Crohn DiseasePhase 1MAINTAINNCT05542355
EXL01 in the Maintenance of Steroid-induced Clinical Response/Remission in Participants With Mild to Moderate Crohn's Disease
A Phase 1 study testing EXL01, SoC corticosteroid - Induction Period and SoC corticosteroid - Tapering in people with Crohn Disease, run by Exeliom Biosciences at 5 sites in 2 countries.
Trial summary
A Phase 1, 2-part, multicentre study to evaluate the safety and preliminary efficacy of the oral administration of EXL01 in the maintenance of corticosteroid-induced clinical response/remission in participants with mild to moderate Crohn's Disease (CD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- EXL01, SoC corticosteroid - Induction Period and SoC corticosteroid - Tapering
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 20 Mar 2023to 2 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must meet all of the following criteria at the start of the Induction Period:
- Male or female aged ≥18 years and <75 years at the time of providing informed consent.
- A diagnosis of CD with ileal involvement for at least 3 months prior to Screening.
- A CDAI score >180 and <350.
- Part B only: Active mucosal inflammation.
Who cannot join
- Stricture with obstructive syndrome <3 months prior to Screening.
- Stenosis making endoscopic access to the terminal ileum difficult.
- Received treatment with high dose corticosteroid (≥40 mg prednisone daily) for >5 weeks within 3 months prior to Screening.
- Part B only: Received >3 prior biologic treatments or JAK inhibitors for CD including infliximab, ustekinumab, vedolizumab, adalimumab, certolizumab, risankizumab, and upadacitinib.
- Major surgery or significant trauma ≤4 weeks prior to Screening.
- Small bowel resection >1 m in total or clinical manifestations of short bowel syndrome.
Show all 11Show fewer
- Current stoma (ileostomy or a colostomy) or had a stoma in the last 6 months or any other intraabdominal surgery within 3 months prior to Screening.
- Started or stopped immunosuppressive therapy (thiopurine, methotrexate, tacrolimus, or other classical immunosuppressant) within 3 months prior to Screening.
- Received faecal microbial transplant within 3 months prior to Screening.
- Systemic infection or other serious infection requiring systemic treatment within 30 days prior to Screening.
- Pregnant, breastfeeding, or expecting to conceive during the study.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Poland4 sites
Zespół Poradni Specjalistycznych REUMED
Lublin, 20582
Centrum Medyczne "Medyk" Sp. zo.o. Sp.K
Rzeszów, 35-326
Endoskopia Sp. z o. o., Ul. B.Chrobrego 6/8
Sopot, 81-756
PlanetMed Sp.z.o.o. Gastroenterology, Ul.Lubinowa 12/8
Wroclaw, 52-210
About this study
Official title: A Phase 1, Multicentre, 2-Part, Randomised, Parallel-arm, Placebo-controlled, Partially Double-blind Study to Evaluate the Safety and Target Engagement of EXL01 in the Maintenance of Steroid-induced Clinical Response or Remission in Participants With Mild to Moderate Crohn's Disease
A Phase 1, 2-part, multicentre study to evaluate the safety and preliminary efficacy of the oral administration of EXL01 in the maintenance of corticosteroid-induced clinical response/remission in participants with mild to moderate Crohn's Disease (CD).
Read the detailed description
Initially, all participants will received standard of care (SoC) corticosteroid induction therapy for 3 to 7 weeks. Participants who meet the protocol defined criteria for response after corticosteroid therapy will enter a Maintenance Period. Participants not in clinical response/remission at the end of the Induction Period will discontinue the study without further study treatment. In the Maintenance Period, participants will receive oral EXL01 or placebo in combination with corticosteroid treatment (that is progressively tapered) and be monitored for safety and efficacy.
The study will be conducted in 2 parts:
- Part A: Participants eligible for maintenance treatment will receive open-label oral EXL01 for up to 24 weeks.
- Part B: Participants eligible for maintenance treatment will be randomised 2:1 to receive double blind oral EXL01 or placebo for up to 24 weeks.
Participants will be monitored for 30 days after end-of-treatment.
Due to the low recruitment rate into Part A, the study was discontinued early; Part B did not start.
