💬In plain words
What the trial is, and whether it could suit you
This study will investigate whether the senicapoc drug can prevent the scarring from worsening in interstitial lung disease.
Researchers will compare Senicapoc to a placebo (a look-alike substance that contains no drug) to see if Senicapoc works to prevent lung function worsening.
Participants will be asked to take 3 tablets a day for 26 weeks. Within this period, doctors will follow the participants, ask for experience of adverse events, check lung function and organ status, and participants will need to fill out quality-of-life questionnaires. A total of 5 visits are required, at initiation, after4, 13, 26 and 52 weeks. The final visit will occur 52 weeks after initiation and consist of a normal visit in the outpatient clinic where the doctor asks for relevant information regarding the period after end of administration of the study drug.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* Clinically significant abnormalities detected on ECG of either rhythm or conduction,
* Moderate to severe hepatic impairment (Child-Pugh B or C); and/or abnormal LFT at screening,
* Clinical laboratory test suggestive of cholestasis with total serum bile acid levels \> 3xULN.
* Abnormal renal function, defined as eGFT \> 30 ml/kg
* History of malignancy within the past 5 years
* 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.
* History of lung volume reduction surgery or lung transplant.
* Diagnosis of severe pulmonary hypertension
* 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.
* Current alcohol or substance abuse in the opinion of the investigator.
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