CDP323 Biomarker Study

Relapsing Multiple Sclerosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726648
• Other study ID #: C32325
• Secondary ID: EudraCT 2008-000
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 29, 2008
• Last updated: September 2, 2011
• Start date: July 2008
• Est. completion date: March 2009

Study information

• Verified date: August 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• CDP323
50mg capsules, 100mg bid for 4 weeks
• CDP323
250mg capsules, 500mg bid for 4 weeks
• CDP323
250mg capsules, 1000mg bid for 4 weeks
• CDP323
250mg capsules, 1000mg daily for 4 weeks
• Placebo
placebo capsules for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
UCB Pharma	Biogen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamic parameters related to leukocyte trafficking		4 weeks	No
Secondary	Standard and disease-related safety variables		4 weeks	Yes
Secondary	Class-related safety parameters		4 weeks	Yes