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To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF
Study Purpose
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
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
40 Years and Over
Gender
All
More Inclusion & Exclusion 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.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 2
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Novartis Pharmaceuticals
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
N/A
Principal Investigator Affiliation
N/A
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Recruiting
Countries
Argentina, Australia, Czechia, Germany, Netherlands, Poland, United States
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Idiopathic Pulmonary Fibrosis
Arms & Interventions
Arms
Experimental: LTP001
Participants will receive LTP001 orally once daily in the morning for approximately 26 weeks
Experimental: Placebo
Participants will receive LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 26 weeks
Interventions
Drug: - LTP001
LTP001 will be administered once daily in the morning
Drug: - Placebo
Placebo to LTP001 will be administered once daily in the morning
Drug: - Standard of Care (SoC)
nintedanib, pirfenidone, or neither
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
University of Alabama at Birmingham ., Birmingham, Alabama
