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
Overview
- Phase
- Phase 2
- Intervention
- LTP001
- Conditions
- Idiopathic Pulmonary Fibrosis
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 46
- Locations
- 18
- Primary Endpoint
- Change From Baseline to End of Treatment Epoch in Forced Vital Capacity (FVC) Expressed in Percent Predicted
- Status
- Terminated
- Last Updated
- 3 months ago
Overview
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
Detailed Description
This was a randomized, placebo-controlled, participant- and investigator-blinded platform study in participants with idiopathic pulmonary fibrosis. Participants underwent a screening period of 42 days, a treatment period of 26 weeks and a post-treatment safety follow-up period of 30 days. This study was designed to safely allow rapid and efficient screening of potentially efficacious investigational products in participants with IPF. The study was terminated for strategic reasons and no additional cohorts were created.
Investigators
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.
Arms & Interventions
LTP001
LTP001 orally once daily in the morning for approximately 26 weeks.
Intervention: LTP001
LTP001
LTP001 orally once daily in the morning for approximately 26 weeks.
Intervention: Standard of Care (SoC)
Placebo
Placebo orally once daily in the morning for approximately 26 weeks.
Intervention: Placebo
Placebo
Placebo orally once daily in the morning for approximately 26 weeks.
Intervention: Standard of Care (SoC)
Outcomes
Primary Outcomes
Change From Baseline to End of Treatment Epoch in Forced Vital Capacity (FVC) Expressed in Percent Predicted
Time Frame: Baseline, up to approximately 26 weeks
Forced Vital Capacity (FVC) is the total amount of air exhaled during the Forced expiratory volume (FEV) test measured through spirometry testing. FEV measures how much air a person can exhale during a forced breath. It is expressed as percent predicted, defined as FVC of the participant divided by the average FVC in the population for any person of similar age, sex, and body composition multiplied by 100. A positive change from baseline is considered a favorable outcome.
Secondary Outcomes
- Change From Baseline to End of Treatment Epoch in FVC(Baseline, up to approximately 26 weeks)
- Progression-free Survival (PFS)(Baseline, up to approximately 26 weeks)
- Number of Participants With Absolute Decline of ≥10% Predicted in FVC(Baseline, up to approximately 26 weeks)
- Change From Baseline to the End of Treatment Epoch in Diffusion Capacity of Lung for Carbon Monoxide (DLCO)(Baseline, up to approximately 26 weeks)
- Change From Baseline to the End of Treatment Epoch in 6-minute Walk Distance (6MWD)(Baseline, up to approximately 26 weeks)
- Change From Baseline to the End of Treatment Epoch in Total Score From the K-BILD Questionnaire(Baseline, up to approximately 26 weeks)
- Change From Baseline to the End of Treatment Epoch in Scores From Leicester Cough Questionnaire(Baseline, up to approximately 26 weeks)
- Change From Baseline to the End of Treatment Epoch in Scores From the the R-Scale for IPF Questionnaire(Baseline, up to approximately 26 weeks)
- Change From Baseline to the End of Treatment Epoch in Total Score From the Living With IPF Questionnaire(Baseline, up to approximately 26 weeks)