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AsthmaPhase 2ARTEMISIANCT06435273

Phase II Study to Evaluate the Effect of AZD4604 on Airway Inflammation and Biomarkers in Adults With Asthma

A Phase 2 study testing AZD4604 in people with Asthma, run by AstraZeneca at 18 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate the effect on airway inflammation and JAK1-associated signalling pathways of AZD4604 compared with placebo in participants with moderate-to-severe asthma. Study details include: The study duration for each participant will be approximately 10 weeks. Read more about this study

Who is it for?
Ages 18 to 75 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
36 participants
Where
18 sitesin 5 countries
Study dates
5 Aug 2024to 15 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented physician-diagnosed asthma ≥ 12 months prior to screening (Visit 1).
  • Participants treated with medium-to-high dose ICS in combination with LABA at a stable dose for at least 2 months prior to Visit 1 (the ICS can be contained within an ICS-LABA fixed dose combination product or as separate inhaled products regularly taken together). Treatment with additional asthma controller therapies (eg, long-acting muscarinic antagonist, leukotriene receptor antagonist) at a stable dose ≥ 2 months prior to Visit 1 is allowed. Treatment with maintenance systemic corticosteroids (oral or injectable) is not allowed.
  • A documented history of ≥ 1 severe asthma exacerbation within 1 year prior to Visit 1 or ACQ-6 ≥ 1.5 at Visit 1. A severe asthma exacerbation is defined as a worsening of asthma that leads to an inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥ 24 hours) due to asthma.
  • Morning pre-BD FEV1 ≥ 60% predicted at Visit 1.
  • Able to perform acceptable lung function testing for FEV1 according to American Thoracic Society/ European Respiratory Society (ATS/ERS) 2019 acceptability criteria.
  • Able and willing to undertake bronchoscopy. There should be no absolute contra-indications to bronchoscopy as outlined in the bronchoscopy manual.
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  • Documented evidence of asthma in the 5 years up to or including Visit 1.
  • Able and willing to comply with the requirements of the protocol including ability to read, write, be fluent in the translated language of all participant-facing questionnaires used at the study site, and use electronic devices, eg, electronic patient reported outcomes (ePRO) device and spirometer.
  • Body weight ≥ 40 kg and body mass index < 35 kg/m2.
  • All females must have a negative serum pregnancy test result at Visit 1.
  • Females not of childbearing potential are defined as females who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal.
  • All FOCBP who are sexually active with a non-sterilised male partner must agree to use one highly effective method of birth control.
  • Highly effective birth control methods include:
  • Non-hormonalTotal sexual abstinence provided it is the usual lifestyle of the participant (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments)
  • A vasectomised partner (with confirmed absence of sperm in semen)
  • Bilateral tubal occlusion (caveat: failure rate >1%)
  • Intrauterine device (copper)Hormonal
  • Levonorgestrel intrauterine system
  • Medroxyprogesterone injections
  • Combined oral or transdermal contraceptives (ethinyl estradiol plus progestin) o Intravaginal device (eg, EE and etonogestrel)
  • The following are not acceptable methods of contraception:
  • Periodic abstinence (calendar, symptothermal, post-ovulation methods)
  • Withdrawal (coitus interruptus)
  • Spermicides only
  • Lactational amenorrhoea
  • Female condom and male condom should not be used together