- Conditions
- Crohn Disease
- Being tested
- EXL01, Placebo, SoC corticosteroid - Induction Period, SoC corticosteroid - Tapering
- Keywords
- Gastrointestinal Diseases, Inflammatory Bowel Disease, Colonic Diseases, Intestinal Diseases, Digestive System Diseases, Microbiota, Crohn Disease, remission, Faecalibacterium prausnitzii
- Medical subject headings
- Crohn Disease, Gastrointestinal Diseases, Inflammatory Bowel Diseases, Colonic Diseases, Intestinal Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXL01Drug
Also called Faecalibacterium prausnitzii EXL01-strain
Oral EXL01 once daily for up to 24 weeks (after SoC corticosteroid induction therapy).
PlaceboDrug
Oral EXL01 matching placebo once daily for up to 24 weeks (after SoC corticosteroid induction therapy).
SoC corticosteroid - Induction PeriodOther
Oral prednisone 40 mg or budesonide 9 mg once daily for 3 to 7 weeks, as assigned by the investigator
SoC corticosteroid - TaperingOther
Same product as the Induction Period.
Oral prednisone: 30 mg for 1 week, 25 mg for 1 week, 20 mg for 1 week, 15 mg for 1 week, 10 mg for 1 week, 5 mg for 1 week and stop.
OR
Oral budesonide: 6 mg for 3 weeks, 3 mg for 3 weeks, stop.
| Study group | Role | What they receive |
|---|---|---|
| Part A (Open-Label EXL01 Maintenance Therapy) | Experimental | Oral EXL01 once daily for up to 24 weeks (after SoC corticosteroid induction therapy). Receives: Drug: EXL01; Other: SoC corticosteroid - Induction Period; Other: SoC corticosteroid - Tapering |
| Part B (EXL01 Maintenance Therapy) | Experimental | Oral EXL01 once daily for up to 24 weeks (after SoC corticosteroid induction therapy). Receives: Drug: EXL01; Other: SoC corticosteroid - Induction Period; Other: SoC corticosteroid - Tapering |
| Part B (Placebo Maintenance Therapy) | Placebo comparator | Oral EXL01 matched placebo once daily for up to 24 weeks (after SoC corticosteroid induction therapy). Receives: Drug: Placebo; Other: SoC corticosteroid - Induction Period; Other: SoC corticosteroid - Tapering |
What is being measured
The primary outcome is the main question the study is designed to answer.
The systemic and intestinal safety and tolerability of orally administered EXL01
Number of participants with adverse events (AE[s]). Number of participants with treatment discontinuations due to an AE. AEs assessed by CTCAE v5.0
Measured: Up to 43 weeks
Secondary outcomes (7)
Proportion of participants in steroid-free clinical remission at Week 24
Endpoints: Crohn's disease activity index (CDAI) score (higher scores indicate more active/severe disease) and use of corticosteroids
Measured: Maintenance Period Week 24
Proportion of participants in steroid-free clinical remission and mucosal healing at Week 24
This is a composite measure. Endpoints: CDAI score, simple endoscopic score for Crohn's Disease (SES-CD; higher scores indicate more severe disease), and use of corticosteroids
Measured: Maintenance Period Week 24
Proportion of participants in steroid free clinical remission and mucosal healing and normal inflammatory markers at Week 24
This is a composite measure. Endpoints: CDAI score, SES-CD score, C-reactive protein (CRP) level (a marker of inflammation), faecal calprotectin level (a marker of intestinal inflammation), and use of corticosteroids
Measured: Maintenance Period Week 24
Proportion of participants with an endoscopic response at Week 24
Endpoint: SES-CD score
Measured: Maintenance Period Week 24
Time to clinical relapse in participants with CD treated with EXL01 to participants treated with placebo (Part B only)
Time to clinical relapse, defined as the time from first dose of EXL01 or placebo to first documented clinical relapse (Part B only)
Measured: Maintenance Period Baseline to Week 24
Comparison of the SES-CD and histology of the intestinal mucosa in participants with CD treated with EXL01 to participants treated with placebo (Part B only)
This is a composite measure. Endpoints: SES-CD score, Robarts Histopathology Index score (measures histological disease activity; higher scores indicate more severe disease activity)
Measured: Maintenance Period Baseline to Week 24
Comparison of the evolution of the faecal and mucosa-associated microbiota in participants with CD treated with EXL01 to participants treated with placebo (Part B only)
This is a composite measure. 16S sequencing / shotgun metagenomics and specific quantitative polymerase chain reaction (qPCR)/digital droplet (dd)PCR
Measured: Maintenance Period Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start20 Mar 2023
- Primary completion2 Oct 2024
- Study completion2 Oct 2024
Why it stopped: Due to low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part A = Single Arm open label. Part B = Randomised, placebo-controlled, double-blind.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exeliom Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alimentiv Inc.
