Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease

Korábbi kezelés

• Previous participation in a clinical study with IMP for fibrotic disease within the last 6 months.
• Concurrent participation in another interventional drug, device, or biological investigational research study, or use of an investigational agent within 5 half-lives of the agent
• Lower respiratory tract infection requiring treatment within 4 weeks prior to screening and/or during the screening period.
• Unstable cardiovascular, pulmonary (other than IPF), or other disease within 6 months prior to screening or during the screening period
• Use of any of the following therapies within 4 weeks prior to screening and during the screening period, or planned during the study: warfarin, imatinib, ambrisentan, azathioprine, cyclophosphamide, cyclosporine A, bosentan, methotrexate, sildenafil (except for occasional use), prednisone at steady dose > 10 mg/day or equivalent.

Más betegség

• Sickle cell disease
• Any clinical condition or other condition or circumstance that, in the opinion of the investigator, may make a subject unsuitable for inclusion or unlikely or unable to complete the study or comply with study procedures and requirements.
• Known hypersensitivity to any of the IMP ingredients or a history of a significant allergic reaction to any drug as determined by the investigator
• A current immunosuppressive condition
• Moderate to severe hepatic impairment (Child-Pugh B or C); and/or abnormal LFT at screening,
• History of malignancy within the past 5 years
• History of lung volume reduction surgery or lung transplant.
• Diagnosis of severe pulmonary hypertension

Laborértékek

• Clinical laboratory test suggestive of cholestasis with total serum bile acid levels > 3xULN.

Egyéb

• Clinically significant abnormalities detected on ECG of either rhythm or conduction,
• Abnormal renal function, defined as eGFT > 30 ml/kg
• Current alcohol or substance abuse in the opinion of the investigator.

• Progressive fibrotic ILD or Progressive IPF diagnosed according to ATS/ERS/JRS/ALAT guidelines at the time of diagnosis
• Age > 18 years
• HRCT historically performed within 24 months
• FVC > 45 %, FEV1/FVC > 0,7 or above LLN
• Annual FVC decline of at least 5% predicted, based on at least three FVC measurements within 6-24 months before enrolment
• Subject able to give informed consent.
• The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan
• Male subjects of reproductive potential agree to use highly effective contraception/preventive exposure measures from the time of first dose of IMP during the study, and until 90 days (male) after the last dose of IMP.
• Female subjects agree to use highly effective contraceptive during the study, and must show a negative pregnancy test before inclution.
• Able to walk at least 150 meters during the 6MWT at screening Visit 1;
• Able to read and complete the EQ-5D, SGRQ-I, K-BILD questionnaire.