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.Estudio de fase II, doble ciego, aleatorizado, controlado con placebo, y de grupos paralelos, en pacientes con esclerosis múltiple (EM) con recaídas, para evaluar la seguridad, la tolerabilidad y los efectos de dos dosis distintas de CDP323 a lo largo de 24 semanas, con seguimiento ciego mediante resonancia magnética (RM) durante 12 semanas.
- Conditions
- Relapsing forms of multiple slerosisEsclerosis multiple (EM) con recaidasMedDRA version: 9.1Level: LLTClassification code 10048393Term: Multiple sclerosis relapse
- Registration Number
- EUCTR2006-002204-33-ES
- Lead Sponsor
- CB Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 279
• written informed consent;
• able to understand the nature of the study and its potential risks;
• willing to comply with the study's safety precautions and with the intended drug-free long-term follow-up over the telephone;
• 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 0-5.5, inclusive;
• female and male subjects aged 18-55 years inclusive at time of informed consent;
• at least one clinical relapse 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 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 or female condom with
spermicide, or diaphragm or cervical cap with spermicide) or
• any contraceptives containing estrogens plus one of the following:
diaphragm or cervical cap with spermicide, male or female condom with
spermicide or
• intrauterine devices or
• contraceptives containing progestins only, e.g., etonogestrel or
levonorgestrel or medroxyprogesterone or norethindrone or
• monogamous relationship with vasectomized partner or,
• sexual abstinence.
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 within reference range;
• 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 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 (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 theophylline or warfarin or the following 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 screening within the following
time frames:
• at any time: natalizumab, mitoxantrone or cyclophosphamide; total lymphoid
irradiation; anti-lymphocyte monoclonal antibody treatment (e.g., anti-CD4,
Campath-1H);
• up to 30 days prior to screening: 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;
• six month prior to screening: azathioprine
• pregnancy or lactation;
• history of alcohol or drug abuse within the year before screening;
• medical, psychiatric or other conditions that compromise the subject's ability to
understand the subject information, to give informed consent, to comply with the trial
protocol, or to complete the study;
• any reason why, in the investigator's opinion, the subject should not participate.
If a subject suffers a relapse during the screening phase, he/she may not be randomized on the planned SoT visit. He/she may be randomized 30 days ± 3 days after the end of the last relapse.
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