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

Sponsor

Melius Pharma AB (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05983471

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis Cough	Drug: ME-015 (Suplatast Tosilate) Other: Identical placebo	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Interactive web response system (IWRS)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ME-015 (Suplatast Tosilate) ME-015 (Suplatast Tosilate) 2 x 100 mg capsule t.i.d. (three times per day), for 2 weeks	Drug: ME-015 (Suplatast Tosilate) Oral capsule form, 200 mg t.i.d. (total 600 mg per 24 hours) Other Names: Suplatast Suplatast Tosilate
Placebo Comparator: Placebo Identical placebo capsules 2 x t.i.d. (three times per day), for 2 weeks	Other: Identical placebo Without active component

Arm

Intervention/Treatment

Experimental: ME-015 (Suplatast Tosilate)

ME-015 (Suplatast Tosilate) 2 x 100 mg capsule t.i.d. (three times per day), for 2 weeks

Drug: ME-015 (Suplatast Tosilate)

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

Other Names:

Suplatast

Suplatast Tosilate

Placebo Comparator: Placebo

Identical placebo capsules 2 x t.i.d. (three times per day), for 2 weeks

Other: Identical placebo

Without active component

Outcome Measures

Primary Outcome Measures

Wake time cough frequency during 24 hours [Change from Baseline to Day 14 in the respective treatment period]
Measured objectively with the cough recording device VitaloJak with centralized, blinded, independent analysis

Secondary Outcome Measures

Cough severity in the last 24 hours [Change from Baseline to Day 14 in the respective treatment period]
Visual Analogue Scale (VAS) ranging from 0 - 100 mm where higher values indicate more severe cough
Cough-related quality of life in the last 24 hours [Change from Baseline to Day 14 in the respective treatment period]
Leicester Cough Questionnaire (LCQ) total score ranging from 3 - 23 where lower values indicate greater impairment of health status due to cough
Overall patient-reported health status [Change from Baseline to Day 14 in the respective treatment period]
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
Safety: Treatment-Emergent Adverse Events [Number of TEAEs from Baseline to Day 14 in the respective treatment period]
Number of patients in each treatment period (active or placebo) who experience a treatment-emergent adverse event (TEAE)
Safety: Serious Adverse Events [Number of SAEs from Baseline to Day 14 in the respective treatment period]
Number of patients in each treatment period (active or placebo) who experience a serious adverse event (SAE)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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