Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2026-01-04 @ 1:59 AM
Study NCT ID:
NCT06925061
Status:
RECRUITING
Last Update Posted:
2025-09-17
First Post:
2025-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Target Engagement of EXL01 in the Prevention of Post-operative Recurrence of Crohn's Disease
Sponsor:
Madeleine Bezault
Organization:
Study Overview
Official Title:
A Phase 2 Multicentre, Randomised, Parallel-arm, Placebo-controlled, Double-blind Study to Evaluate the Safety and Target Engagement of EXL01 in the Prevention of Post-operative Recurrence of Crohn's Disease
Status:
RECRUITING
Status Verified Date:
2025-09
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:
MAINTAIN-POP
Brief Summary:
MAINTAIN-POP is a Phase 2, randomised, double-blind, placebo-controlled, multicenter study of the impact of oral administration of EXL01 in the prevention of post-operative endoscopic recurrence of Crohn's disease after surgery.
Approximately 80 eligible patients will be randomized 1:1 to receive oral EXL01 or placebo with or without SoC treatment (based on investigator decision) for up to 24 weeks or until a study or treatment discontinuation criterion is met. Randomisation will be stratified on post-surgical treatment (none vs anti-TNF), and on smoking status (non-smoker vs smoker).
The primary objective is to compare the distribution of endoscopic modified Rutgeerts scores, as centrally assessed, at 6 months post-surgery in patients with CD treated with EXL01 to patients treated with placebo. Endoscopic recurrence will be assessed using the endoscopic score assessed by central reading at Week 24 after surgery. All participants will be followed for safety until 4 weeks after end of treatment.
Approximately 80 eligible patients will be randomized 1:1 to receive oral EXL01 or placebo with or without SoC treatment (based on investigator decision) for up to 24 weeks or until a study or treatment discontinuation criterion is met. Randomisation will be stratified on post-surgical treatment (none vs anti-TNF), and on smoking status (non-smoker vs smoker).
The primary objective is to compare the distribution of endoscopic modified Rutgeerts scores, as centrally assessed, at 6 months post-surgery in patients with CD treated with EXL01 to patients treated with placebo. Endoscopic recurrence will be assessed using the endoscopic score assessed by central reading at Week 24 after surgery. All participants will be followed for safety until 4 weeks after end of treatment.
Detailed Description:
MAINTAIN-POP is a Phase 2, randomised, double-blind, placebo-controlled, multicenter study of the impact of oral administration of EXL01 in the prevention of post-operative endoscopic recurrence of Crohn's disease after surgery.
After surgery for Crohn's disease, as per institutional Standard of Care (SoC), approximately 80 eligible patients will be randomized 1:1 to receive oral EXL01 or placebo with or without SoC treatment (based on investigator decision) for up to 24 weeks or until a study or treatment discontinuation criterion is met. Randomisation will be stratified on post-surgical treatment (none vs anti-TNF), and on smoking status (non-smoker vs smoker).
The primary objective is to compare the distribution of endoscopic modified Rutgeerts scores, as centrally assessed, at 6 months post-surgery in patients with CD treated with EXL01 to patients treated with placebo.. All patients will be monitored continuously for safety while on the study treatment. Endoscopic recurrence will be assessed using the endoscopic score assessed by central reading at Week 24 after surgery. Faecal and blood samples for biomarker assessments will be obtained at Weeks 0, 4, 12, and 24. Patients who experience disease flare before Week 24 will discontinue the study treatment (EXL01 or placebo) and undergo an early discontinuation (ED) visit. All participants will be followed for safety until 4 weeks after end of treatment.
After surgery for Crohn's disease, as per institutional Standard of Care (SoC), approximately 80 eligible patients will be randomized 1:1 to receive oral EXL01 or placebo with or without SoC treatment (based on investigator decision) for up to 24 weeks or until a study or treatment discontinuation criterion is met. Randomisation will be stratified on post-surgical treatment (none vs anti-TNF), and on smoking status (non-smoker vs smoker).
The primary objective is to compare the distribution of endoscopic modified Rutgeerts scores, as centrally assessed, at 6 months post-surgery in patients with CD treated with EXL01 to patients treated with placebo.. All patients will be monitored continuously for safety while on the study treatment. Endoscopic recurrence will be assessed using the endoscopic score assessed by central reading at Week 24 after surgery. Faecal and blood samples for biomarker assessments will be obtained at Weeks 0, 4, 12, and 24. Patients who experience disease flare before Week 24 will discontinue the study treatment (EXL01 or placebo) and undergo an early discontinuation (ED) visit. All participants will be followed for safety until 4 weeks after end of treatment.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-511357-22-00 | CTIS | None | View |