SENICAPOC for Progressive fibrotic interstitial lung disease | Idiopathic pulmonary fibrosis

Inclusion criteria

• {"criterion_text":"-A diagnosis of F-ILD as per applicable ATS/ERS/JRS/ALAT guideline at the time of diagnosis\n-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.\n-Male or female subject aged ≥18 years on the day of signing the ICF\n-Chest HRCT historically performed within 24 months prior to inclusion\n-FVC > 45 %, FEV1/FVC >0,7 or > LLN\n-An annual FVC decline of at least 5%, based on at least three FVC measurements within 6–24 months before enrolment"}

Exclusion criteria

• {"criterion_text":"-History of malignancy within the past 5 years\n-Lower respiratory tract infection requiring treatment within 4 weeks prior to screening and/or during the screening period.\n-Clinically significant abnormalities detected on ECG of either rhythm or conduction, a QTcF >450 ms, or a known long QT syndrome.\n-A current immunosuppressive condition\n-Diagnosed with Sickle cell disease\n-Abnormal renal function defined as estimated creatinine clearance, adjusted to body surface area <30 mL/min.\n-Current alcohol or substance abuse\n-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\n-Unstable cardiovascular, pulmonary (other than IPF), or other disease within 6 months prior to screening or during the screening period\n-Diagnosis of severe pulmonary hypertension\n-History of lung volume reduction surgery or lung transplant."}

Primary endpoints

• {"endpoint_text":"-Rate of decline of FVC (in mL) over a period of 26 weeks","definition_or_measurement_approach":"Evaluated by the rate of decline of forced vital capacity (FVC) in mL of predicted over a period of 26 weeks."}

Secondary endpoints

• {"endpoint_text":"-Absolute decline in percent predicted forced vital capacity (%FVC) over 13 and 26 weeks","definition_or_measurement_approach":"Absolute decline in percent predicted FVC measured at 13 and 26 weeks."}
• {"endpoint_text":"-All-cause mortality.","definition_or_measurement_approach":"All-cause mortality assessed until the end of the study."}
• {"endpoint_text":"-Chance in Vas of dyspnea","definition_or_measurement_approach":"Change in VAS (visual analogue scale) of dyspnea measured (timepoints not further specified in available text)."}
• {"endpoint_text":"-All-cause non-elective hospitalizations","definition_or_measurement_approach":"Time to or occurrence of all-cause non-elective hospitalizations (assessment until end of study)."}
• {"endpoint_text":"-Respiratory-related mortality","definition_or_measurement_approach":"Respiratory-related mortality assessed until the end of the study."}
• {"endpoint_text":"-Acute exacerbations (as evaluated by the investigator)","definition_or_measurement_approach":"Investigator-evaluated acute exacerbations recorded until the end of study."}
• {"endpoint_text":"-Changes in quality of life, assessed by the EQ-5D","definition_or_measurement_approach":"Quality of life measured using the EQ-5D instrument."}
• {"endpoint_text":"-Amount and type of adverse events.","definition_or_measurement_approach":"Recording and categorisation of adverse events over study duration."}
• {"endpoint_text":"-Changes in quality of life, assessed by the SGRQ-I and K-BILD total score. (Danish and UK sites only)","definition_or_measurement_approach":"Quality of life changes measured by SGRQ-I and K-BILD total scores at specified sites (Danish and UK sites only)."}

Other endpoints

• {"endpoint_text":"-To evaluate the efficacy of Senicapoc on disease progression −Disease progression defined as the composite endpoint of ≥5% absolute decline in percent predicted forced vital capacity (%FVC) or all-cause mortality at 26 weeks.","definition_or_measurement_approach":"Composite endpoint defined as ≥5% absolute decline in %FVC or all-cause mortality at 26 weeks."}
• {"endpoint_text":"-Time to first respiratory-related hospitalization until the end of the study.","definition_or_measurement_approach":"Time-to-event measure until end of study for first respiratory-related hospitalization."}
• {"endpoint_text":"-Time to first all-cause non-elective hospitalization until the end of the study.","definition_or_measurement_approach":"Time-to-event measure until end of study for first all-cause non-elective hospitalization."}
• {"endpoint_text":"-Time to respiratory-related mortality until the end of the study.","definition_or_measurement_approach":"Time-to-event measure until end of study for respiratory-related mortality."}
• {"endpoint_text":"-Time to lung transplant until the end of the study","definition_or_measurement_approach":"Time-to-event measure until end of study for lung transplant."}
• {"endpoint_text":"-Time to first acute exacerbation (as evaluated by the investigator) until the end of the study.","definition_or_measurement_approach":"Investigator-evaluated time to first acute exacerbation measured until end of study."}
• {"endpoint_text":"-Time to all-cause mortality or respiratory-related hospitalizations until the end of the study.","definition_or_measurement_approach":"Composite time-to-event of all-cause mortality or respiratory-related hospitalizations until end of study."}
• {"endpoint_text":"-Change from baseline in the VAS of dyspnea total score at 26 weeks.","definition_or_measurement_approach":"Change from baseline in VAS dyspnea total score measured at 26 weeks."}
• {"endpoint_text":"-Changes from baseline in quality of life","definition_or_measurement_approach":"Changes from baseline in QoL assessed by specified QoL instruments (e.g., EQ-5D, SGRQ-I, K-BILD where applicable)."}
• {"endpoint_text":"-Safety and tolerability of senicapoc over time until the end of the study.","definition_or_measurement_approach":"Safety and tolerability assessed by adverse event reporting and other safety measures over study duration."}
• {"endpoint_text":"-ICA-17043 levels in plasma in the group receiving active treatment.","definition_or_measurement_approach":"Measurement of plasma ICA-17043 (senicapoc) levels in participants receiving active treatment."}
• {"endpoint_text":"-Registration of adverse events.","definition_or_measurement_approach":"Recording and registration of adverse events during the study."}

Denmark

Earliest CTIS Part Ii Submission Date

04-08-2024

Latest Decision Or Authorization Date

26-02-2026

Processing Time Days

571

Number Of Sites

3

Number Of Participants

75

Estonia

Earliest CTIS Part Ii Submission Date

15-08-2024

Latest Decision Or Authorization Date

02-03-2026

Processing Time Days

564

Number Of Sites

1

Number Of Participants

25

Primary sponsor

Full Name

Lillebaelt Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Solural Pharma ApS","duties_or_roles":"['14']","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"['6','7']","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"['1','8']","organisation_type":"Hospital/Clinic/Other health care facility"}