- Responsible party
- Sponsor
- Investigators
- Acting Chief Medical Officer, Study director, Exeliom Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542355
- Sponsor's protocol ID
- EXL01-CD-001
- Other IDs
- 2021-003432-81
- Acronym
- MAINTAIN
- Status last verified
- Oct 2024
- First submitted
- 2 Sep 2022
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guarino-Vignon P, Louis E, Pham HP, Orianne G, Tkacz E, Brot L, Mazzetti E, Sedda D, Ruffie P, Rolhion N, D'Haens G, Hadida B, Langella P, Sokol H. Faecalibacterium prausnitzii EXL01 for the Maintenance of Steroid-induced Clinical Response or Remission in Patients with Crohn's Disease: a first in human trial. Nat Commun. 2026 Apr 28;17(1):5823. doi: 10.1038/s41467-026-72375-y.
PubMed 42049742
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicentre, 2-Part, Randomised, Parallel-arm, Placebo-controlled, Partially Double-blind Study to Evaluate the Safety and Target Engagement of EXL01 in the Maintenance of Steroid-induced Clinical Response or Remission in Participants With Mild to Moderate Crohn's Disease
- ClinicalTrials.gov ID
- NCT05542355
- Acronym / sponsor ID
- MAINTAIN / EXL01-CD-001
- Conditions
- Crohn Disease
- Keywords
- Gastrointestinal Diseases, Inflammatory Bowel Disease, Colonic Diseases, Intestinal Diseases, Digestive System Diseases, Microbiota, Crohn Disease, remission, Faecalibacterium prausnitzii
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low recruitment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Exeliom BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Alimentiv Inc.
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 15 Sep 2022 (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.
A Phase 1, 2-part, multicentre study to evaluate the safety and preliminary efficacy of the oral administration of EXL01 in the maintenance of corticosteroid-induced clinical response/remission in participants with mild to moderate Crohn's Disease (CD).
Detailed description
Initially, all participants will received standard of care (SoC) corticosteroid induction therapy for 3 to 7 weeks. Participants who meet the protocol defined criteria for response after corticosteroid therapy will enter a Maintenance Period. Participants not in clinical response/remission at the end of the Induction Period will discontinue the study without further study treatment. In the Maintenance Period, participants will receive oral EXL01 or placebo in combination with corticosteroid treatment (that is progressively tapered) and be monitored for safety and efficacy.
The study will be conducted in 2 parts:
- Part A: Participants eligible for maintenance treatment will receive open-label oral EXL01 for up to 24 weeks.
- Part B: Participants eligible for maintenance treatment will be randomised 2:1 to receive double blind oral EXL01 or placebo for up to 24 weeks.
Participants will be monitored for 30 days after end-of-treatment.
Due to the low recruitment rate into Part A, the study was discontinued early; Part B did not start.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Part A = Single Arm open label. Part B = Randomised, placebo-controlled, double-blind.
| Arm | Type | Receives |
|---|---|---|
| Part A (Open-Label EXL01 Maintenance Therapy) | Experimental | Drug: EXL01, Other: SoC corticosteroid - Induction Period, Other: SoC corticosteroid - TaperingOral EXL01 once daily for up to 24 weeks (after SoC corticosteroid induction therapy). |
| Part B (EXL01 Maintenance Therapy) | Experimental | Drug: EXL01, Other: SoC corticosteroid - Induction Period, Other: SoC corticosteroid - TaperingOral EXL01 once daily for up to 24 weeks (after SoC corticosteroid induction therapy). |
| Part B (Placebo Maintenance Therapy) | Placebo comparator | Drug: Placebo, Other: SoC corticosteroid - Induction Period, Other: SoC corticosteroid - TaperingOral EXL01 matched placebo once daily for up to 24 weeks (after SoC corticosteroid induction therapy). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged ≥18 years and <75 years at the time of providing informed consent.
- A diagnosis of CD with ileal involvement for at least 3 months prior to Screening.
- A CDAI score >180 and <350.
- Part B only: Active mucosal inflammation.
Key exclusion criteria (11 listed)
- Stricture with obstructive syndrome <3 months prior to Screening.
- Stenosis making endoscopic access to the terminal ileum difficult.
- Received treatment with high dose corticosteroid (≥40 mg prednisone daily) for >5 weeks within 3 months prior to Screening.
- Part B only: Received >3 prior biologic treatments or JAK inhibitors for CD including infliximab, ustekinumab, vedolizumab, adalimumab, certolizumab, risankizumab, and upadacitinib.
- Major surgery or significant trauma ≤4 weeks prior to Screening.
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 |
|---|---|---|
| EXL01Also: Faecalibacterium prausnitzii EXL01-strainOral EXL01 once daily for up to 24 weeks (after SoC corticosteroid induction therapy). | Drug | Part A (Open-Label EXL01 Maintenance Therapy), Part B (EXL01 Maintenance Therapy) |
| PlaceboOral EXL01 matching placebo once daily for up to 24 weeks (after SoC corticosteroid induction therapy). | Drug | Part B (Placebo Maintenance Therapy) |
| SoC corticosteroid - Induction PeriodOral prednisone 40 mg or budesonide 9 mg once daily for 3 to 7 weeks, as assigned by the investigator | Other | Part A (Open-Label EXL01 Maintenance Therapy), Part B (EXL01 Maintenance Therapy), Part B (Placebo Maintenance Therapy) |
| SoC corticosteroid - TaperingSame product as the Induction Period. Oral prednisone: 30 mg for 1 week, 25 mg for 1 week, 20 mg for 1 week, 15 mg for 1 week, 10 mg for 1 week, 5 mg for 1 week and stop. OR Oral budesonide: 6 mg for 3 weeks, 3 mg for 3 weeks, stop. | Other | Part A (Open-Label EXL01 Maintenance Therapy), Part B (EXL01 Maintenance Therapy), Part B (Placebo Maintenance Therapy) |
Primary outcome
The systemic and intestinal safety and tolerability of orally administered EXL01
Time frame: Up to 43 weeks
Number of participants with adverse events (AE[s]). Number of participants with treatment discontinuations due to an AE. AEs assessed by CTCAE v5.0
7 secondary outcomes
Proportion of participants in steroid-free clinical remission at Week 24
Time frame: Maintenance Period Week 24
Proportion of participants in steroid-free clinical remission and mucosal healing at Week 24
Time frame: Maintenance Period Week 24
Proportion of participants in steroid free clinical remission and mucosal healing and normal inflammatory markers at Week 24
Time frame: Maintenance Period Week 24
Proportion of participants with an endoscopic response at Week 24
Time frame: Maintenance Period Week 24
Time to clinical relapse in participants with CD treated with EXL01 to participants treated with placebo (Part B only)
Time frame: Maintenance Period Baseline to Week 24
Comparison of the SES-CD and histology of the intestinal mucosa in participants with CD treated with EXL01 to participants treated with placebo (Part B only)
Time frame: Maintenance Period Baseline to Week 24
Comparison of the evolution of the faecal and mucosa-associated microbiota in participants with CD treated with EXL01 to participants treated with placebo (Part B only)
Time frame: Maintenance Period Baseline to Week 24
Results and safety
The study was stopped early (reason given: Due to low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Derived from this study: PubMed 42049742Guarino-Vignon P, Louis E, Pham HP, Orianne G, Tkacz E, Brot L, Mazzetti E, Sedda D, Ruffie P, Rolhion N, D'Haens G, Hadida B, Langella P, Sokol H. Faecalibacterium prausnitzii EXL01 for the Maintenance of Steroid-induced Clinical Response or Remission in Patients with Crohn's Disease: a first in human trial. Nat Commun. 2026 Apr 28;17(1):5823. doi: 10.1038/s41467-026-72375-y.
- 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. This study is not recruiting at the moment.
Acting Chief Medical Officer study director
Exeliom Biosciences
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EXL01, SoC corticosteroid - Induction Period and SoC corticosteroid - Tapering in people with Crohn Disease, run by Exeliom Biosciences at 5 sites in 2 countries.
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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland, Belgium. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The systemic and intestinal safety and tolerability of orally administered EXL01 (time frame: Up to 43 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05542355, which also lists 1 linked publication.
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 10 Oct 2024.