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Monoclonal Antibodies

AZD4604 for Asthma (AJAX Trial)

Phase 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For female participants, a negative urine pregnancy test prior to administration of IMP
Treated with medium-high dose ICS in combination with LABA at a stable dose for at least 3 months prior to Visit 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

AJAX Trial Summary

This trial tests a new asthma drug to see if it works, is safe, & how it affects the body.

Who is the study for?
Adults aged 18-80 with moderate-to-severe asthma uncontrolled by current meds, who've had a severe asthma attack in the last year. They must have used their inhaler correctly during a run-in period and meet lung function criteria. Smokers or those with certain health conditions like recent serious infections or cancer are excluded.Check my eligibility
What is being tested?
The trial is testing AZD4604, an experimental drug for asthma delivered via inhaler twice daily against a placebo over 12 weeks. It's double-blind, meaning neither participants nor researchers know who gets the real drug versus placebo to ensure unbiased results.See study design
What are the potential side effects?
While specific side effects of AZD4604 aren't listed here, common side effects for new asthma treatments can include throat irritation, headache, respiratory infections, and possible allergic reactions.

AJAX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman and my pregnancy test before starting the treatment was negative.
Select...
I have been on a stable dose of medium-high ICS and LABA for at least 3 months.
Select...
My lung function test shows I'm between 40% and 90% of the expected value.
Select...
I have been diagnosed with asthma in the last 10 years.
Select...
I am between 18 and 80 years old.
Select...
I weigh at least 40 kg and my BMI is less than 35.

AJAX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to first CompEx Asthma event
Secondary outcome measures
ACQ-6
Average morning and average evening PEF
CAAT
+5 more

AJAX Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 1Experimental Treatment1 Intervention
AZD4604
Group II: Arm 2Placebo Group1 Intervention
Placebo

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,271 Previous Clinical Trials
288,612,280 Total Patients Enrolled
328 Trials studying Asthma
638,820 Patients Enrolled for Asthma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the eligibility for this trial restricted to only individuals under twenty years of age?

"This trial is extending its inclusion criteria to patients above the age of consent that are not older than 80."

Answered by AI

Has Arm 1 of this study received approval from the Food and Drug Administration?

"There is some data supporting safety but none for efficacy, so the assessment of Arm 1's security on a scale from 1 to 3 was 2."

Answered by AI

Are there available vacancies for participants in this experiment?

"Clinicaltrials.gov informs us that this study, which was first announced on November 3rd 2023 and last updated August 25th 2023, is not presently accepting applications from interested patients. Nevertheless, 330 other trials are currently recruiting candidates across the globe."

Answered by AI

How many locations are hosting this experiment?

"Currently, this study is taking place at 22 sites around the United States. Sites in New Bern, Houston and Alberdi are amongst these locations - with other nearby cities also available to minimize travel needs for participants."

Answered by AI

Do I meet the qualifications to participate in this research study?

"To be eligible for this asthma research, participants must be between 18-80 years of age. This trial is expected to accept 320 individuals in total."

Answered by AI

Who else is applying?

What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
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
2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06020014.
All > Pediatric Asthma > Asthma
~213 spots leftby Sep 2025
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