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

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

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: LTP001; Drug: Standard of Care (SoC); Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: 1-888-669-6682; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals; Phone Number: +41613241111

Study Locations

• Argentina
  • Parana, Argentina, 3100
    • Recruiting
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1056ABJ
      • Recruiting
      • Novartis Investigative Site
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Recruiting
      • Novartis Investigative Site
    • Ranelagh, Partido De Berazate, Buenos Aires, Argentina, 1884
      • Recruiting
      • Novartis Investigative Site
• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Recruiting
      • Novartis Investigative Site
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Novartis Investigative Site
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • Recruiting
      • Novartis Investigative Site
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Recruiting
      • Novartis Investigative Site
  • Western Australia
    • Spearwood, Western Australia, Australia, 6163
      • Recruiting
      • Novartis Investigative Site
• Czechia
  • Praha 4, Czechia, 140 59
    • Recruiting
    • Novartis Investigative Site
• Germany
  • Coswig, Germany, 01640
    • Recruiting
    • Novartis Investigative Site
  • Essen, Germany, 45147
    • Recruiting
    • Novartis Investigative Site
  • Hannover, Germany, 30625
    • Recruiting
    • Novartis Investigative Site
  • Muenchen, Germany, 81377
    • Recruiting
    • Novartis Investigative Site
• Netherlands
  • Amsterdam, Netherlands, 1081
    • Recruiting
    • Novartis Investigative Site
  • Nieuwegein, Netherlands, 3435 CM
    • Recruiting
    • Novartis Investigative Site
• Poland
  • Bialystok, Poland, 15-044
    • Recruiting
    • Novartis Investigative Site
  • Lodz, Poland, 90 153
    • Recruiting
    • Novartis Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham .
      • Contact: Andrea Ford; Email: afcook@uabmc.edu
      • Principal Investigator: Tejaswini Kulkarni
  • Kansas
    • Kansas City, Kansas, United States, 66160-7330
      • Recruiting
      • University of Kansas Medical Center
      • Principal Investigator: Mark Hamblin
      • Contact: Amy Davis; Phone Number: 913-588-9600; Email: adavis35@kumc.edu
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Vanderbilt Unversity Medical Center .
      • Contact: Phyllis Young; Phone Number: 615-322-0476; Email: phyllis.d.young@vumc.org
      • Principal Investigator: Lisa Lancaster
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital
      • Contact: Brizzna Contreras; Phone Number: 346-238-5685; Email: bvalle@houstonmethodist.org
      • Principal Investigator: Zeenat Safdar
  • Virginia
    • Falls Church, Virginia, United States, 22042-3300
      • Recruiting
      • Inova Fairfax Hosp Inst of Rsrch
      • Principal Investigator: Oksana Shlobin
      • Contact: Priscila Dauphin; Phone Number: 703-698-3580; Email: priscila.dauphin@inova.org
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • University of Washington Med Ctr .
      • Contact: J B Ingram; Email: jingra@uw.edu
      • Principal Investigator: Lawrence Ho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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: Standard of Care (SoC); nintedanib, pirfenidone, or neither; Drug: Placebo; Placebo to LTP001 will be administered once daily in the morning

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Estimated): November 22, 2024
• Study Completion (Estimated): November 22, 2024

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: CADPT09A12201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No