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H01 in Adults With Interstitial Lung Disease (The SOLIS Study)
National Institute of Environmental Health Sciences (NIEHS)
Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis
Lung Diseases, Interstitial
Background:
Interstitial lung disease affects the tissues that aid the transfer of oxygen and carbon
dioxide between the air and the bloodstream. The disease can cause fibrosis, a thickening
and scarring of lung tissue. Fibrosis often continues getting worse, and most people with
this disease die1 expand
Background:
Interstitial lung disease affects the tissues that aid the transfer of oxygen and carbon
dioxide between the air and the bloodstream. The disease can cause fibrosis, a thickening
and scarring of lung tissue. Fibrosis often continues getting worse, and most people with
this disease die in 3 to 5 years.
Objective:
To test a study drug (hymecromone) in people with interstitial lung disease or lung
fibrosis.
Eligibility:
People aged 18 years and older with interstitial lung disease or lung fibrosis.
Design:
Participants will have at least 7 clinic visits over 5 months.
Participants will have screening and baseline visits. They will have blood tests and
tests of their heart function. They will give a sputum sample. Other tests will include:
Spirometry: Participants will breathe in and out through a mouthpiece to measure how much
air they can hold in their lungs and how hard they can breathe.
Diffusion capacity of lungs for carbon monoxide: Participants will breathe in a gas that
contains a small amount of carbon monoxide. Then they will breathe through a mouthpiece.
This test measures how well oxygen moves from the air into the blood.
Resting energy expenditure. Participants will lie still for 30 minutes with a clear dome
over their head. This test measures the calories their body burns at rest.
6-minute walk test. Participants will walk at their normal pace for 6 minutes. Their
vital signs and blood oxygen levels will be checked.
Hymecromone is a tablet taken by mouth. Participants will take 2 tablets every morning
and 2 tablets every night for 12 weeks. Tests will be repeated at study visits.
Type: Interventional
Start Date: May 2025
open study
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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). expand
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
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Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients with IPF
GRI Bio Operations, Inc.
Idiopathic Pulmonary Fibrosis
IPF
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 administra1 expand
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 early-stage patient variability assessment will be completed when 12 subjects have
completed 2 weeks of treatment. Followed by an interim analysis performed when 24
subjects complete 6 weeks of treatment.
Type: Interventional
Start Date: Apr 2024
open study
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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. expand
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
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WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Mediar Therapeutics
Idiopathic Pulmonary Fibrosis
A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy
of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF) expand
A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy
of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)
Type: Interventional
Start Date: May 2025
open study
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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. expand
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
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A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.
Vicore Pharma AB
Idiopathic Pulmonary Fibrosis (IPF)
The ASPIRE trial is a 52 week randomized, double-blind, placebo-controlled,
parallel-group, multicenter trial in which the efficacy, safety, and pharmacokinetics of
orally administered buloxibutid, either on top of stable IPF therapy or as monotherapy,
are assessed in participants with IPF.
Trial1 expand
The ASPIRE trial is a 52 week randomized, double-blind, placebo-controlled,
parallel-group, multicenter trial in which the efficacy, safety, and pharmacokinetics of
orally administered buloxibutid, either on top of stable IPF therapy or as monotherapy,
are assessed in participants with IPF.
Trial website: www.aspire-ipf.com
Type: Interventional
Start Date: Dec 2024
open study
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A Study to Evaluate the Efficacy and Safety of GSK3915393 in Participants With Idiopathic Pulmonary1
GlaxoSmithKline
Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis is a chronic lung disease which causes scarring of the
lungs and difficulty in breathing. GSK3915393 is a new medicine, which is being tested in
participants with IPF for the first time. The study will assess the safety and
effectiveness of GSK3915393 in IPF participan1 expand
Idiopathic Pulmonary Fibrosis is a chronic lung disease which causes scarring of the
lungs and difficulty in breathing. GSK3915393 is a new medicine, which is being tested in
participants with IPF for the first time. The study will assess the safety and
effectiveness of GSK3915393 in IPF participants.
Type: Interventional
Start Date: Apr 2024
open study
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A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiop1
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. expand
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
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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. expand
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
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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. expand
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
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NAL ER IPF Respiratory Function and Safety Study
Trevi Therapeutics
Idiopathic Pulmonary Fibrosis
The primary purpose of this study is to assess the safety and tolerability of escalating
doses of NAL ER and to evaluate its effect on respiratory function in participants with
IPF. expand
The primary purpose of this study is to assess the safety and tolerability of escalating
doses of NAL ER and to evaluate its effect on respiratory function in participants with
IPF.
Type: Interventional
Start Date: Jun 2025
open study
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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. expand
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
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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. expand
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
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A Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosis
Calluna Pharma AS
Idiopathic Pulmonary Fibrosis
The goal of this clinical trial is to learn if the investigational drug CAL101 can help
prevent further decline in lung function in adults with Idiopathic Pulmonary Fibrosis.
Researchers will compare CAL101 with placebo to compare change from baseline in forced
vital capacity (FVC).
Participants1 expand
The goal of this clinical trial is to learn if the investigational drug CAL101 can help
prevent further decline in lung function in adults with Idiopathic Pulmonary Fibrosis.
Researchers will compare CAL101 with placebo to compare change from baseline in forced
vital capacity (FVC).
Participants will be randomly assigned to a study group that will receive an IV infusion
of either the study medication or placebo about once a month for 6 months.
Type: Interventional
Start Date: Jun 2025
open study
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A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis1
Boehringer Ingelheim
Idiopathic Pulmonary Fibrosis
Progressive Pulmonary Fibrosis
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive
pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a
previous study with a medicine called nerandomilast or BI 1015550.
The goal of this study is to find out how well people with1 expand
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive
pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a
previous study with a medicine called nerandomilast or BI 1015550.
The goal of this study is to find out how well people with pulmonary fibrosis tolerate
long- term treatment with nerandomilast. The study also tests whether nerandomilast
improves lung function and prolongs the time until symptoms get worse, participants need
to go to the hospital, or die.
Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The
participants may also continue their regular treatment for pulmonary fibrosis during the
study.
Participants visit their doctors regularly. During these visits, the doctors collect
information on any health problems of the participants. Participants also regularly do
lung function tests.
Type: Interventional
Start Date: Sep 2024
open study
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A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or P1
Boehringer Ingelheim
Idiopathic Pulmonary Fibrosis
Progressive Pulmonary Fibrosis
Adults 40 years of age and older with idiopathic pulmonary fibrosis (IPF) or 18 years and
older with progressive pulmonary fibrosis (PPF) can participate in this study. Only
people who have a chronic cough can take part. The purpose of this study is to find out
how well BI 1839100 helps reduce coug1 expand
Adults 40 years of age and older with idiopathic pulmonary fibrosis (IPF) or 18 years and
older with progressive pulmonary fibrosis (PPF) can participate in this study. Only
people who have a chronic cough can take part. The purpose of this study is to find out
how well BI 1839100 helps reduce coughing in people with IPF or PPF.
Participants who have IPF are put into 4 groups by chance. Participants in 3 groups get
different doses of BI 1839100. Participants in 1 group get placebo. Placebo looks like BI
1839100 but does not contain any medicine. Participants take the treatment for 3 months.
After 1 month of treatment, participants who take the highest dose will have coughing
measured to find out if the medicine works. If it does not work, the study may be
stopped. Participants who have IPF are in the study for slightly longer than 4 months.
During this time, they visit the study site 7 times. This study will also measure the
effects of BI 1839100 on coughing and lung function in a smaller group of people with
PPF.
During the study, coughing is measured over 24 hours about once per month using a
portable device given to participants to use during the study. Participants fill in
questionnaires about their coughing. Doctors also perform breathing tests that measure
how well the lungs are working at the site visits. Researchers compare the results
between participants who take BI 1839100 and placebo. The doctors also regularly check
participants' health and take note of any unwanted effects.
Type: Interventional
Start Date: Aug 2024
open study
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A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary1
Genentech, Inc.
Idiopathic Pulmonary Fibrosis
Systemic Sclerosis With Lung Involvement
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with
placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in
participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Participants who complete 52-weeks of1 expand
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with
placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in
participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Participants who complete 52-weeks of treatment in the Double-blind Treatment (DBT)
period can choose to enroll in the optional Open-label Extension (OLE) period to receive
treatment with vixarelimab for another 52 weeks.
Cohort 1 has completed enrollment and has been closed for further enrollment. Cohort 2 is
enrolling participants.
Type: Interventional
Start Date: May 2023
open study
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Efficacy of Two Doses of Duloxetine & Amitriptyline in Interstitial Lung Disease-related Cough
Mayo Clinic
Interstitial Lung Disease
This research study is evaluating the effectiveness of escalating doses of Amitriptyline
and Duloxetine in reducing cough frequency in patients with interstitial lung disease
(ILD)-related cough. expand
This research study is evaluating the effectiveness of escalating doses of Amitriptyline
and Duloxetine in reducing cough frequency in patients with interstitial lung disease
(ILD)-related cough.
Type: Interventional
Start Date: Nov 2021
open study
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A Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokin1
AstraZeneca
Healthy Participants
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics
(PK) of AZD8965 via single and multiple ascending doses in healthy participants
(including Japanese and Chinese participants), and to assess the effect of food on the
safety, tolerability, and PK of orally adminis1 expand
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics
(PK) of AZD8965 via single and multiple ascending doses in healthy participants
(including Japanese and Chinese participants), and to assess the effect of food on the
safety, tolerability, and PK of orally administered AZD8965.
Type: Interventional
Start Date: Aug 2024
open study
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