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ACTIVE NOT RECRUITING

NCT05983471

PHASE2

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

Sponsor: Melius Pharma AB

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-04-01

Completion Date

2025-09

Last Updated

2025-04-09

Healthy Volunteers

Conditions

Idiopathic Pulmonary Fibrosis Cough IPF Fibrotic Lung Disease Chronic Cough Coughing

Interventions

DRUG

ME-015 (Suplatast Tosilate)

Oral capsule form, 200 mg t.i.d. (total 600 mg per 24 hours)

OTHER

Identical placebo

Without active component

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

Locations (6)

Aditya Multi Specialty Hospital

Guntur, Andhra Pradesh, India

KLE's Dr Prabhakar Kore Hospital & Medical Research Centre

Belagavi, Karnataka, India

ACE Hospital and Research Centre

Pune, Maharashtra, India

Hindusthan Hospital

Coimbatore, Tamil Nadu, India

GSVM Medical College, Murari Lal Chest Hospital

Kanpur, Uttar Pradesh, India

Health Point Hospital

Kolkata, West Bengal, India