To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF

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: NCT05497284

Novartis Reference Number: CADPT09A12201

Last Update: Mar 31, 2023

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

Condition

Idiopathic Pulmonary Fibrosis

Phase

Phase 2

Overall status

Recruiting

Start date

Nov 10, 2022

Completion date

Feb 03, 2025

Gender

All

Age(s)

40 Years and older (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.