NCT06529419

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 537 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	AZD8630	The drug will be administered by inhalation
DRUG	Placebo	The placebo will be administered by inhalation
DEVICE	Inhaler	The drug/placebo will be administered by inhalation using the inhaler

Timeline

• Start date: 2024-08-30
• Primary completion: 2026-02-04
• Completion: 2026-02-04
• First posted: 2024-07-31
• Last updated: 2026-03-02

Locations

196 sites across 23 countries: United States, Argentina, Belgium, Chile, China, Czechia, Denmark, France, Germany, Hong Kong, Israel, Italy, Japan, Mexico, Netherlands, Slovakia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study
• FDA-regulated device study