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

Sponsor
Genentech, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01461317
Collaborator
(none)
121
Enrollment
40
Locations
1
Arm
56.3
Actual Duration (Months)
3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
121 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 29, 2011
Actual Primary Completion Date :
Aug 7, 2016
Actual Study Completion Date :
Aug 7, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Etrolizumab

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

Drug: Etrolizumab
Participants will receive etrolizumab at a dose of 100 mg.

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [Baseline up to approximately Week 246]

  2. Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab [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 Measures

  1. Serum Concentrations of Etrolizumab [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 Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, San Diego La Jolla California United States 92037
2 Atlanta Gastroenterology Associates Atlanta Georgia United States 30342
3 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
4 Long Island Clin Rsch Asc, LLP Great Neck New York United States 11021
5 Consultants for Clin. Rsrch Cincinnati Ohio United States 45219
6 The Canberra Hospital Garran Australian Capital Territory Australia 2065
7 St Vincent's Hospital Melbourne; Department of Gastroenterology Fitzroy Victoria Australia 3065
8 Alfred Hospital Melbourne Victoria Australia 3004
9 Royal Melbourne Hospital; Gastroenterology Parkville Victoria Australia 3050
10 Imeldaziekenhuis Bonheiden Belgium 2820
11 UZ Gent Gent Belgium 9000
12 UZ Leuven Gasthuisberg Leuven Belgium 3000
13 GI Research Institute Vancouver British Columbia Canada V6Z 2K5
14 London Health Sciences Centre; Victoria Hospital London Ontario Canada N6A 4G5
15 London Health Sciences Centre London Ontario Canada N6A 4L6
16 Toronto Digest. Disease Asso. Woodbridge Ontario Canada L4L 4Y7
17 Poliklinika Iii, Hk; Hepatogatroenterolgy Hradec Kralove Czechia 500 12
18 Oblastni nemocnice Nachod a.s.; Endoskopicke centrum Nachod Czechia 547 69
19 Fakultni nemocnice Ostrava Ostrava - Poruba Czechia 708 52
20 Krajska nemocnice Tomase Bati Zlin Czechia 762 75
21 CAMPUS VIRCHOW-KLINIKUM; Charité Centrum 13; Med. Klinik Abt. Hepatologie u. Gastroenterologie Berlin Germany 13353
22 Med. Hochschule Hannover; Gastroenterologie Hannover Germany 30625
23 Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin Kiel Germany 24105
24 Facharzt für Gastroenterologie Minden Germany 32423
25 Univ klinikum Ulm; Medizin Zentrum Innere Medizin I Ulm Germany 89081
26 ENDOMEDIX Kft; Gasztroenterológia Budapest Budapest Hungary 1073
27 Pannónia Klinika Magánorvosi Budapest Hungary 1136
28 Petz Aladar County Hosp; 1St Dept. of Internal Med. Gyor Hungary 9024
29 Rambam Medical Center Haifa Israel 3109601
30 Shaare Zedek Medical Center Jerusalem Israel 9103102
31 Shaare Zedek Medical Ctr; Dept. of Gastroenterology Jerusalem Israel 9103102
32 The Chaim Sheba Medical Center; Multiple Sclerosis Center Ramat-Gan Israel 5262100
33 Tel Aviv Sourasky Medical Ctr; Gastroenterology Department Tel Aviv Israel 6423900
34 Middlemore Hospital Auckland New Zealand
35 University of Otago, Christchurch Christchurch New Zealand 8011
36 Dunedin Hospital; Otago District Health Board Dunedin New Zealand 9054
37 Shakespeare Specialist Group Takapuna New Zealand 0620
38 Hospital Clinic I Provincial Barcelona Spain 08036
39 St. Mark's Hospital; Inflammatory Bowel Disease Unit Harrow United Kingdom HA1 3UJ
40 Royal Victoria Infirmary Newcastle upon Tyne United Kingdom NE1 4LP

Sponsors and Collaborators

  • Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Genentech, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01461317
Other Study ID Numbers:
  • GA27927
  • 2011-003409-36
First Posted:
Oct 28, 2011
Last Update Posted:
Feb 10, 2020
Last Verified:
Feb 1, 2020
Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Etrolizumab

Study Results

No Results Posted as of Feb 10, 2020