Crohn Disease (CD)Phase 2MAINTAIN-POPNCT06925061
Target Engagement of EXL01 in the Prevention of Post-operative Recurrence of Crohn's Disease
A Phase 2 study of Crohn Disease (CD), run by Madeleine Bezault at 12 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease (CD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 12 sitesFrance
- Study dates
- 31 Mar 2025to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 16Show fewer
- 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 locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
France12 sites, 12 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand
Anthony Buisson, +33 (0)4 73 75 05 98, a_buisson@hotmail.fr
- Recruiting
Hôpital Henri Mondor
Créteil
Mathieu Uzzan, +33 01 45 17 81 20, mathieu.uzzan@aphp.fr
- Recruiting
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Franck Carbonnel, +33 01 45 21 20 33, franck.carbonnel@aphp.fr
- Recruiting
CHU Lille
Lille
Pauline Wils, +33 03.20.44.59.62, pauline.wils@chru-lille.fr
- Recruiting
Hospices civils Lyon Sud
Lyon
Stéphane Nancey, +33 04 78 86 45 55, stephane.nancey@chu-lyon.fr
- Recruiting
CHU Marseille Nord
Marseille
Mélanie Serrero, +33 04 91 96 53 75, melanie.serrero@ap-hm.fr
- Recruiting
CHU Montpellier
Montpellier
Pierre Blanc, +33 04 67 33 01 65, p-blanc@chu-montpellier.fr
- Recruiting
CHU Nancy
Nancy
Bénédicte Caron, +33 03.83.15.76.41, caron.benedicte@hotmail.fr
- Recruiting
CHU Nantes
Nantes
Arnaud Boureille, +33 (0)240 08 31 52, arnaud.bourreille@chu-nantes.fr
- Recruiting
CHU Nice Archet 2
Nice
Xavier Hebuterne, +33 (0)4 92 03 93 66, hebuterne.x@chu-nice.fr
- Recruiting
CHU Saint Louis
Paris, 75010
Matthieu Allez, +33(1)57276817, matthieu.allez@aphp.fr
- Recruiting
Hôpital Saint Antoine
Paris, 75012
Philippe Seksik, + 33 (0)1.49.28.31.62, philippe.seksik@aphp.fr
About this study
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
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.
Read the 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.
- Conditions
- Crohn Disease (CD)
- Being tested
- 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
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 weeksDrug
Randomisation will be stratified on post-surgical treatment (none vs anti-TNF), and on smoking status (non-smoker vs smoker).
| Study group | Role | What they receive |
|---|---|---|
| Live biotherapeutic product (EXL01) | Experimental | EXL01 administered with or without SoC treatment orally, once a day during 24 weeks Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start31 Mar 2025
- Primary completion13 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Madeleine Bezault
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Madeleine Bezault, Saint-Louis Hospital, Paris, France
- Investigators
- Matthieu Allez, Principal investigator, Remind
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925061
- Sponsor's protocol ID
- REMIND_2024-001_EXL01
- Other IDs
- 2024-511357-22-00
- Acronym
- MAINTAIN-POP
- Status last verified
- Sep 2025
- First submitted
- 30 Mar 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06925061
- Acronym / sponsor ID
- MAINTAIN-POP / REMIND_2024-001_EXL01
- Conditions
- Crohn Disease (CD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Madeleine BezaultUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 13 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Live biotherapeutic product (EXL01) | Experimental | 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 weeksEXL01 administered with or without SoC treatment orally, once a day during 24 weeks |
| Placebo | Placebo comparator | 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 weeksPlacebo administered with or without SoC treatment orally, once a day during 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 weeksRandomisation will be stratified on post-surgical treatment (none vs anti-TNF), and on smoking status (non-smoker vs smoker). | Drug | Live biotherapeutic product (EXL01), Placebo |
Primary outcome
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.
Time frame: From enrollment to the end of treatment at 24 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthieu Allez principal investigator
Remind
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Crohn Disease (CD), run by Madeleine Bezault at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthieu Allez (+33(1) 57276817, matthieu.allez@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From enrollment to the end of treatment at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.