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)
Facility
City
Region
Status
Aditya Multi Specialty Hospital
Guntur
Andhra Pradesh
KLE's Dr Prabhakar Kore Hospital & Medical Research Centre
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.
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