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Senicapoc in patients with progressive fibrotic interstitial lung disease
EU CTIS ID: 2024-511131-97-00
What this study is testing
To evaluate the safety and efficacy of Senicapoc in addition to local standard of care compared to placebo in subjects with Progressive Fibrotic Interstitial Lung Disease, evaluated by the rate of decline of forced vital capacity (FVC) in mL of predicted over a period of 26 weeks
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- A diagnosis of F-ILD as per applicable ATS/ERS/JRS/ALAT guideline at the time of diagnosis
- Able and willing to comply with the protocol requirements and signed the informed consent form (ICF) as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations.
- Male or female subject aged ≥18 years on the day of signing the ICF
- Chest HRCT historically performed within 24 months prior to inclusion
- FVC > 45 %, FEV1/FVC >0,7 or > LLN
- An annual FVC decline of at least 5%, based on at least three FVC measurements within 6–24 months before enrolment
You likely can't join if
- History of malignancy within the past 5 years
- Lower respiratory tract infection requiring treatment within 4 weeks prior to screening and/or during the screening period.
- Clinically significant abnormalities detected on ECG of either rhythm or conduction, a QTcF >450 ms, or a known long QT syndrome.
- A current immunosuppressive condition
- Diagnosed with Sickle cell disease
- Abnormal renal function defined as estimated creatinine clearance, adjusted to body surface area <30 mL/min.
See the full eligibility criteria
- A diagnosis of F-ILD as per applicable ATS/ERS/JRS/ALAT guideline at the time of diagnosis
- Able and willing to comply with the protocol requirements and signed the informed consent form (ICF) as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations.
- Male or female subject aged ≥18 years on the day of signing the ICF
- Chest HRCT historically performed within 24 months prior to inclusion
- FVC > 45 %, FEV1/FVC >0,7 or > LLN
- An annual FVC decline of at least 5%, based on at least three FVC measurements within 6–24 months before enrolment
- History of malignancy within the past 5 years
- Lower respiratory tract infection requiring treatment within 4 weeks prior to screening and/or during the screening period.
- Clinically significant abnormalities detected on ECG of either rhythm or conduction, a QTcF >450 ms, or a known long QT syndrome.
- A current immunosuppressive condition
- Diagnosed with Sickle cell disease
- Abnormal renal function defined as estimated creatinine clearance, adjusted to body surface area <30 mL/min.
- Current alcohol or substance abuse
- Moderate to severe hepatic impairment (Child-Pugh B or C); and/or abnormal LFT at screening, defined as AST, and/or ALT, and/or total bilirubin ≥1.5xULN, and/or GGT ≥3xULN
- Unstable cardiovascular, pulmonary (other than IPF), or other disease within 6 months prior to screening or during the screening period
- Diagnosis of severe pulmonary hypertension
- History of lung volume reduction surgery or lung transplant.
The study team makes the final eligibility decision.
Where it's taking place
- 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 EU CTIS; the study team decides eligibility.