Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
71 participants
INTERVENTIONAL
2008-07-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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1
CDP323
250mg capsules, 1000mg daily for 4 weeks
Placebo
placebo capsules for 4 weeks
2
CDP323
50mg capsules, 100mg bid for 4 weeks
Placebo
placebo capsules for 4 weeks
3
CDP323
250mg capsules, 500mg bid for 4 weeks
Placebo
placebo capsules for 4 weeks
4
CDP323
250mg capsules, 1000mg bid for 4 weeks
Placebo
placebo capsules for 4 weeks
5
Placebo
placebo capsules for 4 weeks
Interventions
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CDP323
50mg capsules, 100mg bid for 4 weeks
CDP323
250mg capsules, 500mg bid for 4 weeks
CDP323
250mg capsules, 1000mg bid for 4 weeks
CDP323
250mg capsules, 1000mg daily for 4 weeks
Placebo
placebo capsules for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
UCB Pharma
Locations
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Tooting, London, United Kingdom
Croydon, Surrey, United Kingdom
Countries
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References
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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.
Other Identifiers
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EudraCT 2008-000147-34
Identifier Type: -
Identifier Source: secondary_id
IND 74863
Identifier Type: -
Identifier Source: secondary_id
C32325
Identifier Type: -
Identifier Source: org_study_id
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