CDP323 Biomarker Study

NCT ID: NCT00726648

Last Updated: 2011-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Relapsing Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

CDP323

Intervention Type DRUG

250mg capsules, 1000mg daily for 4 weeks

Placebo

Intervention Type DRUG

placebo capsules for 4 weeks

2

Group Type EXPERIMENTAL

CDP323

Intervention Type DRUG

50mg capsules, 100mg bid for 4 weeks

Placebo

Intervention Type DRUG

placebo capsules for 4 weeks

3

Group Type EXPERIMENTAL

CDP323

Intervention Type DRUG

250mg capsules, 500mg bid for 4 weeks

Placebo

Intervention Type DRUG

placebo capsules for 4 weeks

4

Group Type EXPERIMENTAL

CDP323

Intervention Type DRUG

250mg capsules, 1000mg bid for 4 weeks

Placebo

Intervention Type DRUG

placebo capsules for 4 weeks

5

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo capsules for 4 weeks

Interventions

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CDP323

50mg capsules, 100mg bid for 4 weeks

Intervention Type DRUG

CDP323

250mg capsules, 500mg bid for 4 weeks

Intervention Type DRUG

CDP323

250mg capsules, 1000mg bid for 4 weeks

Intervention Type DRUG

CDP323

250mg capsules, 1000mg daily for 4 weeks

Intervention Type DRUG

Placebo

placebo capsules for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role collaborator

UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

Locations

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Tooting, London, United Kingdom

Site Status

Croydon, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 23472197 (View on PubMed)

Other Identifiers

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EudraCT 2008-000147-34

Identifier Type: -

Identifier Source: secondary_id

IND 74863

Identifier Type: -

Identifier Source: secondary_id

C32325

Identifier Type: -

Identifier Source: org_study_id

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