Natalizumab Subcutaneous Immunogenicity and Safety Study

Relapsing Multiple Sclerosis Clinical Trial

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Official title:

A Multicenter, Open-Label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple Sclerosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02142192
• Other study ID #: 101MS207
• Secondary ID: 2014-000917-30
• Status: Terminated
• Phase: Phase 2
• Start date: December 1, 2014
• Est. completion date: June 4, 2015

Study information

• Verified date: May 2024
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 4, 2015
• Est. primary completion date: June 4, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Key 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-ß and glatiramer acetate) within 2 weeks prior to Screening. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• natalizumab
Administered as specified in the treatment arm

Locations

Country	Name	City	State
Belgium	Research Site	Leuven
Belgium	Research Site	Liege

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with persistent anti-natalizumab antibodies	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.	48 weeks
Secondary	Proportion of participants with transient anti-natalizumab antibodies		48 weeks
Secondary	Proportion of participants with post-injection adverse events (AEs)	Including hypersensitivity reactions, anaphylactic reactions and other AEs occurring within 1 hour after SC natalizumab dosing.	48 weeks
Secondary	Proportion of participants with clinical relapse	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.	48 weeks
Secondary	Proportion of participants with gadolinium (Gd) enhancing lesion(s) as assessed by MRI.		48 weeks
Secondary	Proportion of Participants that experience Adverse Events and Serious Adverse Events		up to 56 weeks

External Links

•   EudraCT Tabulated Result