E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To evaluate the efficacy of a selected treatment regimen of ATL 1102 in patients with Relapsing Remitting MS (RRMS) inflammatory lesions using MRI with gadolinium administration compared to placebo. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of a selected treatment regimen of ATL 1102 in patients with Relapsing Remitting MS (RRMS) inflammatory lesions using MRI with gadolinium administration compared to placebo. |
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E.2.2 | Secondary objectives of the trial |
To explore the safety of ATL 1102 To evaluate the pharmacokinetics of ATL 1102 in patients with RRMS
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Males and females aged 18 - 55 years • Diagnosis: “Multiple Sclerosis” Relapsing Remitting MS (RRMS) • At least 9 T2 lesions or at least 4 if one is gadolinium-enhancing • Last relapse in the previous 12 months • No relapse in the previous four weeks • Score of EDSS 0.0 – 6.0 • Reliable contraception (e.g. surgical sterilisation, oral contraceptives) • Written informed consent to participate in the study by signature on the Patients Consent Form.
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E.4 | Principal exclusion criteria |
• Administration of any investigational drug within the previous 2 months before enrolment (4 months if the previous drug was a new chemical entity) • Progressive disease • Concomitant clinically relevant other findings on MRI that may interfere with outcome assessment • Previous treatment with VLA-4 antibodies, anti-CD4 antibodies, or other monoclonal antibodies • Total lymphoid irradiation at any time • Treatment with immune-modulating drugs in the previous two months or treatment with immune-suppresive drugs in the previous six months • HIV positive patients • Detectable levels of JC Virus in the blood measured by Quantitative PCR • Patients with renal impairment with serum creatinine 2,0 mg/dl • History of clinically relevant gastrointestinal, hepatic, renal, endocrine, haematological, metabolic, neurologic (other than MS) and psychiatric disease • Patients with infections (lymphocytes > 3000/µL) • History of any bleeding • History of coagulation abnormalities • Concomitant medication acetyl salicylic acid (> 300 mg/day) and phenprocoumon • Clinically relevant abnormalities in physical findings at screening examination if interfering with the study objective • Pregnant or breast-feeding women • History of drug or alcohol abuse • Epileptics • Suicidal subjects • History of drug allergy and/or known drug hypersensitivity • Inability to communicate or cooperate with the Investigator due to language problem, poor mental development or impaired cerebral function • Any medical condition which, in the judgement of the Investigator, might interfere with the objectives of the study • Repeated participation in this study • Contraindication for application of study drug • Corticoid-treatment in the previous six weeks and during the study period • Exceptions: Corticoid-treatment before the study period (not in the previous six weeks) and of relapses during the study period: Relapses are characterised by the occurrence of neurological dysfunction symptoms, appearing after a 30-day period of stability or improvement and lasting for more than 24 hours (no infection, no fever). A 5-day methylprednisolone treatment 1000 mg i.v. is allowed in this case followed by a reducing procedure. • Corticoid-treatment if applied locally (e.g. inhaled products) is allowed. • Additionally MRI exclusion criteria: - Metal residing in the body (e.g. implants) - Cardiac pacemaker, valves, cochlear implants, CNS vascular clips - Contrast medium allergy (Gd-DTPA)
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E.5 End points |
E.5.1 | Primary end point(s) |
• the cumulative number of new active lesions (either new gadolinium-enhancing, or non-enhancing, new or enlarging on T2) on MRI (to include all lesions from weeks 4, 8, and 12), corrected for the number of enhancing lesions at baseline
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 32 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |