Last Update: Feb 23, 2024
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:CADPT09A12201
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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

Idiopathic Pulmonary Fibrosis
Phase 2
Recruiting
94
Nov 10, 2022
Apr 29, 2026
All
40 Years - (Adult, Older Adult)

Interventions

Drug

LTP001

LTP001 will be administered once daily in the morning
Drug

Placebo

Placebo to LTP001 will be administered once daily in the morning
Drug

Standard of Care (SoC)

nintedanib, pirfenidone, or neither

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

Camperdown,New South Wales,2050,Australia

Novartis Investigative Site

Recruiting

Spearwood,Western Australia,6163,Australia

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

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

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,Christina Good (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 medical Center .

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

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Novartis Pharmaceuticals

Novartis Pharmaceuticals