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Trial record 1 of 1 for:    NCT00726648
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CDP323 Biomarker Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00726648
Recruitment Status : Completed
First Posted : August 1, 2008
Last Update Posted : September 12, 2011
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE July 29, 2008
First Posted Date  ICMJE August 1, 2008
Last Update Posted Date September 12, 2011
Study Start Date  ICMJE July 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2008)
Pharmacodynamic parameters related to leukocyte trafficking [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2008)
  • Standard and disease-related safety variables [ Time Frame: 4 weeks ]
  • Class-related safety parameters [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CDP323 Biomarker Study
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Relapsing Multiple Sclerosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Interventions:
    • Drug: CDP323
    • Drug: Placebo
  • Experimental: 2
    Interventions:
    • Drug: CDP323
    • Drug: Placebo
  • Experimental: 3
    Interventions:
    • Drug: CDP323
    • Drug: Placebo
  • Experimental: 4
    Interventions:
    • Drug: CDP323
    • Drug: Placebo
  • Placebo Comparator: 5
    Intervention: Drug: Placebo
Publications * Wolf C, Sidhu J, Otoul C, Morris DL, Cnops J, Taubel J, Bennett B. Pharmacodynamic consequences of administration of VLA-4 antagonist CDP323 to multiple sclerosis subjects: a randomized, double-blind phase 1/2 study. PLoS One. 2013;8(3):e58438. doi: 10.1371/journal.pone.0058438. Epub 2013 Mar 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2009)
71
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2008)
70
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00726648
Other Study ID Numbers  ICMJE C32325
EudraCT 2008-000147-34
IND 74863
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Biogen
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center UCB Pharma
PRS Account UCB Pharma
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP