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CompletedNCT00726648Updated Sep 12, 2011

CDP323 Biomarker Study

A Phase 1/2 interventional study of CDP323 and CDP323 in Relapsing Multiple Sclerosis, sponsored by UCB Pharma. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-09-12.

Sponsored by UCB Pharma · Phase 1/2, Interventional, and Basic science

Phase
Phase 1/2
Study type
Interventional
Enrollment
71
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Relapsing Multiple Sclerosis

Keywords

  • CDP323
  • Relapsing multiple sclerosis
  • Blood biomarkers
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 71 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
71 participants (actual)

Study arms

  • Experimental
    1

    Drug: CDP323 · Drug: Placebo

  • Experimental
    2

    Drug: CDP323 · Drug: Placebo

  • Experimental
    3

    Drug: CDP323 · Drug: Placebo

  • Experimental
    4

    Drug: CDP323 · Drug: Placebo

  • Placebo comparator
    5

    Drug: Placebo

Interventions

  • DrugCDP323

    50mg capsules, 100mg bid for 4 weeks

  • DrugCDP323

    250mg capsules, 500mg bid for 4 weeks

  • DrugCDP323

    250mg capsules, 1000mg bid for 4 weeks

  • DrugCDP323

    250mg capsules, 1000mg daily for 4 weeks

  • DrugPlacebo

    placebo capsules for 4 weeks

06

What researchers measure

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

07

Study locations

2 sites
  • Tooting, London, United Kingdom
  • Croydon, Surrey, United Kingdom
08

References and documents

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. PubMed 23472197 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00726648
Lead sponsor
UCB Pharma
Collaborators
Biogen
Responsible party
Sponsor
First posted
Aug 1, 2008
Start date
Jul 2008
Primary completion
Mar 2009
Completion
Mar 2009
Last update
Sep 12, 2011

Study contacts

UCB Clinical Trial Call Center
study director · UCB Pharma

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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