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JAK Inhibitor

AZD4604 for Asthma (ARTEMISIA 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

Body weight ≥ 40 kg and body mass index < 35 kg/m2

Able and willing to undertake bronchoscopy

Must not have

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)

History of malignancy other than superficial basal cell carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

Summary

"This trial aims to see how a new medication, AZD4604, affects airway inflammation and specific signaling pathways in people with moderate-to-severe asthma, compared to a placebo. Participants will be

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, common ones associated with asthma treatments may include throat irritation, headache, coughing, and possible reactions at the site of administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am willing and able to undergo a bronchoscopy procedure.

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I am a woman who cannot become pregnant due to surgery or menopause.

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I have a negative pregnancy test result.

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I've had a severe asthma attack in the last year or my asthma control score is poor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had recent hepatitis, unexplained jaundice, or been treated for hepatitis B, C, or HIV.

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

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I haven't taken any immunosuppressive drugs in the last 12 weeks.

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I haven't had immunotherapy in the last 6 months.

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I currently smoke or have smoked a lot in the past.

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A close family member had lung cancer.

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

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I have a significant lung condition that is not asthma.

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I have had blood clots in my veins before.

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I haven't used inhaled steroids or quick-relief inhalers recently.

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I am currently pregnant or breastfeeding.

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I haven't had major surgery in the last 8 weeks and don't plan any soon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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

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

Secondary outcome measures

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

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)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AZD4604Experimental Treatment1 Intervention

AZD4604

Group II: Placebo to AZD4604Placebo Group1 Intervention

Placebo to AZD4604

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,352 Previous Clinical Trials

288,646,761 Total Patients Enrolled

344 Trials studying Asthma

659,918 Patients Enrolled for Asthma

~32 spots leftby Aug 2026

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