Overview

Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323

Status:
Terminated
Trial end date:
2010-07-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of the study is to evaluate the effect, safety and tolerability of CDP323 in patients with relapsing forms of multiple sclerosis
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
UCB Pharma
Collaborator:
Biogen
Criteria
Inclusion Criteria:

- relapsing form of MS

- screening EDSS score 0 - 5.5, inclusive

- at least one clinical relapse in the 12 months before screening

- active disease, defined by set of MRI activity criteria

- failed prior treatment with beta-interferons or glatiramer acetate

Exclusion Criteria:

- signs of silent infections, including positive tests for HIV1, HIV2 or Hepatitis B or
Hepatitis C or tuberculosis

- known allergy to gadolinium-DTPA, and/or ingredients of the study drug formulation

- pre-treatment with immunosuppressive or immunomodulatory drugs prior to screening
within certain time frames