NCT05951296

A Study to Investigate Leramistat in Patients With IPF

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Efficacy and Safety of Leramistat in Patients With Idiopathic Pulmonary Fibrosis (IPF)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Modern Biosciences Ltd · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

To compare the effect of daily oral dosing of leramistat over 12 weeks with placebo in participants aged 40 years or older with idiopathic pulmonary fibrosis (IPF).

Detailed description

This will be a Phase 2, double-blind, placebo-controlled, 2-arm, parallel-group, multi-centre study to investigate leramistat treatment of patients aged 40 years or older with IPF. The study is planned to consist of the following parts: Screening period: 1 to 28 days (Weeks -4 to -1). Treatment period: a 12-week blinded, placebo-controlled treatment period (Weeks 1 to 12). Follow up period: 56 days (Weeks 13 to 20). All participants will return for a follow-up visit 56 days after their final dose. Randomization will be stratified by concomitant use of an approved anti-fibrotic drug (nintedanib or pirfenidone) at randomization versus no concomitant use of an approved anti-fibrotic drug at randomization. Number of Participants: Approximately 150 participants will be enrolled and randomly assigned in a 2:1 ratio to receive either leramistat or matched placebo. If the participant is receiving nintedanib or pirfenidone treatment, it should be stable for at least 8 weeks prior to study entry and be predicted to remain stable during the course of the study. The maximum duration of participation (including screening period and follow-up) is 24 weeks. Data Monitoring/Other Committee: A DSMB has been appointed for this study.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Leramistat	Drug: Leramistat
DRUG	Placebo	Placebo comparator

Timeline

• Start date: 2023-08-30
• Primary completion: 2024-02-27
• Completion: 2024-03-14
• First posted: 2023-07-19
• Last updated: 2025-04-09

Locations

57 sites across 9 countries: United States, France, Germany, Greece, Hungary, Israel, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study