Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis
Tvardi Therapeutics, Incorporated
Idiopathic Pulmonary Fibrosis
The primary objective of this study is to evaluate the safety and tolerability of oral daily
administration of TTI-101 over a 12-week treatment duration in participants with idiopathic
pulmonary fibrosis (IPF).
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The primary objective of this study is to evaluate the safety and tolerability of oral daily
administration of TTI-101 over a 12-week treatment duration in participants with idiopathic
pulmonary fibrosis (IPF).
Type: Interventional
Start Date: May 2023
open study
Atezolizumab for Idiopathic Pulmonary Fibrosis
Cedars-Sinai Medical Center
Idiopathic Pulmonary Fibrosis
The purpose of this study is to determine the safety and preliminary efficacy of
atezolizumab, an immune checkpoint inhibitor approved for the treatment of various cancers,
in patients with idiopathic pulmonary fibrosis (IPF).
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The purpose of this study is to determine the safety and preliminary efficacy of
atezolizumab, an immune checkpoint inhibitor approved for the treatment of various cancers,
in patients with idiopathic pulmonary fibrosis (IPF).
Type: Interventional
Start Date: Feb 2023
open study
Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary...
Pliant Therapeutics, Inc.
Idiopathic Pulmonary Fibrosis
A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy
and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis
(BEACON-IPF).
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A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy
and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis
(BEACON-IPF).
Type: Interventional
Start Date: Nov 2023
open study
Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosis
National Jewish Health
Idiopathic Pulmonary Fibrosis (IPF)
Scarring of the lung, termed pulmonary fibrosis (PF), is a chronic, progressive, and usually
fatal disorder. While two anti-fibrotic drugs have been approved for treating PF of unknown
cause (idiopathic pulmonary fibrosis or IPF), neither drug is curative, and nearly 40% of...
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Scarring of the lung, termed pulmonary fibrosis (PF), is a chronic, progressive, and usually
fatal disorder. While two anti-fibrotic drugs have been approved for treating PF of unknown
cause (idiopathic pulmonary fibrosis or IPF), neither drug is curative, and nearly 40% of
patients stop taking the prescribed drug within a year because of side effects. The study
includes the use of saracatinib, an investigational drug originally developed to treat
certain types of cancers, in the treatment of IPF in a Phase 1b/2a clinical trial.
The objectives of this study are to: i) evaluate the safety, tolerability, pharmacokinetics
and pharmacodynamics, and to explore the efficacy of saracatinib in IPF; ii) identify
biomarkers of Src kinase activity and fibrogenesis linked to pulmonary fibrosis; and iii)
explore the application of these biomarkers to assess the anti-fibrotic effect of saracatinib
in IPF patients
Type: Interventional
Start Date: Nov 2020
open study
Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis
InSilico Medicine Hong Kong Limited
Idiopathic Pulmonary Fibrosis (IPF)
The goal of this clinical trial is to learn about INS018_055 in adults with Idiopathic
Pulmonary Fibrosis (IPF).
The primary objective is to evaluate the safety and tolerability of INS018_055 orally
administered for up to 12 weeks in adult subjects with IPF compared to placebo....
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The goal of this clinical trial is to learn about INS018_055 in adults with Idiopathic
Pulmonary Fibrosis (IPF).
The primary objective is to evaluate the safety and tolerability of INS018_055 orally
administered for up to 12 weeks in adult subjects with IPF compared to placebo.
Type: Interventional
Start Date: Feb 2024
open study
Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients
Hal Chapman
Idiopathic Pulmonary Fibrosis
The primary purpose of this multi-center, double-blind, placebo-controlled, dose-ranging
Phase I study is to assess the safety of a purified from green tea, EGCG, in patients with
idiopathic pulmonary fibrosis (IPF) as a potential novel treatment for pulmonary fibrosis.
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The primary purpose of this multi-center, double-blind, placebo-controlled, dose-ranging
Phase I study is to assess the safety of a purified from green tea, EGCG, in patients with
idiopathic pulmonary fibrosis (IPF) as a potential novel treatment for pulmonary fibrosis.
