Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-30 @ 6:24 PM
Study NCT ID:
NCT03870334
Status:
TERMINATED
Last Update Posted:
2023-12-04
First Post:
2019-03-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
Sponsor:
NImmune Biopharma
Organization:
Study Overview
Official Title:
A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Decision of Landos Biopharma (not related to safety or efficacy)
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study.
Detailed Description:
None
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?: