NCT05983471Fut, nem toboroz2. fázis
Efficacy and Safety of ME-015 (Suplatast Tosilate) in Cough Related to Idiopathic Pulmonary Fibrosis (COSMIC-IPF)
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. ápr. 9.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Fut, nem toboroz
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 40 (tervezett)
- Első benyújtás
- 2023. júl. 24.
- Kezdés
- 2024. ápr. 1.
- Elsődleges befejezés
- 2025. aug.
- Fő szponzor
- Melius Pharma AB
- Betegségek
- Idiopátiás tüdőfibrózis
- NCT-szám
- NCT05983471
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 40
- 2024. ápr. 1. és az elsődleges befejezés (2025. aug.) között
- 6 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Likely need for lung transplantation in next 12 months
- Permanent long-term oxygen therapy
- Use of high-dose corticosteroids or cytotoxic medications
- Treatment with an ACE inhibitor or sitagliptin
- Investigational drug or biologic within the last 2 months
Más betegség
- History of unstable or deteriorating cardiac or pulmonary disease in the preceding 6 months
- 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
- Severe medical/ psychiatric condition posing risk to trial participation
Egyéb
- Current smoking, vaping, or tobacco chewing
- 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
- Resting blood pressure > 160/90 mmHg
- Pregnant/lactating women
- Blood donation within the last 56 days or plasma donation within the last 7 days
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (6)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre | Belagavi | India | Ismeretlen állapot |
| Hindusthan Hospital | Coimbatore | India | Ismeretlen állapot |
| Aditya Multi Specialty Hospital | Guntur | India | Ismeretlen állapot |
| GSVM Medical College, Murari Lal Chest Hospital | Kanpur | India | Ismeretlen állapot |
| Health Point Hospital | Kolkata | India | Ismeretlen állapot |
| Ace Hospital and Research Centre | Pune | India | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.