PsoriasisREMISSIOnNCT06055699
Association Between the Occurrence of a Clinical RElapse and Gut MIcrobiota Modifications: a Cohort Study of Patients With pSOriasis
An observational study of Psoriasis and Microbial Colonization, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The human microbiota corresponds to an extremely rich and varied set of microorganisms that colonize our various epitheliums from birth, including the intestine, lungs and skin, where they interact continuously with our immune system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Microbial Colonization
- What is being tested?
- Fecal sampling and Blood sampling
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Mar 2028
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients with psoriasis in remission after IL23i or IL17inhibitor treatments and who have stopped their medication for 2 to 4 weeks.
Who may be able to join
- Subject over 18 years of age
- Subject diagnosed with psoriasis considered in remission (as defined by absolute PASI<2 within 6 months of follow-up)
- Subject who has stopped his biologic agent including IL-17 inhibitors or IL-23 inhibitors for 2 to 4 weeks.
- Written informed consent for participation in the study
Who cannot join
- Subject currently experiencing or having a history of other concomitant skin conditions that would interfere with evaluation of psoriasis
- Subject treated by NSAIDs, antibiotics, antifungals, antivirals or proton-pump inhibitors within 4 weeks before inclusion (or foreseeable use during the study)
- Subject with a concomitant diagnosis of cirrhosis, coeliac disease or signs of bacterial infection
- Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
- Subject having a personal or familial history of psoriatic arthritis or inflammatory bowel disease
- Subject with BMI<18.5 or BMI>35
Show all 10Show fewer
- Subject consuming probiotics or using specific diet with many dietary exclusions according to the discretion of the investigator
- Pregnant and /or breastfeeding woman,
- Subject deprived of liberty by judicial or administrative decision or patient under guardianship
- Subject unable to understand the purpose and conditions of the study and unable to give consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The human microbiota corresponds to an extremely rich and varied set of microorganisms that colonize our various epitheliums from birth, including the intestine, lungs and skin, where they interact continuously with our immune system. Changes in microbial composition and function, termed dysbiosis, have been linked to alterations in immune responses and to disease development, such as psoriasis. Recent research has shown that the gut microbiota can condition the therapeutic response to checkpoint inhibitors and that fecal microbiota transplant overcomes resistance to these therapy, suggesting a direct role for the microbiota in the ability to shape a therapeutic immune response. Antibiotic exposure during the course of cancer therapy negatively correlates with patients' response to anti-PD-1 treatment response, thus highlighting the link between the enrichment of specific microbial taxa in intestines and the response to immunotherapy. This observation suggests that treatments capable of modulating microbial networks and promoting specific bacterial clades may modulate the host's immune response. Hence, beyond their expected effect in the targeted tissue, part of the therapeutic effect of drugs could rely on this mechanism. In psoriasis patients, observational studies suggest that gut microbiome is altered differently after the use of anti-IL17 or anti-IL23 biologic agents.
Main objective: To determine the evolution of microbial composition of fecal samples issued to patients who responded to a biologic agent (IL-17 inhibitors, IL-23 inhibitors) and have stopped their treatment for 2 to 4 weeks before the index date, at baseline and 6 months or clinical relapse after treatment discontinuation
Read more
Design of the study: Prospective french multicentre observational cohort study
Population of study participants: Patients with psoriasis in remission after IL23i or IL17inhibitor treatments and who have stopped their medication for 2 to 4 weeks.
Number of participants included: 50 adult patients considered in remission and have stopped for at least 2 weeks and a maximum of 4 weeks, one of the following biologic agent: secukinumab, ixekizumab, brodalumab, bimekizumab, guselkumab, tildrakizumab, or risankizumab
- Conditions
- Psoriasis, Microbial Colonization
- Being tested
- Fecal sampling, Blood sampling
- Keywords
- microbiota, pSOriasis, anti-IL17 biologic agents, anti-IL23 biologic agents
- Medical subject headings
- Psoriasis, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal samplingOther
Also called Stool samples
Stool samples are a collection of products derived from the human body that is not invasive in any way and samples not taken as part of usual care.
Stool samples will be collected at home within 7 days of the visit M0, M3 and M6 and within 14 days of the visit M12 in an ethanol tube and in DNA/RNA shield, and transported at room temperature to Saint-Antoine Hospital (CRB SAT, AP-HP, Pr. SIMON ), samples will be aliquoted (3 aliquots per tubes) and stored at -80°C for a period of 5 years (renewable) At the end of the research, stool samples will be analysed using metagenomics sequencing.
DNA extraction will be performed following the standards of the The International Human Microbiome Standards . DNA will be stored at -80°C.
Blood samplingOther
Also called Blood samples (serum)
Blood samples (serum, 15 ml) are an additional and minimal collection performed following a sample taken as part of usual care.
Blood samples (serum) will be collected during the visit at M0, M3 (± 7 days), M6 (± 7 days) and M12 (± 7 days).
In the hours following collection, the samples must be aliquoted and stored at -80°C in a secure place in the participating centre.
| Study group | Role | What they receive |
|---|---|---|
| Patients with psoriasis in remission | Patients with psoriasis in remission after IL23i or IL17inhibitor treatments and who have stopped their medication for 2 to 4 weeks. Receives: Other: Fecal sampling; Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial features
Microbial features (gene richness, species, functional modules) impacted by the discontinuation of the biologic agent after 6 months or the first occurrence of psoriasis clinical relapse.
Measured: after 6 months of the baseline visit or the first occurrence of psoriasis clinical relapse after baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Mar 2024 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie Sbidian, MD-PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055699
- Sponsor's protocol ID
- APHP230758
- Acronym
- REMISSIOn
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between the Occurrence of a Clinical RElapse and Gut MIcrobiota Modifications: a Cohort Study of Patients With pSOriasis
- ClinicalTrials.gov ID
- NCT06055699
- Acronym / sponsor ID
- REMISSIOn / APHP230758
- Conditions
- Psoriasis, Microbial Colonization
- Keywords
- microbiota, pSOriasis, anti-IL17 biologic agents, anti-IL23 biologic agents
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 28 Sep 2023 (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.
The human microbiota corresponds to an extremely rich and varied set of microorganisms that colonize our various epitheliums from birth, including the intestine, lungs and skin, where they interact continuously with our immune system. Changes in microbial composition and function, termed dysbiosis, have been linked to alterations in immune responses and to disease development, such as psoriasis. Recent research has shown that the gut microbiota can condition the therapeutic response to checkpoint inhibitors and that fecal microbiota transplant overcomes resistance to these therapy, suggesting a direct role for the microbiota in the ability to shape a therapeutic immune response. Antibiotic exposure during the course of cancer therapy negatively correlates with patients' response to anti-PD-1 treatment response, thus highlighting the link between the enrichment of specific microbial taxa in intestines and the response to immunotherapy. This observation suggests that treatments capable of modulating microbial networks and promoting specific bacterial clades may modulate the host's immune response. Hence, beyond their expected effect in the targeted tissue, part of the therapeutic effect of drugs could rely on this mechanism. In psoriasis patients, observational studies suggest that gut microbiome is altered differently after the use of anti-IL17 or anti-IL23 biologic agents.
Main objective: To determine the evolution of microbial composition of fecal samples issued to patients who responded to a biologic agent (IL-17 inhibitors, IL-23 inhibitors) and have stopped their treatment for 2 to 4 weeks before the index date, at baseline and 6 months or clinical relapse after treatment discontinuation
Design of the study: Prospective french multicentre observational cohort study
Population of study participants: Patients with psoriasis in remission after IL23i or IL17inhibitor treatments and who have stopped their medication for 2 to 4 weeks.
Number of participants included: 50 adult patients considered in remission and have stopped for at least 2 weeks and a maximum of 4 weeks, one of the following biologic agent: secukinumab, ixekizumab, brodalumab, bimekizumab, guselkumab, tildrakizumab, or risankizumab
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with psoriasis in remission | – | Other: Fecal sampling, Other: Blood samplingPatients with psoriasis in remission after IL23i or IL17inhibitor treatments and who have stopped their medication for 2 to 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with psoriasis in remission after IL23i or IL17inhibitor treatments and who have stopped their medication for 2 to 4 weeks.
Key inclusion criteria (4 listed)
- Subject over 18 years of age
- Subject diagnosed with psoriasis considered in remission (as defined by absolute PASI<2 within 6 months of follow-up)
- Subject who has stopped his biologic agent including IL-17 inhibitors or IL-23 inhibitors for 2 to 4 weeks.
- Written informed consent for participation in the study
Key exclusion criteria (10 listed)
- Subject currently experiencing or having a history of other concomitant skin conditions that would interfere with evaluation of psoriasis
- Subject treated by NSAIDs, antibiotics, antifungals, antivirals or proton-pump inhibitors within 4 weeks before inclusion (or foreseeable use during the study)
- Subject with a concomitant diagnosis of cirrhosis, coeliac disease or signs of bacterial infection
- Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
- Subject having a personal or familial history of psoriatic arthritis or inflammatory bowel disease
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 |
|---|---|---|
| Fecal samplingAlso: Stool samplesStool samples are a collection of products derived from the human body that is not invasive in any way and samples not taken as part of usual care. Stool samples will be collected at home within 7 days of the visit M0, M3 and M6 and within 14 days of the visit M12 in an ethanol tube and in DNA/RNA shield, and transported at room temperature to Saint-Antoine Hospital (CRB SAT, AP-HP, Pr. SIMON ), samples will be aliquoted (3 aliquots per tubes) and stored at -80°C for a period of 5 years (renewable) At the end of the research, stool samples will be analysed using metagenomics sequencing. DNA extraction will be performed following the standards of the The International Human Microbiome Standards . DNA will be stored at -80°C. | Other | Patients with psoriasis in remission |
| Blood samplingAlso: Blood samples (serum)Blood samples (serum, 15 ml) are an additional and minimal collection performed following a sample taken as part of usual care. Blood samples (serum) will be collected during the visit at M0, M3 (± 7 days), M6 (± 7 days) and M12 (± 7 days). In the hours following collection, the samples must be aliquoted and stored at -80°C in a secure place in the participating centre. | Other | Patients with psoriasis in remission |
Primary outcome
Microbial features
Time frame: after 6 months of the baseline visit or the first occurrence of psoriasis clinical relapse after baseline visit
Microbial features (gene richness, species, functional modules) impacted by the discontinuation of the biologic agent after 6 months or the first occurrence of psoriasis clinical relapse.
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 28 Sep 2023.
- 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.
Emilie Sbidian, MD-PhD principal investigator
APHP
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Microbial Colonization, run by Assistance Publique - Hôpitaux de Paris.
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 10 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: opening soon, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Mélanie Rousseaux (01 40 27 57 24 ext. 0033, melanie.rousseaux@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial features (time frame: after 6 months of the baseline visit or the first occurrence of psoriasis clinical relapse after baseline visit). 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 28 Sep 2023.