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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00694980
First received: June 7, 2008
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This is a randomized , double-blind, placebo-controlled study of approximately 7 0 patients with ulcerative colitis.


Condition Intervention Phase
Ulcerative Colitis
Drug: placebo
Drug: rhuMAb Beta7
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Incidence and nature of laboratory abnormalities [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • Incidence, nature, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PK profile and parameters [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • Incidence of antibodies directed against rhuMAb Beta7 [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: September 2008
Study Completion Date: September 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: placebo
Intravenous and subcutaneous escalating doses
Drug: rhuMAb Beta7
Intravenous and subcutaneous escalating doses

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694980

  Hide Study Locations
Locations
United States, Alabama
Anniston, Alabama, United States, 36207
United States, California
San Francisco, California, United States, 94115
United States, Florida
Gainesville, Florida, United States, 32610
United States, Georgia
Atlanta, Georgia, United States, 30308
United States, Kentucky
Lexington, Kentucky, United States, 40536
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, New York
Great Neck, New York, United States, 11021
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
Belgium
Leuven, Belgium, B-3000
Canada, Alberta
Calgary, Alberta, Canada, T2N 2T9
Edmonton, Alberta, Canada, T6G 2X8
Canada, British Columbia
Vancouver, British Columbia, Canada, V6Z 2K5
Victoria, British Columbia, Canada, V8V 3P9
Canada, 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, SW10 9NH
London, United Kingdom, N6A 4L6
London, United Kingdom, W12 0HS
London, United Kingdom, SE1 7EH
Newcastle upon Tyne, United Kingdom, NE1 4LP
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00694980     History of Changes
Other Study ID Numbers: ABS4262g, GA00930
Study First Received: June 7, 2008
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
UC
Ulcerative Colitis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014