Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease

ConditionsPulmonary Fibrosis, Interstitial Lung Disease Idiopathic Pulmonary Fibrosis

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorVejle Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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