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Summary

for people ages 18–55 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this study is to learn about the pharmacokinetics and pharmacodynamics of RPC1063 in RMS.

Official Title

A Phase I, Multicenter, Randomized, 12-Week, Open-Label Study to Evaluate the Multiple Dose Pharmacokinetics and Pharmacodynamics of RPC 1063 in Patients With Relapsing Multiple Sclerosis

Details

The purpose of this study is to characterize the full pharmacokinetic and pharmacodynamics profiles of RPC1063 in patients with relapsing multiple sclerosis (RMS) following multiple-dose administration of the two different dosing regimens that are being evaluated in the Phase 3 RMS studies.

Keywords

Multiple Sclerosis MS RMS Relapsing Multiple Sclerosis Sclerosis

Eligibility

For people ages 18–55

Key Inclusion Criteria:

  • MS, as diagnosed by the revised 2010 McDonald criteria
  • Exhibits a relapsing clinical course consistent with RMS and history of brain MRI lesions consistent with MS
  • Expanded disability status scale (EDSS) score between 0 and 6.0

Key Exclusion Criteria:

  • Primary progressive MS
  • Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk

Locations

  • Multiple Sclerosis Center at UCSF
    San Francisco, California, 94158, United States
  • Breastlink Medical Group, Inc.
    Long Beach, California, 90806, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT02797015
Phase
Phase 1
Lead Scientist
Bruce Cree
Study Type
Interventional
Last Updated
September 13, 2017