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 |
|
Experimental Placebo |
Participants will receive LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 26 weeks |
|
Recruiting Locations
Birmingham, Alabama 35294
Kansas City, Kansas 66160-7330
Nashville, Tennessee 37203
Houston, Texas 77030
Falls Church, Virginia 22042-3300
More Details
- NCT ID
- NCT05497284
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals