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PK and PD Study of Natalizumab in Pediatric Subjects With RRMS

Primary Purpose

Relapsing-Remitting Multiple Sclerosis

Status

Completed

Phase

Phase 1

Locations

Italy

Study Type

Interventional

Intervention

Natalizumab

About this trial

This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis focused on measuring Pediatric

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Research Site
Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Natalizumab

Arm Description

300 mg intravenously (IV) every 4 weeks

Outcomes

Primary Outcome Measures

predose (trough) concentrations from multiple dosing (Cpredose)

maximum plasma concentration (Cmax)

time to maximum plasma concentration (Tmax)

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

apparent clearance (Cl/F)

volume of distribution

elimination half-life (t1/2)

Secondary Outcome Measures

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

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

the presence of anti-natalizumab antibodies

Full Information

NCT ID

NCT01884935

First Posted

June 20, 2013

Last Updated

June 21, 2016

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT01884935

Brief Title

PK and PD Study of Natalizumab in Pediatric Subjects With RRMS

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsing-Remitting Multiple Sclerosis

Keywords

Pediatric

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Natalizumab

Arm Type

Experimental

Arm Description

300 mg intravenously (IV) every 4 weeks

Intervention Type

Biological

Intervention Name(s)

Natalizumab

Other Intervention Name(s)

Tysabri, BG00002

Intervention Description

As specified in the treatment arm

Primary Outcome Measure Information:

Title

predose (trough) concentrations from multiple dosing (Cpredose)

Time Frame

Up to week 16

Title

maximum plasma concentration (Cmax)

Time Frame

Up to Week 16

Title

time to maximum plasma concentration (Tmax)

Time Frame

Up to Week 16

Title

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

Time Frame

Up to Week 16

Title

apparent clearance (Cl/F)

Time Frame

Up to Week 16

Title

volume of distribution

Time Frame

Up to Week 16

Title

elimination half-life (t1/2)

Time Frame

Up to Week 16

Secondary Outcome Measure Information:

Title

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

Time Frame

Up to Week 16

Title

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

Time Frame

Up to Week 16

Title

the presence of anti-natalizumab antibodies

Time Frame

Up to Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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/Exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Biogen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Cefalu

Country

Italy

Facility Name

Research Site

City

Gallarate

Country

Italy

Facility Name

Research Site

City

Milan

Country

Italy

Facility Name

Research Site

City

Padua

Country

Italy

Facility Name

Research Site

City

Rome

Country

Italy

12. IPD Sharing Statement

Links:

URL

https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-005082-13/results

Description

EudraCT Tabulated Result

Learn more about this trial

PK and PD Study of Natalizumab in Pediatric Subjects With RRMS

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