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A Dose Range-Finding Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD8630 in Adults With Uncontrolled Asthma at Risk of Exacerbations | Clinical Trials | Clareo Health

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A Dose Range-Finding Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD8630 in Adults With Uncontrolled Asthma at Risk of Exacerbations

A Phase 2b, Randomised, Double-Blind, Placebo-Controlled Dose Range-Finding Study to Assess Efficacy and Safety of Multiple Dose Levels of Inhaled AZD8630 Given Once Daily for 12 Weeks in Adults With Uncontrolled Asthma at Risk of Exacerbations (LEVANTE)

NCT06529419•AstraZeneca

View on ClinicalTrials.gov

Summary

A dose range-finding study to assess the efficacy and safety of multiple dose levels of AZD8630 administered via a dry powder inhaler in adults with uncontrolled asthma at risk of exacerbations, receiving medium -to -high dose inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA).

Detailed Description

This is a Phase II, randomised, placebo-controlled, double-blind, dose range-finding, multi-centre study to assess the efficacy and safety of inhaled AZD8630 administered at 3 doses via an inhaler in adult patients with uncontrolled asthma, at risk of an exacerbation. The study duration up to 57 weeks for participants in the optional safety extension study and up to 17 weeks for those not included. The maximal treatment period is up to 52 weeks. This study will be conducted in approximately 220 centres in 20-25 countries. Approximately 516 patients will be randomised globally

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient must be 18 to 80 years of age inclusive
•2. Documented physician diagnosis of asthma for at least 12 months, with objective evidence of asthma (spirometric, bronchial challenge, exercise challenge or therapeutic response) within the last 5 years
•4\. Uncontrolled asthma (i.e. ACQ-6 ≥ 1.5)
•5\. Pre-BD FEV1 ≥ 40%
•7\. A history of asthma exacerbations within the last 12 months
•8\. \& 9. Compliant with asthma background mediation, daily ePROs and daily home spirometry.
•10\. BMI within the range 18-37 kg/m2 (inclusive)
•11\. Female patients of child bearing potential must not be pregnant and agree to use highly effective contraception.
•12\. Male patients and their female partners of childbearing potential must agree to use highly effective contraception.
•13\. Capable of giving signed informed consent.

Exclusion Criteria

•1. History of life-threatening asthma
•2. Recently completed treatment for respiratory infection and/or asthma exacerbation
•3. Clinically important pulmonary disease other than asthma; including but not limited to those with co-existent chronic obstructive pulmonary disease.
•4. Any disorder that is not stable in the opinion of the Investigator and could:
•1. Affect the safety of the patient throughout the study
•2. Influence the findings of the study or their interpretation
•3. Impede the patient's ability to complete the entire duration of study
•5. Patients who, in the opinion of the Investigator, have evidence of active TB or are currently on treatment for active or latent TB.
•6. Medical history of or treatment for hepatitis B or hepatitis C, except for cured hepatitis C
•7. Patients with history of HIV infection or who test positive for HIV.
+11 more criteria

Locations (196)

Research Site

Mesa, Arizona, United States

Research Site

Huntington Beach, California, United States

Research Site

La Mesa, California, United States

Research Site

Laguna Niguel, California, United States

Research Site

Lancaster, California, United States

Research Site

Long Beach, California, United States

Research Site

San Jose, California, United States

Research Site

New Haven, Connecticut, United States

Research Site

DeBary, Florida, United States

Research Site

Jacksonville, Florida, United States

Key Dates

Start Date

August 30, 2024

Primary Completion Date

February 4, 2026

Completion Date

February 4, 2026

Last Updated

March 2, 2026

Enrollment

537

ACTUAL participants

Conditions

Asthma

Interventions

AZD8630

DRUG

Placebo

DRUG

Inhaler

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Dose Range-Finding Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD8630 in Adults With Uncontrolled Asthma at Risk of Exacerbations

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

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Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

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