Back to resultsEfficacy and Safety of ME-015 (Suplatast Tosilate) in Cough Related to Idiopathic Pulmonary Fibrosis (COSMIC-IPF) (COSMIC-IPF)
Primary Purpose
Idiopathic Pulmonary Fibrosis, Cough
Status
Not yet recruiting
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
ME-015 (Suplatast Tosilate)
Identical placebo
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring IPF-cough, IPF cough, Idiopathic Pulmonary Fibrosis, Chronic cough, Suplatast, Melius, Refractory cough
Eligibility Criteria
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
Sites / Locations
- Aditya Multi Specialty Hospital
- Hindusthan Hospital
- Government Chest Hospital
- Health Point Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ME-015 (Suplatast Tosilate)
Placebo
Arm Description
ME-015 (Suplatast Tosilate) 2 x 100 mg capsule t.i.d. (three times per day), for 2 weeks
Identical placebo capsules 2 x t.i.d. (three times per day), for 2 weeks
Outcomes
Primary Outcome Measures
Wake time cough frequency during 24 hours
Measured objectively with the cough recording device VitaloJak with centralized, blinded, independent analysis
Secondary Outcome Measures
Cough severity in the last 24 hours
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
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
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 patients in each treatment period (active or placebo) who experience a treatment-emergent adverse event (TEAE)
Safety: Serious Adverse Events
Number of patients in each treatment period (active or placebo) who experience a serious adverse event (SAE)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05983471
Brief Title
Efficacy and Safety of ME-015 (Suplatast Tosilate) in Cough Related to Idiopathic Pulmonary Fibrosis (COSMIC-IPF)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Melius Pharma AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis, Cough
Keywords
IPF-cough, IPF cough, Idiopathic Pulmonary Fibrosis, Chronic cough, Suplatast, Melius, Refractory cough
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Interactive web response system (IWRS)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ME-015 (Suplatast Tosilate)
Arm Type
Experimental
Arm Description
ME-015 (Suplatast Tosilate) 2 x 100 mg capsule t.i.d. (three times per day), for 2 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical placebo capsules 2 x t.i.d. (three times per day), for 2 weeks
Intervention Type
Drug
Intervention Name(s)
ME-015 (Suplatast Tosilate)
Other Intervention Name(s)
Suplatast, Suplatast Tosilate
Intervention Description
Oral capsule form, 200 mg t.i.d. (total 600 mg per 24 hours)
Intervention Type
Other
Intervention Name(s)
Identical placebo
Intervention Description
Without active component
Primary Outcome Measure Information:
Title
Wake time cough frequency during 24 hours
Description
Measured objectively with the cough recording device VitaloJak with centralized, blinded, independent analysis
Time Frame
Change from Baseline to Day 14 in the respective treatment period
Secondary Outcome Measure Information:
Title
Cough severity in the last 24 hours
Description
Visual Analogue Scale (VAS) ranging from 0 - 100 mm where higher values indicate more severe cough
Time Frame
Change from Baseline to Day 14 in the respective treatment period
Title
Cough-related quality of life in the last 24 hours
Description
Leicester Cough Questionnaire (LCQ) total score ranging from 3 - 23 where lower values indicate greater impairment of health status due to cough
Time Frame
Change from Baseline to Day 14 in the respective treatment period
Title
Overall patient-reported health status
Description
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
Time Frame
Change from Baseline to Day 14 in the respective treatment period
Title
Safety: Treatment-Emergent Adverse Events
Description
Number of patients in each treatment period (active or placebo) who experience a treatment-emergent adverse event (TEAE)
Time Frame
Number of TEAEs from Baseline to Day 14 in the respective treatment period
Title
Safety: Serious Adverse Events
Description
Number of patients in each treatment period (active or placebo) who experience a serious adverse event (SAE)
Time Frame
Number of SAEs from Baseline to Day 14 in the respective treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph Nowak, MD, PhD, Dipl-Psych
Phone
+46739806535
Email
chris.nowak@meliuspharma.com
Facility Information:
Facility Name
Aditya Multi Specialty Hospital
City
Guntur
State/Province
Andhra Pradesh
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Goli M Venkata Kasiram, MD
Facility Name
Hindusthan Hospital
City
Chennai
State/Province
Tamil Nadu
Country
India
Facility Name
Government Chest Hospital
City
Hyderabad
State/Province
Telangana
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karthik Velimala, MD
Facility Name
Health Point Hospital
City
Kolkata
State/Province
West Bengal
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amitabha Sengupta, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.meliuspharma.com/
Description
Sponsor website
Learn more about this trial
Efficacy and Safety of ME-015 (Suplatast Tosilate) in Cough Related to Idiopathic Pulmonary Fibrosis (COSMIC-IPF)
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