Type: Interventional
Start Date: Aug 2023
open study
Autoantibody Reduction for Acute Exacerbations of Idiopathic Pulmonary Fibrosis
University of Alabama at Birmingham
Idiopathic Pulmonary Fibrosis, Acute Fatal Form
Acute exacerbations (AE) are a dreaded manifestation of idiopathic pulmonary fibrosis (IPF)
that presents with rapidly worsening respiratory function over days to weeks. AE account for
about 1/2 the deaths in IPF patients, and are refractory to all medical therapies attempted...
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Acute exacerbations (AE) are a dreaded manifestation of idiopathic pulmonary fibrosis (IPF)
that presents with rapidly worsening respiratory function over days to weeks. AE account for
about 1/2 the deaths in IPF patients, and are refractory to all medical therapies attempted
to date.
Considerable preliminary data shows pathological B-cell abnormalities and autoantibodies are
present in AE-IPF and associated with disease severity.
The experimental therapy here (therapeutic plasma exchange plus rituximab plus intravenous
immunoglobulin) is mechanistically targeted to ameliorate autoantibody-mediated pulmonary
injury. Anecdotal pilot studies indicate these treatments have significant benefit for a
disease syndrome that has, until now, been almost invariably inexorable. This clinical trial
has the potential to profoundly affect current paradigms and treatment approaches to patients
with AE-IPF.
Type: Interventional
Start Date: Sep 2018
open study
A Study to Investigate Leramistat in Patients With IPF
Modern Biosciences Ltd
Idiopathic Pulmonary Fibrosis
To compare the effect of daily oral dosing of leramistat over 12 weeks with placebo in
participants aged 40 years or older with idiopathic pulmonary fibrosis (IPF).
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To compare the effect of daily oral dosing of leramistat over 12 weeks with placebo in
participants aged 40 years or older with idiopathic pulmonary fibrosis (IPF).
Type: Interventional
Start Date: Aug 2023
open study
LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
PureTech
Idiopathic Pulmonary Fibrosis
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.
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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.
Type: Interventional
Start Date: Jul 2022
open study
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic...
Bristol-Myers Squibb
Idiopathic Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278
in participants with Idiopathic Pulmonary Fibrosis.
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The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278
in participants with Idiopathic Pulmonary Fibrosis.
Type: Interventional
Start Date: Sep 2023
open study
Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic...
Redx Pharma Plc
IPF
Fibrosis
The purpose of the study is to assess the safety and tolerability of RXC007 when given for 12
weeks (84 days), alone and in combination with nintedanib or pirfenidone.
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The purpose of the study is to assess the safety and tolerability of RXC007 when given for 12
weeks (84 days), alone and in combination with nintedanib or pirfenidone.
Type: Interventional
Start Date: Sep 2022
open study
Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure
Paul Szabolcs
Idiopathic Pulmonary Fibrosis
Emphysema or COPD
The purpose of this study is to determine whether a lung transplantation prior to bone marrow
transplantation (BMT) would allow for restoration of pulmonary function prior to BMT,
allowing to proceed to BMT, to restore hematologic function.
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The purpose of this study is to determine whether a lung transplantation prior to bone marrow
transplantation (BMT) would allow for restoration of pulmonary function prior to BMT,
allowing to proceed to BMT, to restore hematologic function.
Type: Interventional
Start Date: Apr 2018
open study
Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
United Therapeutics
Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against
placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52.
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Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against
placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52.
Type: Interventional
Start Date: Jun 2021
open study
Collagen-targeted Positron Emission Tomography (PET) Imaging for Assessment of EGCG Effect
Hal Chapman
Idiopathic Pulmonary Fibrosis
The primary purpose of this substudy is to determine if collagen-targeted PET using the type
1 collagen-targeted PET probe, Gallium-68 (68Ga)-labeled collagen binding probe 8 (CBP8) can
inform as to drug effect of EGCG and assist in dose selection.
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The primary purpose of this substudy is to determine if collagen-targeted PET using the type
1 collagen-targeted PET probe, Gallium-68 (68Ga)-labeled collagen binding probe 8 (CBP8) can
inform as to drug effect of EGCG and assist in dose selection.
Type: Interventional
Start Date: Feb 2024
open study
To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF
Novartis Pharmaceuticals
Idiopathic Pulmonary Fibrosis
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
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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
Type: Interventional
Start Date: Nov 2022
open study
Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF
Daewoong Pharmaceutical Co. LTD.
Idiopathic Pulmonary Fibrosis
This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the
safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
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This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the
safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
Type: Interventional
Start Date: Jul 2022
open study
The Effect of N115 on Coughing in IPF Patients
Cellular Sciences, inc.
