Efficacy and Safety of ME-015 (Suplatast Tosilate) in Cough Related to Idiopathic Pulmonary Fibrosis (COSMIC-IPF) — COSMIC-IPF  

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title: A Randomized, Double-blind, Placebo-controlled, Cross-over Trial to Evaluate the Efficacy and Safety of ME-015 (Suplatast Tosilate) in Cough Related to Idiopathic Pulmonary Fibrosis

Status Not yet recruiting

Clinical Trial Summary

Orally administered ME-015 (Suplatast Tosilate) has been available on the market as a prescription drug for allergy-related conditions in Japan since 1995 with a very good safety and tolerability profile.

There is preclinical and exploratory clinical evidence suggesting that ME-015 may be effective in treating cough caused by idiopathic pulmonary fibrosis (IPF-cough).

80% of patients with idiopathic pulmonary fibrosis (IPF) are affected by a devastating dry cough that is often not responsive to standard cough treatments and causes significant psychological and physiological suffering as well as reduced quality of life. As of July 2023, there is no approved treatment for the indication of IPF-cough. There is an enormous unmet clinical need for an effective, safe and well-tolerated oral treatment.

The COSMIC-IPF Phase 2 trial is the first clinical trial assessing ME-015 for the treatment of IPF-cough and aims to generate clinical proof-of-concept results regarding the safety and efficacy of ME-015 in this condition.

Clinical Trial Description

This double-blind, cross-over, placebo-controlled clinical trial will randomize patients with stable idiopathic pulmonary fibrosis (IPF) and cough related to IPF (IPF-cough) in a 1:1 fashion to one of two treatment sequences: active treatment followed by placebo, or placebo followed by active treatment. Each 14-day active/placebo treatment phase is preceded by a wash-out period. The treatment sequences are followed by an observational 7-day follow-up period without medication. All subjects in the trial receive standard-of-care antifibrotic treatment for IPF.

Treatment assignment is blinded to patients, investigators, site personnel, data analysts and Sponsor. The active treatment is ME-015 (Suplatast Tosilate) 200 mg t.i.d. (three times per day) administered as oral capsules. The placebo treatment consists of identical capsules without the active component.

The primary efficacy endpoint is the effect on wake time cough frequency measured objectively with the VitaloJak device over a 24-hour period. VitaloJak recordings are analysed using a blinded, independent, central review process.

The study is conducted as a single-country, multi-site clinical trial in India with Melius Pharma AB as the Sponsor. ;

Related Conditions & MeSH terms

• Cough
• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

• NCT number: NCT05983471
• Study type: Interventional
• Source: Melius Pharma AB
• Contact: Christoph Nowak, MD, PhD, Dipl-Psych
• Phone: +46739806535
• Email: chris.nowak@meliuspharma.com
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 2023
• Completion date: March 2025