Multiple Sclerosis Clinical Trial
A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration
Summary
Part 1: The primary objective is to evaluate the efficacy of natalizumab extended interval dosing (EID) in participants who have previously been treated with natalizumab standard interval dosing (SID) for at least 12 months, in relation to continued SID treatment. The secondary objectives is to evaluate relapse-based clinical efficacy measures, disability worsening, additional Magnetic resonance imaging (MRI)-lesion efficacy measures and safety of EID in participants who have previously been treated with natalizumab SID for at least 12 months, in relation to continued SID treatment.
Part 2: The primary objective is to evaluate participant preference for subcutaneous (SC) versus intravenous (IV) route of natalizumab administration. The secondary objectives is to evaluate treatment satisfaction, drug preparation and administration time, safety and immunogenicity, efficacy and characterize pharmacokinetic (PK) and pharmacodynamic (PD) drug preparation and administration time of SC versus IV routes of natalizumab administration.
Full Description
This study will be conducted in 2 parts. At the end of part 1, participants who provide consent and are eligible, and newly enrolled participants, will enter part 2, an Open Label Extension comprising a crossover analysis.
Those participants who completed part 1 and cannot participate, or elect not to participate, in Part 2 (Open label extension) will enter a 12-week follow-up.
Eligibility Criteria
Key Inclusion Criteria:
For Part 1:
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) score <=5.5 at screening.
No relapses in the last 12 months prior to randomization, as determined by the enrolling Investigator.
For Part 2:
Ability of the participants to understand the purpose and risks of the study and provide signed and dated informed consent for Part 2 and authorization to use confidential health information in accordance with national and local participant privacy regulations.
Completed Part 1 Week 72 visit while remaining on their randomized treatment assignment of SID or EID.
Key Exclusion Criteria:
For Part 1:
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.
For Part 2:
Participants treated with natalizumab EID was reverted to natalizumab SID by choice or as rescue treatment in Part 1.
Participant received treatment with any MS disease-modifying therapy other than natalizumab in Part 1 or in the period between Part 1 and Part 2.
History of human immunodeficiency virus or history of other immunodeficient conditions.
Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 30 days (or 5 half-lives of the agent, whichever is longer) prior to the Baseline Visit or at any time during this study.
Inability to comply with study requirements.
Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the participant unsuitable for enrollment.
The inclusion and exclusion criteria for new participants who did not participate in Part 1 of the study are the same as those for participants who did participate in Part 1.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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There are 107 Locations for this study
Cullman Alabama, 35058, United States
Homewood Alabama, 35209, United States
Irvine California, 92607, United States
La Jolla California, 92037, United States
Laguna Hills California, 92653, United States
Palo Alto California, 94304, United States
Aurora Colorado, 80010, United States
Fort Collins Colorado, 80528, United States
Fairfield Connecticut, 06824, United States
Washington District of Columbia, 20007, United States
Miami Florida, 33125, United States
Sunrise Florida, 33351, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30309, United States
Atlanta Georgia, 30327, United States
Evanston Illinois, 60201, United States
Evanston Illinois, 60208, United States
Overland Park Kansas, 66212, United States
Burlington Massachusetts, 01805, United States
Foxboro Massachusetts, 02035, United States
Jamaica Plain Massachusetts, 02130, United States
Wellesley Massachusetts, 02481, United States
Weymouth Massachusetts, 02190, United States
Farmington Hills Michigan, 48334, United States
Grand Rapids Michigan, 49506, United States
Owosso Michigan, 48867, United States
Golden Valley Minnesota, 55422, United States
Saint Louis Missouri, 63110, United States
Las Vegas Nevada, 89106, United States
Newark New Jersey, 07102, United States
Teaneck New Jersey, 07666, United States
New York New York, 10016, United States
New York New York, 10029, United States
New York New York, 10032, United States
Plainview New York, 11803, United States
Raleigh North Carolina, 27607, United States
Winston-Salem North Carolina, 27157, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43214, United States
Dayton Ohio, 45459, United States
Portland Oregon, 97225, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15213, United States
Knoxville Tennessee, 37922, United States
Nashville Tennessee, 37215, United States
Round Rock Texas, 78681, United States
Salt Lake City Utah, 84103, United States
Charlottesville Virginia, 22908, United States
Vienna Virginia, 22182, United States
Seattle Washington, 98101, United States
Milwaukee Wisconsin, 53227, United States
St Leonards New South Wales, 2065, Australia
Sydney New South Wales, 2050, Australia
Elizabeth Vale South Australia, 5112, Australia
Box Hill Victoria, 3128, Australia
Melbourne Victoria, 3004, Australia
Parkville Victoria, 3050, Australia
Bruxelles , 1070, Belgium
Bruxelles , 1200, Belgium
Edegem , 2650, Belgium
La Louvière , 7100, Belgium
Toronto Ontario, M5B 1, Canada
Gatineau Quebec, J8Y 1, Canada
Greenfield Park Quebec, J4V 2, Canada
Montreal Quebec, H2X 0, Canada
Montreal Quebec, H3A 3, Canada
Bordeaux , 33076, France
Caen , 14033, France
Lille , 59037, France
Nice , 6001, France
Saint Herblain , 44800, France
Strasbourg , 67091, France
Bamberg , 96052, Germany
Berlin , 10117, Germany
Bochum , 44791, Germany
Erbach , 64711, Germany
Essen , 45147, Germany
Freiburg , 79106, Germany
Marburg , 35043, Germany
Muenster , 48149, Germany
Munich , 81675, Germany
Stuttgart , 70182, Germany
Ramat Gan , 52363, Israel
Catania , 95123, Italy
Cefalù , 90015, Italy
Milano , 20133, Italy
Napoli , 80131, Italy
Pozzilli , 86077, Italy
Breda , 4818 , Netherlands
Nieuwegein , 3435 , Netherlands
Sittard , 6162 , Netherlands
Lleida Catalonia, 25198, Spain
El Palmar Murcia, 30120, Spain
Madrid , 28034, Spain
Malaga , 29010, Spain
Sevilla , 41009, Spain
London Greater London, SE5 9, United Kingdom
London Greater London, WC1N , United Kingdom
Liverpool Merseyside, L9 7L, United Kingdom
Glasgow Strathclyde, G51 4, United Kingdom
Newcastle upon Tyne Tyne & Wear, NE4 5, United Kingdom
London , W6 8R, United Kingdom
Nottingham , NG7 2, United Kingdom
Salford , M6 8H, United Kingdom
Sheffield , S10 2, United Kingdom
Swansea , SA6 6, United Kingdom
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