Health Condition 1: J841- Other interstitial pulmonary diseases with fibrosis
Conditions
Interventions
Intervention1: C21: IMP will be administered twice daily orally for 36 weeks from Visit 2 to Visit 14 as follows:
1. Morning dose: Two 50 mg capsules to be taken with a glass of water after minimum
Sponsors
Vicore Pharma AB
QED Clinical Services India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Written informed consent, consistent with ICH-GCP R2 and local laws, obtained before the initiation of any trial related procedure 2) A diagnosis of IPF within 3 years prior to Visit 1, as per either ATS/ERS/JRS/ATLAT/Fleischner guidelines 3) Age �40 years 4) FVC �60% predicted at Visit 1 5) FEV1/FVC ratio >0.7 prebronchodilator at Visit 1 6) Oxygen saturation (SpO2) >85% by pulse oximetry while breathing ambient air at rest at Visit 1 7) High-resolution computed tomography (HRCT) within 36 months prior to Visit 1 with central reading demonstrating either a or b, and c: a. A pattern consistent with usual interstitial pneumonitis (UIP) according to either ATS/ERS/JRS/ALAT or Fleischner guidelines ( i.UIP ii.Probable UIP b. A pattern indeterminate for UIP according to either ATS/ERS/JRS/ALAT or Fleischner guidelines (and a historical biopsy consistent with IPF c. Extent of fibrosis > extent of emphysema
Exclusion criteria
Exclusion criteria: 1) Previous and concomitant use of nintedanib or pirfenidone 2) Smoking (including e-cigarettes) within 6 months prior to Visit 1 3) Body mass index (BMI) >35 or 4) IPF exacerbation within 3 months prior to Visit 1Acute worsening or development of dyspnoea typically ââ?¬Â¢ Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia pattern (if no previous computed tomography is available, the qualifier ââ?¬Å?newââ?¬? can be dropped) ââ?¬Â¢ Deterioration not fully explained by cardiac failure or fluid overload 5) Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions (e.g. contraindications to cataract surgery) which in the opinion of the investigator makes the subject inappropriate for this trial 6) Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I 7) Treatment with any of the medications listed below within 4 weeks prior to Visit 1: ââ?¬Â¢ Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. Johnââ?¬•s Wort) ââ?¬Â¢ CYP3A4 inhibitors (e.g. clarithromycin, ketoconazole, nefazodone, itraconazole, ritonavir) ââ?¬Â¢ Medicines that are substrates of CYP1A2, CYP3A4 or CYP2C9 with a narrow therapeutic range ââ?¬Â¢ Experimental drugs ââ?¬Â¢ Any systemic immunosuppressive therapies other than: o Inhaled corticosteroids which can be used throughout the trial period provided the dose is kept stable o Corticosteroids for the treatment of acute exacerbations o The continuation of stable doses of 8. Treatment with any of the medications listed below within 2 weeks prior to Visit 1: ââ?¬Â¢ Proton pump inhibitors (PPIs) more than once daily ââ?¬Â¢ Histamine H2 receptor antagonists (H2RAs) ââ?¬Â¢ Breast cancer resistance protein sensitive substrates (e.g. sulphasalazine, rosuvastatin) 9) Any of the following findings at Visit 1: ââ?¬Â¢ Prolonged QTcF (QT interval with Fridericiaââ?¬•s correction) ( >450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG, as judged by the investigator ââ?¬Â¢ Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus 1+2 antigen/antibody (HIV 1+2 Ag/Ab ââ?¬Â¢ Positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) 10) Inability to generate lung function data at Visit 1 meeting the minimum standards of the ATS/ERS 2005 guideline , as determined by central review 11) Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator 12) Pregnant or breast-feeding female subjects 13) Female subjects of childbearing potential not willing to use contraceptive methods 14) Male subjects not willing to use contraceptive methods 15) Subjects not willing to adhere to dietary restrictions during the trial period 16) Participation in any other interventional trial during the trial period <br/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nature and frequency of adverse events occurring over the trial period i.e from screening till end of study (Visit 15)Timepoint: Nature and frequency of adverse events occurring over the trial period i.e from screening till end of study (Visit 15) | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ Change from baseline in forced vital capacity (FVC) value over 12, 24, and 36 weeks ââ?¬Â¢ Plasma concentration of C21 and derived PK parameters evaluated in a sub-set of subjects Timepoint: The change in FVC from baseline to week 12, 24, and 36 will be calculated for each subject and summarised using the population mean and corresponding 90% two-sided confidence intervals. FVC and FEV1 will further be summarised by visit using descriptive statistics and visualised using mean value plots (with imputation). For FVC, further a plot of the model fit, that is observed means verssus the model predicted curve, will be constructed. ;Exploratory Endpoint: Blood samples will be stored for potential future analyses of biomarkers reflecting inflammation and lung injury. Timepoint: Biomarker data will be exploratory and the analyses data-driven. Collected data will be visualised graphically and summarised descriptively | — |
Countries
India, Russian Federation, Ukraine, United Kingdom
Contacts
Public ContactMr Gajendrasinh Chanchu
QED Clinical Services India Private Limited
Outcome results
None listed