Idiopathic Pulmonary Fibrosis
The purpose of this clinical trial is to administer a sodium pyruvate nasal spray that
eliminates nasal oxidative stresses, caused by oxygen radicals, and demonstrate the efficacy
of sodium pyruvate to reduce coughing and increase lung functions in patients with idiopathic...
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The purpose of this clinical trial is to administer a sodium pyruvate nasal spray that
eliminates nasal oxidative stresses, caused by oxygen radicals, and demonstrate the efficacy
of sodium pyruvate to reduce coughing and increase lung functions in patients with idiopathic
pulmonary fibrosis. This will be a 21-day double-blinded randomized placebo-controlled trial
designed to determine if patients with idiopathic pulmonary fibrosis treated with 20mM sodium
pyruvate in 0.9% sodium chloride nasal spray solution will have reduced chronic coughing, as
well as increased lung function (FEV1, FVC endpoints of 12% or more within the first week)
and improved FEV1/FVC ratios.
Type: Interventional
Start Date: Aug 2023
open study
Human Autologous Lung Stem Cell Transplant for Idiopathic Pulmonary Fibrosis
University of North Carolina, Chapel Hill
Idiopathic Pulmonary Fibrosis
Purpose:
To demonstrate the safety and efficacy of autologous Lung Spheroid Stem Cells (LSCs)
administered by intravenous infusion in patients with idiopathic pulmonary fibrosis.
Participants:
Patients with Idiopathic Pulmonary Fibrosis (IPF)
Procedures...
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Purpose:
To demonstrate the safety and efficacy of autologous Lung Spheroid Stem Cells (LSCs)
administered by intravenous infusion in patients with idiopathic pulmonary fibrosis.
Participants:
Patients with Idiopathic Pulmonary Fibrosis (IPF)
Procedures (methods):
24 patients previously diagnosed with idiopathic pulmonary fibrosis meeting all
inclusion/exclusion criteria will be evaluated at baseline. LSCs will be grown from
autologous trans-bronchial pulmonary biopsy specimens. The first group, consisting of 6
patients will be randomized after completion of the screening procedures to either a
treatment group of 100 million LSCs administered via intravenous infusion or to a control
group (standard care) in a 2:1 LSC to control group ratio. The second group of 18 patients
will be randomized after completion of the screening procedures to either a treatment group
of 200 million LSCs administered via intravenous infusion or to a control group (standard
care) in a 2:1 LSC to control group ratio. Patients will be randomized using permuted blocks
in a 2:1 LSC to control group ratio, providing a distribution of 8:4:12 patients among the
control, low dose, and high dose groups, respectively. If the patient is randomized and 100
million LSCs are not achieved, then the patient will be analyzed separately and another
patient enrolled. Intravenous infusion of LSCs will take place 4-8 weeks after the pulmonary
biopsies are obtained. All patients will be followed up at months 0.5, 1, 3, 6, 9, 12, 18,
and 24 after infusion to complete the safety and efficacy assessments listed herein. All
patients will receive standard of care for their IPF.
Type: Interventional
Start Date: Oct 2020
open study
Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Cumberland Pharmaceuticals
Idiopathic Pulmonary Fibrosis
Ifetroban prevents and treats lung fibrosis due to multiple causes (bleomycin, genetic,
radiation). The safety and efficacy of oral ifetroban will be assessed in patients with IPF.
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Ifetroban prevents and treats lung fibrosis due to multiple causes (bleomycin, genetic,
radiation). The safety and efficacy of oral ifetroban will be assessed in patients with IPF.
Type: Interventional
Start Date: Jan 2024
open study
Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF
GRI Bio Operations, Inc.
Idiopathic Pulmonary Fibrosis
This is a Phase 2a, randomized, double-blind, multi-center, placebo-controlled,
parallel-design, 2-arm study. Approximately 36 subjects with IPF will be randomized in a 2:1
ratio for GRI-0621 4.5mg or Placebo. GRI-0621 dose of 4.5mg will be compared with placebo
following...
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This is a Phase 2a, randomized, double-blind, multi-center, placebo-controlled,
parallel-design, 2-arm study. Approximately 36 subjects with IPF will be randomized in a 2:1
ratio for GRI-0621 4.5mg or Placebo. GRI-0621 dose of 4.5mg will be compared with placebo
following once daily oral administration for 12 weeks. Concurrently, a Sub-Study will be
conducted, examining the number and activity of NKT cells in BAL, for up to 12 eligible
subjects (across various centers). An interim analysis will be performed when 24 subjects
complete 6 weeks of treatment (approximately 8 placebo subjects).
Type: Interventional
Start Date: Mar 2024
open study
IPF mHealth Exercise
University of Washington
Idiopathic Pulmonary Fibrosis
Patients with idiopathic pulmonary fibrosis (IPF) who are stable on antifibrotic therapy at
least 3 months will be randomized to complete a 12-week home exercise intervention using an
mHealth platform, plus a pre- and post-intervention monitoring period (4 weeks each) and...
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Patients with idiopathic pulmonary fibrosis (IPF) who are stable on antifibrotic therapy at
least 3 months will be randomized to complete a 12-week home exercise intervention using an
mHealth platform, plus a pre- and post-intervention monitoring period (4 weeks each) and
in-person study assessments.
Type: Interventional
Start Date: Apr 2021
open study
To Evaluate the Efficacy, Safety, and Tolerability of BBT-877 in Patients With IPF
Bridge Biotherapeutics, Inc.
Idiopathic Pulmonary Fibrosis
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, study to
evaluate the efficacy, safety, and tolerability of 200 mg twice daily (BID) of BBT-877 in
patients with IPF, with or without AF approved background therapies (pirfenidone or
nintedanib)....
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This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, study to
evaluate the efficacy, safety, and tolerability of 200 mg twice daily (BID) of BBT-877 in
patients with IPF, with or without AF approved background therapies (pirfenidone or
nintedanib).
Type: Interventional
Start Date: Apr 2023
open study
GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis
University of Alabama at Birmingham
Idiopathic Pulmonary Fibrosis
A placebo-controlled, multicenter, randomized trial to test GKT137831 in ambulatory patients
with idiopathic pulmonary fibrosis. This drug is an inhibitor of nicotinamide adenine
dinucleotide phosphate (NADPH) oxidase (NOX) isoforms. The investigators hypothesize the drug...
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A placebo-controlled, multicenter, randomized trial to test GKT137831 in ambulatory patients
with idiopathic pulmonary fibrosis. This drug is an inhibitor of nicotinamide adenine
dinucleotide phosphate (NADPH) oxidase (NOX) isoforms. The investigators hypothesize the drug
will decrease pulmonary injury due to reactive oxygen species (ROS) generated by NOX enzymes,
which are believed to play an important role in the development of IPF. Treatment with
GKT137831 could result in significant benefit for a lung disease that has, until now, been
almost invariably inexorable.
This clinical trial represents the bedside application of a series of NOX translational and
basic studies and discoveries, over several years, from the laboratory of Dr. Victor
Thannickal.
Type: Interventional
Start Date: Sep 2020
open study
Effect of CPAP on Abnormal Gastroesophageal Reflux and Lung Inflammation in IPF
University of Arizona
Idiopathic Pulmonary Fibrosis
Obstructive Sleep Apnea
Gastro Esophageal Reflux
This study will evaluate the effect of CPAP therapy on esophageal pH and lung inflammation in
patients with idiopathic pulmonary fibrosis (IPF) and sleep apnea.
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This study will evaluate the effect of CPAP therapy on esophageal pH and lung inflammation in
patients with idiopathic pulmonary fibrosis (IPF) and sleep apnea.
Type: Interventional
Start Date: Oct 2019
open study
Assessment of Continuous Positive Airway Pressure Therapy in IPF
Columbia University
Interstitial Lung Disease
Obstructive Sleep Apnea
The purpose of this study is to evaluate whether biomarkers of lung injury and remodeling are
responsive to effective continuous positive airway pressure (CPAP) treatment in adults with
idiopathic pulmonary fibrosis (IPF) and moderate-to-severe obstructive sleep apnea (OSA)....
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The purpose of this study is to evaluate whether biomarkers of lung injury and remodeling are
responsive to effective continuous positive airway pressure (CPAP) treatment in adults with
idiopathic pulmonary fibrosis (IPF) and moderate-to-severe obstructive sleep apnea (OSA).
Type: Interventional
Start Date: Jan 2023
open study