AZD1402 for Asthma

(APATURA Trial)

No longer recruiting at 60 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, Monoclonal antibodies

Disqualifiers: Pregnancy, Pulmonary disease, COVID-19, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an inhaled medication, AZD1402, to determine its effectiveness for adults with asthma who continue to experience symptoms despite using medium-to-high dose inhaled corticosteroids. These corticosteroids reduce inflammation and swelling in the lungs. The study will first assess the treatment's safety before evaluating its effectiveness in improving asthma control. It seeks participants who have had asthma for at least a year and are using inhaled corticosteroids along with long-acting medications to aid breathing. This trial may suit those who still face asthma issues despite their current treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires participants to continue their current asthma medications, specifically medium-to-high dose inhaled corticosteroids (ICS) with long-acting beta agonists (LABA), at a stable dose before and during the study. If you are taking additional asthma medications, they must also be stable before and during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatment AZD1402, also known as Elarekibep, has been generally safe in earlier studies. In past tests with healthy individuals, the drug was well tolerated, causing few side effects. Some studies found that AZD1402 was safe when administered both as an inhaled treatment and through an IV (intravenous) drip. The drug blocks certain proteins that can cause inflammation, which is crucial for people with asthma.

While the drug has shown promise, it remains under investigation in a Phase 2 trial. This phase helps researchers learn more about its safety for people with asthma. Since AZD1402 is not yet approved for any condition, the ongoing trial will provide more information about its safety for those with asthma. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Researchers are excited about AZD1402 for asthma treatment because it offers a potentially innovative approach by delivering medication directly to the lungs through a dry powder inhaler (DPI). Unlike traditional treatments like inhaled corticosteroids, which can take time to show effects, AZD1402 might work faster due to its targeted delivery method. Moreover, AZD1402 is being tested in multiple doses, which could offer more personalized treatment options for individuals with varying levels of asthma severity. This direct and possibly rapid action has the potential to improve asthma control for those not fully managed by current therapies.

What evidence suggests that this trial's treatments could be effective for asthma?

Research has shown that AZD1402, an inhaled treatment under study in this trial, could benefit people with asthma. In earlier studies, AZD1402 quickly reduced FENO levels, indicators of airway inflammation, more effectively than a placebo. This suggests AZD1402 might help decrease lung inflammation in asthma patients. Additionally, research indicates that AZD1402 may reduce T2-driven inflammation, a common issue in asthma, suggesting its potential effectiveness. These findings support AZD1402 as a promising option for those whose asthma is not fully managed by current medications. Participants in this trial will receive different doses of AZD1402 or a placebo to further evaluate its effectiveness. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

Participants who are able to perform acceptable pulmonary function testing for FEV1.

Participants who are able to demonstrate the ability to use the study inhalation device properly.

Participants who have a documented clinical diagnosis of asthma for ≥ 12 months before Visit 1.

Exclusion Criteria

Any clinically important ECG abnormalities.

You have had three or more severe asthma attacks in the past.

High risk of infection suggesting abnormal immune function.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Run-in

Participants undergo a run-in period to stabilize their condition before treatment

4 weeks

Treatment

Participants receive inhaled AZD1402 or placebo for efficacy and safety assessment

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AZD1402
• ICS-LABA combination
• Placebo
• Short acting beta agonist (SABA)

How Is the Trial Designed?

Group I: Part 1: AZD1402 Dose 3 Experimental Treatment 3 Interventions

Randomised participants will receive oral inhalation of AZD1402 Dose 3 via DPI.

Group II: Part 1 and Part 2: AZD1402 Dose 2 Experimental Treatment 3 Interventions

Randomised participants will receive oral inhalation of AZD1402 Dose 2 via DPI.

Group III: Part 1 and Part 2: AZD1402 Dose 1 Experimental Treatment 3 Interventions

Randomised participants will receive oral inhalation of AZD1402 Dose 1 via DPI.

Group IV: Part 1 and Part 2: Placebo Placebo Group 3 Interventions

Randomised participants will receive oral inhalation of matching placebo via DPI.

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04643158

NCT04643158 | Efficacy and Safety of Inhaled AZD1402 ... The efficacy of inhaled AZD1402 compared to placebo in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was investigated. Baseline and Week 4.

2. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D2912C00003

Efficacy and Safety of Inhaled AZD1402 Administered for ... This is a randomised, placebo-controlled, double-blinded, multi-centre, 2-part study to assess the efficacy and safety of inhaled AZD1402.

3. jacionline.org jacionline.org/article/S0091-6749(22)02588-X/fulltext

Elarekibep (PRS-060/AZD1402), a new class of inhaled ... Efficacy of dupilumab on clinical outcomes in patients with asthma and perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2020; 125:565 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S009167492202588X

Elarekibep (PRS-060/AZD1402), a new class of inhaled ... Our data suggest that mucosal exposure alone may be capable of suppressing T2-driven inflammation in vivo and supports the potential utility of PRS-060 as an ...

5. researchgate.net researchgate.net/publication/337581178_Late_Breaking_Abstract_-_Multiple_ascending_dose_study_of_the_inhaled_IL-4Ra_antagonist_AZD1402PRS-060_in_mild_asthmatics_demonstrates_robust_FeNO_reduction_and_a_promising_clinical_profile_for_the_tr

Multiple ascending dose study of the inhaled IL-4Ra ... After a single administration, AZD1402 induced a rapid decrease in the FENO level, with a significant (p < 0.05) percentage reduction vs. PCB between 24.0% (95% ...

6. atsjournals.org atsjournals.org/doi/pdf/10.1164/ajrccm-conference.2019.199.1_MeetingAbstracts.A7476?download=true

First-in-Human Data for the Inhaled IL-4Ra Antagonist, ... Conclusion The novel IL-4Rα antagonist, AZD1402/PRS-060, was safe and well tolerated when given as single inhaled or IV doses to healthy ...

7. medchemexpress.com medchemexpress.com/elarekibep.html?srsltid=AfmBOooeEfBujT6vGAegNQ4kwtGTJQOpHc17radMgbGHr9Eywgae5Xkd

Elarekibep (PRS-060) | IL-4Ra Antagonist Elarekibep (PRS-060) (AZD1402) is a high affinity, slowly dissociating, long-acting full antagonist of IL-4Ra. Elarekibep can be used for the research of T2 ...