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

Phase 2

Completed

Conditions: Ulcerative Colitis

Interventions: Drug: Etrolizumab

Registration Number: NCT01461317

Lead Sponsor: Genentech, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 121

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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])
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)	Baseline up to approximately Week 246

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (40): University of California, San Diego
🇺🇸
La Jolla, California, United States
Atlanta Gastroenterology Associates
🇺🇸
Atlanta, Georgia, United States
Long Island Clin Rsch Asc, LLP
🇺🇸
Great Neck, New York, United States
Alfred Hospital
🇦🇺
Melbourne, Victoria, Australia
London Health Sciences Centre
🇨🇦
London, Ontario, Canada
Toronto Digest. Disease Asso.
🇨🇦
Woodbridge, Ontario, Canada
Poliklinika Iii, Hk; Hepatogatroenterolgy
🇨🇿
Hradec Kralove, Czechia
Oblastni nemocnice Nachod a.s.; Endoskopicke centrum
🇨🇿
Nachod, Czechia
Fakultni nemocnice Ostrava
🇨🇿
Ostrava - Poruba, Czechia
Med. Hochschule Hannover; Gastroenterologie
🇩🇪
Hannover, Germany
CAMPUS VIRCHOW-KLINIKUM; Charité Centrum 13; Med. Klinik Abt. Hepatologie u. Gastroenterologie
🇩🇪
Berlin, Germany
Krajska nemocnice Tomase Bati
🇨🇿
Zlin, Czechia
Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin
🇩🇪
Kiel, Germany
Univ klinikum Ulm; Medizin Zentrum Innere Medizin I
🇩🇪
Ulm, Germany
Petz Aladar County Hosp; 1St Dept. of Internal Med.
🇭🇺
Gyor, Hungary
Rambam Medical Center
🇮🇱
Haifa, Israel
Shaare Zedek Medical Ctr; Dept. of Gastroenterology
🇮🇱
Jerusalem, Israel
The Chaim Sheba Medical Center; Multiple Sclerosis Center
🇮🇱
Ramat-Gan, Israel
Tel Aviv Sourasky Medical Ctr; Gastroenterology Department
🇮🇱
Tel Aviv, Israel
Dunedin Hospital; Otago District Health Board
🇳🇿
Dunedin, New Zealand
Shakespeare Specialist Group
🇳🇿
Takapuna, New Zealand
Hospital Clinic I Provincial
🇪🇸
Barcelona, Spain
St. Mark's Hospital; Inflammatory Bowel Disease Unit
🇬🇧
Harrow, United Kingdom
Royal Victoria Infirmary
🇬🇧
Newcastle upon Tyne, United Kingdom
The Canberra Hospital
🇦🇺
Garran, Australian Capital Territory, Australia
St Vincent's Hospital Melbourne; Department of Gastroenterology
🇦🇺
Fitzroy, Victoria, Australia
Imeldaziekenhuis
🇧🇪
Bonheiden, Belgium
Royal Melbourne Hospital; Gastroenterology
🇦🇺
Parkville, Victoria, Australia
UZ Gent
🇧🇪
Gent, Belgium
UZ Leuven Gasthuisberg
🇧🇪
Leuven, Belgium
GI Research Institute
🇨🇦
Vancouver, British Columbia, Canada
London Health Sciences Centre; Victoria Hospital
🇨🇦
London, Ontario, Canada
Facharzt für Gastroenterologie
🇩🇪
Minden, Germany
Middlemore Hospital
🇳🇿
Auckland, New Zealand
ENDOMEDIX Kft; Gasztroenterológia Budapest
🇭🇺
Budapest, Hungary
Pannónia Klinika Magánorvosi
🇭🇺
Budapest, Hungary
University of Otago, Christchurch
🇳🇿
Christchurch, New Zealand
Consultants for Clin. Rsrch
🇺🇸
Cincinnati, Ohio, United States
Mayo Clinic Cancer Center
🇺🇸
Rochester, Minnesota, United States
Shaare Zedek Medical Center
🇮🇱
Jerusalem, Israel