Who cannot join

  • A severe asthma exacerbation within 8 weeks prior to Visit 1.
  • History of herpes zoster reactivation (shingles).
  • Clinically important pulmonary disease other than asthma, eg, active lung infection, chronic obstructive pulmonary disease (COPD), bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, history or planned lung lobectomy, alpha-1 anti-trypsin deficiency, primary ciliary dyskinesia, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, and hyper-eosinophilic syndrome.
  • 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.
  • Any clinically significant cardiac or cerebrovascular disease.
  • History of venous thromboembolism.
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  • 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 hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). Positivity for hepatitis B virus (HBV) surface antigen is a reason for exclusion.
  • Current or prior history of alcohol or drug abuse (including marijuana), as judged by the investigator. Positive drug screening result that cannot be justified by participant's medical history and its relevant treatment (over-the-counter product or a valid prescription), or history of or current 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 (short-term or maintenance) use within 8 weeks (oral) or 12 weeks (intramuscular) before Visit 1.
  • Any immunosuppressive therapy (including hydroxychloroquine, methotrexate, cyclosporine, and tacrolimus) within 12 weeks prior to Visit 1.
  • Treatment with marketed biologics including benralizumab, mepolizumab, reslizumab, omalizumab, dupilumab, and tezepelumab within 6 months or 5 half-lives of Visit 1, whichever is longer.
  • Inhaled corticosteroid plus fast-acting β2 agonist as a rescue medication (eg, Symbicort, Fostair, or Airsupra Maintenance and Reliever Treatment) is not allowed 30 days prior to Visit 1, during screening, run-in and baseline periods, throughout the treatment period, and preferably until 1 week after the last administration of the IMP.
  • Live, attenuated, or mRNA vaccines within 4 weeks of Visit 1.
  • Immunoglobulin therapy 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.
  • Anticoagulants (including vitamin K antagonists and Factor Xa inhibitors). Antiplatelet agents are allowable if in the opinion of the investigator they can be safely withheld for 7 days prior to the procedure.
  • Any history of bronchial thermoplasty
  • 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 include, but not limited to: Alanine aminotransferase/transaminase (ALT) or aspartate aminotransferase/transaminase AST ≥ 1.5 × upper limit of normal (ULN), Total bilirubin (TBL) ≥ ULN (unless due to known Gilbert's disease), Evidence of chronic liver disease, International Normalised Ratio (INR) > 1.5, Platelet count < 150,000 per microliter, Abnormal vital signs, after 5 minutes of supine or sitting rest (confirmed by 1 controlled measurement), defined as any of the following: Systolic blood pressure (BP) < 80 mmHg or ≥ 150 mmHg, Diastolic BP < 50 mmHg or ≥ 95 mmHg, Pulse < 50 bpm or > 100 bpm, Signs of pulmonary oedema or volume overload, Any clinically significant rhythm, conduction, or morphology abnormalities in the ECG including but not limited to QT interval corrected using Fridericia's formula (QTcF) > 450 ms.
  • For female participants only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
  • 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, first-degree family history of primary lung cancer.
  • Positive urine cotinine test at Visit 1 and at any timepoint throughout the study.
  • 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

18 sites in 5 countries.

18 sites in 5 countries

United Kingdom8 sites

  • Research Site

    Birmingham, B9 5SS

  • Research Site

    Glasgow, G12 0YN

  • Research Site

    Headington, OX3 9DU

  • Research Site

    Leicester, LE3 9QP

  • Research Site

    Liverpool, L7 8YE

  • Research Site

    London, W12 0HS

  • Research Site

    Manchester, M23 9QZ

  • Research Site

    Southampton, SO9 4XY

Other trials in United Kingdom

Canada4 sites

  • Research Site

    Calgary, Alberta, T2N 4Z6

  • Research Site

    Montreal, Quebec, H4A 3J1

  • Research Site

    Québec, Quebec, G1V 4G5

  • Research Site

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Spain3 sites

  • Research Site

    Barcelona, 8025

  • Research Site

    Palma de Mallorca, 07010

  • Research Site

    Santander, 39008

Other trials in Spain

Germany2 sites

  • Research Site

    Frankfurt, 60596

  • Research Site

    Großhansdorf, 22927

Other trials in Germany

Denmark1 site

  • Research Site

    København NV, 2400

Other trials in Denmark

About this study

Official title: A Randomised, Double-blind, Parallel Group, Placebo Controlled, 4-Week, Phase II Study to Evaluate the Effect of AZD4604 on Airway Inflammation and Biomarkers in Adults With Asthma

The purpose of this study is to investigate the effect on airway inflammation and JAK1-associated signalling pathways of AZD4604 compared with placebo in participants with moderate-to-severe asthma.

