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

Idiopathic Pulmonary Fibrosis Clinical Trial

— COSMIC-IPF  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05983471
• Other study ID #: COSMIC-IPF
• Secondary ID: SYNCD-070-22
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 2023
• Est. completion date: March 2025

Study information

• Verified date: August 2023
• Source: Melius Pharma AB
• Contact: Christoph Nowak, MD, PhD, Dipl-Psych
• Phone: +46739806535
• Email: chris.nowak[@]meliuspharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 very 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 July 2023, there is no approved treatment for the indication of IPF-cough. There is an enormous unmet clinical need for an effective, safe and well-tolerated oral treatment.

The COSMIC-IPF Phase 2 trial is the first clinical trial assessing ME-015 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.

Description:

This double-blind, 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.

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 wake time cough frequency measured objectively with the VitaloJak device over a 24-hour period. VitaloJak recordings are analysed using a blinded, independent, central review process.

The study is conducted as a single-country, multi-site clinical trial in India with Melius Pharma AB as the Sponsor.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of idiopathic pulmonary fibrosis (IPF) according to the 2018 American Thoracic Society (ATS) guidelines, confirmed by high-resolution computed tomography (HRCT) chest scan taken within < 2 years

• 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 informed consent form (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)

• Life expectancy > 6 months

• Stable medical condition: stable treatment for > 12 weeks and absence of acute exacerbations for > 4 weeks

• Antifibrotics pirfenidone and nintedanib are allowed if the patient has been on a stable dose for = 12 weeks and remains on a stable dose throughout the study

• Forced vital capacity (FVC) = 40% predicted

• Ratio between forced expiratory volume in one second and forced vital capacity (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

Exclusion Criteria:

• 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 angiotensin-converting enzyme (ACE) inhibitor or sitagliptin started in the last 12 weeks

• 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

• Recent history of stroke or transient ischemic attack

• Blood pressure > 160/90 mmHg

• Pregnant/lactating women

• Exposure to an investigational drug or biologic within the last 2 months

• Blood donation within the last 56 days or plasma donation within the last 7 days

• Body Mass Index < 18 kg/m2 or = 40 kg/m2

Related Conditions & MeSH terms

• Cough
• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

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

Locations

Country	Name	City	State
India	Hindusthan Hospital	Chennai	Tamil Nadu
India	Aditya Multi Specialty Hospital	Guntur	Andhra Pradesh
India	Government Chest Hospital	Hyderabad	Telangana
India	Health Point Hospital	Kolkata	West Bengal

Sponsors (1)

Lead Sponsor	Collaborator
Melius Pharma AB

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wake time cough frequency during 24 hours	Measured objectively with the cough recording device VitaloJak with centralized, blinded, independent analysis	Change from Baseline to Day 14 in the respective treatment period
Secondary	Cough severity in the last 24 hours	Visual Analogue Scale (VAS) ranging from 0 - 100 mm where higher values indicate more severe cough	Change from Baseline to Day 14 in the respective treatment period
Secondary	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	Change from Baseline to Day 14 in the respective treatment period
Secondary	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	Change from Baseline to Day 14 in the respective treatment period
Secondary	Safety: Treatment-Emergent Adverse Events	Number of patients in each treatment period (active or placebo) who experience a treatment-emergent adverse event (TEAE)	Number of TEAEs from Baseline to Day 14 in the respective treatment period
Secondary	Safety: Serious Adverse Events	Number of patients in each treatment period (active or placebo) who experience a serious adverse event (SAE)	Number of SAEs from Baseline to Day 14 in the respective treatment period

External Links

•   Sponsor website