CDP323 Biomarker Study

Phase 1

Completed

• Conditions: Relapsing Multiple Sclerosis
• Interventions: Drug: CDP323; Drug: Placebo

• Registration Number: NCT00726648
• Lead Sponsor: UCB Pharma

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 available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-29
• Study First Submitted QC: 2008-07-31
• Study First Posted: 2008-08-01
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2009-08
• Disposition First Submitted: 2009-08-26
• Disposition First Submitted QC: 2009-08-26
• Disposition First Posted: 2009-08-27
• Last Update Submitted: 2011-09-02
• Last Update Posted: 2011-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	CDP323	-
1	CDP323	-
1	Placebo	-
2	CDP323	-
2	Placebo	-
3	CDP323	-
3	Placebo	-
4	Placebo	-
5	Placebo	-

Primary Outcome Measures

Name	Time	Method
Pharmacodynamic parameters related to leukocyte trafficking	4 weeks

Secondary Outcome Measures

Name	Time	Method
Standard and disease-related safety variables	4 weeks
Class-related safety parameters	4 weeks