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COMPLETED
NCT06083753
PHASE2

Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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

Interventions

DRUG

PIPE-307 Dose A

Subjects will receive daily oral doses of PIPE-307

DRUG

PIPE-307 Dose B

Subjects will receive daily oral doses of PIPE-307

DRUG

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