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

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 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:

Genetics Home Reference related topics: ulcerative colitis

MedlinePlus related topics: Ulcerative Colitis

U.S. FDA Resources

Further study details as provided by Genentech, Inc.:

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

Show 30 Study Locations

Sponsors and Collaborators

Genentech, Inc.

Investigators


Study Director:	Clinical Trials	Genentech, Inc.

More Information

No publications provided


Responsible Party:	Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00694980 History of Changes
Other Study ID Numbers:	ABS4262g, GA00930
Study First Received:	June 7, 2008
Last Updated:	February 4, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:


UC Ulcerative Colitis

Additional relevant MeSH terms:


Colitis Colitis, Ulcerative Ulcer Colonic Diseases Digestive System Diseases	Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Pathologic Processes

ClinicalTrials.gov processed this record on March 01, 2015