NCT05373914

RESPIRARE - Efficacy and Safety of Cudetaxestat in Patients With Idiopathic Pulmonary Fibrosis (IPF)

RESPIRARE - A Phase 2, Randomized, Double-blinded, Placebo-controlled, Efficacy and Safety Study of Cudetaxestat (BLD-0409) Assessed Across Three Dose Ranges With or Without Standard of Care (Nintedanib or Pirfenidone) in Patients With Idiopathic Pulmonary Fibrosis (IPF)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Blade Therapeutics · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of this study is to evaluate the effectiveness and safety of cudetaxestat (BLD-0409) as compared to placebo with or without standard of care (nintedanib or pirfenidone) in subjects with idiopathic pulmonary fibrosis (IPF)

Detailed description

This is a phase 2, randomized, double-blinded, placebo-controlled, efficacy and safety study of cudetaxestat (BLD-0409) assessed across three dose ranges with or without standard of care (nintedanib or pirfenidone) in patients with idiopathic pulmonary fibrosis (IPF). The study will include a screening period, a treatment period, and a follow-up period.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Cudetaxestat (BLD-0409)	Cudetaxestat - 250mg tablets (orally)
DRUG	Control: Matching Placebo	Placebo - 250mg tablets (orally)

Timeline

• Start date: 2022-05-31
• Primary completion: 2023-12-30
• Completion: 2024-03-31
• First posted: 2022-05-13
• Last updated: 2022-05-18

Regulatory

• FDA-regulated drug study