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
- Relapsing forms of multiple slerosisMedDRA version: 9.1Level: LLTClassification code 10048393Term: Multiple sclerosis relapse
- Registration Number
- EUCTR2006-002204-33-GB
- Lead Sponsor
- CB Pharma S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 317
• written informed consent;
• being of legal capacity and able to understand the nature of the study and its potential risks;
• being willing to comply with the study's safety precautions and with the intended drug-free follow-up at the study site 12 months after the last intake of study medication;
• 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);
• screening EDSS score of 0-6.0, inclusive;
• female and male subjects aged 18-60 years inclusive at time of informed consent;
• Clinical relapse activity in the 12 months before screening and documented in the subject's medical records;
• 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 or glatiramer acetate due to lack of efficacy or tolerability;
• female subjects of childbearing potential must agree to practice one of the following contraception method:
• double-barrier contraception (i.e.,using a male condom together with a diaphragm or cerivcal cap, both in conjunction with spermicide) or
• any hormonal contraceptives (i.e., 'the pill', all mini pills, implants, patches, depot injection), plus one of the following: diaphragm or cervical cap with spermicide, male or female condom, all in conjunction with spermicide or
• intrauterine devices releasing levonorgestrel (Mirena), or
• intrauterine devices without levonorgestrel plus one of the following: diaphragm or cervical cap with spermicide, male or female condom, all in conjunction with spermicide, or
• monogamous relationship with vasectomized partner or
• sexual abstinence
Non-vasectomized, sexually active males with partners of childbearing
potential must use a condom with spermicide when having intercourse.
Contraception precautions should continue for at least 3 months after the
last dose of CDP323
Note: Lack of childbearing potential will be considered under these
circumstances:
• post-menopausal for at least two years,
• bilateral oophorectomy, ovariectomy, salpingectomy, or tubal ligation,
• hysterectomy;
• congenital sterility.
• negative pregnancy tests at screening and at baseline for female subjects of
childbearing potential;
• full immunocompetency: CD4+ lymphocyte count >500/mm3;
• JC viral DNA particles undetectable in blood at two separate measurements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• 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 contrast-enhanced MRI, including an estimated glomerular filtration rate (eGFR) <=60ml/min, or with any other evaluation in the study;
• any clinically significant disease state or findings other than MS, in particular
neoplastic disease or organ transplantation (in case of doubt, UCB's responsible
medical officer will be consulted and a joint documented decision will be made
between investigator and UCB's medical officer);
• any clinically significant deviation from reference ranges in laboratory tests or any
abnormal, clinically significant ECG findings, in particular any marked pre-study
prolongation of the QTcB interval, i.e., if both, the Screening (V1) and the Baseline
(V3) ECG demonstrate a QTcB interval >450 ms (in case of doubt, UCB's responsible
medical officer will be consulted and a joint documented decision will be made
between investigator and UCB's medical officer);
• any significant deviation from reference ranges for hepatic function as defined by either SGOT, SGPT, GGT, or AP elevated 3-fold or higher beyond the upper limit of the
reference range or total bilirubin elevated 2-fold or higher beyond the upper limit of the reference range;
• signs of silent infections, including positive tests for HIV1, HIV2, or Hepatitis B or
Hepatitis C, or tuberculosis;
• any condition possibly interfering with drug absorption;
• known allergy to gadolinium-DTPA, and/or ingredients of the study drug formulation;
• history of severe AEs to any drug;
• participation in any clinical drug trial within 30 days prior to screening;
• concomitant treatment with the CYP1A substrates mexiletine, propafenone, theophylline, verapamil or warfarin or statins (e.g., atorvastatin), or rosiglitazone, pioglitazone, repaglinide, amodiaquine and any other compound metabolized primarily through cytochrome P450 2C8, or protease inhibitors (e.g., ritonvavir), systemic triazole antifungals (e.g., ketoconazole) for either their interference with transport protein systems or for their strong inhibition of the P450 cytochrome pathway, or these drugs known for their potential to interfere with cardiac repolarization: amiodarone, arsenic trioxide, bepredil, budipine, cisapride, chinidine (quinidine), chloroquine, chlorpromazine, clarithromycin, disopyramide, dofetilide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, ibutilide, levomethadyl, mesoridazine, methadone, pentamidine, pimozide, procainamide, sotalol, sparfloxacin, thioridazine
• pre-treatment with the following substances prior to study participation within the following time frames:
• at any time: rituximab, mitoxantrone or cyclophosphamide; total lymphoid
irradiation; anti-lymphocyte monoclonal antibody treatment (e.g., anti-CD4,
Campath-1H); cladribine, mycophenolate;
• up to 30 days prior to baseline: any interferons, glatiramer acetate,
corticosteroids and ACTH, IvIg, cyclosporine A, human antibodies, any other
immunomodulating or immunosuppressive drugs including recombinant
cytokines, any other putative or experimental MS treatment; any inoculation with attenuated live vaccines
• six month prior to baseline: azathioprine or natalizumab.
Treatment with natalizumab must not have been terminated due to lack of efficacy, however subjects with documented natalizumab neutralizing antibodies ma
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method