Crohn's IleocolitisPhase 2ACROHNEMNCT02281916
Safety Study of P28GST Treatment in Crohn's Disease Patients
A Phase 2 study testing P28GST in people with Crohn's Ileocolitis, run by University Hospital, Lille at 5 sites in France.
Trial summary
This multicenter phase 2 clinical trial is designed to assess safety of P28GST (protein 28 Kd glutathion S Transferrase), aiming to control inflammation in moderate Crohn's Disease (CD), before or after intestinal resection surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Ileocolitis
- What is being tested?
- P28GST
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 5 sitesFrance
- Study dates
- Mar 2014to Feb 2018
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects between the ages of ≥18 years at inclusion.
- Subjects with ileal or ileo-colic CD without fistula
- Subjects operated or not
- CDAI score < 220
- no concomitant treatment excepted salicylates
- Women of child bearing potential must be negative for pregnancy prior to study enrolment
Show all 10Show fewer
- contraceptive means : females of childbearing potential as well as males are required to use adequate contraceptive methods for 6 months starting at the inclusion, i;e 4 months after the 3rd injection .
- No tobacco consumption (end date of tobacco consumption 8 days before surgery).
- Signed consent form
- French social security coverage.
Who cannot join
- Subject who use of azathioprine, anti-TNF (Tumor Necrosis Factor), methotrexate, Vedolizumab, Ustekinumab and other immunosuppressors for 8 weeks before first injection of P28GST
- Subject who use of corticosteroids for 15 days before first injection of P28GST
- Subject with history of vaccine hyper sensitivity or allergy.
- Subject with any other clinical manifestation determined by the investigator
- Subject wih AIDS, B or C hepatitis.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre hospitalier
Amiens
Centre Hospitalier de Boulogne
Boulogne-sur-Mer
Centre Hospitalier Dunkerque
Dunkirk
CHRU, Hôpital Claude Huriez
Lille, 59037
Centre Hospitalier,
Valenciennes
About this study
Official title: Safety Study of P28GST Treatment in Crohn's Disease Patients, a Multicenter Phase 2 Clinical Trial
This multicenter phase 2 clinical trial is designed to assess safety of P28GST (protein 28 Kd glutathion S Transferrase), aiming to control inflammation in moderate Crohn's Disease (CD), before or after intestinal resection surgery. P28GST is a parasite enzyme molecule from Schistosoma with potent immunogenic and anti-oxidant properties. Based on experimental evidence of its anti-inflammatory properties, the investigators hypothesized that administration of P28GST could protect against recurrence after intestinal resection surgery in CD.
Read the detailed description
To carry out this study, 24 moderate CD patients will be enrolled in a safety phase 2a study. CD patients will be included after intestinal resection surgery or in moderate Crohn's Disease (CD). Drug therapy will consisted in 3 injections of 100 µg of P28GST within 3 months (one injection per month). The main objective of this study is to follow-up monthly rate and seriousness of adverse events during one year. Secondary objectives are to control immunologic and inflammatory blood and tissue markers, appearance or not of a clinical recurrence assessed by CDAI (Crohn Disease Activity Index).
- Conditions
- Crohn's Ileocolitis
- Being tested
- P28GST
- Keywords
- Crohn disease, Immunotherapy, Helminth antigen
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P28GSTDrug
Also called immunotherapy
3 injections of 100 µg of P28GST within 3 months (one injection per month)
| Study group | Role | What they receive |
|---|---|---|
| P28GST treatment | Experimental | P28GST as a parasite enzyme Receives: Drug: P28GST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants wtih adverse events as a measure of safety and tolerability
Clinical and blood markers change from baseline
Measured: up to one year
Secondary outcomes (3)
Main immunologic and inflammatory blood and tissue markers.
Measured: up to one year
Appearance or not of a clinical recurrence assessed by CDAI (Crohn Disease Activity Index) and confirmed by a morphologic examination.
