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

• ClinicalTrials.gov Identifier: NCT00694980
• Recruitment Status: Completed
• First Posted: June 11, 2008
• Last Update Posted: November 2, 2016
• Sponsor: Genentech, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Ulcerative Colitis	Drug: placebo; Drug: rhuMAb Beta7	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: September 2008
• Actual Primary Completion Date: September 2011
• Actual Study Completion Date: September 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Incidence and nature of laboratory abnormalities [ Time Frame: Through study completion or early study discontinuation ]
2. Incidence, nature, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ]

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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, 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, Ontario

London, Ontario, Canada, N6A 4L6

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, SE1 7EH

London, United Kingdom, SW10 9NH

London, United Kingdom, W12 0HS

Newcastle upon Tyne, United Kingdom, NE1 4LP

Nottingham, United Kingdom, NG7 2UH

Sponsors and Collaborators

Genentech, Inc.

Investigators

• Study Director: Clinical Trials; Genentech, Inc.

More Information

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT00694980
• Other Study ID Numbers: ABS4262g; GA00930 ( Other Identifier: Hoffmann-La Roche )
• First Posted: June 11, 2008
• Last Update Posted: November 2, 2016
• Last Verified: November 2016

Keywords provided by Genentech, Inc.:

UC; Ulcerative Colitis

Additional relevant MeSH terms:

Colitis; Colitis, Ulcerative; Ulcer; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Inflammatory Bowel Diseases; rhuMAb Beta7; Gastrointestinal Agents; Immunologic Factors; Physiological Effects of Drugs