Target Engagement of EXL01 in the Prevention of Post-operative Recurrence of Crohn's Disease

NCT06925061 | Recruiting Phase 2 DMC

• 2 other identifiers: REMIND_2024-001_EXL012024-511357-22-00
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 12

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.

Conditions

Crohn Disease (CD)

Outcome Measures

Primary Outcomes (1)

• 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.

  Evaluation of the distribution of modified Rutgeerts score grouped in 4 categories (i0: No lesions in the neoterminal ileum, i1: ≤ 5 ulcerations in the neoterminal ileum - i2a: Isolated anastomotic ulceration, i2b: \>5 ulcerations in the neoterminal ileum, i3: Diffuse ileitis - i4: Diffuse ileitis with deep ulcerations and/or stenosis) at Week 24/EOT, evaluated by endoscopy with video capture, and assessed by BICR.

  From enrollment to the end of treatment at 24 weeks

Study Arms (2)

Live biotherapeutic product (EXL01)

EXPERIMENTAL

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

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

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

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

Interventions

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 DRUG

Randomisation will be stratified on post-surgical treatment (none vs anti-TNF), and on smoking status (non-smoker vs smoker).

Live biotherapeutic product (EXL01); Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Has a not recovered adequately from any toxicity and/or complications from the surgery before the first dose of study intervention
• 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 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.

Sponsors & Collaborators

• Madeleine Bezault: lead

Study Sites (12)

CHU Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

Hôpital Henri Mondor

Créteil, France

RECRUITING

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

RECRUITING

CHU Lille

Lille, France

RECRUITING

Hospices civils Lyon Sud

Lyon, France

RECRUITING

CHU Marseille Nord

Marseille, France

RECRUITING

CHU Montpellier

Montpellier, France

RECRUITING

CHU Nancy

Nancy, France

RECRUITING

CHU Nantes

Nantes, France

RECRUITING

CHU Nice Archet 2

Nice, France

RECRUITING

CHU Saint Louis

Paris, 75010, France

RECRUITING

Hôpital Saint Antoine

Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Postoperative Period

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Matthieu Allez

  Remind

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthieu Allez

CONTACT

+33(1) 57276817; matthieu.allez@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 13, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): September 13, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)