Ignite Creation Date:
2024-07-17 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496607
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
A Study to Evaluate Solriktug in Adult Participants With Asthma
Sponsor:
Uniquity One UNI
Organization:
Uniquity One UNI
Study Overview
Official Title:
A Phase 2a Randomized Double-blind Placebo-controlled Multiple Dose-Ranging Study to Assess the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Solrikitug in Adult Participants With Asthma RAINIER
Status:
RECRUITING
Status Verified Date:
2024-07
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:
RAINIER
Brief Summary:
Phase 2 study to evaluate the safety tolerability PK immunogenicity and pharmacodynamics of solriktug with adult participants with asthma
Detailed Description:
This is a 12-week randomized double-blind placebo-controlled Phase 2a clinical study to evaluate the safety tolerability PK immunogenicity and pharmacodynamics of 3 dose levels of solrikitug versus placebo on top of standard of care in adult participants with asthma
Approximately 84 adult participants with asthma will be randomized at approximately 20 sites Participants will receive solrikitug or placebo administered via subcutaneous injection at the study site over a 12-week treatment period The study also includes a post-treatment follow-up period of 16 weeks
Approximately 84 adult participants with asthma will be randomized at approximately 20 sites Participants will receive solrikitug or placebo administered via subcutaneous injection at the study site over a 12-week treatment period The study also includes a post-treatment follow-up period of 16 weeks
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