PK and PD Study of Natalizumab in Pediatric Subjects With RRMS

June 21, 2016 updated by: Biogen

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Cefalu, Italy
        • Research Site
      • Gallarate, Italy
        • Research Site
      • Milan, Italy
        • Research Site
      • Padua, Italy
        • Research Site
      • Rome, Italy
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Natalizumab
300 mg intravenously (IV) every 4 weeks
Biological: Natalizumab
As specified in the treatment arm
Other Names:
  • Tysabri
  • BG00002

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

June 20, 2013

First Submitted That Met QC Criteria

June 20, 2013

First Posted (Estimate)

June 24, 2013

Study Record Updates

Last Update Posted (Estimate)

June 23, 2016

Last Update Submitted That Met QC Criteria

June 21, 2016

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101MS328
  • 2012-005082-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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