Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)

Biogen

Status and phase: Completed; Phase 1

Conditions: Relapsing-Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis

Treatments: Drug: natalizumab; Other: standard of care

Study type: Interventional

Funder types: Industry

Identifiers

NCT00559702

101MS102

Details and patient eligibility

About

The primary objective of this study is to compare the pharmacokinetic (PK) and pharmacodynamics (PD) of single subcutaneous (SC) and intramuscular (IM) doses of 300 mg natalizumab to intravenous (IV) administration of 300 mg natalizumab in multiple sclerosis (MS) participants. The secondary objectives are to investigate the safety, tolerability and PK of repeated natalizumab doses administered SC and IM, to investigate the immunogenicity of repeated natalizumab doses administered SC and IM, to explore proof of concept within the secondary progressive multiple sclerosis (SPMS) population using change from baseline in clinical measures including: expanded disability status scale (EDSS), multiple sclerosis functional composite scale (MSFC), symbol digit modalities test (SDMT), visual analogue scale (VAS), and visual function test; and brain magnetic resonance imaging (MRI) measures including: number of new or newly-enlarging T2 hyperintense lesions, number of new T1 hypointense lesions, number of new gadolinium-enhancing (Gd+) lesions, whole brain atrophy, magnetization transfer ratio (MTR), and diffusion tensor imaging (DTI) and to observe the effect of natalizumab administered IV and SC on brain MRI measures in participants with relapsing forms of MS.

Enrollment: 76 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• For arms 1,2,3 and 4: Diagnosis of Secondary Progressive Multiple Sclerosis (SPMS)
• For arms 5 and 6: Diagnosis of relapsing forms of Multiple Sclerosis (MS).
• No past history of receiving natalizumab.

Key Exclusion Criteria:

• For arms 1,2,3 and 4 Diagnosis of primary progressive MS or relapsing-remitting MS.
• Form arms 5 and 6: Diagnosis of primary progressive MS or secondary progressive MS without the occurrence of relapses.

NOTE: Other protocol defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 6 patient groups

1

Experimental group

Description:

Natalizumab IV (Participants with secondary progressive multiple sclerosis)

Treatment:

Drug: natalizumab

2

Experimental group

Description:

Natalizumab IM (Participants with secondary progressive multiple sclerosis)

Treatment:

Drug: natalizumab

3

Experimental group

Description:

Natalizumab SC (Participants with secondary progressive multiple sclerosis)

Treatment:

Drug: natalizumab

4

Other group

Description:

Standard of care as determined by the Investigator and Treating Neurologist (Participants with secondary progressive multiple sclerosis)

Treatment:

Other: standard of care

5

Experimental group

Description:

Natalizumab SC (Participants with relapsing forms of multiple sclerosis)

Treatment:

Drug: natalizumab

6

Experimental group

Description:

Natalizumab IV (Participants with relapsing forms of multiple sclerosis)

Treatment:

Drug: natalizumab