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New treatment option for Pulmonary Fibrosis, Interstitial Lung Disease
Official title Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease
ClinicalTrials.gov ID: NCT06714123
What this study is testing
What is Senicapoc?
Senicapoc is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for pulmonary fibrosis, interstitial lung disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 26 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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,
See the full eligibility 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 people 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 people 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.
- 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...
- 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 treatment 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...
- Current alcohol or substance abuse in the opinion of the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus N, Denmark
- Copenhagen, Denmark
- Tartu, Estonia
- Leicester, United Kingdom
- Norwich, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 26 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus N, Denmark; Copenhagen, Denmark; Tartu, Estonia; Leicester, United Kingdom; Norwich, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.