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

Study Overview
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Brief Summary
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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 participants with idiopathic pulmonary fibrosis

Official Title
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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 Participants With Idiopathic Pulmonary Fibrosis

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: LTP001
* Drug: Placebo
* Drug: Standard of Care (SoC)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LTP001<br>Participants will receive LTP001 orally once daily in the morning for approximately 26 weeks | Drug: LTP001<br>* LTP001 will be administered once daily in the morning<br>Drug: Standard of Care (SoC)<br>* nintedanib, pirfenidone, or neither<br>|
| Experimental: Placebo<br>Participants will receive LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 26 weeks | Drug: Placebo<br>* Placebo to LTP001 will be administered once daily in the morning<br>Drug: Standard of Care (SoC)<br>* nintedanib, pirfenidone, or neither<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to end of treatment epoch in Forced Vital Capacity (FVC) expressed in percent predicted | To assess the efficacy of the investigational products compared to placebo in participants with IPF | Baseline, Weeks 4, 8, 12, 16, 20, 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to end of treatment epoch in Forced Vital Capacity (FVC) | To assess the efficacy of the investigational products compared to placebo in participants with IPF | Baseline, Weeks 4, 8, 12, 16, 20, 26 | 
| Time to progression | 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 | Baseline, Weeks 4, 8, 12, 16, 20, 26 | 
| Number of participants with absolute decline of ≥10% predicted in FVC | To assess the incidence of absolute decline in FVC over 10% predicted | Baseline, Weeks 4, 8, 12, 16, 20, 26 | 
| Change from baseline to the end of treatment epoch in DLCO | To assess the impact of the investigational products on pulmonary physiology | Baseline, Weeks 12 and 26 | 
| Change from baseline to the end of treatment epoch in 6-minute walk distance | To assess the impact of the investigational products on exercise capacity | Baseline, Weeks 12 and 26 | 
| Change from baseline to the end of treatment epoch in scores from the K-BILD questionnaire | To assess the patient reported impacts of cough of the investigational products compared to placebo in K-Bild Scores | Baseline, Weeks 12 and 26 | 
| Change from baseline to the end of treatment epoch in scores from Leicester Cough questionnaire | To assess the patient reported impacts of cough of the investigational products compared to placebo in Leicester Cough Scores | Baseline, Weeks 12 and 26 | 
| Change from baseline to the end of treatment epoch in scores from the the R-Scale for IPF questionnaire | To assess the patient reported impacts IPF on quality of life of the investigational products compared to placebo in R-Scale Scores | Baseline, Weeks 12 and 26 | 
| Change from baseline to the end of treatment epoch in scores from the Living with IPF questionnaire (Impacts) | To assess the patient reported impacts of Living with IPF of the investigational products compared to placebo in L-IPF Scores | Baseline, Weeks 12 and 26 | 
| Change from baseline to the end of treatment epoch in scores from the Living with IPF questionnaire (Symptoms) | To assess the patient reported impacts of Living with IPF of the investigational products compared to placebo in L-IPF Scores and Symptoms | Baseline, Weeks 12 and 26 |