Vanderbilt Clinical Trials

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

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

Condition

Idiopathic Pulmonary Fibrosis

Eligibility

Eligible Ages: Over 40 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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 Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
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: Placebo Placebo to LTP001 will be administered once daily in the morning Drug: Standard of Care (SoC) nintedanib, pirfenidone, or neither

Recruiting Locations

Vanderbilt Unversity Medical Center .
Nashville, Tennessee 37203

Contact:
Phyllis Young
615-322-0476
phyllis.d.young@vumc.org

More Details

Status: Recruiting
Sponsor: Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.