A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment

Phase 1

Conditions: Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2018-002145-11-ES

Lead Sponsor: Biogen Idec Research Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Not specified

Target Recruitment: 480

Inclusion Criteria

• Ability of the participant to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations.
• Diagnosis of relapsing remitting multiple sclerosis (RRMS) according to the McDonald criteria [Thompson
2018].
• Treatment with natalizumab as disease-modifying monotherapy for RRMS that is consistent with the
approved dosing for a minimum of 12 months prior to randomization. The participant must have received at
least 11 doses of natalizumab in the 12 months prior to randomization with no missed doses in the 3 months
prior to randomization.
• Expanded Disability Status Scale (EDSS) <=5.5 at screening.
• No relapses in the last 12 months prior to randomization, as determined by the enrolling Investigator

NOTE: Other protocol-defined inclusion criteria may apply.
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 480
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Primary and secondary progressive multiple sclerosis (MS).
• MRI positive for Gd-enhancing lesions at screening.
• Participants for whom MRI is contraindicated (e.g., have a contraindicated pacemaker or other contraindicated implanted metal device, have suffered, or are at risk for, side effects from Gd, or have claustrophobia that cannot be medically managed).
• History of any clinically significant (as determined by the Investigator) 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, in the opinion of the Investigator.
• Presence of anti-natalizumab antibodies at screening.

NOTE: Other protocol-defined exclusion criteria may apply.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: The primary objective of this study is to evaluate the efficacy of natalizumab extended interval dosing (EID) in<br> subjects who have previously been treated with natalizumab standard interval dosing (SID) for at least<br> 12 months, in relation to continued SID treatment.<br> ;<br> Secondary Objective: The secondary objectives are to evaluate additional clinical and MRI based efficacy endpoints, and safety of<br> EID in subjects who have previously been treated with natalizumab SID for at least 12 months, in relation to<br> continued SID treatment.<br> ;Primary end point(s): Number of New or Newly Enlarging T2 Hyperintense Lesions at Week 48;Timepoint(s) of evaluation of this end point: Week 48

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): •Time to First Relapse as Adjudicated by an Independent Neurology Evaluation Committee (INEC)<br> •Number of new Gadolinium (Gd) Enhancing and new T1 Hypointense Lesions at Weeks 24, 48 and 72<br> •Annualized Relapse Rate at Weeks 48 and 72<br> •Number of New or Newly Enlarging T2 Hyperintense Lesions at Weeks 24 and 72<br> •Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)<br> ;Timepoint(s) of evaluation of this end point: Variable time frames throughout the study

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