Study details include:

  • The study duration for each participant will be approximately 10 weeks.
  • The duration of IMP administration will be approximately 4 weeks.
Read the detailed description

This is a multicentre, randomised, placebo-controlled, double-blind study to investigate the effect on airway inflammation and JAK1-associated signalling pathways of AZD4604, administered over a 4-week treatment period to adult patients with moderate-to-severe asthma. The study will recruit patients receiving treatment with medium-to-high dose inhaled corticosteroid-long-acting beta-agonist (ICS-LABA) at screening and having a history of at least one severe asthma exacerbation within the year prior to Visit 1 or have an Asthma control questionnaire-6 (ACQ-6) score ≥ 1.5 at Visit 1. Enrolled participants will be randomised into the study to either AZD4604 or placebo. Participants discontinuing the study before the completion of Visit 6a (including the second bronchoscopy) will be replaced. Participants will be randomised using an interactive response technology/randomisation and trial supply management system at a ratio of 2:1 to AZD4604 or placebo, respectively. Randomisation will be stratified based on fractional exhaled nitric oxide (FeNO) levels to ensure a similar proportion of participants with FeNO above and below 25 parts per billion (ppb) in the 2 treatment arms. The study will be conducted at approximately 28 sites in approximately 6 countries.

Conditions
Asthma
Being tested
AZD4604, Placebo to AZD4604
Keywords
Asthma, Mechanistic Study, Bronchoscopy
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD4604Drug

    Also called Londamocitinib

    Janus kinase 1 (JAK1) inhibitor

  • Placebo to AZD4604Drug

    Placebo to AZD4604

Study groups in NCT06435273
Study groupRoleWhat they receive
AZD4604ExperimentalAZD4604
Receives: Drug: AZD4604
Placebo to AZD4604Placebo comparatorPlacebo to AZD4604
Receives: Drug: Placebo to AZD4604

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline to end of investigational medicinal product (IMP) administration in expression of T2 and non-T2, and JAK1-related genes and gene signatures in bronchial brushings

    Gene expression in airway epithelial cells

    Measured: 4 weeks

Secondary outcomes (2)

  1. Change from baseline to end of IMP administration in STAT phosphorylation in bronchial biopsies

    To evaluate the effect of AZD4604 as compared to placebo on STAT phosphorylation in the airways

    Measured: 4 weeks

  2. Change in number of airway cells, including but not limited to inflammatory cells, airway smooth muscle cells, and goblet cells from baseline to end of IMP administration in bronchial biopsies (cells per mm² determined by microscopic evaluation)

    To explore the effect of AZD4604 on cellular pathology in the airways as compared to placebo

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2024
  2. Study start5 Aug 2024
  3. Primary completion15 Oct 2025
  4. Study completion15 Oct 2025

Resources

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
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06435273
Sponsor's protocol ID
D8210C00005
Other IDs
2023-510291-32-00, 2023
Acronym
ARTEMISIA
Status last verified
Oct 2025
First submitted
24 May 2024
Last updated
23 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Dosanjh DPS, Darrah E, Jensen TJ, Jevnikar Z, Halvorson A, Cardner M, Hughes R, Grant SS, Platt A, Brightling CE. ARTEMISIA: a mechanistic study of a novel Janus kinase 1 inhibitor to advance molecular understanding and precision medicine in asthma. Respir Res. 2025 Jul 2;26(1):233. doi: 10.1186/s12931-025-03309-3.

    PubMed 40604958

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD4604 in people with Asthma, run by AstraZeneca at 18 sites in 5 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 26 inclusion and 26 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 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United Kingdom, Canada, Spain, Germany, Denmark. 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?

Change from baseline to end of investigational medicinal product (IMP) administration in expression of T2 and non-T2, and JAK1-related genes and gene signatures in bronchial brushings (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06435273, which also lists 1 linked publication.

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 23 Oct 2025.

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