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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461317
• Other study ID #: GA27927
• Secondary ID: 2011-003409-36
• Status: Completed
• Phase: Phase 2
• Start date: November 29, 2011
• Est. completion date: August 7, 2016

Study information

• Verified date: February 2020
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: August 7, 2016
• Est. primary completion date: August 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
Australia	St Vincent's Hospital Melbourne; Department of Gastroenterology	Fitzroy	Victoria
Australia	The Canberra Hospital	Garran	Australian Capital Territory
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Royal Melbourne Hospital; Gastroenterology	Parkville	Victoria
Belgium	Imeldaziekenhuis	Bonheiden
Belgium	UZ Gent	Gent
Belgium	UZ Leuven Gasthuisberg	Leuven
Canada	London Health Sciences Centre	London	Ontario
Canada	London Health Sciences Centre; Victoria Hospital	London	Ontario
Canada	GI Research Institute	Vancouver	British Columbia
Canada	Toronto Digest. Disease Asso.	Woodbridge	Ontario
Czechia	Poliklinika Iii, Hk; Hepatogatroenterolgy	Hradec Kralove
Czechia	Oblastni nemocnice Nachod a.s.; Endoskopicke centrum	Nachod
Czechia	Fakultni nemocnice Ostrava	Ostrava - Poruba
Czechia	Krajska nemocnice Tomase Bati	Zlin
Germany	CAMPUS VIRCHOW-KLINIKUM; Charité Centrum 13; Med. Klinik Abt. Hepatologie u. Gastroenterologie	Berlin
Germany	Med. Hochschule Hannover; Gastroenterologie	Hannover
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
Hungary	ENDOMEDIX Kft; Gasztroenterológia Budapest	Budapest
Hungary	Pannónia Klinika Magánorvosi	Budapest
Hungary	Petz Aladar County Hosp; 1St Dept. of Internal Med.	Gyor
Israel	Rambam Medical Center	Haifa
Israel	Shaare Zedek Medical Center	Jerusalem
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
New Zealand	Middlemore Hospital	Auckland
New Zealand	University of Otago, Christchurch	Christchurch
New Zealand	Dunedin Hospital; Otago District Health Board	Dunedin
New Zealand	Shakespeare Specialist Group	Takapuna
Spain	Hospital Clinic I Provincial	Barcelona
United Kingdom	St. Mark's Hospital; Inflammatory Bowel Disease Unit	Harrow
United Kingdom	Royal Victoria Infirmary	Newcastle upon Tyne
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Consultants for Clin. Rsrch	Cincinnati	Ohio
United States	Long Island Clin Rsch Asc, LLP	Great Neck	New York
United States	University of California, San Diego	La Jolla	California
United States	Mayo Clinic Cancer Center	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  Germany,  Hungary,  Israel,  New Zealand,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)		Baseline up to approximately Week 246
Primary	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	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)