Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323

September 2, 2011 updated by: UCB Pharma

Double-blind, Placebo-controlled, Randomized, Parallel-group Phase II Study in Subjects With Relapsing Forms of Multiple Sclerosis (MS) to Evaluate the Safety, Tolerability, and Effects of CDP323.

The objective of the study is to evaluate the effect, safety and tolerability of CDP323 in patients with relapsing forms of multiple sclerosis

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

232

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Diepenbeek, Belgium
      • Gent, Belgium
      • Melsbroek, Belgium
      • Overpelt, Belgium
      • Sijsele, Belgium
      • Sint-Truiden, Belgium
  • Canada
    • Ontario
      • London, Ontario, Canada
      • Ottawa, Ontario, Canada
    • Quebec
      • Gatineau, Quebec, Canada
      • Greenfield Park, Quebec, Canada
      • Sherbrooke, Quebec, Canada
  • Finland
      • Oulu, Finland
      • Tampere, Finland
      • Turku, Finland
  • France
      • Besancon, France
      • Clermont-Ferrand, France
      • Lyon Cedex 03, France
      • Rennes, France
      • Strasbourg, France
  • Germany
      • Bayreuth, Germany
      • Berlin, Germany
      • Giessen, Germany
      • Hamburg, Germany
      • Marburg, Germany
      • Rostock, Germany
      • Ulm, Germany
      • Wiesbaden, Germany
  • Hungary
      • Budapest, Hungary
      • Gyor, Hungary
      • Nyiregyhaza, Hungary
      • Pecs, Hungary
  • Netherlands
      • Amsterdam, Netherlands
      • Breda, Netherlands
      • Nieuwegein, Netherlands
      • Nijmegen, Netherlands
  • Spain
      • Barcelona, Spain
      • Bilbao, Spain
      • Girona, Spain
      • Madrid, Spain
      • Malaga, Spain
      • Oviedo, Spain
      • Santa Cruz de Tenerife, Spain
      • Sevilla, Spain
  • Sweden
      • Goteborg, Sweden
      • Umea, Sweden
  • United Kingdom
      • Hartshill, United Kingdom
      • Newcastle, United Kingdom
      • Nottingham, United Kingdom
      • Sheffield, United Kingdom
  • United States
    • Alabama
      • Cullman, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • Colorado
      • Springs, Colorado, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Maitland, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Northbrook, Illinois, United States
    • Indiana
      • Fort Wayne, Indiana, United States
    • Kansas
      • Kansas City, Kansas, United States
      • Lenexa, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Michigan
      • Farmington Hills, Michigan, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • Ohio
      • Columbus, Ohio, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
    • Washington
      • Kirkland, Washington, United States
    • West Virginia
      • Charleston, West Virginia, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • relapsing form of MS
  • screening EDSS score 0 - 5.5, inclusive
  • at least one clinical relapse in the 12 months before screening
  • active disease, defined by set of MRI activity criteria
  • failed prior treatment with beta-interferons or glatiramer acetate

Exclusion Criteria:

  • signs of silent infections, including positive tests for HIV1, HIV2 or Hepatitis B or Hepatitis C or tuberculosis
  • known allergy to gadolinium-DTPA, and/or ingredients of the study drug formulation
  • pre-treatment with immunosuppressive or immunomodulatory drugs prior to screening within certain time frames

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
capsules, once daily
Experimental: CDP323 1000 mg/day
Drug: CDP323
250 mg capsules, 500 mg bid (1000 mg/day)
Drug: CDP323
250 mg Capsules, 500 mg, once daily
Experimental: CDP323 500 mg/day
Drug: CDP323
250 mg capsules, 500 mg bid (1000 mg/day)
Drug: CDP323
250 mg Capsules, 500 mg, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cumulative number of newly active lesions on standardized brain MRI scans after 24 weeks of treatment (Week 28).
Time Frame: Cumulative number of newly active lesions from baseline to Week 28.
The following lesions are considered newly active: new gadolinium enhancement on T1-weighted images; new lesions on T2-weighted images, but non-enhancing on T1-weighted images; new enlargement on T2-weighted images, but non-enhancing on T1-weighted images.
Cumulative number of newly active lesions from baseline to Week 28.

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of any treatment emergent adverse event.
Time Frame: During up to 24 weeks of treatment.
During up to 24 weeks of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Collaborators

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

June 8, 2007

First Submitted That Met QC Criteria

June 8, 2007

First Posted (Estimate)

June 11, 2007

Study Record Updates

Last Update Posted (Estimate)

September 12, 2011

Last Update Submitted That Met QC Criteria

September 2, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C32322
  • 2006-002204-33 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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