CDP323 Biomarker Study

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.

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00726648

Enrollment

Registered

2008-08-01

Start date

2008-07-31

Completion date

2009-03-31

Last updated

2011-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Multiple Sclerosis

Keywords

CDP323, Relapsing multiple sclerosis, Blood biomarkers

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.

Interventions

DRUGCDP323

50mg capsules, 100mg bid for 4 weeks

DRUGPlacebo

placebo capsules for 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pharmacodynamic parameters related to leukocyte trafficking	4 weeks

Secondary

Measure	Time frame
Standard and disease-related safety variables	4 weeks
Class-related safety parameters	4 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026