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)
2 other identifiers
interventional
13
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2013
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2013
CompletedFirst Posted
Study publicly available on registry
June 24, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedJune 23, 2016
January 1, 2015
1.2 years
June 20, 2013
June 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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 Outcomes (3)
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
Study Arms (1)
Natalizumab
EXPERIMENTAL300 mg intravenously (IV) every 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- \- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (5)
Research Site
Cefalù, Italy
Research Site
Gallarate, Italy
Research Site
Milan, Italy
Research Site
Padua, Italy
Research Site
Rome, Italy
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2013
First Posted
June 24, 2013
Study Start
July 1, 2013
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
June 23, 2016
Record last verified: 2015-01