Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease (NCT06714123) | Clinical Trial Compass
RecruitingPhase 2
Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease
Denmark, Estonia, United Kingdom140 participantsStarted 2025-08-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Clini…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The rate of decline of forced vital capacity (FVC) in mL of predicted.