Natalizumab Subcutaneous Immunogenicity and Safety Study

Phase 2

Terminated

• Conditions: Relapsing Multiple Sclerosis
• Interventions: Drug: natalizumab

• Registration Number: NCT02142192
• Lead Sponsor: Biogen

Brief Summary

The primary objective of this study is to evaluate the immunogenicity of natalizumab (BG00002) 300 mg subcutaneous (SC) administered to participants with relapsing multiple sclerosis (RMS). The secondary objectives of the study are to evaluate the safety of natalizumab SC injections and to evaluate the efficacy of natalizumab SC injections on relapses and on new magnetic resonance imaging (MRI) lesions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-16
• Study First Submitted QC: 2014-05-16
• Study First Posted: 2014-05-20
• Study Start: 2014-12-01
• Primary Completion: 2015-06-04
• Study Completion: 2015-06-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Must have documented diagnosis of RMS at screening.
• Must fall within the therapeutic indications stated in the locally approved label for natalizumab.
• Must have an EDSS score from 0 to 6.5, inclusive.

Key

Exclusion Criteria

• Any prior use of natalizumab.
• Positive for anti-natalizumab antibodies at screening.
• Treatment with immunomodulatory injections (including IFN-β and glatiramer acetate) within 2 weeks prior to Screening.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
natalizumab	natalizumab	natalizumab 300mg SC every 4 weeks for up to 12 treatment administrations (i.e. Day 1 through Week 44)

Primary Outcome Measures

Name	Time	Method
Proportion of participants with persistent anti-natalizumab antibodies	48 weeks	Persistent anti-natalizumab antibodies are defined as 2 positive anti-natalizumab test results separated by at least 6 weeks, with at least 1 positive test result occurring at or after the Week 24 Visit.

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with transient anti-natalizumab antibodies	48 weeks
Proportion of participants with post-injection adverse events (AEs)	48 weeks	Including hypersensitivity reactions, anaphylactic reactions and other AEs occurring within 1 hour after SC natalizumab dosing.
Proportion of participants with clinical relapse	48 weeks	This may include new or enlarging T2 lesion(s), as determined by magnetic resonance imaging (MRI). Clinical relapse is defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the neurologist.
Proportion of participants with gadolinium (Gd) enhancing lesion(s) as assessed by MRI.	48 weeks
Proportion of Participants that experience Adverse Events and Serious Adverse Events	up to 56 weeks

Trial Locations

Locations (1)

Research Site; 🇧🇪 Liege, Belgium