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Clinical Trials

-Welcome to our Clinical Trial Resources page connecting the ATS community to current, ongoing clinical trials in pulmonary, critical care, and sleep medicine being conducted by participating pharmaceutical and device companies.  The ATS does not endorse any trial listed, however we hope the below trial opportunities will be a valuable resource to clinicians, patients, and researchers in the combined goal of improving and advancing patient care. A complete US Clinical Trial listing can be found at http://clinicaltrials.gov/.


Companies that are ATS Corporate Members at the Supporter Level or higher can list clinical trials at no charge as part of member benefits. If your company is not a current ATS Corporate Member and you would like to see your company’s trials listed, please contact Vlada Kagan O'Hara.

Trials in Allergic Bronchopulmonary Aspergillosis (ABPA)

Trials in Alpha-1 Antitrypsin Deficiency (AATD)

Trials in Asthma

Trials in Bronchiectasis

Trials in COPD

Trials in COVID-19

Trials in Idiopathic Pulmonary Fibrosis (IPF)

Trials in Influenza

Trials in Interstitial Lung Disease (ILD)

Trials in Lung Infection

Trials in PAH

Trials in Pulmonary Hypertension (PH)


AATD

Company:

Vertex Pharmaceuticals Incorporated

Clinical Trial Title:

A Phase 2, Open-label Study Evaluating Efficacy and Safety of VX-864 in Subjects With Alpha-1 Antitrypsin Deficiency Who Have the PiZZ Genotype, Over 48 Weeks (NCT05643495)

Clinical Trial Description:

This clinical research study is exploring an investigational treatment for adults living with Alpha-1 Antitrypsin Deficiency (AATD) who have the PiZZ genotype. The purpose of the study is to evaluate the efficacy and safety of VX-864 over 48 weeks.  The study will enroll approximately 20 participants.

Eligible Patients:

This clinical research study is for adults ages 18-80 with the PiZZ genotype. Additional eligibility requirements can be found at AATDstudy-HCP.com.

Contact:

A Clinical Trials Contact https://aatdstudy-hcp.com/

Date Posted:

August 14, 2023

Learn more about this clinical trial


sanofiandregeneronlogo

AERIFY1

Company:

Sanofi and Regeneron

Clinical Trial Title:

Randomized, double-blind, placebo-controlled, parallel-group Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (anti-IL-33 mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) Study # EFC16750

Clinical Trial Description:

EFC16750 is a clinical research study for former smoker patients with moderate to very severe chronic obstructive pulmonary disease (COPD), to evaluate an injectable investigational study drug. The study will enroll approximately 186 patients with COPD in at approximately 47 study centers throughout the United States.

Eligible Patients:

This clinical research study is for adults aged 40-85 years old who have experienced moderate to severe exacerbations of COPD in the last year.

Contact:

A Clinical Trials Contact What is COPD | AERIFY COPD Clinical Study | Sanofi Studies

Date Posted:

April 11, 2022

Learn more about this clinical trial



sanofiandregeneronlogo

AERIFY2

Company:

Sanofi and Regeneron

Clinical Trial Title:

Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) (AERIFY-2)

Clinical Trial Description:

Sanofi and Regeneron are researching if an investigational medicine plus certain controller therapies could potentially lessen COPD symptoms and improve breathing and overall well-being in former smokers (>10 packs year) who are between 40 and 85 years old with moderate-to-severe COPD. This global, multi-center, phase 3 clinical trial (AERIFY 2) is a randomized, double-blind, placebo-controlled, parallel-group Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/ REGN3500/ Itepekimab (Anti-IL-33 mAb) in former smokers with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). The study expects to enroll 1,210 participants across 254 sites.

