Target Engagement of EXL01 in the Prevention of Post-operative Recurrence of Crohn's Disease (MAINTAIN-POP)

Madeleine Bezault

Status and phase: Enrolling; Phase 2

Conditions: Crohn Disease (CD)

Treatments: Drug: After surgery for Crohn's disease, 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

Study type: Interventional

Funder types: Other

Identifiers

NCT06925061

2024-511357-22-00 (EU Trial (CTIS) Number)

REMIND_2024-001_EXL01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is male or female aged ≥18 years at the time of providing documented informed consent.
• Has a diagnosis of CD with ileal involvement (ileal only or ileocolonic; L1 or L3 in Montreal classification) for at least 3 months prior to Screening.
• Has undergone an ileocecal resection or iterative ileo-colonic resection, as per institutional SoC, between 5 days to 5 weeks before randomization.
• Is scheduled, in SoC context, to receive no treatment for CD or anti-TNF agents in the 6 months after surgery

Exclusion criteria

• Has a not recovered adequately from any toxicity and/or complications from the surgery before the first dose of study intervention
• Has a current stoma. Inclusion will be possible after continuity restoration (during the 5 weeks following continuity restoration)
• Has active anal fistula
• Is scheduled, according to SoC, to receive a biotherapy at the exception of anti-TNF agent in the 6 months after surgery
• Has had more than 2 past small bowel resections or cumulated intestinal resection superior to 50 cm
• Has a contraindication to endoscopy or anaesthesia.
• Is receiving antibiotics at time of randomization or is likely to require antibiotic treatment within 6 weeks of the first dose of EXL01 or placebo.
• Has a history of hypersensitivity to EXL01 and/or any excipients, which are listed in the Investigator Brochure (IB), and/or to soybean or soy-containing products.
• Has a not recovered adequately from any toxicity and/or complications from the surgery before the first dose of study intervention
• Has a current stoma. Inclusion will be possible after continuity restoration (during the 5 weeks following continuity restoration)
• Has active anal fistula
• Is scheduled, according to SoC, to receive a biotherapy at the exception of anti-TNF agent in the 6 months after surgery
• Has had more than 2 past small bowel resections or cumulated intestinal resection superior to 50 cm
• Has a contraindication to endoscopy or anaesthesia.
• Is receiving antibiotics at time of randomization or is likely to require antibiotic treatment within 6 weeks of the first dose of EXL01 or placebo.
• Has a history of hypersensitivity to EXL01 and/or any excipients, which are listed in the Investigator Brochure (IB), and/or to soybean or soy-containing products.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Live biotherapeutic product (EXL01)

Experimental group

Description:

EXL01 administered with or without SoC treatment orally, once a day during 24 weeks

Treatment:

Drug: After surgery for Crohn's disease, 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

Placebo

Placebo Comparator group

Description:

Placebo administered with or without SoC treatment orally, once a day during 24 weeks

Treatment:

Drug: After surgery for Crohn's disease, 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