CDP323 Biomarker Study

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00726648
First received: July 29, 2008
Last updated: September 2, 2011
Last verified: August 2009
  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 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

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 ]

Enrollment: 71
Study Start Date: July 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: CDP323
250mg capsules, 1000mg daily for 4 weeks
Drug: Placebo
placebo capsules for 4 weeks
Experimental: 2 Drug: CDP323
50mg capsules, 100mg bid for 4 weeks
Drug: Placebo
placebo capsules for 4 weeks
Experimental: 3 Drug: CDP323
250mg capsules, 500mg bid for 4 weeks
Drug: Placebo
placebo capsules for 4 weeks
Experimental: 4 Drug: CDP323
250mg capsules, 1000mg bid for 4 weeks
Drug: Placebo
placebo capsules for 4 weeks
Placebo Comparator: 5 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
Tooting, London, United Kingdom
Croydon, Surrey, United Kingdom
Sponsors and Collaborators
UCB, Inc.
Biogen Idec
Investigators
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

No publications provided by UCB, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00726648     History of Changes
Other Study ID Numbers: C32325, EudraCT 2008-000147-34, IND 74863
Study First Received: July 29, 2008
Last Updated: September 2, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by UCB, Inc.:
CDP323
Relapsing multiple sclerosis
Blood biomarkers

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014