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

Sponsor

Genentech, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00694980

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

1.6

Patients Per Site

Patients Per Site Per Month

Study Details

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

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 :

Sep 1, 2008

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

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

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

Incidence and nature of laboratory abnormalities [Through study completion or early study discontinuation]
Incidence, nature, and severity of adverse events [Through study completion or early study discontinuation]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	City	State	Country	Postal Code
1	Anniston	Alabama	United States	36207
2	San Francisco	California	United States	94115
3	Gainesville	Florida	United States	32610
4	Atlanta	Georgia	United States	30308
5	Lexington	Kentucky	United States	40536
6	Rochester	Minnesota	United States	55905
7	Great Neck	New York	United States	11021
8	Chapel Hill	North Carolina	United States	27599
9	Leuven		Belgium	3000
10	Calgary	Alberta	Canada	T2N 2T9
11	Edmonton	Alberta	Canada	T6G 2X8
12	Vancouver	British Columbia	Canada	V6Z 2K5
13	Victoria	British Columbia	Canada	V8V 3P9
14	London	Ontario	Canada	N6A 4L6
15	Montreal	Quebec	Canada	H1T 2M4
16	Berlin		Germany	13353
17	Frankfurt		Germany	60431
18	Kiel		Germany	24105
19	Regensburg		Germany	93053
20	Ulm		Germany	89081
21	Leiden		Netherlands	2333 ZA
22	Maastricht		Netherlands	6229 HX
23	Nijmegen		Netherlands	6525 GA
24	Utrecht		Netherlands	3584 CX
25	Bristol		United Kingdom	BS2 8HW
26	London		United Kingdom	SE1 7EH
27	London		United Kingdom	SW10 9NH
28	London		United Kingdom	W12 0HS
29	Newcastle upon Tyne		United Kingdom	NE1 4LP
30	Nottingham		United Kingdom	NG7 2UH