Measured: up to one year
Intestinal microbiota
Evolution of bacterial species by genomic analysis
Measured: at inclusion, at 4 month , at 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2018
- Study completionFeb 2018
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's IleocolitisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Dominique DEPLANQUE, MD, PhD, Study chair, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281916
- Sponsor's protocol ID
- 2013_02
- Other IDs
- 2013-000595-15
- Acronym
- ACROHNEM
- Status last verified
- Jun 2018
- First submitted
- 28 Oct 2014
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Foligne B, Ple C, Titecat M, Dendooven A, Pagny A, Daniel C, Singer E, Pottier M, Bertin B, Neut C, Deplanque D, Dubuquoy L, Desreumaux P, Capron M, Standaert A. Contribution of the Gut Microbiota in P28GST-Mediated Anti-Inflammatory Effects: Experimental and Clinical Insights. Cells. 2019 Jun 12;8(6):577. doi: 10.3390/cells8060577.
PubMed 31212833
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of P28GST Treatment in Crohn's Disease Patients, a Multicenter Phase 2 Clinical Trial
- ClinicalTrials.gov ID
- NCT02281916
- Acronym / sponsor ID
- ACROHNEM / 2013_02
- Conditions
- Crohn's Ileocolitis
- Keywords
- Crohn disease, Immunotherapy, Helminth antigen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- National Research Agency, France, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Mar 2014
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 4 Nov 2014 (estimated)
- 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.
This multicenter phase 2 clinical trial is designed to assess safety of P28GST (protein 28 Kd glutathion S Transferrase), aiming to control inflammation in moderate Crohn's Disease (CD), before or after intestinal resection surgery. P28GST is a parasite enzyme molecule from Schistosoma with potent immunogenic and anti-oxidant properties. Based on experimental evidence of its anti-inflammatory properties, the investigators hypothesized that administration of P28GST could protect against recurrence after intestinal resection surgery in CD.
Detailed description
To carry out this study, 24 moderate CD patients will be enrolled in a safety phase 2a study. CD patients will be included after intestinal resection surgery or in moderate Crohn's Disease (CD). Drug therapy will consisted in 3 injections of 100 µg of P28GST within 3 months (one injection per month). The main objective of this study is to follow-up monthly rate and seriousness of adverse events during one year. Secondary objectives are to control immunologic and inflammatory blood and tissue markers, appearance or not of a clinical recurrence assessed by CDAI (Crohn Disease Activity Index).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| P28GST treatment | Experimental | Drug: P28GSTP28GST as a parasite enzyme |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects between the ages of ≥18 years at inclusion.
- Subjects with ileal or ileo-colic CD without fistula
- Subjects operated or not
- CDAI score < 220
- no concomitant treatment excepted salicylates
Key exclusion criteria (5 listed)
- Subject who use of azathioprine, anti-TNF (Tumor Necrosis Factor), methotrexate, Vedolizumab, Ustekinumab and other immunosuppressors for 8 weeks before first injection of P28GST
- Subject who use of corticosteroids for 15 days before first injection of P28GST
- Subject with history of vaccine hyper sensitivity or allergy.
- Subject with any other clinical manifestation determined by the investigator
- Subject wih AIDS, B or C hepatitis.
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 |
|---|---|---|
| P28GSTAlso: immunotherapy3 injections of 100 µg of P28GST within 3 months (one injection per month) | Drug | P28GST treatment |
Primary outcome
Number of participants wtih adverse events as a measure of safety and tolerability
Time frame: up to one year
Clinical and blood markers change from baseline
3 secondary outcomes
Main immunologic and inflammatory blood and tissue markers.
Time frame: up to one year
Appearance or not of a clinical recurrence assessed by CDAI (Crohn Disease Activity Index) and confirmed by a morphologic examination.
Time frame: up to one year
Intestinal microbiota
Time frame: at inclusion, at 4 month , at 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Results publication: PubMed 31212833Foligne B, Ple C, Titecat M, Dendooven A, Pagny A, Daniel C, Singer E, Pottier M, Bertin B, Neut C, Deplanque D, Dubuquoy L, Desreumaux P, Capron M, Standaert A. Contribution of the Gut Microbiota in P28GST-Mediated Anti-Inflammatory Effects: Experimental and Clinical Insights. Cells. 2019 Jun 12;8(6):577. doi: 10.3390/cells8060577.
- Individual participant dataSharing planned: Undecided
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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.
Dominique DEPLANQUE, MD, PhD study chair
University Hospital, Lille
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing P28GST in people with Crohn's Ileocolitis, run by University Hospital, Lille at 5 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 10 inclusion and 5 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: finished, as of the sponsor's last update on 20 Feb 2026. 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 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants wtih adverse events as a measure of safety and tolerability (time frame: up to one year). 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 NCT02281916, 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 20 Feb 2026.