AZD4604 for Asthma

(AJAX Trial)

Recruiting at129 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: AstraZeneca

Must be taking: ICS, LABA

Must not be taking: Systemic corticosteroids, Biologics

Disqualifiers: Severe asthma exacerbation, COVID-19, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a new asthma medication called AZD4604, which is inhaled regularly using a dry-powder inhaler. It targets adults whose moderate-to-severe asthma is not well-controlled by current treatments. The medication likely works by opening up the airways and reducing inflammation, making it easier to breathe.

Will I have to stop taking my current medications?

The trial requires participants to continue their current asthma medications, specifically medium-high dose inhaled corticosteroids (ICS) with long-acting beta-agonists (LABA), at a stable dose for at least 28 days before starting the trial. However, certain medications like systemic corticosteroids and some biologics must be stopped before the trial.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I am a woman and my pregnancy test before starting the treatment was negative.

Your ACQ-6 score is 1.5 or higher.

Your lung function falls between 40% and 90% of what is expected for someone your age and size.

Exclusion Criteria

Participant treated with any investigational drug within 4 months or 5 half-lives, whichever is longer, prior to Visit 1

I do not have any major heart or brain blood vessel problems.

I have TB that is either untreated or not fully treated.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AZD4604 or placebo twice daily using a dry-powder inhaler over a 12-week period

12 weeks

Regular visits for assessment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AZD4604 (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Arm 1 Experimental Treatment 1 Intervention

AZD4604

Group II: Arm 2 Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

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