CDP323 Biomarker Study

UCB Pharma71 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Relapsing Multiple Sclerosis

Interventions

CDP323DRUG

50mg capsules, 100mg bid for 4 weeks

CDP323DRUG

250mg capsules, 500mg bid for 4 weeks

CDP323DRUG

250mg capsules, 1000mg bid for 4 weeks

CDP323

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Tooting, London, United Kingdom

Unnamed facility

Croydon, Surrey, United Kingdom

Outcomes

Primary Outcomes

Pharmacodynamic parameters related to leukocyte trafficking

Time frame: 4 weeks

Secondary Outcomes

Standard and disease-related safety variables

Time frame: 4 weeks

Class-related safety parameters

Time frame: 4 weeks

Data from ClinicalTrials.gov

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