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Myositis Interstitial Lung Disease Nintedanib Trial
Rohit Aggarwal, MD
Myositis Associated Interstitial Lund Disease (MA-ILD)
This research study will evaluate safety and how well the study drug, nintedanib improve
symptoms in participants with myositis associated interstitial lung disease (MA-ILD).
Interstitial lung disease is a disorder caused by the abnormal accumulation of cells
structures between... expand
This research study will evaluate safety and how well the study drug, nintedanib improve
symptoms in participants with myositis associated interstitial lung disease (MA-ILD).
Interstitial lung disease is a disorder caused by the abnormal accumulation of cells
structures between air sacs of the lungs resulting in thickening, stiffness and scarring of
the tissues of the lung.
This study will enroll a total of 134 participants across 15 clinical sites located in the
United States. A subset of participants will be enrolled remotely via telemedicine utilizing
certified mobile home research nurses and various remote monitoring devices.
The research visits may include a physical exam, vital signs (such as blood pressure, heart
rate, etc.), pulmonary function tests (PFT and/or home spirometry), Computerized Tomography
(or CT) scans of the chest, blood draws, wearing a physical activity monitor and completing
questionnaires. Some of these events may be done at home, at a local facility or remotely
(via telemedicine).
Type: Interventional
Start Date: Aug 2023
open study
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Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis
Paul Szabolcs
Systemic Sclerosis
Diffuse Sclerosis Systemic
Interstitial Lung Disease
Pulmonary Hypertension
The purpose of this study is to determine whether a regimen of high-dose immunoablative
therapy will demonstrate safety that is consistent or improved with other published regimens
in SSc patients, while maintaining a treatment effect.
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The purpose of this study is to determine whether a regimen of high-dose immunoablative
therapy will demonstrate safety that is consistent or improved with other published regimens
in SSc patients, while maintaining a treatment effect.
Type: Interventional
Start Date: Jul 2018
open study
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Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis...
United Therapeutics
Progressive Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in
subjects with progressive pulmonary fibrosis (PPF) over a 52-week period.
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Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in
subjects with progressive pulmonary fibrosis (PPF) over a 52-week period.
Type: Interventional
Start Date: Oct 2023
open study
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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
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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.
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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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Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis...
aTyr Pharma, Inc.
Interstitial Lung Disease
This is a double-blind, randomized, placebo-controlled, PoC study to evaluate the efficacy,
safety, and tolerability of efzofitimod in patients with SSc-ILD. The primary objective of
the study is to evaluate the PoC for efficacy in a population with SSc-ILD. While improvement... expand
This is a double-blind, randomized, placebo-controlled, PoC study to evaluate the efficacy,
safety, and tolerability of efzofitimod in patients with SSc-ILD. The primary objective of
the study is to evaluate the PoC for efficacy in a population with SSc-ILD. While improvement
of ILD is the outcome of interest, the study will also evaluate changes in the skin. After
initial screening (up to 4 weeks), approximately 25 eligible participants will be randomized
2:2:1 to 1 of 2 active (experimental) dose arms or placebo, administered every 4 weeks up to
and including Week 20.
Type: Interventional
Start Date: Oct 2023
open study
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Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis...
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Diffuse Cutaneous Systemic Sclerosis
Interstitial Lung Disease
The purpose of this study is to assess the safety and efficacy of tulisokibart in
participants with SSc-ILD.
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The purpose of this study is to assess the safety and efficacy of tulisokibart in
participants with SSc-ILD.
Type: Interventional
Start Date: Jul 2022
open study
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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).... expand
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
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Oxygen Savings With Administered Oxygen and High Flow Ambient Air At Rest
Johns Hopkins University
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Interstitial
Pulmonary Fibrosis
Hypoxemia
Dyspnea
This study is meant to compare the amount of oxygen required for hypoxemia relief between
current standard of care (oxygen only) and oxygen with the addition of high flow air for
Chronic Obstructive Pulmonary Disease (COPD), Interstitial Lung Disease (ILD), and Pulmonary
Hypertension... expand
This study is meant to compare the amount of oxygen required for hypoxemia relief between
current standard of care (oxygen only) and oxygen with the addition of high flow air for
Chronic Obstructive Pulmonary Disease (COPD), Interstitial Lung Disease (ILD), and Pulmonary
Hypertension (PH) patients during rest. Subjects will be titrated from 0 L/min until they
maintain 95% SpO2 for each of the following delivery methods:
1. Pulses of pure oxygen (control)
2. Constant high flow air with pulses of pure oxygen
3. Out of phase pulses of high flow air and pure oxygen
Type: Interventional
Start Date: Dec 2020
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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Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension
University of Florida
Sarcoidosis
Precapillary Pulmonary Hypertension
Interstitial Lung Disease
This study aims to evaluate the efficacy and safety of inhaled treprostinil in subjects with
sarcoidosis-associated interstitial lung disease and pulmonary hypertension.
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This study aims to evaluate the efficacy and safety of inhaled treprostinil in subjects with
sarcoidosis-associated interstitial lung disease and pulmonary hypertension.
