NCT05983471Active, not recruitingPhase 2
Efficacy and Safety of ME-015 (Suplatast Tosilate) in Cough Related to Idiopathic Pulmonary Fibrosis (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
Source: ClinicalTrials.gov · Last updated 9 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 24 Jul 2023
- Start date
- 1 Apr 2024
- Primary completion date
- Aug 2025
- Lead sponsor
- Melius Pharma AB
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT05983471
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 1 Apr 2024 to the primary completion date, Aug 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Likely need for lung transplantation in next 12 months
- Permanent long-term oxygen therapy
- Use of high-dose corticosteroids or cytotoxic medications
- Treatment with an ACE inhibitor or sitagliptin
- Investigational drug or biologic within the last 2 months
Other illness
- History of unstable or deteriorating cardiac or pulmonary disease in the preceding 6 months
- Suspected acute infection, including COVID-19 or influenza or any upper respiratory tract infection
- History of malignancy within the last 2 years
- History of drug/ alcohol dependency/ abuse within the last 2 years
- Condition that could affect drug absorption
- Recent history of stroke or TIA
- Severe medical/ psychiatric condition posing risk to trial participation
Other
- Current smoking, vaping, or tobacco chewing
- Any antitussive treatment, including opioid-based and OTC, for treatment of cough within 4 weeks of Screening or at any point during the study
- BMI \< 18 kg/m2 or ≥ 40 kg/m2
- Resting blood pressure \> 160/90 mmHg
- Pregnant/lactating women
- Blood donation within the last 56 days or plasma donation within the last 7 days
Who the study is looking for
- Diagnosis of IPF according to 2018 ATS/ERS/JRS/ALAT guidelines, confirmed by high-resolution computed tomography (HRCT) chest scan taken \< 2 years ago
- Age ≥ 18 years
- Cough attributed to IPF unresponsive to standard anti-tussive treatment and present for \> 8 weeks
- Arithmetic mean of ≥ 10 coughs/hour during waking hours
- Ability to read, comprehend, and complete the ICF and all questionnaires in the study without help
- Cough severity score of ≥ 40 mm on a 0-to-100 mm Visual Analogue Scale (VAS)
- Willing and able to comply with the protocol
- Life expectancy \> 6 months
- Stable medical condition: stable treatment for \> 12 weeks and absence of acute exacerbations for \> 4 weeks
- FVC ≥ 40% predicted
- FEV1 / FVC ≥ 65%
- Women of childbearing potential must agree to use a highly effective method of contraception
- Male partner must agree to use a condom during the study, unless they had a vasectomy \> 6 months prior to first study drug administration
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre Coordinator of this site? Confirm its status | Belagavi | India | Unknown status |
| Hindusthan Hospital Coordinator of this site? Confirm its status | Coimbatore | India | Unknown status |
| Aditya Multi Specialty Hospital Coordinator of this site? Confirm its status | Guntur | India | Unknown status |
| GSVM Medical College, Murari Lal Chest Hospital Coordinator of this site? Confirm its status | Kanpur | India | Unknown status |
| Health Point Hospital Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Ace Hospital and Research Centre Coordinator of this site? Confirm its status | Pune | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.