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

Double-blind, Placebo-controlled, Randomized, Parallel-group Phase II Study in Subjects With Relapsing Forms of Multiple Sclerosis (MS) to Evaluate the Safety, Tolerability, and Effects of CDP323.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00484536

Enrollment

232

Registered

2007-06-11

Start date

2007-05-31

Completion date

2010-07-31

Last updated

2011-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

CDP323, Relapsing Multiple Sclerosis, Magnetic Resonance Imaging, Oral Compound, MS

Brief summary

The objective of the study is to evaluate the effect, safety and tolerability of CDP323 in patients with relapsing forms of multiple sclerosis

Interventions

DRUGCDP323

250 mg capsules, 500 mg bid (1000 mg/day)

DRUGplacebo

capsules, once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The cumulative number of newly active lesions on standardized brain MRI scans after 24 weeks of treatment (Week 28).	Cumulative number of newly active lesions from baseline to Week 28.	The following lesions are considered newly active: new gadolinium enhancement on T1-weighted images; new lesions on T2-weighted images, but non-enhancing on T1-weighted images; new enlargement on T2-weighted images, but non-enhancing on T1-weighted images.

Secondary

Measure	Time frame
Occurrence of any treatment emergent adverse event.	During up to 24 weeks of treatment.

Countries

Belgium, Canada, Finland, France, Germany, Hungary, Netherlands, Spain, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026