Eligible Patients:

Former smokers, ages 40-85, with moderate-to-severe COPD

Contact:

Sanofi Trial Transparency

800-633-1610, option 6

Contact-US@sanofi.com

Date Posted:

July 10, 2023

Learn more about this clinical trial


sanofiandregeneronlogo

AERIFY3

Company:

Sanofi and Regeneron

Clinical Trial Title:

A Phase 2 Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients with COPD (AERIFY-3)

Clinical Trial Description:

Treatments for chronic obstructive pulmonary disease (COPD) may still leave you looking for relief from wheezing, coughing, and shortness of breath. That’s why Sanofi and Regeneron are researching the mechanism of action of an investigational medicine in former and current smokers who are between 40 and 70 years old with COPD.

This phase 2a clinical trial (AERIFY 3) is an exploratory, two-part, 12-week study to evaluate the mechanism of action of itepekimab (Anti-IL-33 mAb) and its impact on airway inflammation. This study consists of participants who have been on a standard-of-care (SoC) mono (long-acting β2-agonist [LABA]) or long-acting muscarinic antagonist [LAMA]), double (inhaled corticosteroid [ICS] + LABA, LABA + LAMA or ICS + LAMA), or triple (ICS + LABA + LAMA) controller therapy for COPD for at least 3 months prior to Screening (Visit 1) with stable dose and regimen for controller therapy for ≥1 month prior to Screening (Visit 1) and during the screening period. Participants will stay on their established controller medications for COPD throughout the duration of the study, with the exception of systemic corticosteroids and/or antibiotics used for acute exacerbation of COPD (AECOPD). The study expects to enroll 60 participants.

Eligible Patients:

Former and current smokers, between 40-70 years old, with COPD

Contact:

Sanofi Trial Transparency

800-633-1610, option 6

Contact-US@sanofi.com

Date Posted:

July 10, 2023

Learn more about this clinical trial


ARISE and ENCORE

ARISE and ENCORE

Company:

Insmed Incorporated

Clinical Trial Titles:

ARISE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)

ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)

Clinical Trial Description:

ARISE and ENCORE are parallel clinical research studies for adults with a recent diagnosis of Mycobacterial avium complex (MAC) lung infection to evaluate an inhaled investigational study drug (amikacin liposome inhalation suspension). Eligible patients will be assigned to one of these two studies that together will enroll approximately 350 individuals with MAC lung infection in at approximately 150 study centers globally.

Eligible Patients:

These clinical research studies are for adults age 18 and older with a current diagnosis of Mycobacterium avium Complex (MAC) lung infection.

Contacts:

Insmed Medical Information
844-4-INSMED
medicalinformation@insmed.com

Date Posted:

June 7, 2021

Learn more about this clinical trial


arnasa

ARNASA

Company:

Genentech/Roche

Clinical Trial Titles:

ARNASA

Clinical Trial Description:

This Phase 3 study will evaluate the efficacy and safety of astegolimab compared with placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD), who are former or current smokers, have experienced ≥ 2 exacerbations within the last 12 months and independent of eosinophil counts.

Eligible Patients:

This clinical research study is for adults age 40 – 80 years.

Contacts:

https://forpatients.roche.com or 888-662-6728

Reference Study ID Number: GB44332

Date Posted:

July 10, 2023

Learn more about this clinical trial



Aspen

ASPEN

Company:

Insmed Incorporated

Clinical Trial Title:

A Phase 3, Randomized, Double blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study

Clinical Trial Description:

ASPEN is a clinical research study for adults with a clinical diagnosis of non-cystic fibrosis bronchiectasis (NCFBE) to evaluate an investigational study drug (brensocatib). The study will enroll approximately 1620 individuals with NCFBE in at approximately 480 study centers globally.

Eligible Patients:

This clinical research study is for adults age 18 to 85 with a clinical history consistent with NCFBE that is confirmed by chest computerized tomography scan, and a history of at least 2 pulmonary exacerbations in the prior 12 months.

Contacts:

Insmed Medical Information
844-4-INSMED
medicalinformation@insmed.com

Date Posted:

February 17, 2021

Learn more about this clinical trial


sanofiandregeneronlogo

ATLAS

Company:

Sanofi and Regeneron

Clinical Trial Title:

A Phase 3b/4 Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma     

Clinical Trial Description:

Sanofi and Regeneron are studying the long-term effect of dupliumab on the prevention of lung function decline in adult patients with uncontrolled moderate to severe asthma. This Phase 3b/4 study (ATLAS), is an interventional, randomized, parallel group, treatment, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function decline in adult patients with uncontrolled moderate to severe asthma.

The estimated duration is 4±1 weeks of screening and run-in period, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.

The study expects to enroll approximately 1860 participants across 168 study sites worldwide.

Eligible Patients:

Adults, between 18-65, with asthma

Contacts:

Sanofi Trial Transparency

800-633-1610, option 6

Contact-US@sanofi.com

Date Posted:

July 10, 2023

Learn more about this clinical trial


CARE PAH LOGO

CARE PAH

Company:

Janssen Research & Development, LLC

Clinical Trial Title:

67896062PAH4005 (Care PAH)

Clinical Trial Description:

The purpose of this study is to collect data to describe PAH patients in terms of their clinical characteristics, therapies used, disease progression, and outcomes (eg, death, hospitalization, risk category for predicted mortality risk, and patient-reported outcomes [PROs]) in routine clinical practice.

Eligible Patients:

This clinical research study is for adults age 18 and older with pulmonary arterial hypertension (PAH) who have initiated a new PAH-specific therapy or have been on stable therapy of the investigational medication for at least 3 months.

Contacts:

Email: Participate-In-This-Study@its.jnj.com

Date Posted:

September 19, 2022

Learn more about this clinical trial


Centerstone

CENTERSTONE

Company:

Genentech, a Member of the Roche Group

Clinical Trial Title:

CENTERSTONE

Clinical Trial Description:

CENTERSTONE is a study to assess the efficacy of a single oral dose of baloxavir marboxil versus placebo to reduce the direct transmission of influenza A or B in households and is taking place at multiple sites around the United States and other countries.

Eligible Patients:

CENTERSTONE is open to otherwise-healthy participants between the ages of 5 and 64 with confirmed influenza infection, who have had influenza symptoms for no more than 48 hours. Participants must also have at least 2 household members who are confirmed influenza-negative and are willing to participate.

Contacts:

For more information or to locate a site near you, please visit  https://www.centerstoneflutrial.com/en-us/

Date Posted:

February 17, 2021

Learn more about this clinical trial


Verona

ENHANCE 1 Trial

Company:

Verona Pharma

Clinical Trial Title:

ENHANCE 1 clinical trial

Clinical Trial Description:

The ENHANCE 1 ( Ensifentrine as a Novel In HAled Nebulized COPD th Erapy) clinical trial is a clinical research study for adults with moderate to severe chronic obstructive pulmonary disease (COPD), including patients on no maintenance/background therapy or patients on stable maintenance LAMA or LABA therapy. The study will enroll approximately 800 individuals with COPD at approximately 100 study centers throughout the United States, Europe, Russia, and South Korea and will last up to 48 weeks.

Eligible Patients:

This clinical research study is for adults age 40 and older.

Contacts:

A Clinical Trials Contact
Robin Morris | Sr. Director | Verona Pharma
8045 Arco Corporate Drive, Suite 130
Raleigh, NC 27617 
M: (646)565-8944
Email: Robin.Morris@Veronapharma.com

Date Posted:

February 17, 2021

Learn more about this clinical trial


Verona

ENHANCE 2 Trial

Company:

Verona Pharma

Clinical Trial Title:

ENHANCE 2 clinical trial

Clinical Trial Description:

The ENHANCE 2 ( Ensifentrine as a Novel In HAled Nebulized COPD th Erapy) clinical trial is a clinical research study for adults with moderate to severe chronic obstructive pulmonary disease (COPD), including patients on no maintenance/background therapy or patients on stable maintenance LAMA or LABA therapy. The study will enroll approximately 800 individuals with COPD in at approximately 100 study centers throughout the United States and Europe and will last 24 weeks.

Eligible Patients:

This clinical research study is for adults age 40 and older.

Contacts:

Robin Morris | Sr. Director | Verona Pharma
8045 Arco Corporate Drive, Suite 130
Raleigh, NC 27617 
M: (646)565-8944
Email: Robin.Morris@Veronapharma.com

Date Posted:

February 17, 2021

Learn more about this clinical trial


Fibroneer ILD

FIBRONEER - ILD

Company:

Boehringer Ingelheim

Clinical Trial Title:

A Study to Find Out Whether BI 1015550 Improves Lung Function in People with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

Clinical Trial Description:

This study is open to adults with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). People who have a form of PF-ILD other than Idiopathic Pulmonary Fibrosis (IPF) can join the study. If they already take nintedanib, they can continue treatment throughout the study.

The purpose of this study is to find out whether a medicine called BI 1015550 helps people with PF-ILD. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine.

Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.

Eligible Patients:

  • Patients ≥18 years old at the time of signed informed consent.
  • Diagnosis of progressive fibrosing ILD other than IPF (physician confirmed).
  • Patients may be either:
    • On a stable therapy with nintedanib for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization.
    • Not on treatment with nintedanib for at least 8 weeks prior to Visit 1 and during the screening period (e.g. either Antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment.

Contact:

clintriage.rdg@boehringer-ingelheim.com  (1-800-243-0127)

Date Posted:

04/5/2023

Learn more about this clinical trial


Fibroneer IPF

FIBRONEER - IPF

Company:

Boehringer Ingelheim

Clinical Trial Title:

A Study to Find Out Whether BI 1015550 Improves Lung Function in People with Idiopathic Pulmonary Fibrosis (IPF)

Clinical Trial Description:

This study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). People can join the study if they are 40 years or older. If they already take nintedanib or pirfenidone for their IPF, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with IPF.

Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine.

Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.

Eligible Patients:

  • Patients ≥40 years old at the time of signed informed consent.
  • Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
  • Patients may be either:
    • On a stable therapy with nintedanib or pirfenidone for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization.
    • Not on a treatment with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 and during the screening period (e.g. either Antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment.

Contact:

clintriage.rdg@boehringer-ingelheim.com  (1-800-243-0127)

Date Posted:

04/5/2023

Learn more about this clinical trial


Freesia

FREESIA

Company:

Janssen Sciences Ireland Unlimited Company  

Clinical Trial Title:

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Outcomes, Antiviral Activity, Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics/Pharmacodynamics of JNJ-53718678 in Adult and Adolescent Hematopoietic Stem Cell Transplant Recipients with Respiratory Syncytial Virus Infection of the Upper Respiratory Tract

Clinical Trial Description:

The FREESIA study is a clinical research study to evaluate a study medicine in people who have had a stem cell transplant and have since been diagnosed with respiratory syncytial virus (RSV) of the upper airways. The safety and efficacy of using the study drug in RSV treatment for people with stem cell transplants has not yet been established.

The study will enroll approximately 300 individuals at approximately 100 study centers globally.

Eligible Patients:

Adult and adolescent stem cell transplant recipients aged 13 to 75 years of age, with respiratory syncytial virus infection of the upper respiratory tract and having started experiencing RSV symptoms within 4 days of beginning this study (like runny or stuffy nose, sneezing, cough, sore throat, and/or fever).

Date Posted:

01/17/2020

Learn more about this clinical trial


Insignia

INSIGNIA PH-COPD

Company:

Merck Sharp & Dohme LLC

Clinical Trial Title:

A Phase 2a Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease

Clinical Trial Description:

The purpose of this study is to evaluate the safety and efficacy of once daily oral inhalation dose of MK-5475 380µg in participants 40 to 80 years (inclusive) with Pulmonary Hypertension associated with Chronic Obstructive Pulmonary Disease (PH-COPD). The primary hypothesis of the study is MK-5475, a soluble Guanylate Cyclase (sGC) stimulator is superior to placebo in increasing 6 Minute Walking Distance (6MWD) from baseline at Week 24.

