Idiopathic Pulmonary FibrosisPhase 2COSMIC-IPFNCT05983471
Efficacy and Safety of ME-015 (Suplatast Tosilate) in Cough Related to Idiopathic Pulmonary Fibrosis (COSMIC-IPF)
A Phase 2 study testing ME-015 (Suplatast Tosilate) in people with Idiopathic Pulmonary Fibrosis and Cough, run by Melius Pharma AB at 6 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Cough, IPF
- What is being tested?
- ME-015 (Suplatast Tosilate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 6 sitesIndia
- Study dates
- 1 Apr 2024to Sep 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
- Likely need for lung transplantation in next 12 months
- Permanent long-term oxygen therapy
- Use of high-dose corticosteroids or cytotoxic medications
- History of unstable or deteriorating cardiac or pulmonary disease in the preceding 6 months
- Current smoking, vaping, or tobacco chewing
- Treatment with an ACE inhibitor or sitagliptin
Show all 18Show fewer
- 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
- 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
- Resting blood pressure > 160/90 mmHg
- Pregnant/lactating women
- Investigational drug or biologic within the last 2 months
- Blood donation within the last 56 days or plasma donation within the last 7 days
- Severe medical/ psychiatric condition posing risk to trial participation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
India6 sites
KLE's Dr Prabhakar Kore Hospital & Medical Research Centre
Belagavi, Karnataka, 590010
Hindusthan Hospital
Coimbatore, Tamil Nadu, 641028
Aditya Multi Specialty Hospital
Guntur, Andhra Pradesh, 522001
GSVM Medical College, Murari Lal Chest Hospital
Kanpur, Uttar Pradesh, 208002
Health Point Hospital
Kolkata, West Bengal, 700025
ACE Hospital and Research Centre
Pune, Maharashtra, 411004
About this study
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
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).
Read more
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.
Read the detailed description
This quadruple blinded, cross-over, placebo-controlled clinical trial will randomize patients with stable idiopathic pulmonary fibrosis (IPF) and cough related to IPF (IPF cough) in a 1:1 fashion to one of two treatment sequences: active treatment followed by placebo, or placebo followed by active treatment. Each 14-day active/placebo treatment phase is preceded by a wash out period. The treatment sequences are followed by an observational 7-day follow-up period without medication. All subjects in the trial receive standard-of-care antifibrotic treatment for IPF. There is a single-blinded placebo run-in period before randomization to create a stable baseline and adjust for the anticipated placebo effect at study entry.
Treatment assignment is blinded to patients, investigators, site personnel, data analysts and Sponsor. The active treatment is ME-015 (Suplatast Tosilate) 200 mg t.i.d. (three times per day) administered as oral capsules. The placebo treatment consists of identical capsules without the active component.
The primary efficacy endpoint is the effect on awake time cough frequency measured objectively with the VitaloJak device over a 24-hour period. VitaloJak recordings are analysed using a blinded, independent, central review and validation process.
The study is conducted as a single-country, multi-centre clinical trial in India with Melius Pharma AB as the Sponsor. External central adjudication of HRCT images by a UK-based KOL ensures guideline-based diagnoses of IPF. Treatment needs to follow international guideline-based standard of care for IPF, and all Indian sites have been chosen to reflect a similar standard of care as practiced in Europe and the U.S. Only literate patients are enrolled into the trial and all patient-facing material is made available in English and all common local languages.
