Therapeutic exploratory study (Phase II).The purpose of this study the efficacy of a new compound (CPD323) for the treatment of Relapsing Remitting Multiple Sclerose (RRMS).CDP323 is a small chemical molecule. It is taken orally (by mouth) as a…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primaire objective.
Compare the effects of 500 mg CDP323 once daily and twice daily on MS-related
imaging parameters in subjects with relapsing MS (RMS) with the effects seen
under placebo treatment in that population over a period of 24 weeks.
Secondary outcome
Exploratory Objectives
* Compare CDP323's tolerability and safety in RMS subjects with placebo
treatment in that population over a period of 24 weeks;
* Compare the effects of CDP323 on the occurrence of relapses in RMS subjects
with the effects seen under placebo treatment in that population over a period
of 24 weeks;
* Compare the effects of twice daily dosing of CDP323 vs once daily dosing of
CDP323 including the related time course of *4/VCAM-1 binding between the two
dosing regimen and placebo;
* Characterize the main pharmacokinetic parameters of CDP323 and its
metabolites in subjects suffering from RMS.
* Assess potential withdrawal effects after termination of treatment with
CDP323.
Background summary
The purpose of this study is to find out whether a new drug named CDP323 will
reduce inflammation in the brain of patients with MS. The best way to do so is
to take frequent pictures of inflamed brain tissue and to decide whether the
inflammation can be reduced by CDP323. The pictures are taken with a MRI
scanner (Magnetic Resonance Imaging). The study will also check whether CDP323
causes side effects and how much CDP323 is in the blood.
Study objective
Therapeutic exploratory study (Phase II).
The purpose of this study the efficacy of a new compound (CPD323) for the
treatment of Relapsing Remitting Multiple Sclerose (RRMS).
CDP323 is a small chemical molecule. It is taken orally (by mouth) as a
capsule.
Up to now, 60 healthy volunteers have taken CDP323 in studies. CDP323 was
considered to be safe and well tolerated in these studies. Research will now
start to see whether CDP323 is effective as a treatment in patients with MS.
This study is multinational and will involve a total of about 317 patients
across approximately 70 institutions in Europe and North America.
Study design
The study period is about 40 weeks. Eligibility will be assessed during a
4-week period. After eligibility has been confirmed, subjects will be
randomized to one of the three treatment arms and will receive study drug;
placebo/CDP323 500mg daily/CDP323 1000 mg daily taken ith water.
The double-blind treatment period will be 24 weeks. After completion of the
treatment period (EoT), subjects will undergo a 12-week rater-blind drug-free
MRI follow-up in order to evaluate potential rebound effects. All subjects
having received study drug will come back to the clinic 12 months after week 40
for follow-up visit.
Intervention
Blood sampling at every visit (inclusive: for women with childbearing potential
a urine pregnancy test will be done at every visit),
MRI scan (8x);
Physical examination;
ECG (6x).
Study burden and risks
Visit schedule:
screening (Day 0); wk1;
baseline (wk 4, randomization and SoT);
study visits (including telephone visits ): wk 5, wk 6, wk 8, wk 10, wk 13, wk
16, wk 19, wk 22, wk 25
wk 28 = EoT;
follow-up wk 30, wk 34, wk 40 = EoS.
12 months follow up (=wk 80)
There will be done 8 MRI-scans with gadolinium: at screening, baseline and than
every 6 weeks.
Chemin du Foriest
B-1420 Braine-l'Alleud
Belgie
Chemin du Foriest
B-1420 Braine-l'Alleud
Belgie
Listed location countries
Age
Inclusion criteria
*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;
Exclusion criteria
*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;
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-002204-33-NL |
| CCMO | NL15910.029.07 |