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
- Between 40 Years and 100 Years
- Eligible Sex
- 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 |
LTP001 orally once daily in the morning for approximately 26 weeks. |
|
|
Experimental Placebo |
Placebo orally once daily in the morning for approximately 26 weeks. |
|
Recruiting Locations
More Details
- NCT ID
- NCT05497284
- Status
- Terminated
- Sponsor
- Novartis Pharmaceuticals
Detailed Description
This was a randomized, placebo-controlled, participant- and investigator-blinded platform study in participants with idiopathic pulmonary fibrosis. Participants underwent a screening period of 42 days, a treatment period of 26 weeks and a post-treatment safety follow-up period of 30 days. This study was designed to safely allow rapid and efficient screening of potentially efficacious investigational products in participants with IPF. The study was terminated for strategic reasons and no additional cohorts were created.