Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
A Randomized Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
This study a randomized, double-blind, four arm study to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in adults with Idiopathic Pulmonary Fibrosis.
This study is a randomized, double-blind, being conducted at centers globally to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in 240 treatment naïve adult patients with IPF ≥ 40 years in age. Patients will be randomized in a ratio of 1:1:1:1 to receive treatment of LYT-100, pirfenidone, or placebo to be taken daily for up to 183 days (26 week treatment period) with the primary outcome of Rate of decline in Forced Vital Capacity (FVC; in mL) over 26 weeks. Secondary endpoints, including spirometry, inflammatory biomarkers, and patient-reported outcomes will also be evaluated. After completion of the double-blind period of the study, patients may participate in a long-term extension to evaluate tolerability and long-term safety. Patients receiving LYT-100 in the double-blind period will continue the dose throughout the long-term extension. Patients receiving pirfenidone or placebo in the double-blind period will be re-randomized in a 1:1 ratio to receive LYT-100 550mg or 825mg TID dose throughout the long-term extension. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05984992 -
The First-in-human Study of SRN-001 in Healthy Participants
|
Phase 1 | |
| Active, not recruiting |
NCT04312594 -
Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis
|
Phase 2 | |
| Recruiting |
NCT03865927 -
GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis
|
Phase 2 | |
| Completed |
NCT03979430 -
Early Detection of Acute Exacerbation in Patients With Idiopathic Lung Fibrosis - a Pilot Study
|
N/A | |
| Enrolling by invitation |
NCT04905693 -
Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
|
Phase 3 | |
| Terminated |
NCT04419558 -
Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
|
Phase 3 | |
| Completed |
NCT03725852 -
A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF)
|
Phase 2 | |
| Terminated |
NCT03573505 -
An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis
|
Phase 2 | |
| Recruiting |
NCT04148157 -
Quality of Life in IPF - Patient and Physician Perceptions
|
||
| Active, not recruiting |
NCT03222648 -
Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis
|
N/A | |
| Completed |
NCT02268981 -
Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)
|
N/A | |
| Completed |
NCT02257177 -
RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT01524068 -
A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations
|
Phase 2 | |
| Enrolling by invitation |
NCT01382368 -
Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients
|
Phase 4 | |
| Completed |
NCT01199887 -
Trial Of IW001 in Patients With Idiopathic Pulmonary Fibrosis
|
Phase 1 | |
| Completed |
NCT01110694 -
Prospective Observation of Fibrosis in the Lung Clinical Endpoints Study
|
||
| Active, not recruiting |
NCT02951416 -
Clinical Course of Interstitial Lung Diseases: European IPF Registry and Biobank
|
||
| Terminated |
NCT00981747 -
Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis
|
Phase 2/Phase 3 | |
| Completed |
NCT00532233 -
SD, IL-13 Production Rate in IPF
|
Phase 2 | |
| Completed |
NCT00540475 -
Pennsylvania Idiopathic Pulmonary Fibrosis Research Registry
|