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

NCT01461317 | Completed Phase 2

• 2 other identifiers: GA279272011-003409-36
• Study Type: interventional
• Target: 121
• Locations: 11 countries
• Sites: 40

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

  Baseline up to approximately Week 246

• 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 Outcomes (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)

Study Arms (1)

Etrolizumab

EXPERIMENTAL

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

Drug: Etrolizumab

Interventions

Etrolizumab DRUG

Participants will receive etrolizumab at a dose of 100 mg.

Etrolizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (40)

University of California, San Diego

La Jolla, California, 92037, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Long Island Clin Rsch Asc, LLP

Great Neck, New York, 11021, United States

Location

Consultants for Clin. Rsrch

Cincinnati, Ohio, 45219, United States

Location

The Canberra Hospital

Garran, Australian Capital Territory, 2065, Australia

Location

St Vincent's Hospital Melbourne; Department of Gastroenterology

Fitzroy, Victoria, 3065, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Royal Melbourne Hospital; Gastroenterology

Parkville, Victoria, 3050, Australia

Location

Imeldaziekenhuis

Bonheiden, 2820, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

GI Research Institute

Vancouver, British Columbia, V6Z 2K5, Canada

Location

London Health Sciences Centre; Victoria Hospital

London, Ontario, N6A 4G5, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Toronto Digest. Disease Asso.

Woodbridge, Ontario, L4L 4Y7, Canada

Location

Poliklinika Iii, Hk; Hepatogatroenterolgy

Hradec Králové, 500 12, Czechia

Location

Oblastni nemocnice Nachod a.s.; Endoskopicke centrum

Náchod, 547 69, Czechia

Location

Fakultni nemocnice Ostrava

Ostrava - Poruba, 708 52, Czechia

Location

Krajska nemocnice Tomase Bati

Zlín, 762 75, Czechia

Location

CAMPUS VIRCHOW-KLINIKUM; Charité Centrum 13; Med. Klinik Abt. Hepatologie u. Gastroenterologie

Berlin, 13353, Germany

Location

Med. Hochschule Hannover; Gastroenterologie

Hanover, 30625, Germany

Location

Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin

Kiel, 24105, Germany

Location

Facharzt für Gastroenterologie

Minden, 32423, Germany

Location

Univ klinikum Ulm; Medizin Zentrum Innere Medizin I

Ulm, 89081, Germany

Location

ENDOMEDIX Kft; Gasztroenterológia Budapest

Budapest, 1073, Hungary

Location

Pannónia Klinika Magánorvosi

Budapest, 1136, Hungary

Location

Petz Aladar County Hosp; 1St Dept. of Internal Med.

Győr, 9024, Hungary

Location

Rambam Medical Center

Haifa, 3109601, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Shaare Zedek Medical Ctr; Dept. of Gastroenterology

Jerusalem, 9103102, Israel

Location

The Chaim Sheba Medical Center; Multiple Sclerosis Center

Ramat Gan, 5262100, Israel

Location

Tel Aviv Sourasky Medical Ctr; Gastroenterology Department

Tel Aviv, 6423900, Israel

Location

Middlemore Hospital

Auckland, New Zealand

Location

University of Otago, Christchurch

Christchurch, 8011, New Zealand

Location

Dunedin Hospital; Otago District Health Board

Dunedin, 9054, New Zealand

Location

Shakespeare Specialist Group

Takapuna, 0620, New Zealand

Location

Hospital Clinic I Provincial

Barcelona, 08036, Spain

Location

St. Mark's Hospital; Inflammatory Bowel Disease Unit

Harrow, HA1 3UJ, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

etrolizumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2011
• First Posted: October 28, 2011
• Study Start: November 29, 2011
• Primary Completion: August 7, 2016
• Study Completion: August 7, 2016
• Last Updated: February 10, 2020

Record last verified: 2020-02

Locations

CA (4); CZ (4); DE (5); IL (5); BE (3); NZ (4); US (5); GB (2); HU (3); ES (1); AU (4)