NCT05483907

To Evaluate the Efficacy, Safety, and Tolerability of BBT-877 in Patients With IPF

A Phase 2, Randomized, Double-blind, Placebo-controlled, 24-Week Study to Evaluate the Efficacy, Safety, and Tolerability of BBT-877, as Mono- or add-on Therapy, in Patients With Idiopathic Pulmonary Fibrosis (IPF)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Bridge Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy, safety, and tolerability of 200 mg twice daily (BID) of BBT-877 in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	BBT-877	BBT-877 24 weeks + Follow-up 4 weeks
DRUG	Placebo	Placebo 24 weeks + Follow-up 4 weeks

Timeline

• Start date: 2023-04-12
• Primary completion: 2025-01-26
• Completion: 2025-02-23
• First posted: 2022-08-02
• Last updated: 2025-04-01

Locations

44 sites across 5 countries: United States, Australia, Israel, Poland, South Korea

Regulatory

• FDA-regulated drug study