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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00694980

Enrollment

Registered

2008-06-11

Start date

2008-09-30

Completion date

2012-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

UC, Ulcerative Colitis

Brief summary

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

Interventions

DRUGplacebo

Intravenous and subcutaneous escalating doses

DRUGrhuMAb Beta7

Intravenous and subcutaneous escalating doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026