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

NCT05532163 | Terminated Phase 4

• 2 other identifiers: DE-TYS-120722022-001820-14
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Cumulative Number of Active Lesions (CUALs) Through Week 24

  Cumulative number of active lesions will be calculated as the sum of the number of gadolinium (Gd)-enhancing lesions and new or enlarging T2 hyperintense lesions that are non-enhancing on post-gadolinium T1-weighted (T1w) scans. It is also referred to as combined unique active lesions (CUALs).

  Up to Week 24

Secondary Outcomes (20)

• Cumulative Number of CUALs Through Weeks 4, 8, and 12

  Weeks 4, 8, and 12

• Absolute Number of CUALs at Weeks 4, 8, 12, and 24

  Weeks 4, 8, 12, and 24

• Mean Change From Baseline of CUALs at Weeks 4, 8, 12, and 24

  Baseline, Weeks 4, 8, 12, and 24

• Cumulative Number of New Gd-Enhancing Lesions Through Weeks 4, 8, 12, and 24

  Weeks 4, 8, 12, and 24

• Absolute Number of New Gd-Enhancing Lesions at Weeks 4, 8, 12, and 24

  Weeks 4, 8, 12, and 24

Study Arms (1)

Natalizumab

EXPERIMENTAL

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

Drug: Natalizumab

Interventions

Natalizumab DRUG

Administered as specified in the treatment arm

Also known as: Tysabri, BG00002

Natalizumab

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (2)

Neurologische Praxis Dr. med. Boris-Alexander Kallmann

Bamberg, 96052, Germany

Location

Neurologische Studiengesellschaft Bonn GbR

Bonn, 53111, Germany

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 8, 2022
• Study Start: January 23, 2023
• Primary Completion: October 9, 2023
• Study Completion: October 9, 2023
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

DE (2)