Association Between the Occurrence of a Clinical RElapse and Gut MIcrobiota Modifications: a Cohort Study of Patients With pSOriasis
REMISSIOn
1 other identifier
observational
50
0 countries
N/A
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2024
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
September 28, 2023
September 1, 2023
3.5 years
September 20, 2023
September 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
after 6 months of the baseline visit or the first occurrence of psoriasis clinical relapse after baseline visit
Study Arms (1)
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.
Interventions
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 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.
Eligibility Criteria
Patients with psoriasis in remission after IL23i or IL17inhibitor treatments and who have stopped their medication for 2 to 4 weeks.
You may qualify if:
- 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
You may not qualify if:
- Subject currently experiencing or having a history of other concomitant skin conditions that would interfere with evaluation of psoriasis
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
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 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).
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emilie Sbidian, MD-PhD
APHP
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2023
First Posted
September 28, 2023
Study Start
March 1, 2024
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
September 28, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share