Study identifier:D6830C00003
ClinicalTrials.gov identifier:NCT06529419
EudraCT identifier:N/A
CTIS identifier:2024-514228-18-00
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)
asthma
Phase 2
No
AZD8630, Placebo
All
516
Interventional
18 Years - 80 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 May 2025 by AstraZeneca
AstraZeneca
-
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).
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
Location
Status
Location
Berlin, Germany, 10119
Status
Recruiting
Location
Frankfurt, Germany, 60596
Status
Recruiting
Location
Landsberg, Germany, 86899
Status
Recruiting
Location
Marburg, Germany, 35037
Status
Recruiting
Location
Bonn, Germany, 53127
Status
Recruiting
Location
Ahrensburg, Germany, 22926
Status
Suspended
Location
Leipzig, Germany, 04207
Status
Recruiting
Location
Mainz, Germany, 55128
Status
Recruiting
Arms | Assigned Interventions |
---|---|
Experimental: AZD8630 dose A Inhaled AZD8630 administered at a dose A | Drug: AZD8630 The drug will be administered by inhalation Device: Inhaler The drug/placebo will be administered by inhalation using the inhaler |
Experimental: AZD8630 dose B Inhaled AZD8630 administered at a dose B | Drug: AZD8630 The drug will be administered by inhalation Device: Inhaler The drug/placebo will be administered by inhalation using the inhaler |
Experimental: AZD8630 dose C Inhaled AZD8630 administered at a dose C | Drug: AZD8630 The drug will be administered by inhalation Device: Inhaler The drug/placebo will be administered by inhalation using the inhaler |
Placebo Comparator: Placebo Inhaled placebo | Drug: Placebo The placebo will be administered by inhalation Device: Inhaler The drug/placebo will be administered by inhalation using the inhaler |
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