PK and PD Study of Natalizumab in Pediatric Subjects With RRMS

Relapsing-Remitting Multiple Sclerosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884935
• Other study ID #: 101MS328
• Secondary ID: 2012-005082-13
• Status: Completed
• Phase: Phase 1
• First received: June 20, 2013
• Last updated: June 21, 2016
• Start date: July 2013
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Biological:
• Natalizumab
As specified in the treatment arm

Locations

Country	Name	City	State
Italy	Research Site	Cefalu
Italy	Research Site	Gallarate
Italy	Research Site	Milan
Italy	Research Site	Padua
Italy	Research Site	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	predose (trough) concentrations from multiple dosing (Cpredose)		Up to week 16	No
Primary	maximum plasma concentration (Cmax)		Up to Week 16	No
Primary	time to maximum plasma concentration (Tmax)		Up to Week 16	No
Primary	area under the plasma concentration curve from time of first dose to infinity (AUCinf)		Up to Week 16	No
Primary	apparent clearance (Cl/F)		Up to Week 16	No
Primary	volume of distribution		Up to Week 16	No
Primary	elimination half-life (t1/2)		Up to Week 16	No
Secondary	the average and minimum saturation values of a4 integrin over the dosing interval		Up to Week 16	No
Secondary	incidence of serious adverse events (SAEs), infusion and hypersensitivity reactions, and other AEs		Up to Week 16	Yes
Secondary	the presence of anti-natalizumab antibodies		Up to Week 16	No

External Links

•   EudraCT Tabulated Result