NCT05497284

To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF

A Participant- and Investigator-blinded, Randomized, Placebo-controlled, Multicenter, Platform Study to Investigate Efficacy, Safety, and Tolerability of Various Single Treatments in Participants With Idiopathic Pulmonary Fibrosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis

Detailed description

This was a randomized, placebo-controlled, participant- and investigator-blinded platform study in participants with idiopathic pulmonary fibrosis. Participants underwent a screening period of 42 days, a treatment period of 26 weeks and a post-treatment safety follow-up period of 30 days. This study was designed to safely allow rapid and efficient screening of potentially efficacious investigational products in participants with IPF. The study was terminated for strategic reasons and no additional cohorts were created.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	LTP001	LTP001 administered once daily in the morning
DRUG	Placebo	Placebo to LTP001 administered once daily in the morning
DRUG	Standard of Care (SoC)	nintedanib, pirfenidone, or neither

Timeline

• Start date: 2022-11-10
• Primary completion: 2024-08-26
• Completion: 2024-09-26
• First posted: 2022-08-11
• Last updated: 2026-01-13
• Results posted: 2025-09-18

Locations

15 sites across 7 countries: United States, Argentina, Australia, Czechia, Germany, Netherlands, Poland

Regulatory

• FDA-regulated drug study