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

Completed · Phase 2

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT01461317

Run by

Genentech, Inc.

People needed

121

Starts

2011-11-29

Expected to finish

2016-08-07

Last updated by the study team

2020-02-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of California, San Diego — La Jolla, California, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States
• Long Island Clin Rsch Asc, LLP — Great Neck, New York, United States
• Consultants for Clin. Rsrch — Cincinnati, Ohio, United States
• The Canberra Hospital — Garran, Australian Capital Territory, Australia
• St Vincent's Hospital Melbourne; Department of Gastroenterology — Fitzroy, Victoria, Australia
• Alfred Hospital — Melbourne, Victoria, Australia
• Royal Melbourne Hospital; Gastroenterology — Parkville, Victoria, Australia
• Imeldaziekenhuis — Bonheiden, Belgium
• UZ Gent — Ghent, Belgium
• UZ Leuven Gasthuisberg — Leuven, Belgium
• GI Research Institute — Vancouver, British Columbia, Canada
• London Health Sciences Centre; Victoria Hospital — London, Ontario, Canada
• London Health Sciences Centre — London, Ontario, Canada
• Toronto Digest. Disease Asso. — Woodbridge, Ontario, Canada
• Poliklinika Iii, Hk; Hepatogatroenterolgy — Hradec Králové, Czechia
• Oblastni nemocnice Nachod a.s.; Endoskopicke centrum — Náchod, Czechia
• Fakultni nemocnice Ostrava — Ostrava - Poruba, Czechia
• Krajska nemocnice Tomase Bati — Zlín, Czechia
• CAMPUS VIRCHOW-KLINIKUM; Charité Centrum 13; Med. Klinik Abt. Hepatologie u. Gastroenterologie — Berlin, Germany
• Med. Hochschule Hannover; Gastroenterologie — Hanover, Germany
• Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin — Kiel, Germany
• Facharzt für Gastroenterologie — Minden, Germany
• Univ klinikum Ulm; Medizin Zentrum Innere Medizin I — Ulm, Germany

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.