AZD4604 for Asthma

(ARTEMISIA Trial)

Recruiting at 24 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AstraZeneca

Must be taking: ICS, LABA

Must not be taking: Systemic corticosteroids, Biologics

Disqualifiers: Severe asthma exacerbation, COPD, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

48 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

Eligibility Criteria

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

I have been diagnosed with asthma for over a year.

I've been on a stable dose of ICS and LABA for my asthma for at least 2 months.

I weigh at least 40 kg and my BMI is under 35.

Exclusion Criteria

Current or prior history of alcohol or drug abuse

I have not taken systemic corticosteroids recently.

I have had cancer before, but it wasn't just a minor skin cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive AZD4604 or placebo for 4 weeks to evaluate the effect on airway inflammation and JAK1-associated signalling pathways

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

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.

Participant Groups

Group I: AZD4604 Experimental Treatment 1 Intervention

AZD4604

Group II: Placebo to AZD4604 Placebo Group 1 Intervention

Placebo to AZD4604

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