To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF
NCT ID: NCT05497284
Last Updated: 2026-01-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
46 participants
INTERVENTIONAL
2022-11-10
2024-09-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LTP001
LTP001 orally once daily in the morning for approximately 26 weeks.
LTP001
LTP001 administered once daily in the morning
Standard of Care (SoC)
nintedanib, pirfenidone, or neither
Placebo
Placebo orally once daily in the morning for approximately 26 weeks.
Placebo
Placebo to LTP001 administered once daily in the morning
Standard of Care (SoC)
nintedanib, pirfenidone, or neither
Interventions
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LTP001
LTP001 administered once daily in the morning
Placebo
Placebo to LTP001 administered once daily in the morning
Standard of Care (SoC)
nintedanib, pirfenidone, or neither
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
Ranelagh Partido de Berazate, Buenos Aires, Argentina
Novartis Investigative Site
Paraná, , Argentina
Novartis Investigative Site
Camperdown, New South Wales, Australia
Novartis Investigative Site
Chermside, Queensland, Australia
Novartis Investigative Site
Spearwood, Western Australia, Australia
Novartis Investigative Site
Prague, , Czechia
Novartis Investigative Site
Munich, Bavaria, Germany
Novartis Investigative Site
Coswig, , Germany
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Amsterdam, North Holland, Netherlands
Novartis Investigative Site
Nieuwegein, Utrecht, Netherlands
Novartis Investigative Site
Bialystok, , Poland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on www.novctrd.com
Other Identifiers
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CADPT09A12201
Identifier Type: -
Identifier Source: org_study_id
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