PK and PD Study of Natalizumab in Pediatric Subjects With RRMS

Biogen

Status and phase: Completed; Phase 1

Conditions: Relapsing-Remitting Multiple Sclerosis

Treatments: Biological: Natalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01884935

101MS328

2012-005082-13

Details and patient eligibility

About

The primary objective of the study is to determine the pharmacokinetic (PK) profile of multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives are as follows: to characterize the pharmacodynamic (PD) profile of natalizumab (as defined by α4 integrin binding) and to explore the safety and tolerability of multiple doses of natalizumab in the pediatric population.

Enrollment: 13 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Rapidly evolving severe relapsing remitting multiple sclerosis, defined by 2 or more disabling relapses in 1 year, and with 1 or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load, as compared to a previous recent magnetic resonance imaging (MRI)

Key Exclusion Criteria:

• History of, or abnormal laboratory values indicative of, significant medical, neurologic (other than MS), or psychiatric disorders that might preclude participation in the study in the opinion of the Investigator.
• Prior natalizumab therapy.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Natalizumab

Experimental group

Description:

300 mg intravenously (IV) every 4 weeks

Treatment:

Biological: Natalizumab