Study of efficacy and safety of various treatments in participants with idiopathic pulmonary fibrosis (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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005066-17-DE

Enrollment

Registered

2022-10-07

Start date

2023-03-07

Completion date

Unknown

Last updated

2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic pulmonary fibrosis MedDRA version: 21.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: LTP001 Product Code: LTP001 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Not yet established Current Sponsor code: LTP001 Concentration unit: mg milligram(s) Concentration typ

Eligibility

Sex/Gender

All

Inclusion 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 Additional protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 47 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 47

Exclusion criteria

Exclusion criteria: -Airway obstruction (i.e. prebronchodilator FEV1/ FVC 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 exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of the investigational products compared to placebo in participants with IPF;Secondary Objective: -To assess the efficacy of the investigational products compared to placebo in participants with IPF -Time to progression -To assess the incidence of absolute decline in FVC over 10% predicted -To assess the impact of the investigational products on pulmonary physiology -To assess the impact of the investigational products on exercise capacity -To assess the patient reported impacts of cough of the investigational products compared to placebo in K-Bild Scores -To assess the patient reported impacts of cough of the investigational products compared to placebo in Leicester Cough Scores -To assess the patient reported impacts IPF on quality of life of the investigational products compared to placebo in R-Scale Scores -To assess the patient reported impacts of Living with IPF of the investigational products compared to placebo in L-IPF Scores -To assess the patient reported impacts of Living with IPF of the investigational products compared to placebo in L-IPF Scores and Symptoms;Primary end point(s): Change from baseline to end of treatment in Forced Vital Capacity (FVC) expressed in percent predicted;Timepoint(s) of evaluation of this end point: Baseline, Weeks 4, 8, 12, 16, 20, 26	—

Measure

Time frame

Main Objective: To assess the efficacy of the investigational products compared to placebo in participants with IPF;Secondary Objective: -To assess the efficacy of the investigational products compared to placebo in participants with IPF -Time to progression -To assess the incidence of absolute decline in FVC over 10% predicted -To assess the impact of the investigational products on pulmonary physiology -To assess the impact of the investigational products on exercise capacity -To assess the patient reported impacts of cough of the investigational products compared to placebo in K-Bild Scores -To assess the patient reported impacts of cough of the investigational products compared to placebo in Leicester Cough Scores -To assess the patient reported impacts IPF on quality of life of the investigational products compared to placebo in R-Scale Scores -To assess the patient reported impacts of Living with IPF of the investigational products compared to placebo in L-IPF Scores -To assess the patient reported impacts of Living with IPF of the investigational products compared to placebo in L-IPF Scores and Symptoms;Primary end point(s): Change from baseline to end of treatment in Forced Vital Capacity (FVC) expressed in percent predicted;Timepoint(s) of evaluation of this end point: Baseline, Weeks 4, 8, 12, 16, 20, 26

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Secondary

Measure	Time frame
Secondary end point(s): 1. Change from baseline to end of treatment epoch in Forced Vital Capacity (FVC) 2. Time to progression 3. Number of participants with absolute decline of =10% predicted in FVC 4. Change from baseline to the end of treatment epoch in DLCO 5. Change from baseline to the end of treatment epoch in 6-minute walk distance 6. Change from baseline to the end of treatment epoch in scores from the k-BILD questionnaire 7. Change from baseline to the end of treatment epoch in scores from Leicester Cough questionnaire 8. Change from baseline to the end of treatment epoch in scores from the the R-Scale for IPF questionnaire 9. Change from baseline to the end of treatment epoch in scores from the Living with IPF questionnaire (Impacts) 10. Change from baseline to the end of treatment epoch in scores from the Living with IPF questionnaire (Symptoms);Timepoint(s) of evaluation of this end point: 1. Baseline, Weeks 4, 8, 12, 16, 20, 26 2. Baseline, Weeks 4, 8, 12, 16, 20, 26 3. Baseline, Weeks 4, 8, 12, 16, 20, 26 4. Baseline, Weeks 12 and 26 5. Baseline, Weeks 12 and 26 6. Baseline, Weeks 12 and 26 7. Baseline, Weeks 12 and 26 8. Baseline, Weeks 12 and 26 9. Baseline, Weeks 12 and 26 10. Baseline, Weeks 12 and 26	—

Measure

Time frame

Secondary end point(s): 1. Change from baseline to end of treatment epoch in Forced Vital Capacity (FVC) 2. Time to progression 3. Number of participants with absolute decline of =10% predicted in FVC 4. Change from baseline to the end of treatment epoch in DLCO 5. Change from baseline to the end of treatment epoch in 6-minute walk distance 6. Change from baseline to the end of treatment epoch in scores from the k-BILD questionnaire 7. Change from baseline to the end of treatment epoch in scores from Leicester Cough questionnaire 8. Change from baseline to the end of treatment epoch in scores from the the R-Scale for IPF questionnaire 9. Change from baseline to the end of treatment epoch in scores from the Living with IPF questionnaire (Impacts) 10. Change from baseline to the end of treatment epoch in scores from the Living with IPF questionnaire (Symptoms);Timepoint(s) of evaluation of this end point: 1. Baseline, Weeks 4, 8, 12, 16, 20, 26 2. Baseline, Weeks 4, 8, 12, 16, 20, 26 3. Baseline, Weeks 4, 8, 12, 16, 20, 26 4. Baseline, Weeks 12 and 26 5. Baseline, Weeks 12 and 26 6. Baseline, Weeks 12 and 26 7. Baseline, Weeks 12 and 26 8. Baseline, Weeks 12 and 26 9. Baseline, Weeks 12 and 26 10. Baseline, Weeks 12 and 26

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Countries

Argentina, Australia, Czechia, Germany, Netherlands, Poland, United Kingdom, United States

Contacts

Public ContactMedizinischer Infoservice (MCC)

Novartis Pharma GmbH

infoservice.novartis@novartis.com+49 911 273-121 00

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026