Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06196879
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2023-12-24
Brief Title:
A Study to Investigate the Efficacy and Safety of Verekitug UPB-101 in Adult Participants With Severe Asthma VALIANT
Sponsor:
Upstream Bio Inc
Organization:
Upstream Bio Inc
Study Overview
Official Title:
A Phase 2 Randomized Double-blind Placebo-controlled Multi-center Dose-ranging Study to Evaluate the Efficacy and Safety of Verekitug UPB-101 in Adult Participants With Severe Asthma VALIANT
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The purpose of this study is to evaluate the efficacy and safety of verekitug UPB-101 in participants with severe asthma The study will evaluate the incidence of asthma exacerbations other pharmacodynamic PD parameters such as lung function and asthma control and the safety and tolerability of verekitug UPB-101 compared to placebo
Detailed Description:
This is a multicenter randomized placebo-controlled parallel group study to assess the efficacy and safety of verekitug UPB-101 administered subcutaneously SC A total of approximately 436 adult participants with severe asthma are planned for enrolment and will be randomized in a 1111 ratio to receive verekitug UPB-101 at doses of 100 mg every 12 weeks Q12W 400 mg every 24 weeks Q24W and 100 mg every 24 weeks Q24W or placebo administered SC In order to maintain the blinding of different doses all participants will receive 2 SC injections at each dosing visit This study consists of a ScreeningRun-In Period approximately 4 weeks Treatment Period up to 60 weeks with a minimum of 24 weeks and Follow-up Period ending approximately 16 weeks after the last administration of study intervention
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 |
|---|---|---|---|
| 2023-507410-27-00 | OTHER | EUCT | None |