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 two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks.
- Conditions
- muscle diseasenerve disease10012303
- Registration Number
- NL-OMON33867
- Lead Sponsor
- CB Pharma S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
*female and male subjects aged 18-60 years inclusive at time of informed consent;
*diagnosis of MS according to the revised McDonald criteria (Polman et al. Ann Neurol 2005;58:840-6);
*relapsing form of MS, i.e., RRMS or SPMS (with superimposed relapses) according to Lublin and Reingold (Neurology 1996;46:907-11);
*at least one clinical relapse in the 12 months before screening;
*active disease, defined by the presence of either,
* at least nine lesions on the screening T2 scan or,
* Gd enhancement on the screening T1 scan or,
* Gd enhancement on an MRI scan during the past 12 months or,
* at least two new T2 lesions during the past 12 months;
* failed prior treatment with beta-interferons due to lack of efficacy or tolerability;
*type of MS other than relapsing;
*any disease other than MS that could better explain the subject's signs and symptoms;
*any conditions that could interfere with the MRI or any other evaluation in the study;
*any clinically significant disease state or findings other than MS, in particular neoplastic disease or organ transplantation;
*any clinically significant deviation from reference ranges in laboratory tests or any abnormal, clinically significant ECG findings;
*any significant deviation from reference ranges for hepatic function;
*signs of silent infections, including positive tests for HIV1, HIV2, or Hepatitis B or Hepatitis C, or tuberculosis;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primaire objective.<br /><br>Compare the effects of 500 mg CDP323 once daily and twice daily on MS-related<br /><br>imaging parameters in subjects with relapsing MS (RMS) with the effects seen<br /><br>under placebo treatment in that population over a period of 24 weeks.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Exploratory Objectives<br /><br>* Compare CDP323's tolerability and safety in RMS subjects with placebo<br /><br>treatment in that population over a period of 24 weeks;<br /><br>* Compare the effects of CDP323 on the occurrence of relapses in RMS subjects<br /><br>with the effects seen under placebo treatment in that population over a period<br /><br>of 24 weeks;<br /><br>* Compare the effects of twice daily dosing of CDP323 vs once daily dosing of<br /><br>CDP323 including the related time course of *4/VCAM-1 binding between the two<br /><br>dosing regimen and placebo;<br /><br>* Characterize the main pharmacokinetic parameters of CDP323 and its<br /><br>metabolites in subjects suffering from RMS.<br /><br>* Assess potential withdrawal effects after termination of treatment with<br /><br>CDP323.</p><br>