A Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosis
Trial Parameters
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Brief Summary
The goal of this clinical trial is to learn if the investigational drug CAL101 can help prevent further decline in lung function in adults with Idiopathic Pulmonary Fibrosis. Researchers will compare CAL101 with placebo to compare change from baseline in forced vital capacity (FVC). Participants will be randomly assigned to a study group that will receive an IV infusion of either the study medication or placebo about once a month for 6 months.
Eligibility Criteria
Inclusion Criteria: * ≥ 40 years of age * Diagnosis of IPF supported by centrally read chest high-resolution computed tomography * Definite or probable usual interstitial pneumonia (UIP) pattern on chest high-resolution computed tomography (HRCT) performed within 12 months of screening, confirmed by central review (if an evaluable HRCT \< 12 months is not available, the baseline HRCT will be used to determine eligibility). * FVC ≥ 45% of predicted (at Screening). * Diffusing capacity of the lung for carbon monoxide (DLCO) ≥ 25% predicted. * Forced expiratory volume in 1 second (FEV1)/FVC ≥ 0.70 at Screening or FEV1/FVC ≥ predicted value minus 0.10 (if predicted value according to the spirometry report at Screening is \<0.80). * Either stable dose with an approved antifibrotic for at least 8 weeks prior to screening or not treated with antifibrotics for at least 8 weeks prior to screening. Exclusion Criteria: * In the opinion of the Investigator, other clinically significant lung diseas