NCT06083753

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Contineum Therapeutics · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, double-blind study of PIPE-307 or placebo given to 168 subjects randomized into one of 3 separate cohorts. They will be randomized 1:1:1 (PIPE-307 Dose A:Pipe 307 Dose B: Placebo). There will be a 28-day screening period followed by a 26-week treatment period. Safety will be assessed by periodic measurements of vital signs (VS), physical (PE) and neurological examinations, electrocardiograms (ECG), blood laboratory analyses and occurrence of adverse events (AE).

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-11-06
• Primary completion: 2025-07-14
• Completion: 2025-08-04
• First posted: 2023-10-16
• Last updated: 2025-10-23

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study