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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694980
• Other study ID #: ABS4262g
• Secondary ID: GA00930
• Status: Completed
• Phase: Phase 1
• First received: June 7, 2008
• Last updated: November 1, 2016
• Start date: September 2008
• Est. completion date: September 2012

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• placebo
Intravenous and subcutaneous escalating doses
• rhuMAb Beta7
Intravenous and subcutaneous escalating doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and nature of laboratory abnormalities		Through study completion or early study discontinuation	No
Primary	Incidence, nature, and severity of adverse events		Through study completion or early study discontinuation	No
Secondary	PK profile and parameters		Through study completion or early study discontinuation	No
Secondary	Incidence of antibodies directed against rhuMAb Beta7		Through study completion or early study discontinuation	No