PK and PD Study of Natalizumab in Pediatric Subjects With RRMS

Phase 1

Completed

• Conditions: Relapsing-Remitting Multiple Sclerosis
• Interventions: Biological: Natalizumab

• Registration Number: NCT01884935
• Lead Sponsor: Biogen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-20
• Study First Submitted QC: 2013-06-20
• Study First Posted: 2013-06-24
• Study Start: 2013-07
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-01
• Last Update Submitted: 2016-06-21
• Last Update Posted: 2016-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Natalizumab	Natalizumab	300 mg intravenously (IV) every 4 weeks

Primary Outcome Measures

Name	Time	Method
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
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
elimination half-life (t1/2)	Up to Week 16

Secondary Outcome Measures

Name	Time	Method
the average and minimum saturation values of α4 integrin over the dosing interval	Up to Week 16
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

Trial Locations

Locations (1)

Research Site; 🇮🇹 Rome, Italy