To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Registration Number
- NCT05497284
- Lead Sponsor
- Novartis Pharmaceuticals
- 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
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 46
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LTP001 Standard of Care (SoC) Participants will receive LTP001 orally once daily in the morning for approximately 26 weeks Placebo Placebo Participants will receive LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 26 weeks LTP001 LTP001 Participants will receive LTP001 orally once daily in the morning for approximately 26 weeks Placebo Standard of Care (SoC) Participants will receive LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 26 weeks
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (3)
University of Kansas Hospital Main Centre
🇺🇸Kansas City, Kansas, United States
University of Alabama at Birmingham .
🇺🇸Birmingham, Alabama, United States
Novartis Investigative Site
🇵🇱Bialystok, Poland