CDP323 Biomarker Study - Full Text View

Sponsors and Collaborators:	UCB Biogen Idec
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00726648

Purpose

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.

Condition	Intervention	Phase
Relapsing Multiple Sclerosis	Drug: CDP323 Drug: Placebo	Phase I Phase II

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Pharmacokinetics/Dynamics 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.

Further study details as provided by UCB:

Primary Outcome Measures:

Pharmacodynamic parameters related to leukocyte trafficking [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Standard and disease-related safety variables [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Class-related safety parameters [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	70
Study Start Date:	July 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: CDP323 250mg capsules, 1000mg daily for 4 weeks Drug: Placebo placebo capsules for 4 weeks
2: Experimental	Drug: CDP323 50mg capsules, 100mg bid for 4 weeks Drug: Placebo placebo capsules for 4 weeks
3: Experimental	Drug: CDP323 250mg capsules, 500mg bid for 4 weeks Drug: Placebo placebo capsules for 4 weeks
4: Experimental	Drug: CDP323 250mg capsules, 1000mg bid for 4 weeks Drug: Placebo placebo capsules for 4 weeks
5: Placebo Comparator	Drug: Placebo placebo capsules for 4 weeks

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726648

Contacts

Contact: UCB Clinical Trial Call Center

+1 877 822 9493

Locations

United Kingdom, London
	Recruiting
Tooting, London, United Kingdom
United Kingdom, Surrey
	Recruiting
Croydon, Surrey, United Kingdom

Sponsors and Collaborators

UCB

Biogen Idec

Investigators

Study Director:

UCB Clinical Trial Call Center

UCB

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	C32325, EudraCT 2008-000147-34, IND 74863
Study First Received:	July 29, 2008
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00726648
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by UCB:

CDP323
Relapsing multiple sclerosis
Blood biomarkers

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009