Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598462
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
A Study to Investigate the Efficacy and Safety of NSI-8226 in Adults With Eosinophilic Esophagitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Randomized Double-Blind Multicenter Placebo Controlled Study With an Open Label Extension to Investigate the Efficacy and Safety of NSI-8226 in Adults With Eosinophilic Esophagitis ALAMERE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
Phase 2 study to evaluate the safety tolerability PK immunogenicity and pharmacodynamics of solrikitug in adult participants with Eosinophilic Esophagitis
Detailed Description:
This is a 24-week randomized double-blind placebo-controlled Phase 2 clinical study with a 28-week extension 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 EoE
Approximately 157 adult participants with EoE will be randomized at approximately 80 sites Participants will receive solrikitug or placebo administered via subcutaneous injection at the study site over a 24-week treatment period followed by a 28-week extension period The study also includes a post-treatment follow-up period of 16 weeks
Approximately 157 adult participants with EoE will be randomized at approximately 80 sites Participants will receive solrikitug or placebo administered via subcutaneous injection at the study site over a 24-week treatment period followed by a 28-week extension 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?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None