Inflammatory Pulmonary Diseases

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  • ARO-RAGE

    Phase 2

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Inflammatory Pulmonary Diseases

What are Inflammatory Pulmonary Diseases?

Inflammatory pulmonary diseases are a group of conditions that cause inflammation in the lungs, such as chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, and asthma, or inflammation induced by viral infections such as influenza and coronavirus.

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  • Asthma is caused by chronic inflammation of the lungs that leads to coughing, wheezing, shortness of breath, chest tightness, or coughing.
  • COPD is a progressive lung disease characterized by limited airflow and chronic inflammation. Smoking is a risk factor for COPD.
  • The causes of inflammatory pulmonary diseases vary depending on the diseases, but common causes include infections, allergies, smoking, air pollution, and genetics.

34MM

People in the U.S. live with some form of chronic lung disease.

3rd

Leading cause of death worldwide is COPD

$170B

Is the annual cost of lung diseases in the U.S.

Our Research

ARO-RAGE

Inflammatory Pulmonary DiseasesLungPhase 2

ARO-RAGE is designed to reduce production of the Receptor for Advanced Glycation End products (RAGE) as a potential treatment for various muco-obstructive and inflammatory pulmonary diseases.

Clinical Trials

ActiveID: NCT07241546

The purpose of this study is to evaluate the impact of inhaled ARO-RAGE on the late asthmatic response (LAR) following an inhaled allergen challenge in participants with mild atopic asthma.

CompleteID: NCT05276570

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ARO-RAGE in normal healthy volunteers (NHVs) and in participants with inflammatory lung disease. In Part 1 of the study, NHVs will receive a single dose of ARO-RAGE or placebo. In Part 2 of the study, adult participants with inflammatory lung disease will receive 2 doses of ARO-RAGE or placebo. Additional NHVs may be randomized to receive 1 or 2 doses of ARO-RAGE or placebo at Sponsor discretion. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.

CompleteID: NCT05533294

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-RAGE Injection in normal healthy volunteers.

Study of Inhaled ARO-RAGE in Allergen-induced Mild Asthma

Inflammatory Pulmonary Diseases Active ID: NCT07241546

The purpose of this study is to evaluate the impact of inhaled ARO-RAGE on the late asthmatic response (LAR) following an inhaled allergen challenge in participants with mild atopic asthma.

View on ClinicalTrials.gov

Inclusion Criteria

  • Clinically stable, mild atopic asthma (FEV1 ≥70% predicted)
  • Established allergy confirmed by positive skin prick test at screening
  • Willing and able to perform lung function tests and other study-related procedures
  • Participants of childbearing potential must consent to use a method of highly-effective contraception in addition to a condom during the study and for at least 90 days following the end of study or last investigational product administration, whichever is later

Timeline

  • November 21, 2025

    Study First Posted

  • December 2025

    Study Start Date

  • April 2028

    Estimated Completion Date

Trial Details

Start date:

December 2025

End date:

April 2028

Participants:

36

Eligibility criteria:

18 to 65 Years Old, All Sexes, No Healthy Volunteers

A Phase 1/2a Study Evaluating the Effects of ARO-RAGE in Healthy Subjects and Patients With Inflammatory Lung Disease

Inflammatory Pulmonary Diseases Complete ID: NCT05276570

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ARO-RAGE in normal healthy volunteers (NHVs) and in participants with inflammatory lung disease. In Part 1 of the study, NHVs will receive a single dose of ARO-RAGE or placebo. In Part 2 of the study, adult participants with inflammatory lung disease will receive 2 doses of ARO-RAGE or placebo. Additional NHVs may be randomized to receive 1 or 2 doses of ARO-RAGE or placebo at Sponsor discretion. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.

View on ClinicalTrials.gov

Inclusion Criteria

  • Normal pulmonary function tests at Screening (NHVs only)
  • Confirmed diagnosis of asthma based on source verifiable medical record (asthma patients only)
  • No abnormal finding of clinical relevance at Screening (other than asthma for asthma patients)
  • Stable dose of asthma controller medications for at least 4 weeks prior to Screening (asthma patients only)
  • Non-smoking
  • Able to produce an induced sputum sample at Screening
  • Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception. Males must not donate sperm during the study and for at least 12 weeks following the last dose of study drug
  • Willing to provide written informed consent and to comply with study requirements

Timeline

  • March 2022

    Study First Posted

  • June 2022

    Study Start Date

  • February 2024

    Estimated Study Completion Date

Trial Details

Start date:

June 2022

End date:

February 2024

Locations:

Australia, New Zealand

Participants:

121

Eligibility criteria:

18 Years to 65 Years, All Sexes, Accepts Healthy Volunteers

A Phase 1 Study Evaluating the Effects of ARO-RAGE Injection for Subcutaneous Administration in Healthy Subjects

AsthmaInflammatory Pulmonary Diseases Complete ID: NCT05533294

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-RAGE Injection in normal healthy volunteers.

View on ClinicalTrials.gov

Inclusion Criteria

  • Normal pulmonary function tests at Screening prior to sputum induction
  • Normal 12-lead electrocardiogram (ECG) at Screening
  • Non-smoking
  • Able to produce an induced sputum sample at Screening
  • Participants of child-bearing potential (male and female) must use highly effective contraception and cannot donate sperm or eggs during the study or for at least 12 weeks following the end of the study or last dose of study drug, whichever is later. Women must have a negative pregnancy test and cannot be breastfeeding
  • Willing to provide written informed consent and to comply with study requirements

Timeline

  • September 2022

    Study First Posted

  • November 2022

    Study Start Date

  • February 8, 2024

    Estimated Study Completion Date

Trial Details

Start date:

November 2022

End date:

February 8, 2024

Locations:

New Zealand

Participants:

50

Eligibility criteria:

18 Years to 55 Years (Adult), All Sexes, Accepts Healthy Volunteers

Active Clinical Trials

Complete

Inflammatory Pulmonary DiseasesID: NCT05276570

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ARO-RAGE in normal healthy volunteers (NHVs) and in participants with inflammatory lung disease. In Part 1 of the study, NHVs will receive a single dose of ARO-RAGE or placebo. In Part 2 of the study, adult participants with inflammatory lung disease will receive 2 doses of ARO-RAGE or placebo. Additional NHVs may be randomized to receive 1 or 2 doses of ARO-RAGE or placebo at Sponsor discretion. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.

A Phase 1/2a Study Evaluating the Effects of ARO-RAGE in Healthy Subjects and Patients With Inflammatory Lung Disease

Inflammatory Pulmonary Diseases Complete ID: NCT05276570

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ARO-RAGE in normal healthy volunteers (NHVs) and in participants with inflammatory lung disease. In Part 1 of the study, NHVs will receive a single dose of ARO-RAGE or placebo. In Part 2 of the study, adult participants with inflammatory lung disease will receive 2 doses of ARO-RAGE or placebo. Additional NHVs may be randomized to receive 1 or 2 doses of ARO-RAGE or placebo at Sponsor discretion. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.

View on ClinicalTrials.gov

Inclusion Criteria

  • Normal pulmonary function tests at Screening (NHVs only)
  • Confirmed diagnosis of asthma based on source verifiable medical record (asthma patients only)
  • No abnormal finding of clinical relevance at Screening (other than asthma for asthma patients)
  • Stable dose of asthma controller medications for at least 4 weeks prior to Screening (asthma patients only)
  • Non-smoking
  • Able to produce an induced sputum sample at Screening
  • Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception. Males must not donate sperm during the study and for at least 12 weeks following the last dose of study drug
  • Willing to provide written informed consent and to comply with study requirements

Timeline

  • March 2022

    Study First Posted

  • June 2022

    Study Start Date

  • February 2024

    Estimated Study Completion Date

Trial Details

Start date:

June 2022

End date:

February 2024

Locations:

Australia, New Zealand

Participants:

121

Eligibility criteria:

18 Years to 65 Years, All Sexes, Accepts Healthy Volunteers
Complete

AsthmaInflammatory Pulmonary DiseasesID: NCT05533294

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-RAGE Injection in normal healthy volunteers.

A Phase 1 Study Evaluating the Effects of ARO-RAGE Injection for Subcutaneous Administration in Healthy Subjects

AsthmaInflammatory Pulmonary Diseases Complete ID: NCT05533294

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-RAGE Injection in normal healthy volunteers.

View on ClinicalTrials.gov

Inclusion Criteria

  • Normal pulmonary function tests at Screening prior to sputum induction
  • Normal 12-lead electrocardiogram (ECG) at Screening
  • Non-smoking
  • Able to produce an induced sputum sample at Screening
  • Participants of child-bearing potential (male and female) must use highly effective contraception and cannot donate sperm or eggs during the study or for at least 12 weeks following the end of the study or last dose of study drug, whichever is later. Women must have a negative pregnancy test and cannot be breastfeeding
  • Willing to provide written informed consent and to comply with study requirements

Timeline

  • September 2022

    Study First Posted

  • November 2022

    Study Start Date

  • February 8, 2024

    Estimated Study Completion Date

Trial Details

Start date:

November 2022

End date:

February 8, 2024

Locations:

New Zealand

Participants:

50

Eligibility criteria:

18 Years to 55 Years (Adult), All Sexes, Accepts Healthy Volunteers
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