Phase
Condition
Cystic Fibrosis
Idiopathic Pulmonary Fibrosis
Scar Tissue
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
Royal Prince Alfred Hospital
Camperdown, New South Wales 2050
AustraliaSite Not Available
Royal Prince Alfred Hospital
Camperdown 2172563, New South Wales 2155400 2050
AustraliaSite Not Available
Prince Charles Hospital
Brisbane, Queensland 4032
AustraliaSite Not Available
Prince Charles Hospital
Brisbane 2174003, Queensland 2152274 4032
AustraliaSite Not Available
Austin Health
Melbourne, Victoria 3000
AustraliaSite Not Available
Austin Health
Melbourne 2158177, Victoria 2145234 3000
AustraliaSite Not Available
University of Calgary
Calgary, Alberta T2N 4Z6
CanadaSite Not Available
University of Calgary
Calgary 5913490, Alberta 5883102 T2N 4Z6
CanadaSite Not Available
University of British Columbia
Vancouver, British Columbia V6Z 1Y6
CanadaSite Not Available
University of British Columbia
Vancouver 6173331, British Columbia 5909050 V6Z 1Y6
CanadaSite Not Available
University College Dublin
Dublin 2964574, Ireland D04 T6F4
IrelandSite Not Available
University College Dublin
Dublin, D04 T6F4
IrelandSite Not Available
Royal Brompton
London, Greater London SW3 6NP
United KingdomSite Not Available
Royal Brompton
London 2643743, Greater London SW3 6NP
United KingdomSite Not Available
University Hospital Southampton
Southampton, Hampshire SO16 7DL
United KingdomSite Not Available
University Hospital Southampton
Southampton 2637487, Hampshire SO16 7DL
United KingdomSite Not Available
University of Massachusetts Chan Medical School
Worcester, Massachusetts 01655
United StatesSite Not Available
University of Massachusetts Chan Medical School
Worcester 4956184, Massachusetts 6254926 01655
United StatesActive - Recruiting
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109
United StatesActive - Recruiting
University of Texas Southwestern
Dallas, Texas 75390
United StatesSite Not Available
University of Texas Southwestern
Dallas 4684888, Texas 4736286 75390
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22908
United StatesSite Not Available
University of Virginia
Charlottesville 4752031, Virginia 6254928 22908
United StatesSite Not Available
University of Washington
Seattle, Washington 98195
United StatesSite Not Available
University of Washington
Seattle 5809844, Washington 5815135 98195
United StatesSite Not Available

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