- Conditions
- Idiopathic Pulmonary Fibrosis, Cough, IPF, Fibrotic Lung Disease, Chronic Cough, Coughing
- Being tested
- ME-015 (Suplatast Tosilate), Identical placebo
- Keywords
- IPF-cough, IPF cough, Idiopathic Pulmonary Fibrosis, Chronic cough, Suplatast, Melius, Refractory cough, IPF, Fibrotic cough, Melius Pharma, RCT, Sequential, Cough frequency, Cough severity, India, fibrosis, Oral, New Chemical Entity, Small molecule, Nowak
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Cough, Chronic Cough, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ME-015 (Suplatast Tosilate)Drug
Also called Suplatast, Suplatast Tosilate
Oral capsule form, 200 mg t.i.d. (total 600 mg per 24 hours)
Identical placeboOther
Without active component
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 | Experimental | 2 weeks of blinded active treatment, followed by 2 weeks of blinded placebo treatment (wash-out), followed by 2 weeks of blinded placebo treatment, followed by 1 week of follow-up with neither active nor placebo treatment Receives: Drug: ME-015 (Suplatast Tosilate); Other: Identical placebo |
| Treatment Arm 2 | Experimental | 2 weeks of blinded placebo treatment, followed by 2 weeks of blinded placebo treatment (wash-out), followed by 2 weeks of blinded active treatment, followed by 1 week of follow-up with neither active nor placebo treatment Receives: Drug: ME-015 (Suplatast Tosilate); Other: Identical placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wake time cough frequency during 24 hours
Measured objectively over a 24-hour period with the cough recording device VitaloJak and processed using centralized, blinded, QC'd analysis
Measured: Change from Baseline to Day 14 in the respective treatment period
Secondary outcomes (9)
Cough severity in the last 24 hours
Visual Analogue Scale (VAS) ranging from 0 - 100 mm where higher values indicate more severe cough
Measured: Change from Baseline to Day 14 in the respective treatment period
Cough-related quality of life in the last 24 hours
Leicester Cough Questionnaire (LCQ) total score ranging from 3 - 23 where lower values indicate greater impairment of health status due to cough
Measured: Change from Baseline to Day 14 in the respective treatment period
Overall patient-reported health status
Global Rating of Change Scale of cough severity (range -7 to +7) and cough frequency (range -7 to +7) where 0 indicates no change, higher values above 0 indicate larger improvement, and lower values below 0 indicate increased declined
Measured: Change from Baseline to Day 14 in the respective treatment period
Safety: Treatment-Emergent Adverse Events
Incidence of treatment-emergent adverse events (TEAE)
Measured: From enrolment into the trial until end of follow-up, circa 50-60 days per subject
Safety: Adverse Events and Serious Adverse Events
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From enrolment into the trial until end of follow-up, circa 50-60 days per subject
Safety: Vital Signs - blood pressure
Resting blood pressure (mmHg), assessed weekly
Measured: From enrolment into the trial until end of follow-up, circa 50-60 days per subject
Safety: Vital Signs - heart rate
Heart rate (bpm) - assessed weekly during the trial
Measured: From enrolment into the trial until end of follow-up, circa 50-60 days per subject
Safety: Vital Signs - body temperature
Body temperature (degrees Celsius) - assessed weekly during the trial
Measured: From enrolment into the trial until end of follow-up, circa 50-60 days per subject
Safety: Clinical Laboratory Results
Clinical laboratory results (chemistry, hematology, urine dipstick) analysed by a central laboratory
Measured: From enrolment into the trial until end of follow-up, circa 50-60 days per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Apr 2024
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melius Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983471
- Sponsor's protocol ID
- COSMIC-IPF
- Other IDs
- SYNCD-070-22
- Acronym
- COSMIC-IPF
- Status last verified
- Apr 2025
- First submitted
- 24 Jul 2023
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05983471
- Acronym / sponsor ID
- COSMIC-IPF / COSMIC-IPF
- Conditions
- Idiopathic Pulmonary Fibrosis, Cough, IPF, Fibrotic Lung Disease, Chronic Cough, Coughing
- Keywords
- IPF-cough, IPF cough, Idiopathic Pulmonary Fibrosis, Chronic cough, Suplatast, Melius, Refractory cough, IPF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Melius Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This quadruple blinded, cross-over, placebo-controlled clinical trial will randomize patients with stable idiopathic pulmonary fibrosis (IPF) and cough related to IPF (IPF cough) in a 1:1 fashion to one of two treatment sequences: active treatment followed by placebo, or placebo followed by active treatment. Each 14-day active/placebo treatment phase is preceded by a wash out period. The treatment sequences are followed by an observational 7-day follow-up period without medication. All subjects in the trial receive standard-of-care antifibrotic treatment for IPF. There is a single-blinded placebo run-in period before randomization to create a stable baseline and adjust for the anticipated placebo effect at study entry.
