NCT07284459

Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 324 (estimated)
• Sponsor: Contineum Therapeutics · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of PIPE-791 in subjects with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) with or without background treatment.

Detailed description

This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and PK of PIPE-791 in subjects with a diagnosis of Idiopathic Pulmonary Fibrosis with or without background treatment. The treatment period is 26 weeks and full study duration is up to 36 weeks including Screening and Follow-Up. Approximately 324 subjects will be enrolled into one of three treatment arms, PIPE-791 Dose A, PIPE-791 Dose B, or placebo.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	PIPE-791 Dose A	Subjects will receive a daily oral dose of PIPE-791 in tablet form
DRUG	PIPE-791 Dose B	Subjects will receive a daily oral dose of PIPE-791 in tablet form
DRUG	Placebo	Subjects will receive a daily oral dose of matching Placebo in tablet form

Timeline

• Start date: 2026-01-08
• Primary completion: 2028-05-01
• Completion: 2028-06-01
• First posted: 2025-12-16
• Last updated: 2026-02-04

Locations

2 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study