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Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis
Sponsor: Janssen Research & Development, LLC
Summary
This is a randomized, double-blind study of PIPE-307 or placebo in subjects with relapsing-remitting multiple sclerosis. Subjects will be randomized into 1 of 3 separate cohorts (1:1:1 randomization ratio, PIPE-307 Dose A:PIPE-307 Dose B: Placebo) for a total duration of approximately 30 weeks.
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Multicenter Study to Evaluate the Safety and Efficacy of Oral PIPE-307 as an Adjunctive Treatment in Subjects With Relapsing-Remitting Multiple Sclerosis
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
182
Start Date
2023-11-06
Completion Date
2025-08-04
Last Updated
2026-09-25
Healthy Volunteers
No
Conditions
Interventions
PIPE-307 Dose A
Subjects will receive daily oral doses of PIPE-307
PIPE-307 Dose B
Subjects will receive daily oral doses of PIPE-307
Placebo
Subjects will receive daily oral matching dose of Placebo
Locations (21)
Xenosciences
Phoenix, Arizona, United States
Arizona Neuroscience Research, LLC
Phoenix, Arizona, United States
Alta Bates Summit Medical Center
Berkeley, California, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
MS and Neuromuscular Center of Excellence
Clearwater, Florida, United States
Aqualane Clinical Research
Naples, Florida, United States
Shepherd Center
Atlanta, Georgia, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Neurology Center of New England P.C.
Foxborough, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of New Mexico/Health Science Center/MIND Imaging Center/MS Specialty Clinic
Albuquerque, New Mexico, United States
Dent Neurologic Institute
Amherst, New York, United States
Neurological Associates of Long Island, P.C.
Lake Success, New York, United States
Oklahoma Research Foundation - MS Center of Excellence
Oklahoma City, Oklahoma, United States
Sibyl Wray Neurology PC
Knoxville, Tennessee, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Bhupesh Dihenia, MD, PA
Lubbock, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
UW Medicine MS Center
Seattle, Washington, United States
Multicare Neuroscience Center of Washington
Tacoma, Washington, United States