CDP323 Biomarker Study

September 2, 2011 updated by: UCB Pharma

Double-blind, Placebo-controlled, Randomized, Parallel-group Study in Subjects With Relapsing Forms of Multiple Sclerosis to Evaluate the Effects of Different CDP323 Doses on Biomarker Patterns as Well as on Safety and Tolerability.

Comparison of the effects of different CDP323 doses given over a period of four weeks on blood biomarkers in subjects with relapsing forms of multiple sclerosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 2
  • Phase 1

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

  • United Kingdom
    • London
      • Tooting, London, United Kingdom
    • Surrey
      • Croydon, Surrey, United Kingdom

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Female and male subjects aged 18-65 years
  • Relapsing form of MS with at least one clinical relapse in the 24 months before screening;
  • Screening EDSS score of 0-6.5;
  • Must be fully immunocompetent
  • Female subjects of childbearing potential must agree to practice contraception methods

Exclusion Criteria:

  • Any conditions that could interfere with the contrast-enhanced MRI;
  • Any clinically significant disease state or findings other than MS;
  • Any clinically significant deviation from the pre-defined ranges for laboratory tests;
  • Concomitant treatment with MS disease modifying drugs

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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: CDP323
50mg capsules, 100mg bid for 4 weeks
Drug: CDP323
250mg capsules, 500mg bid for 4 weeks
Drug: CDP323
250mg capsules, 1000mg bid for 4 weeks
Drug: CDP323
250mg capsules, 1000mg daily for 4 weeks
Drug: Placebo
placebo capsules for 4 weeks
EXPERIMENTAL: 2
Drug: CDP323
50mg capsules, 100mg bid for 4 weeks
Drug: CDP323
250mg capsules, 500mg bid for 4 weeks
Drug: CDP323
250mg capsules, 1000mg bid for 4 weeks
Drug: CDP323
250mg capsules, 1000mg daily for 4 weeks
Drug: Placebo
placebo capsules for 4 weeks
EXPERIMENTAL: 3
Drug: CDP323
50mg capsules, 100mg bid for 4 weeks
Drug: CDP323
250mg capsules, 500mg bid for 4 weeks
Drug: CDP323
250mg capsules, 1000mg bid for 4 weeks
Drug: CDP323
250mg capsules, 1000mg daily for 4 weeks
Drug: Placebo
placebo capsules for 4 weeks
EXPERIMENTAL: 4
Drug: CDP323
50mg capsules, 100mg bid for 4 weeks
Drug: CDP323
250mg capsules, 500mg bid for 4 weeks
Drug: CDP323
250mg capsules, 1000mg bid for 4 weeks
Drug: CDP323
250mg capsules, 1000mg daily for 4 weeks
Drug: Placebo
placebo capsules for 4 weeks
PLACEBO_COMPARATOR: 5
Drug: Placebo
placebo capsules for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamic parameters related to leukocyte trafficking
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Standard and disease-related safety variables
Time Frame: 4 weeks
4 weeks
Class-related safety parameters
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

UCB Pharma

Collaborators

Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

July 29, 2008

First Submitted That Met QC Criteria

July 31, 2008

First Posted (ESTIMATE)

August 1, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 12, 2011

Last Update Submitted That Met QC Criteria

September 2, 2011

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C32325
  • EudraCT 2008-000147-34
  • IND 74863

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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