Dose-finding study for SAR442168 in relapsing multiple sclerosis

Dose-finding study for SAR442168 in relapsing multiple sclerosis

Brief Summary:

Primary Objective: To determine the efficacy of SAR442168 in reducing the number of new brain lesions reported in Magnetic Resonance Imaging (MRI)

Secondary Objectives:

  • To evaluate the efficacy of SAR442168 on clinical symptoms and imaging measures
  • To evaluate the safety and tolerability of SAR442168

Detailed Description: The total study duration is 24 weeks which includes a screening period of 4 weeks, a treatment period of 16 weeks and a follow-up period of up to 4 weeks. Participants completing the Week 16 visit will be proposed to enroll in a long-term safety (LTS) follow-up study to assess safety and tolerability of SAR442168.

Study Type: Interventional(Clinical Trial)
Estimated Enrollment: 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b Dose-finding Study for SAR442168, a Bruton’s Tyrosine Kinase Inhibitor, in Participants With Relapsing Multiple Sclerosis
ActualStudy Start Date: February 21, 2019
EstimatedPrimary Completion Date: December 2019
EstimatedStudy Completion Date: December 2019

Patients who are diagnosed with Relapsing Multiple Sclerosis may qualify for a new study titled “Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis”. More information is available in the study pamphlet and on https://clinicaltrials.gov/ct2/show/NCT03889639?term=dri15928&rank=1.

CMSC Disclaimer

The industry news information and articles are for informational purposes only, and are not intended to represent any trends, partnerships, commitments, or research of the Consortium of MS Centers or any of it's members in any way whatsoever, nor should any party be libel in any way to the reader or to any other person, firm or corporation reading this industry news section. Although the CMSC site includes links providing direct access to other Internet sites, CMSC takes no responsibility for the content or information contained on those other sites, and does not exert any editorial or other control over those other sites. CMSC is providing information and services on the Internet as a benefit and service in furtherance of CMSC's nonprofit and tax-exempt status. CMSC makes no representations about the suitability of this information and these services for any purpose.

Elizabeth Porco

Comments are closed.

CMSC provides leadership in clinical research and education; develops vehicles to share information and knowledge among members; disseminates information to the health care community and to persons affected by MS.

Contact Us
Contact Us
I have a question about
First
Last

Feel Free To contact Us
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Nam molestie, tellus id pellen tesque feugiat, sem sem cursus orci, a placerat ante ante nec massa. consectetuer adipiscing elit.

+1-222-333-4444

New York, NY 10123 USA

Mon - Sat 9:00 AM