Treatment assignment is blinded to patients, investigators, site personnel, data analysts and Sponsor. The active treatment is ME-015 (Suplatast Tosilate) 200 mg t.i.d. (three times per day) administered as oral capsules. The placebo treatment consists of identical capsules without the active component.
The primary efficacy endpoint is the effect on awake time cough frequency measured objectively with the VitaloJak device over a 24-hour period. VitaloJak recordings are analysed using a blinded, independent, central review and validation process.
The study is conducted as a single-country, multi-centre clinical trial in India with Melius Pharma AB as the Sponsor. External central adjudication of HRCT images by a UK-based KOL ensures guideline-based diagnoses of IPF. Treatment needs to follow international guideline-based standard of care for IPF, and all Indian sites have been chosen to reflect a similar standard of care as practiced in Europe and the U.S. Only literate patients are enrolled into the trial and all patient-facing material is made available in English and all common local languages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1 | Experimental | Drug: ME-015 (Suplatast Tosilate), Other: Identical placebo2 weeks of blinded active treatment, followed by 2 weeks of blinded placebo treatment (wash-out), followed by 2 weeks of blinded placebo treatment, followed by 1 week of follow-up with neither active nor placebo treatment |
| Treatment Arm 2 | Experimental | Drug: ME-015 (Suplatast Tosilate), Other: Identical placebo2 weeks of blinded placebo treatment, followed by 2 weeks of blinded placebo treatment (wash-out), followed by 2 weeks of blinded active treatment, followed by 1 week of follow-up with neither active nor placebo treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (18 listed)
- Likely need for lung transplantation in next 12 months
- Permanent long-term oxygen therapy
- Use of high-dose corticosteroids or cytotoxic medications
- History of unstable or deteriorating cardiac or pulmonary disease in the preceding 6 months
- Current smoking, vaping, or tobacco chewing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ME-015 (Suplatast Tosilate)Also: Suplatast, Suplatast TosilateOral capsule form, 200 mg t.i.d. (total 600 mg per 24 hours) | Drug | Treatment Arm 1, Treatment Arm 2 |
| Identical placeboWithout active component | Other | Treatment Arm 1, Treatment Arm 2 |
Primary outcome
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
9 secondary outcomes
Cough severity in the last 24 hours
Time frame: Change from Baseline to Day 14 in the respective treatment period
Cough-related quality of life in the last 24 hours
Time frame: Change from Baseline to Day 14 in the respective treatment period
Overall patient-reported health status
Time frame: Change from Baseline to Day 14 in the respective treatment period
Safety: Treatment-Emergent Adverse Events
Time frame: From enrolment into the trial until end of follow-up, circa 50-60 days per subject
Safety: Adverse Events and Serious Adverse Events
Time frame: From enrolment into the trial until end of follow-up, circa 50-60 days per subject
Safety: Vital Signs - blood pressure
Time frame: From enrolment into the trial until end of follow-up, circa 50-60 days per subject
Safety: Vital Signs - heart rate
Time frame: From enrolment into the trial until end of follow-up, circa 50-60 days per subject
Safety: Vital Signs - body temperature
Time frame: From enrolment into the trial until end of follow-up, circa 50-60 days per subject
Safety: Clinical Laboratory Results
Time frame: From enrolment into the trial until end of follow-up, circa 50-60 days per subject
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Sponsor websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ME-015 (Suplatast Tosilate) in people with Idiopathic Pulmonary Fibrosis and Cough, run by Melius Pharma AB at 6 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wake time cough frequency during 24 hours (time frame: Change from Baseline to Day 14 in the respective treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.