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

NCT05983471 | Active Not Recruiting Phase 2

• 2 other identifiers: COSMIC-IPFSYNCD-070-22
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

Brief 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.

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; Fibrotic cough; Melius Pharma; RCT; Sequential; Cough frequency; Cough severity; India; fibrosis; Oral; New Chemical Entity; Small molecule; Nowak; Kornfeld; Sweden

Outcome Measures

Primary Outcomes (1)

• 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

  Change from Baseline to Day 14 in the respective treatment period

Secondary Outcomes (9)

• Cough severity in the last 24 hours

  Change from Baseline to Day 14 in the respective treatment period

• Cough-related quality of life in the last 24 hours

  Change from Baseline to Day 14 in the respective treatment period

• Overall patient-reported health status

  Change from Baseline to Day 14 in the respective treatment period

• Safety: Treatment-Emergent Adverse Events

  From enrolment into the trial until end of follow-up, circa 50-60 days per subject

• Safety: Adverse Events and Serious Adverse Events

  From enrolment into the trial until end of follow-up, circa 50-60 days per subject

Other Outcomes (7)

• Exploratory Endpoint: 24-hour Cough Frequency

  Change from Baseline to Day 14 in the respective treatment period

• Exploratory Endpoint: Sleep-time Cough Frequency

  Change from Baseline to Day 14 in the respective treatment period

• Exploratory Endpoint: Patient-Reported Breathlessness

  Change from Baseline to Day 14 in the respective treatment period

Study Arms (2)

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

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

Drug: ME-015 (Suplatast Tosilate); Other: Identical placebo

Interventions

ME-015 (Suplatast Tosilate) DRUG

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

Also known as: Suplatast, Suplatast Tosilate

Treatment Arm 1; Treatment Arm 2

Identical placebo OTHER

Without active component

Treatment Arm 1; Treatment Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Melius Pharma AB: lead

Study Sites (6)

Aditya Multi Specialty Hospital

Guntur, Andhra Pradesh, 522001, India

Location

KLE's Dr Prabhakar Kore Hospital & Medical Research Centre

Belagavi, Karnataka, 590010, India

Location

ACE Hospital and Research Centre

Pune, Maharashtra, 411004, India

Location

Hindusthan Hospital

Coimbatore, Tamil Nadu, 641028, India

Location

GSVM Medical College, Murari Lal Chest Hospital

Kanpur, Uttar Pradesh, 208002, India

Location

Health Point Hospital

Kolkata, West Bengal, 700025, India

Location

Related Links

• Sponsor website

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Cough; Chronic Cough; Fibrosis

Interventions

MO 113; suplatast tosilate

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Interactive web response system (IWRS)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 9, 2023
• Study Start: April 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (6)