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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease (CD)
• Intervention / 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

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Matthieu Allez; Phone Number: +33(1) 57276817; Email: matthieu.allez@aphp.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • Recruiting
    • CHU Clermont-Ferrand
    • Contact: Anthony Buisson; Phone Number: +33 (0)4 73 75 05 98; Email: a_buisson@hotmail.fr
  • Créteil, France
    • Recruiting
    • Hôpital Henri Mondor
    • Contact: Mathieu Uzzan; Phone Number: +33 01 45 17 81 20; Email: mathieu.uzzan@aphp.fr
  • Le Kremlin-Bicêtre, France, 94270
    • Recruiting
    • Hôpital Bicêtre
    • Contact: Franck Carbonnel; Phone Number: +33 01 45 21 20 33; Email: franck.carbonnel@aphp.fr
  • Lille, France
    • Recruiting
    • Chu Lille
    • Contact: Pauline Wils; Phone Number: +33 03.20.44.59.62; Email: pauline.wils@chru-lille.fr
  • Lyon, France
    • Recruiting
    • Hospices civils Lyon Sud
    • Contact: Stéphane Nancey; Phone Number: +33 04 78 86 45 55; Email: stephane.nancey@chu-lyon.fr
  • Marseille, France
    • Recruiting
    • CHU Marseille Nord
    • Contact: Mélanie Serrero; Phone Number: +33 04 91 96 53 75; Email: melanie.serrero@ap-hm.fr
  • Montpellier, France
    • Recruiting
    • CHU Montpellier
    • Contact: Pierre Blanc; Phone Number: +33 04 67 33 01 65; Email: p-blanc@chu-montpellier.fr
  • Nancy, France
    • Recruiting
    • CHU Nancy
    • Contact: Bénédicte Caron; Phone Number: +33 03.83.15.76.41; Email: caron.benedicte@hotmail.fr
  • Nantes, France
    • Recruiting
    • Chu Nantes
    • Contact: Arnaud Boureille; Phone Number: +33 (0)240 08 31 52; Email: arnaud.bourreille@chu-nantes.fr
  • Nice, France
    • Recruiting
    • CHU Nice Archet 2
    • Contact: Xavier Hebuterne; Phone Number: +33 (0)4 92 03 93 66; Email: hebuterne.x@chu-nice.fr
  • Paris, France, 75012
    • Recruiting
    • Hôpital Saint Antoine
    • Contact: Philippe Seksik; Phone Number: + 33 (0)1.49.28.31.62; Email: philippe.seksik@aphp.fr
  • Paris, France, 75010
    • Recruiting
    • CHU Saint Louis
    • Contact: Matthieu Allez; Phone Number: +33(1)57276817; Email: matthieu.allez@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Live biotherapeutic product (EXL01); 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; Randomisation will be stratified on post-surgical treatment (none vs anti-TNF), and on smoking status (non-smoker vs smoker).
Placebo Comparator: Placebo; 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; Randomisation will be stratified on post-surgical treatment (none vs anti-TNF), and on smoking status (non-smoker vs smoker).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Madeleine Bezault
• Investigators: Principal Investigator: Matthieu Allez, Remind

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Estimated): September 13, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 30, 2025
• First Submitted That Met QC Criteria: April 5, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Substandard Drugs; Pharmaceutical Preparations; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services; Perioperative Period; Counterfeit Drugs; Postoperative Period
• Other Study ID Numbers: REMIND_2024-001_EXL01; 2024-511357-22-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No