Safety, Efficacy and Pharmacokinetics of C21 in Subjects With IPF
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Layout table for eligibility information
Ages Eligible for Study:
40 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Written informed consent, consistent with ICH-GCP R2 and local laws, obtained before the initiation of any trial related procedure
A diagnosis of IPF within 3 years prior to Visit 1, as per either ATS/ERS/JRS/ATLAT/Fleischner guidelines
Age ≥40 years
FVC ≥60% predicted at Visit 1 (specifically for UK: FVC ≥80% predicted at Visit 1)
FEV1/FVC ratio ≥0.7 prebronchodilator at Visit 1
Oxygen saturation (SpO2) >85% by pulse oximetry while breathing ambient air at rest at Visit 1
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 ATS/ERS/JRS/ALAT or Fleischner guidelines i. UIP ii. Probable UIP or 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
Fully vaccinated against COVID-19 prior to screening (Visit 1). Subjects are considered fully vaccinated for COVID-19 ≥14 days after they have received vaccination dose(s) according to local label
Previous and concomitant use of nintedanib or pirfenidone
Smoking (including e-cigarettes) within 6 months prior to Visit 1
Body mass index (BMI) >35 or <18
IPF exacerbation within 3 months prior to Visit 1:
Acute worsening or development of dyspnoea typically <1 month duration
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 "new" can be dropped)
Deterioration not fully explained by cardiac failure or fluid overload
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
Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I
Treatment with any of the medications listed below within 4 weeks prior to Visit 1: