CDP323 Biomarker Study

UCB

Status and phase: Completed; Phase 2; Phase 1

Conditions: Relapsing Multiple Sclerosis

Treatments: Drug: Placebo; Drug: CDP323

Study type: Interventional

Funder types: Industry

Identifiers

NCT00726648

C32325

EudraCT 2008-000147-34

IND 74863

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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71 participants in 5 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Placebo

Drug: CDP323

Drug: CDP323

Drug: CDP323

Drug: CDP323

2

Experimental group

Treatment:

Drug: Placebo

Drug: CDP323

Drug: CDP323

Drug: CDP323

Drug: CDP323

3

Experimental group

Treatment:

Drug: Placebo

Drug: CDP323

Drug: CDP323

Drug: CDP323

Drug: CDP323

4

Experimental group

Treatment:

Drug: Placebo

Drug: CDP323

Drug: CDP323

Drug: CDP323

Drug: CDP323

5

Placebo Comparator group

Treatment:

Drug: Placebo