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

This study is ongoing, but not recruiting participants.

First Received on June 7, 2008. Last Updated on November 11, 2010 History of Changes

Sponsor:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00694980

Purpose

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

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

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:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

U.S. FDA Resources

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 ]
Incidence, nature, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ]

Secondary Outcome Measures:

PK profile and parameters [ Time Frame: Through study completion or early study discontinuation ]
Incidence of antibodies directed against rhuMAb Beta7 [ Time Frame: Through study completion or early study discontinuation ]

Enrollment:	23
Study Start Date:	April 2008

Arms	Assigned Interventions
Experimental: 1	Drug: placebo Intravenous and subcutaneous escalating doses Drug: rhuMAb Beta7 Intravenous and subcutaneous escalating doses

Eligibility

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

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

Locations

United States, Florida
Univ of Florida College of Med
Gainesville, Florida, United States, 32610
Belgium
University of Leuven Hospitals
Leuven, Belgium, B-3000
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 2T9
University of Alberta
Edmonton, Alberta, Canada, T6G 2X8
Canada, Quebec
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Canada
GIRI Gastrointestinal Research
Vancouver BC, Canada, V6Z 2K5
Germany
Universitaetsklinikum Ulm
Ulm, BW, Germany, 89070
Markus-Krankenhaus Med Klinik
Frankfurt, HE, Germany, 60431
Charite-Campus Virchow Kliniku
Berlin, Germany, 13353
Univer Schleswig-Holstein
Kiel, Germany, 24105
Klinikum der Univer Regenburg
Regensburg, BY, Germany, 93053
Netherlands
LUMC Leiden
Leiden, Netherlands, 2333 ZA
AZm Maastricht
Maastricht, Netherlands, 6229 HX
Univ Med Centrum St Radbound
Nijmegen, Netherlands, 6525 GA
University Medical Ctr Utrecht
Utrecht, Netherlands, 3584 CX
United Kingdom
Nottingham University Hospital
Nottingham, Notts, United Kingdom, NG7 2UH
Royal Victoria Infirmary
Newcastle upon Tyne, T&W, United Kingdom, NE14LP
Bristol Royal Infirmary
Bristol, United Kingdom, BS2 8HW
Chelsea & Westminster Hospital
London, United Kingdom, SW10 9NH
Imperial College
London, United Kingdom, W12 0HS
St. Thomas Hospital
London, United Kingdom, SE1 7EH

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Sharon O' Byrne, M.D.

Genentech

More Information

No publications provided

Responsible Party:	Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00694980 History of Changes
Other Study ID Numbers:	ABS4262g
Study First Received:	June 7, 2008
Last Updated:	November 11, 2010
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 February 09, 2012