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OpenTrials
Completed

NCT Number: NCT01884935

PK and PD Study of Natalizumab in Pediatric Subjects With RRMS

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.

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Key information

Conditions

Relapsing-Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Cefalù, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Natalizumab

Biological

As specified in the treatment arm

Other names: Tysabri, BG00002

Primary outcomes

  1. predose (trough) concentrations from multiple dosing (Cpredose)

    Time frame: Up to week 16

  2. maximum plasma concentration (Cmax)

    Time frame: Up to Week 16

  3. time to maximum plasma concentration (Tmax)

    Time frame: Up to Week 16

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

    Time frame: Up to Week 16

  5. apparent clearance (Cl/F)

    Time frame: Up to Week 16

  6. volume of distribution

    Time frame: Up to Week 16

  7. elimination half-life (t1/2)

    Time frame: Up to Week 16

Secondary outcomes

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

    Time frame: Up to Week 16

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

    Time frame: Up to Week 16

  3. the presence of anti-natalizumab antibodies

    Time frame: Up to Week 16

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 24, 2013
Registry last updated
Jun 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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