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OpenTrials
Completed

NCT Number: NCT00726648

CDP323 Biomarker Study

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.

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Key information

Conditions

Relapsing Multiple Sclerosis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tooting, London, United Kingdom

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

CDP323

Drug

50mg capsules, 100mg bid for 4 weeks

Placebo

Drug

placebo capsules for 4 weeks

Primary outcomes

  1. Pharmacodynamic parameters related to leukocyte trafficking

    Time frame: 4 weeks

Secondary outcomes

  1. Standard and disease-related safety variables

    Time frame: 4 weeks

  2. Class-related safety parameters

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Collaborators

  • Biogen

Registry information

Official study title

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.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 1, 2008
Registry last updated
Sep 12, 2011

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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