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

NCT04048577 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-07-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dosing Interruption of Natalizumab

Planned 12 week dosing interruption of natalizumab

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • Cedars-Sinai Medical Center

    collaborator OTHER

  • Berkovich, Regina MD, PhD Inc.

    lead OTHER

Principal Investigators

  • Regina R Berkovich, MD, PhD · Regina Berkovich MD, PhD Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-03
Primary Completion
2021-11-01
Completion
2021-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04048577 on ClinicalTrials.gov