Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435273
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-24
Brief Title:
A Randomised Double-blind Parallel Group Placebo Controlled 4-Week Phase II Study to Evaluate the Effect of AZD4604 on Airway Inflammation and Biomarkers in Adults With Asthma
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Randomised Double-blind Parallel Group Placebo Controlled 4-Week Phase II Study to Evaluate the Effect of AZD4604 on Airway Inflammation and Biomarkers in Adults With Asthma
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARTEMISIA
Brief Summary:
The purpose of this study is to investigate the effect on airway inflammation and JAK1-associated signalling pathways of AZD4604 compared with placebo in participants with moderate-to-severe asthma
Study details include
The study duration for each participant will be approximately 10 weeks
The duration of IMP administration will be approximately 4 weeks
Study details include
The study duration for each participant will be approximately 10 weeks
The duration of IMP administration will be approximately 4 weeks
Detailed Description:
This is a multicentre randomised placebo-controlled double-blind study to investigate the effect on airway inflammation and JAK1-associated signalling pathways of AZD4604 administered over a 4-week treatment period to adult patients with moderate-to-severe asthma The study will recruit patients receiving treatment with medium-to-high dose inhaled corticosteroid-long-acting beta-agonist ICS-LABA at screening and having a history of at least one severe asthma exacerbation within the year prior to Visit 1 or have an Asthma control questionnaire-6 ACQ-6 score 15 at Visit 1 Enrolled participants will be randomised into the study to either AZD4604 or placebo Participants discontinuing the study before the completion of Visit 6a including the second bronchoscopy will be replaced Participants will be randomised using an interactive response technologyrandomisation and trial supply management system at a ratio of 21 to AZD4604 or placebo respectively Randomisation will be stratified based on fractional exhaled nitric oxide FeNO levels to ensure a similar proportion of participants with FeNO above and below 25 parts per billion ppb in the 2 treatment arms The study will be conducted at approximately 28 sites in approximately 5 countries
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-510291-32-00 | OTHER | EMA | None |