NCT05983471: COSMIC-IPF

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

Active, enrolled Phase 2 Last updated 8 April 2025

What this trial tests

Phase 2 trial testing ME-015 (Suplatast Tosilate) in Idiopathic Pulmonary Fibrosis in 40 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 April 2024

Primary endpoint
1 August 2025

1 September 2025

Quick facts

Lead sponsor	Melius Pharma AB
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	1 April 2024
Primary completion	1 August 2025
Estimated completion	1 September 2025
Sites	6 locations across India

Drugs / interventions tested

• ME-015 (Suplatast Tosilate) — full drug profile →
• Identical placebo

Conditions studied

• Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →
• Cough — all drugs for Cough →
• IPF — all drugs for IPF →
• Fibrotic Lung Disease — all drugs for Fibrotic Lung Disease →

Sponsor

Melius Pharma AB — full company profile →

Who can join

18 and older, any sex, with Idiopathic Pulmonary Fibrosis or Cough. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Wake time cough frequency during 24 hours
  Time frame: Change from Baseline to Day 14 in the respective treatment period
  Measured objectively over a 24-hour period with the cough recording device VitaloJak and processed using centralized, blinded, QC'd analysis

Sponsor's own description

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 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 November 2024, there is no approved treatment for IPF cough. There is an enormous unmet clinical need for an effective, safe and well-tolerated oral treatment; particularly as approved antifibrotic treatments (pirfenidone and nintedanib) have not been shown to reduce cough in controlled clinical trials.

The COSMIC-IPF Phase 2a trial is the first clinical trial assessing ME-015 (an NCE outside of Japan) 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Plastic Interplay between Lung Regeneration Phenomena and Fibrotic Evolution: Current Challenges and Novel Therapeutic Perspectives.
   Lettieri S, Bertuccio FR, Del Frate L, Perrotta F, et al · · 2023 · cited 6× · PMID 38203718 · DOI 10.3390/ijms25010547
2. Idiopathic Pulmonary Fibrosis, Today and Tomorrow: Certainties and New Therapeutic Horizons.
   Giulianelli G, Cocconcelli E, Fiorentù G, Bernardinello N, et al · · 2025 · cited 3× · PMID 40323570 · DOI 10.1007/s41030-025-00296-0