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A participant - and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in patients with idiopathic pulmonary fibrosis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508729-28-00
Acronym
CADPT09A12201
Enrollment
36
Registered
2024-03-04
Start date
2023-04-25
Completion date
2024-09-26
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic pulmonary fibrosis

Brief summary

Change from baseline to end of treatment epoch (26 weeks of treatment) in Forced Vital Capacity (FVC) expressed in percent predicted

Detailed description

Change from baseline to end of treatment epoch (26 weeks of treatment) in Forced Vital Capacity (FVC) expressed in mL, • Time to progression as defined by a composite endpoint including any of the following events: • Absolute reduction from baseline of ≥10% predicted in FVC • Nonelective hospitalization for respiratory events • Lung Transplant • Death, Number of participants with absolute decline of ≥10% predicted in FVC, Change from baseline to the end of treatment epoch (26 weeks of treatment) in DLCO absolute and percent predicted, Change from baseline to the end of treatment epoch (26 weeks of treatment) in 6-minute walk distance, Change from baseline to the end of treatment epoch (26 weeks of treatment) in scores from the L-IPF (Impacts and Symptoms Modules), K-BILD, Leicester cough, and R-Scale for PF questionnaires, Adverse Events, physical examinations, labs, ECGs, vital signs

Interventions

DRUGLTP001
DRUGPlacebo to LTP001 1mg and 5mg hard gelatin capsules

Sponsors

Novartis Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline to end of treatment epoch (26 weeks of treatment) in Forced Vital Capacity (FVC) expressed in percent predicted

Secondary

MeasureTime frame
Change from baseline to end of treatment epoch (26 weeks of treatment) in Forced Vital Capacity (FVC) expressed in mL, • Time to progression as defined by a composite endpoint including any of the following events: • Absolute reduction from baseline of ≥10% predicted in FVC • Nonelective hospitalization for respiratory events • Lung Transplant • Death, Number of participants with absolute decline of ≥10% predicted in FVC, Change from baseline to the end of treatment epoch (26 weeks of treatment) in DLCO absolute and percent predicted, Change from baseline to the end of treatment epoch (26 weeks of treatment) in 6-minute walk distance, Change from baseline to the end of treatment epoch (26 weeks of treatment) in scores from the L-IPF (Impacts and Symptoms Modules), K-BILD, Leicester cough, and R-Scale for PF questionnaires, Adverse Events, physical examinations, labs, ECGs, vital signs

Countries

Czechia, Germany, Netherlands, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026