PK and PD Study of Natalizumab in Pediatric Subjects With RRMS

Biogen13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Relapsing-Remitting Multiple Sclerosis

Interventions

NatalizumabBIOLOGICAL

As specified in the treatment arm

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (5)

Research Site

Cefalù, Italy

Research Site

Gallarate, Italy

Research Site

Milan, Italy

Research Site

Padua, Italy

Research Site

Rome, Italy

Outcomes

Primary Outcomes

predose (trough) concentrations from multiple dosing (Cpredose)

Time frame: Up to week 16

maximum plasma concentration (Cmax)

Time frame: Up to Week 16

time to maximum plasma concentration (Tmax)

Time frame: Up to Week 16

area under the plasma concentration curve from time of first dose to infinity (AUCinf)

Time frame: Up to Week 16

apparent clearance (Cl/F)

Time frame: Up to Week 16

volume of distribution

Time frame: Up to Week 16

elimination half-life (t1/2)

Time frame: Up to Week 16

Secondary Outcomes

the average and minimum saturation values of α4 integrin over the dosing interval

Time frame: Up to Week 16

incidence of serious adverse events (SAEs), infusion and hypersensitivity reactions, and other AEs

Time frame: Up to Week 16

the presence of anti-natalizumab antibodies

Time frame: Up to Week 16

Data from ClinicalTrials.gov

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