Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456593
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-16
Brief Title:
Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohns Disease
Sponsor:
Abivax SA
Organization:
Abivax SA
Study Overview
Official Title:
A Phase 2b Multicenter Double-blind Placebo-controlled Study to Evaluate the Efficacy Safety Pharmacokinetics and Pharmacodynamics of Obefazimod in Subjects With Moderately to Severely Active Crohns Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
ENHANCE-CD
Brief Summary:
This study has 3 treatment phases a 12-Week Induction Phase a 40-Week Maintenance Phase and a 48-Week Extension Phase
The objective is to evaluate the efficacy and safety of obefazimod compared to placebo as induction and maintenance therapy in subjects with moderately to severely active CD after inadequate response no response loss of response or intolerance to conventional therapies andor advanced therapies
The primary objective for the 48-Week Extension Phase is to evaluate the safety and tolerability of obefazimod compared with placebo in subjects who are enrolled in the Extension Phase
The objective is to evaluate the efficacy and safety of obefazimod compared to placebo as induction and maintenance therapy in subjects with moderately to severely active CD after inadequate response no response loss of response or intolerance to conventional therapies andor advanced therapies
The primary objective for the 48-Week Extension Phase is to evaluate the safety and tolerability of obefazimod compared with placebo in subjects who are enrolled in the Extension Phase
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?:
None