AsthmaPhase 2AJAXNCT06020014
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
A Phase 2 study testing AZD4604 in people with Asthma, run by AstraZeneca at 124 sites in 18 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- AZD4604
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 339 participants
- Where
- 124 sitesin 18 countries
- Study dates
- 16 Nov 2023to 28 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 years of age inclusive, at the time of signing the informed consent.
- Treated with medium-high dose ICS in combination with LABA at a stable dose for at least 28 days prior to Visit 1.
- Note: EU participants must be treated with high dose ICS in combination with LABA at a stable dose for at least 28 days prior to V1.
- Documented history of ≥ 1 severe asthma exacerbation within 1 year prior to Visit 1.
- Morning pre-BD FEV1 ≥ 40% predicted at Visit 1 and Visit 3.
- Able to perform acceptable lung function testing for FEV1 according to ATS/ERS 2019 acceptability criteria.
Show all 16Show fewer
- 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).
- An ACQ-6 score ≥ 1.5 at Visit 1 and at Visit 3.
- 9. Body weight of ≥ 40 kg and body mass index of < 35 kg/m2. 10. Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. There are no restrictions on male participants or their female partners
- At the end of the Run-in period (Visit 3), participants must fulfil the following additional criteria in order to be randomised into the study and enter the Treatment period:
- Pre-BD FEV1 ≥ 40%.
- 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.
- An ACQ-6 score of ≥ 1.5.
- 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.
- Minimum 80% compliance with daily eCOAs (electronic Clinical Outcome Assessments) during the 14 days preceding Visit 3.
- For female of child bearing potential participants, a negative urine pregnancy test prior to administration of IMP.
Who cannot join
- A severe asthma exacerbation within 8 weeks prior to randomisation.
- History of herpes zoster reactivation.
- Participants with a significant COVID-19 illness within 6 months of enrolment.
- Clinically important pulmonary disease other than asthma.
- 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,
Show all 34Show fewer
- influence the findings of the study or the interpretation, or
- impede the participant's ability to complete the entire duration of study.
- Any clinically significant cardiac or cerebrovascular disease.
- History of venous thromboembolism.
- 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.
- 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.
- Current or prior history of alcohol or drug abuse (including marijuana and marijuana containing valid prescriptions), as judged by the investigator.
- History of malignancy other than superficial basal cell carcinoma.
- Treatment with systemic corticosteroid within 4 weeks (oral) or 8 weeks (intramuscular) before Visit 1.
- Any immunosuppressive therapy within 12 weeks prior to Visit 1.
- Treatment with marketed biologics within 6 months of Visit 1 or 5 half-lives, whichever is longer.
- 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.
- Live, attenuated, or mRNA vaccines within 4 weeks of Visit 1.
- Immunoglobulin or blood products within 4 weeks of Visit 1.
- 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.
- Concurrent enrolment in another interventional clinical study
- Participant treated with any investigational drug within 4 months or 5 half-lives, whichever is longer, prior to Visit 1.
- Participants with a known hypersensitivity to AZD4604 or any of the excipients of the product.
- Abnormal findings identified on physical examination, ECG, or laboratory testing.
- For female participants only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
- Current smokers or participants with smoking history ≥ 10 pack-years.
- Participants with a known long-term exposure to occupational asbestos, silica, radon, heavy metals, and polycyclic aromatic hydrocarbons.
- Positive family history of primary lung cancer in first degree relatives (mother, father, sisters, brothers and children).
- Positive urine cotinine test or exhaled carbon monoxide test at Visit 1 and at any timepoint throughout the study.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- 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.
- Donation of blood (≥ 450 mL) within 3 months or donation of plasma within 14 days before Visit 1.
- 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.
Trial locations and contacts
124 sites in 18 countries.
124 sites in 18 countries
United States22 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Atlanta, Georgia, 30344
Research Site
Birmingham, Alabama, 35209
Research Site
Boerne, Texas, 78006
Research Site
Chandler, Arizona, 85224
Research Site
Charlotte, North Carolina, 28207
Research Site
Columbus, Ohio, 43207
Research Site
El Paso, Texas, 79902
Research Site
Hammond, Indiana, 46324
Research Site
Houston, Texas, 77074
Research Site
Lakeland, Florida, 33813
Research Site
Las Vegas, Nevada, 89106
Research Site
Miami, Florida, 33126
Research Site
New Bedford, Massachusetts, 02740
Research Site
New Bern, North Carolina, 28562
Research Site
Newport Beach, California, 92663
Research Site
Sacramento, California, 95817
Research Site
Saint Charles, Missouri, 63301
Research Site
Salisbury, North Carolina, 28144
Research Site
Southfield, Michigan, 48075
Research Site
Union City, New Jersey, 07087
Research Site
Winston-Salem, North Carolina, 27104
Brazil9 sites
Research Site
Barretos, 14784-400
Research Site
Blumenau, 89030-101
Research Site
Campinas, 13060-080
Research Site
Campinas, 13060-904
Research Site
Porto Alegre, 90035074
Research Site
Porto Alegre, 90160-093
Research Site
São Bernardo do Campo, 09715090
Research Site
São Bernardo do Campo, 09750-420
Research Site
São José do Rio Preto, 15090-000
Germany9 sites
Research Site
Berlin, 10367
Research Site
Berlin, 12159
Research Site
Berlin, 12203
Research Site
Berlin, 13187
Research Site
Cottbus, 03050
Research Site
Frankfurt am Main, 60596
Research Site
Koblenz, 56068
Research Site
Mainz, 55128
Research Site
Peine, 31224
Taiwan9 sites
Research Site
Kaohsiung City, 80756
Research Site
Taichung, 40705
Research Site
Taipei, 100
Research Site
Taipei, 10449
Research Site
Taipei, 110
Research Site
Taipei, 112
Research Site
Taipei, 11696
Research Site
Taoyuan City, 330
Research Site
Yunlin, 640
United Kingdom9 sites
Research Site
Birmingham, B9 5SS
Research Site
Bradford, BD9 6RJ
Research Site
Chesterfield, S40 4AA
Research Site
Leeds, LS9 7TF
Research Site
Liverpool, L7 8YE
Research Site
London, W6 7HY
Research Site
Penzance, TR18 3DX
Research Site
Thetford, IP24 1JD
Research Site
Wellingborough, NN8 4RW
Argentina7 sites
Research Site
Buenos Aires, C1012AAR
Research Site
Buenos Aires, C1425BEN
Research Site
Ciudad de Buenos Aires, 1425
Research Site
Ciudad de Buenos Aires, C1414AIF
Research Site
Florida, B1602DQD
Research Site
La Plata, B1900AVG
Research Site
Ranelagh, 1886
India7 sites
Research Site
Ajmer, 305001
Research Site
Belagavi, 590010
Research Site
Coimbatore, 641028
Research Site
Hyderabad, 500068
Research Site
Kolkata, 700014
Research Site
Kozhikode, 673008
Research Site
New Delhi, 110029
Malaysia7 sites
Research Site
Kajang, 43000
Research Site
Kota Bharu, 15586
Research Site
Kuala Lumpur, 59100
Research Site
Kuantan, 25100
Research Site
Malacca, 75400
Research Site
Sarawak Miri, 98000
Research Site
Sungai Buloh, 47000
Vietnam7 sites
Research Site
Da Nang, 55000
Research Site
Hà Nội, 100000
Research Site
Hanoi, 100000
Research Site
Hồ Chí Minh, 700000
Research Site
Ho Chi Minh City, 700000
Research Site
Hochiminh, 70000
Research Site
Huế, 530000
Denmark6 sites
Research Site
Aalborg, 9000
Research Site
Aarhus, 8200
Research Site
Hvidovre, 2650
Research Site
København NV, 2400
Research Site
København Ø, 2100
Research Site
Vejle, 7100
Philippines6 sites
Research Site
Dagupan, 2400
Research Site
Davao City, PH-8000
Research Site
Mabalacat, 2023
Research Site
Manadaluyong City, 1552
Research Site
Quezon City, 0870
Research Site
Roxas City, 5800
South Africa6 sites
Research Site
Cape Town, 7764
Research Site
Durban, 4001
Research Site
Durban, 4091
Research Site
eMkhomazi, 4170
Research Site
Newton, 2113
Research Site
Observatory, 7925
South Korea5 sites
Research Site
Daegu, 42415
Research Site
Gyeonggi-do, 13620
Research Site
Incheon, 21565
Research Site
Seoul, 03722
Research Site
Seoul, 04763
Thailand5 sites
Research Site
Bangkok, 10400
Research Site
Chiang Mai, 50200
Research Site
Hat Yai, 90110
Research Site
Khlong Luang, 12120
Research Site
Khon Kaen, 40002
Spain4 sites
Research Site
Barcelona, 8035
Research Site
Madrid, 28041
Research Site
Majadahonda, 28222
Research Site
Palma de Mallorca, 07010
Sweden3 sites
Research Site
Linköping, 587 58
Research Site
Lund, 22185
Research Site
Örebro, 70185
About this study
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
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.
- Conditions
- Asthma
- Being tested
- AZD4604, Placebo
- Keywords
- asthma, Janus kinase inhibitor
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4604Drug
AZD4604
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | AZD4604 Receives: Drug: AZD4604 |
| Arm 2 | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first CompEx Asthma event
CompEx Asthma is a composite surrogate endpoint for exacerbations that captures: - acute worsening events based on a combination of events based on ePRO data (asthma symptoms and rescue medication use), PEF data, and severe asthma exacerbation events.
Measured: 12 weeks
Secondary outcomes (11)
Pre-BD FEV1
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second.
Measured: 12 weeks
CAAT
Change from baseline in the Chronic Airways Assessment Test (CAAT). The CAAT is an 8-item patient-reported outcome measure developed to measure health status in patients with asthma and COPD.
Measured: 12 weeks
ACQ-6
Change from baseline in the Asthma Control Questionnaire 6 (ACQ-6). The ACQ-6 has 6 questions (regarding asthma symptoms and rescue bronchodilator use). Answering the questions results in a score out of 6. A Score of 0 indicates complete control and 6 reflects severely uncontrolled disease.
Measured: 12 weeks
Average morning and average evening PEF
Change from baseline in 2-weekly average morning and evening Peak Expiratory Flow (PEF).
Measured: 12 weeks
Daily asthma symptom score (total, daytime, and night-time)
Change from baseline in 2-weekly average Daily asthma symptom score. Asthma symptoms are assessed (0 to 3 scale) twice daily, once in the morning and once in the evening.
Measured: 12 weeks
Time to first CompEx acute worsening event
Time to first CompEx Asthma acute worsening event.
Measured: 12 weeks
CompEx event rate
The number of CompEx Asthma events recorded in the 12-week period.
Measured: 12 weeks
CompEx acute worsening event rate
The number of CompEx Asthma acute worsening events recorded in the 12-week period.
Measured: 12 weeks
FeNO
Change from baseline in FeNO at Week 4 and Week 12.
Measured: 12 weeks
Cough
Change from baseline in cough severity at Week 4 and Week 12. This will be measured by Cough Severity Item Visual Analogue Scale, a 100-point linear scale marked with a horizontal or vertical line by the participant between the 2 extremes. Zero represents no cough while 100 represents worst cough imaginable.
Measured: 12 weeks
PK
AZD4604 plasma concentration pre- and post-dose at Week 4, pre-dose at Week 12.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start16 Nov 2023
- Primary completion28 Oct 2025
- Study completion28 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020014
- Sponsor's protocol ID
- D8210C00003
- Acronym
- AJAX
- Status last verified
- Nov 2025
- First submitted
- 25 Aug 2023
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06020014
- Acronym / sponsor ID
- AJAX / D8210C00003
- Conditions
- Asthma
- Keywords
- asthma, Janus kinase inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 28 Oct 2025 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: AZD4604AZD4604 |
| Arm 2 | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 18 to 80 years of age inclusive, at the time of signing the informed consent.
- Treated with medium-high dose ICS in combination with LABA at a stable dose for at least 28 days prior to Visit 1.
- Note: EU participants must be treated with high dose ICS in combination with LABA at a stable dose for at least 28 days prior to V1.
- Documented history of ≥ 1 severe asthma exacerbation within 1 year prior to Visit 1.
- Morning pre-BD FEV1 ≥ 40% predicted at Visit 1 and Visit 3.
Key exclusion criteria (34 listed)
- A severe asthma exacerbation within 8 weeks prior to randomisation.
- History of herpes zoster reactivation.
- Participants with a significant COVID-19 illness within 6 months of enrolment.
- Clinically important pulmonary disease other than asthma.
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD4604AZD4604 | Drug | Arm 1 |
| PlaceboPlacebo | Other | Arm 2 |
Primary outcome
Time to first CompEx Asthma event
Time frame: 12 weeks
CompEx Asthma is a composite surrogate endpoint for exacerbations that captures: - acute worsening events based on a combination of events based on ePRO data (asthma symptoms and rescue medication use), PEF data, and severe asthma exacerbation events.
11 secondary outcomes
Pre-BD FEV1
Time frame: 12 weeks
CAAT
Time frame: 12 weeks
ACQ-6
Time frame: 12 weeks
Average morning and average evening PEF
Time frame: 12 weeks
Daily asthma symptom score (total, daytime, and night-time)
Time frame: 12 weeks
Time to first CompEx acute worsening event
Time frame: 12 weeks
CompEx event rate
Time frame: 12 weeks
CompEx acute worsening event rate
Time frame: 12 weeks
FeNO
Time frame: 12 weeks
Cough
Time frame: 12 weeks
PK
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
124 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD4604 in people with Asthma, run by AstraZeneca at 124 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 124 sites in United States, Brazil, Germany, Taiwan, United Kingdom and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first CompEx Asthma event (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.