RecruitingPhase 2NCT06714123

Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease

Senicapoc in Patients With Progressive Fibrotic ILD (Interstitial Lung Disease) and IPF (Idiopathic Pulmonary Fibrosis) to Prevent Progression.


Sponsor

Vejle Hospital

Enrollment

140 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called senicapoc in people whose lung scarring (fibrosis) is getting worse over time, a condition called progressive fibrotic interstitial lung disease (ILD) or idiopathic pulmonary fibrosis (IPF). Researchers want to see if this drug can slow the decline in lung function. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with progressive fibrotic ILD or IPF - Your lung function (measured by a breathing test called FVC) is above 45% and has been declining by at least 5% per year over the past 6–24 months - You can walk at least 150 meters in a standard walk test - You have had a chest CT scan in the past 2 years - You are able to use contraception if you are of childbearing potential **You may NOT be eligible if...** - You have sickle cell disease - You are currently on immunosuppressive therapy - You have significant heart rhythm problems or liver problems - You have had cancer in the past 5 years - You have had a lung transplant or lung volume reduction surgery - You have severe pulmonary hypertension - You are currently taking certain medications like warfarin, methotrexate, or high-dose prednisone Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSenicapoc

administering 30 mg senicapoc a day, in addition to standard of care.

DRUGPlacebo

Tablets similar in size and color


Locations(3)

Aarhus University Hospital

Aarhus N, Denmark

Odense University Hospital

Odense C, Denmark

Tartu University Hospital,

Tartu, Estonia

View Full Details on ClinicalTrials.gov

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NCT06714123


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