Clinical trial NCT00694980: A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ulcerative Colitis
Keywords: UC
Ulcerative Colitis
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Incidence and nature of laboratory abnormalities
timeFrame: Through study completion or early study discontinuation
measure: Incidence, nature, and severity of adverse events
timeFrame: Through study completion or early study discontinuation
Secondary outcomes:
measure: PK profile and parameters
timeFrame: Through study completion or early study discontinuation
measure: Incidence of antibodies directed against rhuMAb Beta7
timeFrame: Through study completion or early study discontinuation
Other outcomes:
Locations:
city: Anniston
country: United States
state: Alabama
city: San Francisco
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Lexington
country: United States
state: Kentucky
city: Rochester
country: United States
state: Minnesota
city: Great Neck
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Leuven
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: London
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Berlin
country: Germany
city: Frankfurt
country: Germany
city: Kiel
country: Germany
city: Regensburg
country: Germany
city: Ulm
country: Germany
city: Leiden
country: Netherlands
city: Maastricht
country: Netherlands
city: Nijmegen
country: Netherlands
city: Utrecht
country: Netherlands
city: Bristol
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Newcastle upon Tyne
country: United Kingdom
city: Nottingham
country: United Kingdom
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: