COMPLETED

Phase 2a Study to Assess the Efficacy and Safety of AZD4604 in Adult Patients With Moderate-to-Severe Asthma Uncontrolled on Medium-High Dose ICS-LABA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 2a, multicentre, randomised, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy, safety and PK of AZD4604 administered BID using a dry-powder inhaler at one dose level over a 12-week Treatment period in adult participants with uncontrolled moderate-to-severe asthma.

Official Title

A Phase 2a Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AZD4604 Twice Daily for Twelve Weeks in Adult Patients With Moderate-to-Severe Asthma Uncontrolled on Medium-High Dose ICS-LABA

Quick Facts

Study Start:2023-11-16

Study Completion:2025-10-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06020014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 18 to 80 years of age inclusive, at the time of signing the informed consent. 2. Treated with medium-high dose ICS in combination with LABA at a stable dose for at least 28 days prior to Visit 1. 3. Documented history of ≥ 1 severe asthma exacerbation within 1 year prior to Visit 1. 4. Morning pre-BD FEV1 ≥ 40% predicted at Visit 1 and Visit 3. 5. Able to perform acceptable lung function testing for FEV1 according to ATS/ERS 2019 acceptability criteria. 6. Documented evidence of asthma in the 10 years up to or including Visit 1. A clinical diagnosis of asthma must be documented at least 12 months prior to Screening (Visit 1). 7. An ACQ-6 score ≥ 1.5 at Visit 1 and at Visit 3. 1. Pre-BD FEV1 ≥ 40%. 2. A pre-BD/pre-IMP dose FEV1 at Visit 3 that has not increased or decreased by 20% or more from the pre-BD FEV1 recorded at Visit 1 and at Visit 2. 3. An ACQ-6 score of ≥ 1.5. 4. At least 80% compliance with usual asthma background medication during Run-in period (from Visit 2 to Visit 3) based on the daily asthma ePROs. 5. Minimum 80% compliance with daily eCOAs (electronic Clinical Outcome Assessments) during the 14 days preceding Visit 3. 6. For female of child bearing potential participants, a negative urine pregnancy test prior to administration of IMP.	1. A severe asthma exacerbation within 8 weeks prior to randomisation. 2. History of herpes zoster reactivation. 3. Participants with a significant COVID-19 illness within 6 months of enrolment. 4. Clinically important pulmonary disease other than asthma. 5. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could: * affect the safety of the participant throughout the study, * influence the findings of the study or the interpretation, or * impede the participant's ability to complete the entire duration of study. 6. Any clinically significant cardiac or cerebrovascular disease. 7. History of venous thromboembolism. 8. Participants who, as judged by the investigator, have evidence of active TB, or latent TB without completion of an appropriate course of treatment or appropriate ongoing prophylactic treatment. 9. Participants with a recent history of, or who have a positive test for, infective hepatitis or unexplained jaundice, or participants who have been treated for HIV. 10. Current or prior history of alcohol or drug abuse (including marijuana and marijuana containing valid prescriptions), as judged by the investigator. 11. History of malignancy other than superficial basal cell carcinoma. 12. Treatment with systemic corticosteroid within 4 weeks (oral) or 8 weeks (intramuscular) before Visit 1. 13. Any immunosuppressive therapy within 12 weeks prior to Visit 1. 14. Treatment with marketed biologics within 6 months of Visit 1 or 5 half-lives, whichever is longer. 15. Inhaled corticosteroid plus fast-acting β2 agonist as a reliever is not allowed 15 days prior to Visit 1, during Screening/Run-in and throughout the Treatment period and preferably 1 week after the last dose of IMP. 16. Live, attenuated, or mRNA vaccines within 4 weeks of Visit 1. 17. Immunoglobulin or blood products within 4 weeks of Visit 1. 18. Any immunotherapy within 6 months of Visit 1, except for stable maintenance dose allergen-specific immunotherapy started at least 4 weeks prior to Visit 1 and expected to continue through to the end of the Follow-up period. 19. Concurrent enrolment in another interventional clinical study 20. Participant treated with any investigational drug within 4 months or 5 half-lives, whichever is longer, prior to Visit 1. 21. Participants with a known hypersensitivity to AZD4604 or any of the excipients of the product. 22. Abnormal findings identified on physical examination, ECG, or laboratory testing. 23. For female participants only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding. 24. Current smokers or participants with smoking history ≥ 10 pack-years. 25. Participants with a known long-term exposure to occupational asbestos, silica, radon, heavy metals, and polycyclic aromatic hydrocarbons. 26. Positive family history of primary lung cancer in first degree relatives (mother, father, sisters, brothers and children). 27. Positive urine cotinine test or exhaled carbon monoxide test at Visit 1 and at any timepoint throughout the study. 28. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 29. Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements. 30. Donation of blood (≥ 450 mL) within 3 months or donation of plasma within 14 days before Visit 1. 31. Major surgery within 8 weeks prior to Visit 1, or planned inpatient surgery, major dental procedure or hospitalisation during Screening, Treatment, or Follow-up periods.

Inclusion Criteria

Exclusion Criteria

1. 18 to 80 years of age inclusive, at the time of signing the informed consent.
2. Treated with medium-high dose ICS in combination with LABA at a stable dose for at least 28 days prior to Visit 1.
3. Documented history of ≥ 1 severe asthma exacerbation within 1 year prior to Visit 1.
4. Morning pre-BD FEV1 ≥ 40% predicted at Visit 1 and Visit 3.
5. Able to perform acceptable lung function testing for FEV1 according to ATS/ERS 2019 acceptability criteria.
6. Documented evidence of asthma in the 10 years up to or including Visit 1. A clinical diagnosis of asthma must be documented at least 12 months prior to Screening (Visit 1).
7. An ACQ-6 score ≥ 1.5 at Visit 1 and at Visit 3.
1. Pre-BD FEV1 ≥ 40%.
2. A pre-BD/pre-IMP dose FEV1 at Visit 3 that has not increased or decreased by 20% or more from the pre-BD FEV1 recorded at Visit 1 and at Visit 2.
3. An ACQ-6 score of ≥ 1.5.
4. At least 80% compliance with usual asthma background medication during Run-in period (from Visit 2 to Visit 3) based on the daily asthma ePROs.
5. Minimum 80% compliance with daily eCOAs (electronic Clinical Outcome Assessments) during the 14 days preceding Visit 3.
6. For female of child bearing potential participants, a negative urine pregnancy test prior to administration of IMP.

1. A severe asthma exacerbation within 8 weeks prior to randomisation.
2. History of herpes zoster reactivation.
3. Participants with a significant COVID-19 illness within 6 months of enrolment.
4. Clinically important pulmonary disease other than asthma.
5. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
* affect the safety of the participant throughout the study,
* influence the findings of the study or the interpretation, or
* impede the participant's ability to complete the entire duration of study.
6. Any clinically significant cardiac or cerebrovascular disease.
7. History of venous thromboembolism.
8. Participants who, as judged by the investigator, have evidence of active TB, or latent TB without completion of an appropriate course of treatment or appropriate ongoing prophylactic treatment.
9. Participants with a recent history of, or who have a positive test for, infective hepatitis or unexplained jaundice, or participants who have been treated for HIV.
10. Current or prior history of alcohol or drug abuse (including marijuana and marijuana containing valid prescriptions), as judged by the investigator.
11. History of malignancy other than superficial basal cell carcinoma.
12. Treatment with systemic corticosteroid within 4 weeks (oral) or 8 weeks (intramuscular) before Visit 1.
13. Any immunosuppressive therapy within 12 weeks prior to Visit 1.
14. Treatment with marketed biologics within 6 months of Visit 1 or 5 half-lives, whichever is longer.
15. Inhaled corticosteroid plus fast-acting β2 agonist as a reliever is not allowed 15 days prior to Visit 1, during Screening/Run-in and throughout the Treatment period and preferably 1 week after the last dose of IMP.
16. Live, attenuated, or mRNA vaccines within 4 weeks of Visit 1.
17. Immunoglobulin or blood products within 4 weeks of Visit 1.
18. Any immunotherapy within 6 months of Visit 1, except for stable maintenance dose allergen-specific immunotherapy started at least 4 weeks prior to Visit 1 and expected to continue through to the end of the Follow-up period.
19. Concurrent enrolment in another interventional clinical study
20. Participant treated with any investigational drug within 4 months or 5 half-lives, whichever is longer, prior to Visit 1.
21. Participants with a known hypersensitivity to AZD4604 or any of the excipients of the product.
22. Abnormal findings identified on physical examination, ECG, or laboratory testing.
23. For female participants only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
24. Current smokers or participants with smoking history ≥ 10 pack-years.
25. Participants with a known long-term exposure to occupational asbestos, silica, radon, heavy metals, and polycyclic aromatic hydrocarbons.
26. Positive family history of primary lung cancer in first degree relatives (mother, father, sisters, brothers and children).
27. Positive urine cotinine test or exhaled carbon monoxide test at Visit 1 and at any timepoint throughout the study.
28. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
29. Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
30. Donation of blood (≥ 450 mL) within 3 months or donation of plasma within 14 days before Visit 1.
31. Major surgery within 8 weeks prior to Visit 1, or planned inpatient surgery, major dental procedure or hospitalisation during Screening, Treatment, or Follow-up periods.

Contacts and Locations

Study Locations (Sites)

Research Site

Birmingham, Alabama, 35209

United States

Research Site

Chandler, Arizona, 85224

United States

Research Site

Newport Beach, California, 92663

United States

Research Site

Sacramento, California, 95817

United States

Research Site

Lakeland, Florida, 33813

United States

Research Site

Miami, Florida, 33126

United States

Research Site

Atlanta, Georgia, 30344

United States

Research Site

Hammond, Indiana, 46324

United States

Research Site

New Bedford, Massachusetts, 02740

United States

Research Site

Ann Arbor, Michigan, 48109

United States

Research Site

Southfield, Michigan, 48075

United States

Research Site

Saint Charles, Missouri, 63301

United States

Research Site

Las Vegas, Nevada, 89106

United States

Research Site

Union City, New Jersey, 07087

United States

Research Site

Charlotte, North Carolina, 28207

United States

Research Site

New Bern, North Carolina, 28562

United States

Research Site

Salisbury, North Carolina, 28144

United States

Research Site

Winston-Salem, North Carolina, 27104

United States

Research Site

Columbus, Ohio, 43207

United States

Research Site

Boerne, Texas, 78006

United States

Research Site

El Paso, Texas, 79902

United States

Research Site

Houston, Texas, 77074

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-16

Study Completion Date2025-10-28

Study Record Updates

Study Start Date2023-11-16

Study Completion Date2025-10-28

Terms related to this study

Keywords Provided by Researchers

asthma, Janus kinase inhibitor

Additional Relevant MeSH Terms

Asthma