NCT00726648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

September 12, 2011

Status Verified

August 1, 2009

Enrollment Period

8 months

First QC Date

July 29, 2008

Last Update Submit

September 2, 2011

Conditions

Relapsing Multiple Sclerosis

Keywords

CDP323Relapsing multiple sclerosisBlood biomarkers

Outcome Measures

Primary Outcomes (1)

  • Pharmacodynamic parameters related to leukocyte trafficking

    4 weeks

Secondary Outcomes (2)

  • Standard and disease-related safety variables

    4 weeks

  • Class-related safety parameters

    4 weeks

Study Arms (5)

1

EXPERIMENTAL
Drug: CDP323Drug: Placebo

2

EXPERIMENTAL
Drug: CDP323Drug: Placebo

3

EXPERIMENTAL
Drug: CDP323Drug: Placebo

4

EXPERIMENTAL
Drug: CDP323Drug: Placebo

5

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CDP323DRUG

50mg capsules, 100mg bid for 4 weeks

2
PlaceboDRUG

placebo capsules for 4 weeks

12345

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Tooting, London, United Kingdom

Location

Unknown Facility

Croydon, Surrey, United Kingdom

Location

Related Publications (1)

  • Wolf C, Sidhu J, Otoul C, Morris DL, Cnops J, Taubel J, Bennett B. Pharmacodynamic consequences of administration of VLA-4 antagonist CDP323 to multiple sclerosis subjects: a randomized, double-blind phase 1/2 study. PLoS One. 2013;8(3):e58438. doi: 10.1371/journal.pone.0058438. Epub 2013 Mar 5.

    PMID: 23472197DERIVED

MeSH Terms

Interventions

CDP323

Study Officials

  • UCB Clinical Trial Call Center

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2008

First Posted

August 1, 2008

Study Start

July 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

September 12, 2011

Record last verified: 2009-08

Locations

GB(2)