To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LTP001 Participants will receive LTP001 orally once daily in the morning for approximately 26 weeks |
Drug: LTP001
LTP001 will be administered once daily in the morning
Drug: Standard of Care (SoC)
nintedanib, pirfenidone, or neither
|
| Experimental: Placebo Participants will receive LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 26 weeks |
Drug: Placebo
Placebo to LTP001 will be administered once daily in the morning
Drug: Standard of Care (SoC)
nintedanib, pirfenidone, or neither
|
Outcome Measures
Primary Outcome Measures
- Change from baseline to end of treatment epoch in Forced Vital Capacity (FVC) expressed in percent predicted [Baseline, Weeks 4, 8, 12, 16, 20, 26]
To assess the efficacy of the investigational products compared to placebo in participants with IPF
Secondary Outcome Measures
- Change from baseline to end of treatment epoch in Forced Vital Capacity (FVC) [Baseline, Weeks 4, 8, 12, 16, 20, 26]
To assess the efficacy of the investigational products compared to placebo in participants with IPF
- Time to progression [Baseline, Weeks 4, 8, 12, 16, 20, 26]
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 [Baseline, Weeks 4, 8, 12, 16, 20, 26]
To assess the incidence of absolute decline in FVC over 10% predicted
- Change from baseline to the end of treatment epoch in DLCO [Baseline, Weeks 12 and 26]
To assess the impact of the investigational products on pulmonary physiology
- Change from baseline to the end of treatment epoch in 6-minute walk distance [Baseline, Weeks 12 and 26]
To assess the impact of the investigational products on exercise capacity
- Change from baseline to the end of treatment epoch in scores from the K-BILD questionnaire [Baseline, Weeks 12 and 26]
To assess the patient reported impacts of cough of the investigational products compared to placebo in K-Bild Scores
- Change from baseline to the end of treatment epoch in scores from Leicester Cough questionnaire [Baseline, Weeks 12 and 26]
To assess the patient reported impacts of cough of the investigational products compared to placebo in Leicester Cough Scores
- Change from baseline to the end of treatment epoch in scores from the the R-Scale for IPF questionnaire [Baseline, Weeks 12 and 26]
To assess the patient reported impacts IPF on quality of life of the investigational products compared to placebo in R-Scale Scores
- Change from baseline to the end of treatment epoch in scores from the Living with IPF questionnaire (Impacts) [Baseline, Weeks 12 and 26]
To assess the patient reported impacts of Living with IPF of the investigational products compared to placebo in L-IPF Scores
- Change from baseline to the end of treatment epoch in scores from the Living with IPF questionnaire (Symptoms) [Baseline, Weeks 12 and 26]
To assess the patient reported impacts of Living with IPF of the investigational products compared to placebo in L-IPF Scores and Symptoms
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CADPT09A12201