Type: Interventional
Start Date: Jan 2020
open study
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Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)
AstraZeneca
Systemic Sclerosis
Scleroderma
The purpose of this study is to evaluate the efficacy and safety of treatment with
subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis. The
target population for this study includes patients who meet the 2013 American College of
Rheumatology/European... expand
The purpose of this study is to evaluate the efficacy and safety of treatment with
subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis. The
target population for this study includes patients who meet the 2013 American College of
Rheumatology/European League Against Rheumatism (ACR/EULAR) classification for systemic
sclerosis, either limited or diffuse cutaneous subsets, with a disease duration of less than
6 years from first non-Raynaud's phenomenon symptom.
Type: Interventional
Start Date: Nov 2023
open study
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A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial...
GlaxoSmithKline
Systemic Sclerosis Associated Interstitial Lung Disease
Scleroderma, Systemic
This study investigates the efficacy and safety of belimumab compared to placebo, in addition
to standard therapy, for the treatment of participants with systemic sclerosis associated
interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab
treatment... expand
This study investigates the efficacy and safety of belimumab compared to placebo, in addition
to standard therapy, for the treatment of participants with systemic sclerosis associated
interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab
treatment on lung function as well as on extra-pulmonary disease manifestations, including
skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).
Type: Interventional
Start Date: Sep 2023
open study
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Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease
Children's Hospital Medical Center, Cincinnati
Interstitial Lung Disease
Common Variable Immunodeficiency
There is no standard of care therapy for patients with granulomatous-lymphocytic interstitial
lung disease (GLILD) seen in common variable immunodeficiency (CVID). Abatacept has recently
looked promising for the treatment of patients with complex CVID. This study is a multi-site,... expand
There is no standard of care therapy for patients with granulomatous-lymphocytic interstitial
lung disease (GLILD) seen in common variable immunodeficiency (CVID). Abatacept has recently
looked promising for the treatment of patients with complex CVID. This study is a multi-site,
phase II, randomized, blinded/placebo-controlled clinical trial in pediatric and adult
subjects to determine the efficacy of abatacept compared to placebo for treatment of subjects
with GLILD in the context of CVID.
Funding Source - FDA OOPD
Type: Interventional
Start Date: Jul 2021
open study
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A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension
Mayo Clinic
Pulmonary Arterial Hypertension
Interstitial Lung Disease
Healthy Adults
The purpose of this research study is to find out more about the drug treprostinil via
inhaler and the mechanisms of why patients with pulmonary arterial hypertension related to
Interstitial Lung disease (PAH-ILD) have limitations during exercise. The investigator is
studying... expand
The purpose of this research study is to find out more about the drug treprostinil via
inhaler and the mechanisms of why patients with pulmonary arterial hypertension related to
Interstitial Lung disease (PAH-ILD) have limitations during exercise. The investigator is
studying treprostinil's effect on patients with PAH-ILD during exercise and its effect on
their quality of life after using it for 3 months.
Type: Interventional
Start Date: Mar 2023
open study
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A Study to Evaluate the Safety and Tolerability of Oral Ixazomib in Scleroderma-related Lung Disease...
W. Leroy Griffing
Systemic Sclerosis
Scleroderma
Diffuse Systemic Sclerosis
Diffuse Scleroderma
Diffuse Cutaneous Systemic Sclerosis
The purpose of this research study is to learn about the effects of the medication ixazomib
in participants with scleroderma/systemic sclerosis including its safety and tolerability,
its effects on skin, lungs and other organs, and its effects on overall health and quality of... expand
The purpose of this research study is to learn about the effects of the medication ixazomib
in participants with scleroderma/systemic sclerosis including its safety and tolerability,
its effects on skin, lungs and other organs, and its effects on overall health and quality of
life.
Type: Interventional
Start Date: Apr 2021
open study
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A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary Fibrosis...
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... 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.
Type: Interventional
Start Date: May 2023
open study
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Feasibility of Semaglutide in Advanced Lung Disease
University of Pennsylvania
Obesity
Interstitial Lung Disease
Chronic Obstructive Pulmonary Disease
Sarcoidosis, Pulmonary
Pulmonary Hypertension
The goal of this clinical trial is to learn whether semaglutide, an FDA-approved treatment
for diabetes and obesity, is feasible and tolerable in patients with advanced lung disease.
The main question[s] it aims to answer are:
1. Are patients with advanced lung disease... expand
The goal of this clinical trial is to learn whether semaglutide, an FDA-approved treatment
for diabetes and obesity, is feasible and tolerable in patients with advanced lung disease.
The main question[s] it aims to answer are:
1. Are patients with advanced lung disease able to tolerate semaglutide therapy?
2. Are we able to titrate semaglutide therapy to a target weight?
Participants will be asked to perform pulmonary function, physical function and body
composition testing, as well as a blood draw before and after 12-weeks of semaglutide
therapy. While on therapy, subjects will be surveyed regarding any adverse events or side
effects.
Type: Interventional
Start Date: Jan 2024
open study
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