A Study to Investigate the Radiological Onset of Action After Treatment Initiation With Subcutaneous (SC) Natalizumab in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)

NCT ID: NCT05532163

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-23
• Study Completion Date: 2023-10-09

Brief Summary

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Natalizumab

Participants will receive natalizumab 300 milligrams (mg) (2\*150 mg), SC injection, once every 4 weeks (Q4W) up to Week 24.

Group Type: EXPERIMENTAL

Natalizumab

Intervention Type: DRUG

Administered as specified in the treatment arm

Interventions

Natalizumab

Administered as specified in the treatment arm

Intervention Type: DRUG

Other Intervention Names

Tysabri; BG00002

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Neurologische Praxis Dr. med. Boris-Alexander Kallmann

Bamberg, , Germany

Neurologische Studiengesellschaft Bonn GbR

Bonn, , Germany

Countries

Germany

Other Identifiers

2022-001820-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DE-TYS-12072

Identifier Type: -

Identifier Source: org_study_id