A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis

A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous and Subcutaneous rhuMAb Beta7 Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients With Ulcerative Colitis

This is a randomized , double-blind, placebo-controlled study of approximately 70 patients with ulcerative colitis.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: placebo; Drug: rhuMAb Beta7

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
    • Edmonton, Alberta, Canada, T6G 2X8
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2K5
    • Victoria, British Columbia, Canada, V8V 3P9
  • Ontario
    • London, Ontario, Canada, N6A 4L6
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
• Germany
  • Berlin, Germany, 13353
  • Frankfurt, Germany, 60431
  • Kiel, Germany, 24105
  • Regensburg, Germany, 93053
  • Ulm, Germany, 89081
• Netherlands
  • Leiden, Netherlands, 2333 ZA
  • Maastricht, Netherlands, 6229 HX
  • Nijmegen, Netherlands, 6525 GA
  • Utrecht, Netherlands, 3584 CX
• United Kingdom
  • Bristol, United Kingdom, BS2 8HW
  • London, United Kingdom, SE1 7EH
  • London, United Kingdom, W12 0HS
  • London, United Kingdom, SW10 9NH
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
  • Nottingham, United Kingdom, NG7 2UH
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
  • California
    • San Francisco, California, United States, 94115
  • Florida
    • Gainesville, Florida, United States, 32610
  • Georgia
    • Atlanta, Georgia, United States, 30308
  • Kentucky
    • Lexington, Kentucky, United States, 40536
  • Minnesota
    • Rochester, Minnesota, United States, 55905
  • New York
    • Great Neck, New York, United States, 11021
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able and willing to provide written informed consent
• 18-70 years of age
• Males and females with reproductive potential: Willing to use a reliable method of contraception
• Diagnosis of ulcerative colitis
• Eligible to receive biologic therapy
• Disease duration of >=12 weeks

Exclusion Criteria:

• Requirement for hospitalization due to severity of ulcerative colitis
• Moderate to severe anemia
• Any manifestation of ulcerative colitis or other conditions likely to require, in the investigator's judgment, treatment with >20 mg/day of prednisone, or prednisone equivalent, during the course of the study
• Pregnant or lactating
• Lack of peripheral venous access
• Inability to comply with study protocol
• History or presence of contraindicated diseases
• Congenital immune deficiency
• Active or prior infection with HIV or hepatitis B or C
• History of severe systemic bacterial, fungal, viral, or parasitic infections
• History of any other opportunistic infections within 12 weeks prior to initiation of study treatment
• Received a live attenuated vaccine within 4 weeks prior to screening
• Hospitalized within 4 weeks prior to screening
• Received any contraindicated therapy within 12 weeks prior to screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: placebo; Intravenous and subcutaneous escalating doses; Drug: rhuMAb Beta7; Intravenous and subcutaneous escalating doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence, nature, and severity of adverse events	Through study completion or early study discontinuation
Incidence and nature of laboratory abnormalities	Through study completion or early study discontinuation

Secondary Outcome Measures

Outcome Measure	Time Frame
PK profile and parameters	Through study completion or early study discontinuation
Incidence of antibodies directed against rhuMAb Beta7	Through study completion or early study discontinuation

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: June 7, 2008
• First Submitted That Met QC Criteria: June 7, 2008
• First Posted (Estimate): June 11, 2008

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; UC
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Immunologic Factors; Gastrointestinal Agents; Etrolizumab
• Other Study ID Numbers: ABS4262g; GA00930 (Other Identifier: Hoffmann-La Roche)