drugset / Trial / NCT02503657

Safety, Tolerability, and Efficacy of MN-001 (Tipelukast) in Patients With Idiopathic Pulmonary Fibrosis

NCT02503657 ↗

Phase 2 Completed 15 enrolled MediciNova
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, placebo-controlled, double-blind, 6-month study followed by a 6-month open-label extension phase to evaluate the efficacy, safety, and tolerability of MN-001 in patients diagnosed with moderate to severe idiopathic pulmonary fibrosis (IPF). Participants were randomly assigned to receive MN-001 or matching placebo twice daily over a 26-week period. A total of 15 participants were enrolled.

Timeline

Start
2016-03-09
Primary completion
2020-12-07
Completion
2022-03-15

Drugs

EvaluationDrugModalityDoseRoute
Subject tipelukast Small molecule 750 mg —