Eligible Patients:

This clinical research study is for adults ages 40 - 80.

Contacts:

1-888-577-8839  or Trialsites@merck.com

Date Posted:

September 5, 2023

Learn more about this clinical trial


liberty

LIBERTY ABPA AIRED STUDY

Company:

Regeneron Pharmaceuticals, Inc.

Clinical Trial Title:

LIBERTY-ABPA AIRED study

Clinical Trial Description:

The LIBERTY-ABPA AIRED study is a clinical research study to test whether an investigational medication helps to decrease episodes of severe breathing difficulties. The study will also evaluate the safety and tolerability of the investigational medication. The study will enroll approximately 170 patients with ABPA.

Eligible Patients:  

This clinical research study is for adults and adolescents age 12 years and older.

Contacts:

Clinical Trials Administrator
844- 734-6643
clinicaltrials@regeneron.com

Date Posted:

January 19, 2022

Learn more about this clinical trial


liberty

LIBERTY COPD NOTUS

Company:

Sanofi

Clinical Trial Title:

Liberty Notus: Safety & Efficacy of dupilumab in moderate to severe COPD patients

Clinical Trial Description:

Study EFC15805, also called NOTUS, is a Phase 3 clinical research studies for people aged 40-85 who have moderate to severe chronic obstructive pulmonary disease (COPD) and are currently being treated with standard of care therapy.  The study will evaluate whether the study medication can reduce the rate of moderate to severe acute exacerbations of COPD; improve the way patients feel; improve their level of activity; improve their breathing, which may potentially reduce the need for rescue or reliever medications.

During the study, participants will receive either dupilumab or placebo as an injection once every 2 weeks for a year.  All study-related medical care for their COPD as well as their standard of care COPD medication will be covered by the sponsor, Sanofi, at no cost to the study participant.  Compensation for time and travel may also be available for study participants.

The study is currently enrolling patients at ~150 centers throughout the US and Canada.

Eligible Patients:  

This clinical research study is for adults aged 40-85 with a diagnosis of COPD for at least 1 year prior to enrollment.

Contacts:

Contact-US@sanofi.com

Date Posted:

April 22, 2022

Learn more about this clinical trial


mahale

MACiTEPH

Company:

Janssen Research & Development, LLC

Clinical Trial Title:

67896062CTP3001 (MACiTEPH)

Clinical Trial Description:

MACiTEPH is a clinical research study to evaluate an investigational medication for people with chronic thromboembolic pulmonary hypertension (CTEPH) that is either inoperable or persistent/recurrent after surgery or balloon pulmonary angioplasty (BPA). Doctors want to look at its effect on your ability to exercise over time and compare the results with placebo.

Eligible Patients:  

This clinical research study is for adults age 18 to 80 years old with inoperable CTEPH or persistent/ recurrent CTEPH.

Contacts:

Participate-In-This-Study@its.jnj.com

Date Posted:

October 14, 2022

Learn more about this clinical trial


mahale

MAHALE

Company:

AstraZeneca

Clinical Trial Title:

A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52-Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE).

Clinical Trial Description:

MAHALE is a clinical research study to test the hypothesis that benralizumab, an eosinophil depleting antibody, will reduce exacerbation rates compared with placebo on top of standard-of-care therapy in adult patients with non-cystic fibrosis bronchiectasis with eosinophilic inflammation. The study will enroll approximately 420 patients at approximately 105 study centers in 17 countries. All patients who complete the 52-week double-blind treatment period on investigational product may be eligible to continue into an open-label extension, during which all patients will receive benralizumab.

