Overview

A Pilot Study to Characterize the Biological Effect of a Pre-planned 12 Week Dose Interruption of Natalizumab

Status:
Recruiting

Trial end date:
2021-12-01

Target enrollment:
0

Participant gender:
All

Summary

This is an open-label study of patients with relapsing forms of MS is designed to assess the biochemical, immunological, and kinetic profiles of natalizumab being used with specific brief dosing interruption. The study will be conducted at one site in the US. Ten subjects currently treated with natalizumab will be enrolled and will be evaluated for both PK/PD and cell trafficking in blood and/or CSF during standard dosing of natalizumab and at the end of a planned 12-week dosing interruption. MS disease activity will be carefully monitored clinically and by MRI and NfL.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Berkovich, Regina MD, PhD Inc.

Collaborators:

Biogen
Cedars-Sinai Medical Center

Treatments:

Natalizumab

Criteria

Inclusion Criteria:

To be eligible for entry into this study, candidates must meet all of the following
eligibility criteria at the time of randomization:

Screening Visit:

1. Ability to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use protected health information (PHI) in
accordance with national and local subject privacy regulations.

2. At least 18 years old at the time of informed consent.

3. Must be a patient with a relapsing form of Multiple Sclerosis enrolled in the TOUCH
Prescribing Program who is not expected to discontinue Tysabri® therapy prior to
completion of the requirements of this study.

4. Must weigh between 50 and 110 kg, inclusive.

5. Patients must be considered clinically stable and scheduled for their pre-planned
annual dose interruption of 2 consecutive skipped doses.

6. No evidence of disease activity with on standard (28-day interval) dosing of
natalizumab.

Exclusion Criteria:

Candidates will be excluded from study entry if any of the following exclusion criteria
exist at the time of screening:

Medical History

1. If subject answers 'Yes" to any question on the PML questionnaire that is not resolved
prior to infusion as per standard operating procedure for natalizumab infusion.

2. If subject consumes alcohol within 24 hours of blood specimen collection.