Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 2

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

140 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Quadruple masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (5)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

5 locations

Study team and timeline

Lead sponsor

Vejle Hospital

Study start

Aug 1, 2025 Actual

Primary completion

2028-12 Estimated

Study completion

2028-12 Estimated

First posted

Dec 3, 2024 Actual

Last updated

Nov 9, 2026 Actual

Official study contacts