PK and PD Study of Natalizumab in Pediatric Subjects With RRMS

A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RMS)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01884935

Enrollment

Registered

2013-06-24

Start date

2013-07-31

Completion date

2014-09-30

Last updated

2016-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

Pediatric

Brief summary

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.

Interventions

BIOLOGICALNatalizumab

As specified in the treatment arm

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 17 Years

Healthy volunteers

Inclusion 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/

Design outcomes

Primary

Measure	Time frame
elimination half-life (t1/2)	Up to Week 16
area under the plasma concentration curve from time of first dose to infinity (AUCinf)	Up to Week 16
apparent clearance (Cl/F)	Up to Week 16
volume of distribution	Up to Week 16
predose (trough) concentrations from multiple dosing (Cpredose)	Up to week 16
maximum plasma concentration (Cmax)	Up to Week 16
time to maximum plasma concentration (Tmax)	Up to Week 16

Secondary

Measure	Time frame
incidence of serious adverse events (SAEs), infusion and hypersensitivity reactions, and other AEs	Up to Week 16
the presence of anti-natalizumab antibodies	Up to Week 16
the average and minimum saturation values of α4 integrin over the dosing interval	Up to Week 16

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026