AZD4604 for Asthma
(ARTEMISIA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment, AZD4604, for individuals with moderate-to-severe asthma. The goal is to determine if AZD4604 can reduce airway inflammation and affect specific cell signals linked to asthma, compared to a placebo (a harmless pill with no active drug). Participants will receive treatment for about four weeks and remain in the study for a total of ten weeks. The trial seeks individuals diagnosed with asthma for at least a year, who have been on certain asthma medications for at least two months, and have experienced severe asthma attacks requiring hospitalization in the past year. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial requires participants to be on a stable dose of certain asthma medications, like medium-to-high dose inhaled corticosteroids and long-acting beta agonists, for at least 2 months before starting. However, you cannot be on systemic corticosteroids or certain other medications like immunosuppressive therapies and some biologics. It's best to discuss your current medications with the trial team to see if they fit the criteria.
Is there any evidence suggesting that AZD4604 is likely to be safe for humans?
Research has shown that AZD4604, an inhaled treatment, is generally well-tolerated. In studies with patients who have mild asthma, AZD4604 was used at certain dose levels without causing major side effects. It quickly reduced FeNO, a marker of inflammation in the airways, which is a positive sign for asthma treatment. The treatment caused few side effects throughout the body, suggesting it mainly targets the lungs.
However, limited safety data exists from studies with healthy volunteers or those with more severe asthma. This trial remains in an early stage, so researchers are primarily assessing the treatment's safety for people. Any common or serious side effects will be closely monitored.12345Why do researchers think this study treatment might be promising for asthma?
AZD4604 is unique because it offers a new approach for treating asthma by targeting specific pathways involved in the inflammatory response. Unlike current standard treatments like inhaled corticosteroids and bronchodilators, AZD4604 may work by modulating the immune system at a molecular level, potentially leading to improved control of asthma symptoms. Researchers are excited about AZD4604 because it could provide a more targeted and effective option for patients who do not respond well to existing therapies.
What evidence suggests that AZD4604 might be an effective treatment for asthma?
Research has shown that AZD4604, an inhaled treatment, may help asthma patients. One study found that AZD4604 reduced a marker of airway inflammation by about 50% compared to a placebo after just three days in patients with mild asthma. This suggests that AZD4604 effectively reduces airway inflammation, a key issue in asthma. The treatment affects specific pathways in the body involved in inflammation. These early results are promising for people with moderate-to-severe asthma.23678
Are You a Good Fit for This Trial?
This trial is for adults with moderate-to-severe asthma who are interested in testing a new treatment. Participants should be available for about 10 weeks and willing to take the study medication or placebo for around 4 weeks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AZD4604 or placebo for 4 weeks to evaluate the effect on airway inflammation and JAK1-associated signalling pathways
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD4604
Trial Overview
The trial is evaluating AZD4604, a potential new asthma medication, against a placebo. The focus is on how well AZD4604 can reduce airway inflammation compared to no active treatment over a period of four weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
AZD4604
Placebo to AZD4604
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Citations
AZD4604, An Inhaled, Selective JAK1 Inhibitor Reduces ...
Approximately 50% reductions in mean FeNO versus placebo were seen for two AZD4604 dose levels in patients with mild asthma after 3 days of dosing that ...
NCT06020014 | Phase 2a Study to Assess the Efficacy and ...
This is a Phase 2a, multicentre, randomised, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy, safety and PK of AZD4604 ...
Phase II Study to Evaluate the Effect of AZD4604 on Airway ...
The purpose of this study is to investigate the effect on airway inflammation and JAK1-associated signalling pathways of AZD4604 compared with placebo in ...
Study Details | NCT04769869 | A Clinical Trial in Healthy ...
A single-blind, randomized, placebo-controlled 3 part study in healthy volunteers and patients with mild asthma to investigate the safety, tolerability, and ...
Phase 2a Study to Assess the Efficacy and Safety of ...
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 ...
6.
openinnovation.astrazeneca.com
openinnovation.astrazeneca.com/home/preclinical-research/preclinical-molecules/azd4604.htmlAZD4604
The first-in-human study in with AZD4604 (xinafoate salt) in healthy volunteers is ongoing. Human safety and tolerability data is therefore not yet available.
A clinical trial in healthy volunteers and patients with mild ...
The safety analysis set included all subjects who received at least one dose of AZD4604 or placebo and for whom any safety post-dose data were available.
8.
atsjournals.org
atsjournals.org/doi/pdf/10.1164/ajrccm-conference.2024.209.1_MeetingAbstracts.A4328?download=trueInhaled AZD4604: Local Janus Kinase 1 Inhibition Without ...
B71 ASTHMA PATHOGENESIS: MORE THAN MEETS THE EYE / Thematic ... and in-house data for AZD4604 using the anticipated therapeutic dose.
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