Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-29 @ 1:25 PM
Study NCT ID:
NCT07120503
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma
Sponsor:
Windward Bio
Organization:
Study Overview
Official Title:
A Phase 2 Randomized, Double-blind Placebo-Controlled Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety and Efficacy of WIN378 in Adult Participants With Moderate or Severe Asthma
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is trying to identify the right dose of a long-acting medicine called WIN378 for people with moderate or severe asthma. WIN378 blocks the action of a protein called TSLP which causes inflammation in the lung and may contribute to your asthma control and symptoms. The study will test how doses of WIN378 are handled by your body (pharmacokinetics) and assess the safety of the medicine and will assess markers of asthma inflammation in your breath and in your blood, lung function and asthma control (pharmacodynamics).
Detailed Description:
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, efficacy and pharmacokinetics of WIN378 in adult participants with moderate to severe asthma. Participants will continue their standard background asthma therapy according to GINA Steps 3-5. Eligible participants will be randomized to receive WIN378 or placebo administered subcutaneously over a 48-week treatment period, followed by a 12-week safety follow-up.
Study Oversight
Has Oversight DMC:
False
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?: