Study Description
A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis
Interventions
LTP001
Placebo
Standard of Care (SoC)
Eligibility Criteria
Inclusion Criteria:
Male and female participants at least 40 years of age
IPF diagnosed based on ATS/ERS/JRS/ALAT IPF 2018 modified guidelines
FVC ≥45% predicted
DLCO, corrected for hemoglobin, ≥25% predicted (inclusive)
Unlikely to undergo lung transplantation during this trial in the opinion of the investigator
If a participant is taking nintedanib or pirfenidone, they must be on a stable regimen for at least 8 weeks prior to randomization
Exclusion Criteria:
Airway obstruction (i.e. prebronchodilator FEV1/ FVC < 0.7) or evidence of a bronchodilator response at screening
Emphysema >20% on screening HRCT
Fibrosis <10% on screening HRCT
Clinical diagnosis of any connective tissue disease
Clinically diagnosed acute exacerbation of IPF (AE-IPF) or other significant clinical worsening within 3 months of randomization
Additional protocol-defined inclusion / exclusion criteria may apply.
Study Location
Novartis Investigative Site
Recruiting
Mar del Plata,Buenos Aires,7600,Argentina
Novartis Investigative Site
Recruiting
Parana,3100,Argentina
Novartis Investigative Site
Recruiting
Caba,Buenos Aires,C1056ABJ,Argentina
Novartis Investigative Site
Recruiting
Ranelagh, Partido De Berazate,Buenos Aires,1884,Argentina
Novartis Investigative Site
Recruiting
Chermside,Queensland,4032,Australia
Novartis Investigative Site
Recruiting
Westmead,New South Wales,2145,Australia
Novartis Investigative Site
Recruiting
Heidelberg,Victoria,3084,Australia
Novartis Investigative Site
Recruiting
Camperdown,New South Wales,2050,Australia
Novartis Investigative Site
Recruiting
Spearwood,Western Australia,6163,Australia
Novartis Investigative Site
Recruiting
Praha 4,140 59,Czech Republic
Novartis Investigative Site
Recruiting
Muenchen,81377,Germany
Novartis Investigative Site
Recruiting
Coswig,01640,Germany
Novartis Investigative Site
Recruiting
Essen,45147,Germany
Novartis Investigative Site
Recruiting
Hannover,30625,Germany
Novartis Investigative Site
Recruiting
Nieuwegein,3435 CM,Netherlands
Novartis Investigative Site
Recruiting
Amsterdam,1081,Netherlands
Novartis Investigative Site
Recruiting
Bialystok,15-044,Poland
Novartis Investigative Site
Recruiting
Lodz,90 153,Poland
Houston Methodist Hospital
Recruiting
Houston,Brizzna Contreras (346-238-5685) email: [email protected] -- Zeenat Safdar,77030 - Texas,United States
University of Alabama at Birmingham .
Recruiting
Birmingham,Andrea Ford email: [email protected] -- Tejaswini Kulkarni,35294 - Alabama,United States
Inova Fairfax Hosp Inst of Rsrch
Recruiting
Falls Church,Priscila Dauphin (703-698-3580) email: [email protected] -- Oksana Shlobin,22042-3300 - Virginia,United States
University of Kansas Medical Center
Recruiting
Kansas City,Amy Davis (913-588-9600) email: [email protected] -- Mark Hamblin,66160-7330 - Kansas,United States
University of Washington Med Ctr .
Recruiting
Seattle,J B Ingram email: [email protected] -- Lawrence Ho,98105 - Washington,United States
Vanderbilt Unversity Medical Center .
Recruiting
Nashville,Phyllis Young (615-322-0476) email: [email protected] -- Lisa Lancaster,37203 - Tennessee,United States
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.