Phase
Condition
Lung Disease
Cystic Fibrosis
Idiopathic Pulmonary Fibrosis
Treatment
N/AClinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18-80 years with a diagnosis of non-IPF fibrosing ILD due to CTD-ILD, fHP, ornon-IPF IIP based on central review
Diagnosis of Fibrotic ILD as determined by site investigator.
Willingness to comply with study procedures and follow-up.
Provide written informed consent.
Exclusion
Exclusion Criteria:
Site diagnosis of fibrosing ILD >5 years prior to Visit 1 (Screening and BaselineVisit).
Minimal ILD, defined as reticular opacities and/or ground-glass opacities withoutarchitectural distortion (traction bronchiolectasis/bronchiectasis or honeycombing)affecting < 5% of the lung on centralized evaluation of HRCT at Visit 1 (Screeningand Baseline Visit). High quality historical chest HRCT may be used if performedwithin 90 days prior to Visit 1.
Extent of emphysema >15% of total lung volume or greater than extent of fibrosisbased on central, qualitative assessment of HRCT at Visit 1. High quality historicalchest HRCT may be used if performed within 90 days prior to Visit 1.
Active malignancy within one year prior to Visit 1 (except for non-melanoma skincancer requiring local treatment).
Inability to complete full PFT (spirometry and DLCO) at Visit 1. Historical PFT maybe used if performed within 90 days prior to Visit 1.
Taking nintedanib or nerandomilast at Visit 1.
Pregnancy at screening or plans to become pregnant during follow-up.
Participation in an interventional clinical trial for fibrotic ILD at the time ofVisit 1, or receipt of an investigational drug within the previous 4 weeks of theenrollment visit (Visit 1) or 5 times the half-life, if longer.
Study Design
Study Description
Connect with a study center
University of Massachusetts Chan Medical School
Worcester, Massachusetts 01655
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
University of Texas Southwestern
Dallas, Texas 75390
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22908
United StatesSite Not Available
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