Eligible Patients:  

This clinical research study is for adults age 18 and older with a diagnosis of non-cystic fibrosis bronchiectasis (NCFB) confirmed by computed tomography and a documented history of ≥ 2 exacerbations within a year of the screening visit. Patients will be excluded if they have pulmonary disease other than bronchiectasis (eg, asthma, chronic obstructive pulmonary disease, cystic fibrosis).

Contacts:

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Date Posted:

Febraury 17, 2022

Learn more about this clinical trial


mandara

MANDARA

Company:

AstraZeneca

Clinical Trial Title:

A Randomized, Double-blind, Active-controlled 52-week Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab compared to Mepolizumab in the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) in patients receiving Standard of Care Therapy (MANDARA).

Clinical Trial Description:

MANDARA is a Phase III study in patients with relapsing or refractory EGPA on corticosteroid therapy with or without stable immunosuppressive therapy. The study will enroll approximately 120 patients globally. All patients who complete the 52-week double-blind treatment period on investigational product may be eligible to continue into an open-label extension, during which all patients will receive benralizumab.

Eligible Patients:  

The clinical research study is for patients age 18 and above who have documented EGPA diagnosis, based on the history or presence of asthma and eosinophilia, plus documentation of at least 2 additional features of EGPA and a history of relapsing or refractory disease.

Contacts:

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Date Posted:

February 17, 2022

Learn more about this clinical trial


MOONBEAM

MOONBEAM

Company:

Merck Sharp & Dohme LLC

Clinical Trial Title:

A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children From 1 to Less Than 18 Years of Age With PAH on Standard of Care

Clinical Trial Description:

The primary objectives of the study are to evaluate the safety and tolerability, and pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to <18 years of age with PAH World Health Organization (WHO) Group 1 on standard of care (SoC). There is no formal hypothesis.

Eligible Patients:  

This clinical research study is for children from 1 to less than 18 years of age.

Contacts:

1-888-577-8839  or Trialsites@merck.com 

Date Posted:

September 5, 2023

Learn more about this clinical trial


sanofiandregeneronlogo

MORPHEO

Company:

Sanofi and Regeneron

Clinical Trial Title:

A Phase 4, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients with Uncontrolled Persistent Asthma

Clinical Trial Description:

Sanofi and Regeneron are studying the effect of dupliumab on sleep in adults ages 18-65 with asthma, who are currently using a medium to high dose inhaled corticosteroid (ICS) and a second controller.

Study duration per participant will be approximately 16 weeks and up to 29 weeks including up to 5 weeks screening period, a 12-week treatment period and up to 12 weeks post-treatment follow-up period or until the participant switches to commercialized dupilumab (or other biologic product), whichever comes first.

The study expects to enroll approximately 260 participants across 59 study sites worldwide.

Eligible Patients:  

Adults, ages 18-65, with asthma

Contacts:

Sanofi Trial Transparency

800-633-1610, option 6

Contact-US@sanofi.com

Date Posted:

July 10, 2023

Learn more about this clinical trial


natron

NATRON

Company:

AstraZeneca

Clinical Trial Title:

A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 24-week Phase 3 Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES) (NATRON).

Clinical Trial Description:

Hypereosinophilic Syndrome (HES) is a devastating and potentially fatal disease that can cause damage to multiple organs and systems. Benralizumab is an afucosylated monoclonal IgG1 antibody that selectively targets IL-5Rα. Treatment with Benralizumab have demonstrated reductions in exacerbations, improvements in lung function and symptoms in severe eosinophilic asthmatics. NATRON clinical research study will evaluate the potential benefit of if Benralizumab in the treatment of HES. The study will enroll approximately 120 eligible patients in 12 countries.

Eligible Patients:  

The target patient population is male and female patients 12 years of age and older with symptomatic active HES.

