Back to resultsCDP323 Biomarker Study
Primary Purpose
Relapsing Multiple Sclerosis
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
CDP323
CDP323
CDP323
CDP323
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Relapsing Multiple Sclerosis focused on measuring CDP323, Relapsing multiple sclerosis, Blood biomarkers
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
4
5
Arm Description
Outcomes
Primary Outcome Measures
Pharmacodynamic parameters related to leukocyte trafficking
Secondary Outcome Measures
Standard and disease-related safety variables
Class-related safety parameters
Full Information
NCT ID
NCT00726648
First Posted
July 29, 2008
Last Updated
September 2, 2011
Sponsor
UCB Pharma
Collaborators
Biogen
1. Study Identification
Unique Protocol Identification Number
NCT00726648
Brief Title
CDP323 Biomarker Study
Official 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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
Collaborators
Biogen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Multiple Sclerosis
Keywords
CDP323, Relapsing multiple sclerosis, Blood biomarkers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Arm Title
5
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CDP323
Intervention Description
50mg capsules, 100mg bid for 4 weeks
Intervention Type
Drug
Intervention Name(s)
CDP323
Intervention Description
250mg capsules, 500mg bid for 4 weeks
Intervention Type
Drug
Intervention Name(s)
CDP323
Intervention Description
250mg capsules, 1000mg bid for 4 weeks
Intervention Type
Drug
Intervention Name(s)
CDP323
Intervention Description
250mg capsules, 1000mg daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo capsules for 4 weeks
Primary Outcome Measure Information:
Title
Pharmacodynamic parameters related to leukocyte trafficking
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Standard and disease-related safety variables
Time Frame
4 weeks
Title
Class-related safety parameters
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
Facility Information:
City
Tooting
State/Province
London
Country
United Kingdom
City
Croydon
State/Province
Surrey
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23472197
Citation
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.
Results Reference
derived
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CDP323 Biomarker Study
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