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Sponsor: Biogen
Conditions: Multiple Sclerosis, Relapsing-Remitting
Interventions: Natalizumab
Countries: Germany
The primary objective of this study is to evaluate the radiological efficacy of SC natalizumab over time through Week 24 in natalizumab-naïve participants, as measured by brain magnetic resonance imaging (MRI). The secondary objectives of this study are to evaluate additional lesion-related radiological efficacy measures over time, relapse-based clinical efficacy measures, disability improvement and worsening (EDSS), pharmacokinetic and pharmacodynamic parameters, the immunogenicity of repeated doses, and safety in treatment-naïve participants of SC natalizumab.
Sex: ALL
Age: 18 Years to 60 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Key Inclusion Criteria: * Diagnosis of RRMS according to the McDonald criteria * Treatment-naïve in respect to natalizumab as disease modifying monotherapy for RRMS * No or not more than one prior MS disease-modifying therapy * Highly active RRMS, as defined by at least one relapse in the previous year and at least one T1 gadolinium-enhancing lesion or ≥3 new or enlarging T2 lesions * EDSS score ≤ 5.5 at Screening * Estimated glomerular filtration rate (eGFR) \>30 millilitre per min (mL/min), as estimated using the Cockcroft-Gault formula. Key Exclusion Criteria: * Primary- and secondary-progressive MS * Participants for whom MRI is contraindicated * History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic (including diabetes), urologic, pulmonary, neurologic (except for RRMS), dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical study * History of severe allergic or anaphylactic reactions or known hypersensitivity to any antibody drug therapy. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
- Bamberg, Germany
- Bonn, Germany