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Completed

NCT Number: NCT00694980

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

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

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Intravenous and subcutaneous escalating doses

rhuMAb Beta7

Drug

Intravenous and subcutaneous escalating doses

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Jun 11, 2008
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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