Contacts:

AstraZeneca Clinical Study Information Center
1-877-240-9479               
information.center@astrazeneca.com

Date Posted:

February 17, 2022

Learn more about this clinical trial


 NIMBLE

Company:

GlaxoSmithKline

Clinical Trial Title:

A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype (NIMBLE)

Clinical Trial Description:

This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining current treatment on the annualized rate of clinically significant exacerbations in participants with severe asthma with an eosinophilic phenotype. Throughout the study, all participants will continue their non-biologic Baseline standard of care (SoC) asthma treatment.

Eligible Patients:  

This clinical research study is for participants 12 Years and older with severe Asthma. For Germany, UK and Norway only adult participants (≥18 years) are to be included in this clinical trial and ≥16 years in Austria.

Contacts:

trial_information_depemokimab@gsk.com

Date Posted:

August 14, 2023

Learn more about this clinical trial


Oberon

OBERON

Company:

AstraZeneca

Clinical Trial Title:

Efficacy and Safety of Tozorakimab (MEDI3506) in Symptomatic Chronic Obstructive Pulmonary Disease with a History of Exacerbations.

Clinical Trial Description:

OBERON is one out of two identical global phase 3 trials to evaluate the efficacy and safety of Tozorakimab (MEDI3506) administered subcutaneously in adult participants with symptomatic COPD with a history of exacerbations of COPD in the previous 12 months. Participants should be receiving optimized treatment with maintenance inhaled triple or dual therapy if triple is not indicated or contraindicated, at a stable dose for at least the last 3 months.

Recruitment is currently ongoing and is planned to continue until June 2024. Approximately 1272 participants will be randomized to receive treatment with Tozorakimab (MEDI3506) or matching placebo for 52 weeks on top of standard of care.

The OBERON study will be conducted at about 275 sites in 20 countries: Argentina, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Finland, Hungary, India, Japan, Mexico, Netherlands, Norway, Portugal, South Korea, Spain, Sweden, Turkey, US and Vietnam.

Eligible Patients:  

This clinical research study is for adults age 40 and older with a diagnosis of COPD for at least one year prior to enrollment.

Contacts:

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Date Posted:

March 1, 2022

Learn more about this clinical trial


Resolute

RESOLUTE

Company:

AstraZeneca

Clinical Trial Title:

A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) with a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE)

Clinical Trial Description:

RESOLUTE is a study to evaluate the efficacy and safety of a benralizumab in patients with moderate to very severe COPD with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils. Eosinophils are a type of blood cell that helps the body to fight infections and is involved in inflammation, immune and allergic reactions.

Eligible Patients:  

Eligible patients must have a history of ≥2 COPD exacerbations that needed the use of oral or intravenous corticosteroids for at least 3 days and/or hospitalizations in the previous year despite receiving stable triple optimized treatment (ICS/LABA/LAMA) for at least 3 months and dual inhaled treatment, where one of the medications must be an inhaled corticosteroid, for the remainder of the year.

Patients who fulfill those criteria will undergo a run-in period with additional tests to confirm eligibility for the study.

Contacts:

AstraZeneca Clinical Study Information Center

Date Posted:

March 1, 2022

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janssen

SALTO STUDY

Company:

Janssen Research & Development, LLC

Clinical Trial Title:

AC-065A310 (SALTO)

Clinical Trial Description:

The purpose of this study is to evaluate whether the addition of an investigational medication to standard of care treatment delays disease progression in children with Pulmonary Arterial Hypertension (PAH) in comparison to placebo.

Eligible Patients:

This clinical research study is for children ages 2 to <18 years old who have pulmonary arterial hypertension (PAH).

Contacts:

Email: Participate-In-This-Study@its.jnj.com

Date Posted:

September 19, 2022

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SUPERNOVA

Company:

AstraZeneca

Clinical Trial Title:

SUPERNOVA clinical research study to protect immunocompromised people from COVID-19

Clinical Trial Description:

SUPERNOVA is a pivotal Phase I/III trial for AZD3152, a next-generation long-acting antibody developed to protect and treat vulnerable patients such as the immunocompromised from COVID-19.

Eligible Patients:

You or someone you care for, may be able to take part if you/they:

  • Are 18 years of age or older and have an impaired immune system
  • Have not tested positive for COVID-19 or received a COVID-19 vaccine in the past three months
  • Weigh at least 40 kg

Contacts:

Date Posted:

August 30th, 2023

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Titania

TITANIA

Company:

AstraZeneca

Clinical Trial Title:

TITANIA

Efficacy and Safety of Tozorakimab (MEDI3506) in Symptomatic Chronic Obstructive Pulmonary Disease with a History of Exacerbations.

Clinical Trial Description:

TITANIA is one out of two identical global phase 3 trials conducted to evaluate the efficacy and safety of Tozorakimab (MEDI3506) administered subcutaneously in adult participants with symptomatic COPD with a history of exacerbations of COPD in the previous 12 months. Participants should be receiving optimized treatment with maintenance inhaled triple or dual therapy if triple is not indicated or contraindicated, at a stable dose for at least the last 3 months.

Recruitment is currently ongoing and is planned to continue until June 2024. Approximately 1272 participants will be randomized to receive treatment with Tozorakimab (MEDI3506) or matching placebo for 52 weeks on top of standard of care.

The TITANIA study will be conducted at about 250 sites in 19 countries: Australia, Brazil, Chile, China, Colombia, France, Germany, Greece, Israel, Italy, Peru, Philippines, Poland, Romania, Russia, Taiwan, Thailand, UK and US.

Eligible Patients:  

This clinical research study is for adults age 40 and older with a diagnosis of COPD for at least one year prior to enrolment.

Contacts:

AstraZeneca Clinical Study Information Center

Date Posted:

March 1, 2022

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tomorrow

TOMORROW

Company:

Janssen Research & Development, LLC

Clinical Trial Title:

AC-055-312 (TOMORROW)

Clinical Trial Description:

This is a study evaluating an investigational medication in comparison to standard of care with regard to delaying disease progression in children with pulmonary arterial hypertension (PAH).

Eligible Patients:

This clinical research study is for children 1 month to 17 years old. Currently, we are prioritizing enrollment of children under 2 years old.

Contacts:

Email: Participate-In-This-Study@its.jnj.com

Date Posted:

July 10, 2023

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Sleepiness

SLEEPINESS

Company:

Janssen Research & Development, LLC

Clinical Trial Title:

AC-055-315 (DROWSINESS)

Clinical Trial Description:

The purpose of this study is to compare the safety and effectiveness of a higher dose of an investigational medication against a lower dose for adults with pulmonary arterial hypertension (PAH).

Eligible Patients:

This clinical research study is for adults age 18 and older.

Contacts:

Email: Participate-In-This-Study@its.jnj.com

Date Posted:

September 19, 2022

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Vestige

VESTIGE

Company:

Sanofi

Clinical Trial Title:

VESTIGE

Clinical Trial Description:

The goal of the phase 4, randomized, double-blind, placebo-controlled VESTIGE study (NCT04400318) is to assess dupilumab's effect on lung function and structural airway changes using functional respiratory
imaging (FRI), a novel technology using high-resolution CT (HRCT) scans to produce 3D visualizations and quantify airway structure and function. This study also assesses key biomarkers of airway inflammation, clinical and patient-reported outcomes (PROs), providing data towards a preliminary understanding of the potential relationships between these parameters.

Eligible Patients:  

VESTIGE will enroll patients aged 18–70 years with uncontrolled, moderate-to-severe asthma, ≥300 blood eosinophils/mL, and FeNO≥ 25 ppb at screening. Study sites will be initiated following approval from institutional review boards per local guidelines; all patients will provide written informed consent. Approximately 153 patients will be randomized (2:1) to receive dupilumab 300 mg or matched placebo every 2 weeks for 24 weeks. All patients will receive standard of care

Contacts:

Contact-US@sanofi.com

Date Posted:

March 25, 2022

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