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
Poliklinika Iii, Hk; Hepatogatroenterolgy
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
Oblastni nemocnice Nachod a.s.; Endoskopicke centrum
City
Nachod
ZIP/Postal Code
547 69
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Krajska nemocnice Tomase Bati
City
Zlin
ZIP/Postal Code
762 75
Country
Czechia
Facility Name
CAMPUS VIRCHOW-KLINIKUM; Charité Centrum 13; Med. Klinik Abt. Hepatologie u. Gastroenterologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Med. Hochschule Hannover; Gastroenterologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Facharzt für Gastroenterologie
City
Minden
ZIP/Postal Code
32423
Country
Germany
Facility Name
Univ klinikum Ulm; Medizin Zentrum Innere Medizin I
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
ENDOMEDIX Kft; Gasztroenterológia Budapest
City
Budapest
ZIP/Postal Code
1073
Country
Hungary
Facility Name
Pannónia Klinika Magánorvosi
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Petz Aladar County Hosp; 1St Dept. of Internal Med.
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Shaare Zedek Medical Ctr; Dept. of Gastroenterology
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
The Chaim Sheba Medical Center; Multiple Sclerosis Center
City
Ramat-Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Ctr; Gastroenterology Department
City
Tel Aviv
ZIP/Postal Code
6423900
Country
Israel
Facility Name
Middlemore Hospital
City
Auckland
Country
New Zealand
Facility Name
University of Otago, Christchurch
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Dunedin Hospital; Otago District Health Board
City
Dunedin
ZIP/Postal Code
9054
Country
New Zealand
Facility Name
Shakespeare Specialist Group
City
Takapuna
ZIP/Postal Code
0620
Country
New Zealand
Facility Name
Hospital Clinic I Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
St. Mark's Hospital; Inflammatory Bowel Disease Unit
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis

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