Clinical trial NCT01461317: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2011-10-28
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to approximately Week 246
measure: Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
timeFrame: 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 outcomes:
measure: Serum Concentrations of Etrolizumab
timeFrame: 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)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Great Neck
country: United States
facility: Long Island Clin Rsch Asc, LLP
state: New York
city: Cincinnati
country: United States
facility: Consultants for Clin. Rsrch
state: Ohio
city: Garran
country: Australia
facility: The Canberra Hospital
state: Australian Capital Territory
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne; Department of Gastroenterology
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital; Gastroenterology
state: Victoria
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Vancouver
country: Canada
facility: GI Research Institute
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre; Victoria Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Woodbridge
country: Canada
facility: Toronto Digest. Disease Asso.
state: Ontario
city: Hradec Kralove
country: Czechia
facility: Poliklinika Iii, Hk; Hepatogatroenterolgy
city: Nachod
country: Czechia
facility: Oblastni nemocnice Nachod a.s.; Endoskopicke centrum
city: Ostrava - Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Zlin
country: Czechia
facility: Krajska nemocnice Tomase Bati
city: Berlin
country: Germany
facility: CAMPUS VIRCHOW-KLINIKUM; Charité Centrum 13; Med. Klinik Abt. Hepatologie u. Gastroenterologie
city: Hannover
country: Germany
facility: Med. Hochschule Hannover; Gastroenterologie
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin
city: Minden
country: Germany
facility: Facharzt für Gastroenterologie
city: Ulm
country: Germany
facility: Univ klinikum Ulm; Medizin Zentrum Innere Medizin I
city: Budapest
country: Hungary
facility: ENDOMEDIX Kft; Gasztroenterológia Budapest
city: Budapest
country: Hungary
facility: Pannónia Klinika Magánorvosi
city: Gyor
country: Hungary
facility: Petz Aladar County Hosp; 1St Dept. of Internal Med.
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Ctr; Dept. of Gastroenterology
city: Ramat-Gan
country: Israel
facility: The Chaim Sheba Medical Center; Multiple Sclerosis Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Ctr; Gastroenterology Department
city: Auckland
country: New Zealand
facility: Middlemore Hospital
city: Christchurch
country: New Zealand
facility: University of Otago, Christchurch
city: Dunedin
country: New Zealand
facility: Dunedin Hospital; Otago District Health Board
city: Takapuna
country: New Zealand
facility: Shakespeare Specialist Group
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Harrow
country: United Kingdom
facility: St. Mark's Hospital; Inflammatory Bowel Disease Unit
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: