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

NCT06020014 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: D8210C00003
• Study Type: interventional
• Target: 339
• Locations: 18 countries
• Sites: 124

Brief 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.

Conditions

Asthma

Keywords

asthma, Janus kinase inhibitor

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (11)

• Pre-BD FEV1

  12 weeks

• CAAT

  12 weeks

• ACQ-6

  12 weeks

• Average morning and average evening PEF

  12 weeks

• Daily asthma symptom score (total, daytime, and night-time)

  12 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

AZD4604

Drug: AZD4604

Arm 2

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

AZD4604 DRUG

AZD4604

Arm 1

Placebo OTHER

Placebo

Arm 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• \. 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.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (124)

Research Site

Birmingham, Alabama, 35209, United States

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Chandler, Arizona, 85224, United States

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Newport Beach, California, 92663, United States

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Sacramento, California, 95817, United States

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Lakeland, Florida, 33813, United States

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Miami, Florida, 33126, United States

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Atlanta, Georgia, 30344, United States

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Hammond, Indiana, 46324, United States

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New Bedford, Massachusetts, 02740, United States

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Ann Arbor, Michigan, 48109, United States

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Southfield, Michigan, 48075, United States

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Saint Charles, Missouri, 63301, United States

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Las Vegas, Nevada, 89106, United States

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Union City, New Jersey, 07087, United States

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Charlotte, North Carolina, 28207, United States

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New Bern, North Carolina, 28562, United States

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Salisbury, North Carolina, 28144, United States

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Winston-Salem, North Carolina, 27104, United States

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Columbus, Ohio, 43207, United States

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Boerne, Texas, 78006, United States

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El Paso, Texas, 79902, United States

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Houston, Texas, 77074, United States

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Buenos Aires, C1012AAR, Argentina

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Buenos Aires, C1425BEN, Argentina

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Ciudad de Buenos Aires, 1425, Argentina

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Ciudad de Buenos Aires, C1414AIF, Argentina

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Florida, B1602DQD, Argentina

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La Plata, B1900AVG, Argentina

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Ranelagh, 1886, Argentina

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Barretos, 14784-400, Brazil

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Blumenau, 89030-101, Brazil

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Campinas, 13060-080, Brazil

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Campinas, 13060-904, Brazil

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Porto Alegre, 90035074, Brazil

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Porto Alegre, 90160-093, Brazil

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São Bernardo do Campo, 09715090, Brazil

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São Bernardo do Campo, 09750-420, Brazil

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São José do Rio Preto, 15090-000, Brazil

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Pazardzhik, 4400, Bulgaria

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Aalborg, 9000, Denmark

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Aarhus, 8200, Denmark

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Hvidovre, 2650, Denmark

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København NV, 2400, Denmark

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København Ø, 2100, Denmark

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Vejle, 7100, Denmark

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Lyon, 69317, France

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Strasbourg, 67091, France

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Berlin, 10367, Germany

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Berlin, 12159, Germany

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Berlin, 12203, Germany

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Berlin, 13187, Germany

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Cottbus, 03050, Germany

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Frankfurt am Main, 60596, Germany

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Koblenz, 56068, Germany

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Mainz, 55128, Germany

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Peine, 31224, Germany

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Ajmer, 305001, India

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Belagavi, 590010, India

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Coimbatore, 641028, India

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Hyderabad, 500068, India

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Kolkata, 700014, India

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Kozhikode, 673008, India

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New Delhi, 110029, India

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Kajang, 43000, Malaysia

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Kota Bharu, 15586, Malaysia

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Kuala Lumpur, 59100, Malaysia

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Kuantan, 25100, Malaysia

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Malacca, 75400, Malaysia

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Sarawak Miri, 98000, Malaysia

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Sungai Buloh, 47000, Malaysia

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Dagupan, 2400, Philippines

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Davao City, PH-8000, Philippines

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Mabalacat, 2023, Philippines

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Manadaluyong City, 1552, Philippines

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Quezon City, 0870, Philippines

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Roxas City, 5800, Philippines

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Cape Town, 7764, South Africa

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Durban, 4001, South Africa

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Durban, 4091, South Africa

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eMkhomazi, 4170, South Africa

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Newton, 2113, South Africa

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Observatory, 7925, South Africa

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Daegu, 42415, South Korea

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Gyeonggi-do, 13620, South Korea

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Incheon, 21565, South Korea

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Seoul, 03722, South Korea

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Seoul, 04763, South Korea

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Barcelona, 8035, Spain

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Madrid, 28041, Spain

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Majadahonda, 28222, Spain

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Palma de Mallorca, 07010, Spain

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Linköping, 587 58, Sweden

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Lund, 22185, Sweden

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Örebro, 70185, Sweden

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Kaohsiung City, 80756, Taiwan

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Taichung, 40705, Taiwan

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Taipei, 100, Taiwan

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Taipei, 10449, Taiwan

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Taipei, 110, Taiwan

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Taipei, 112, Taiwan

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Taipei, 11696, Taiwan

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Taoyuan, 330, Taiwan

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Yunlin, 640, Taiwan

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Bangkok, 10400, Thailand

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Chiang Mai, 50200, Thailand

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Hat Yai, 90110, Thailand

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Khlong Luang, 12120, Thailand

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Khon Kaen, 40002, Thailand

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Birmingham, B9 5SS, United Kingdom

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Bradford, BD9 6RJ, United Kingdom

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Chesterfield, S40 4AA, United Kingdom

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Leeds, LS9 7TF, United Kingdom

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Liverpool, L7 8YE, United Kingdom

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London, W6 7HY, United Kingdom

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Penzance, TR18 3DX, United Kingdom

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Thetford, IP24 1JD, United Kingdom

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Wellingborough, NN8 4RW, United Kingdom

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Da Nang, 55000, Vietnam

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Hanoi, 100000, Vietnam

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Hà Nội, 100000, Vietnam

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Ho Chi Minh City, 700000, Vietnam

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Hochiminh, 70000, Vietnam

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Hồ Chí Minh, 700000, Vietnam

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Huế, 530000, Vietnam

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MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 31, 2023
• Study Start: November 16, 2023
• Primary Completion: October 28, 2025
• Study Completion: October 28, 2025
• Last Updated: November 13, 2025

Record last verified: 2025-11

Locations

IN (7); TH (5); DK (6); TW (9); FR (2); ES (4); AR (7); ZA (6); US (22); PH (6); BU (1); KR (5); SE (3); GB (9); MY (7); BR (9); DE (9); VN (7)