PK and PD Study of Natalizumab in Pediatric Subjects With RRMS

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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)

13 participants in 1 patient group

Natalizumab
Experimental group
Description:
300 mg intravenously (IV) every 4 weeks
Treatment:
Biological: Natalizumab

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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