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| ID | Type | Description | Link |
|---|---|---|---|
| SYNCD-070-22 | Other Identifier | Syngene International |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ME-015 (Suplatast Tosilate) | Drug | Oral capsule form, 200 mg t.i.d. (total 600 mg per 24 hours) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cough-related quality of life in the last 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Endpoint: 24-hour Cough Frequency | 24-hr cough frequency recording with the VitaloJak device and analysed using central, blinded review and QC | Change from Baseline to Day 14 in the respective treatment period |
| Exploratory Endpoint: Sleep-time Cough Frequency |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aditya Multi Specialty Hospital | Guntur | Andhra Pradesh | 522001 | India | ||
| KLE's Dr Prabhakar Kore Hospital & Medical Research Centre |
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| Label | URL |
|---|---|
| Sponsor website | View source |
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Interactive web response system (IWRS)
| Identical placebo | Other | Without active component |
|
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 |
| 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 |
| Safety: Treatment-Emergent Adverse Events | Incidence of treatment-emergent adverse events (TEAE) | 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) | 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 | 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 | 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 | 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 | From enrolment into the trial until end of follow-up, circa 50-60 days per subject |
Sleep-time cough frequency based on 24-hour recording with the VitaloJak device and analysed using central, blinded review and QC |
| Change from Baseline to Day 14 in the respective treatment period |
| Exploratory Endpoint: Patient-Reported Breathlessness | Patient-reported outcome breathlessness assessed using the 12-item Dyspnoea-12 Questionnaire | Change from Baseline to Day 14 in the respective treatment period |
| Exploratory Endpoint: Patient-reported Cough Hypersensitivity | Patient-reported outcome assessed using the Cough Hypersensitivity Questionnaire (CHQ) | Change from Baseline to Day 14 in the respective treatment period |
| Exploratory Endpoint: Eosinophilia | Eosinophil count (total and % of white blood cells in peripheral blood) measured using a central laboratory | Change from Baseline to Day 14 in the respective treatment period |
| Exploratory Endpoint: Pulmonary Function | Pulmonary function assessed using local spirometry assessments; specifically forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and ratio of FEV1/FVC | Change from Baseline to Day 14 in the respective treatment period |
| Exploratory Endpoint: ME-015 Concentration in Blood | Concentration of ME-015 and its major metabolie M-1 is peripheral blood samples taken once at each visit alongside safety lab samples | Change from Baseline to Day 14 in the respective treatment period |
| Belagavi |
| Karnataka |
| 590010 |
| India |
| ACE Hospital and Research Centre | Pune | Maharashtra | 411004 | India |
| Hindusthan Hospital | Coimbatore | Tamil Nadu | 641028 | India |
| GSVM Medical College, Murari Lal Chest Hospital | Kanpur | Uttar Pradesh | 208002 | India |
| Health Point Hospital | Kolkata | West Bengal | 700025 | India |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D003371 | Cough |
| D000096822 | Chronic Cough |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C050143 | MO 113 |
| C073028 | suplatast tosilate |
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