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Clinical Trials in India / NCT05983471
Active, not recruiting Phase 2

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

NCT05983471 · tracked via the Priya Life Science India tracker
Sponsor
Melius Pharma AB
Phase
Phase 2
Started
2024-04-01
Last updated
2025-04-09

Condition(s) studied

Idiopathic Pulmonary FibrosisCoughIPFFibrotic Lung DiseaseChronic CoughCoughing

Investigational drug(s) / intervention(s)

ME-015 (Suplatast Tosilate)Identical placebo

ME-015 (Suplatast Tosilate): Oral capsule form, 200 mg t.i.d. (total 600 mg per 24 hours)

Identical placebo: Without active component

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Diagnosis of IPF according to 2018 ATS/ERS/JRS/ALAT guidelines, confirmed by high-resolution computed tomography (HRCT) chest scan taken \< 2 years ago 2. Age ≥ 18 years 3. Cough attributed to IPF unresponsive to standard anti-tussive treatment and present for \> 8 weeks 4. Arithmetic mean of ≥ 10 coughs/hour during waking hours 5. Ability to read, comprehend, and complete the ICF and all questionnaires in the study without help 6. Cough severity score of ≥ 40 mm on a 0-to-100 mm Visual Analogue Scale (VAS) 7. Willing and able to comply with the protocol 8. Life expectancy \> 6 months 9. Stable medical condition: stable treatment for \> 12 weeks and absence of acute exacerbations for \> 4 weeks 10. FVC ≥ 40% predicted 11. FEV1 / FVC ≥ 65% 12. Women of childbearing potential must agree to use a highly effective method of contraception 13. Male partner must agree to use a condom during the study, unless they had a vasectomy \> 6 months prior to first study drug administration Exclusion Criteria: 1. Likely need for lung transplantation in next 12 months 2. Permanent long-term oxygen therapy 3. Use of high-dose corticosteroids or cytotoxic medications 4. History of unstable or deteriorating cardiac or pulmonary disease in the preceding 6 months 5. Current smoking, vaping, or tobacco chewing 6. Treatment with an ACE inhibitor or sitagliptin 7. Any antitussive treatment, including opioid-based and OTC, for treatment of cough within 4 weeks of Screening or at any point during the study 8. BMI \< 18 kg/m2 or ≥ 40 kg/m2 9. Suspected acute infection, including COVID-19 or influenza or any upper respiratory tract infection 10. History of malignancy within the last 2 years 11. History of drug/ alcohol dependency/ abuse within the last 2 years 12. Condition that could affect drug absorption 13. Recent history of stroke or TIA 14. Resting blood pressure \> 160/90 mmHg 15. Pregnant/lactating women 16. Investigational drug or biologic within the last 2 months 17. Blood donation within the last 56 days or plasma donation within the last 7 days 18. Severe medical/ psychiatric condition posing risk to trial participation

Primary outcome measure(s)

  • Wake time cough frequency during 24 hours — 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

Trial sites (6)

FacilityCityRegionStatus
Aditya Multi Specialty Hospital Guntur Andhra Pradesh
KLE's Dr Prabhakar Kore Hospital & Medical Research Centre Belagavi Karnataka
ACE Hospital and Research Centre Pune Maharashtra
Hindusthan Hospital Coimbatore Tamil Nadu
GSVM Medical College, Murari Lal Chest Hospital Kanpur Uttar Pradesh
Health Point Hospital Kolkata West Bengal

Other trials for the same condition

A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough Active, not recruiting
LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF) Active, not recruiting
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis Active, not recruiting
A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05983471 on ClinicalTrials.gov ↗ ← All trials in India