Shortening Treatments Of Chronic Inflammatory Conditions (STOIC)
Primary Purpose
Psoriasis, Inflammatory Bowel Diseases
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Study arm
Sponsored by
About this trial
This is an interventional basic science trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Psoriasis under systemic treatment for more than a year and in remission for at least 12 weeks: Physician Global Assessment [PGA] score 0-1, Psoriasis Area and Severity Index [PASI] score ≤ 3 OR inflammatory Bowel Disease [IBD] (Crohn's disease or ulcerative colitis) under systemic treatment for more than a year and in deep remission (clinical and endoscopic = SES CD 0-2 score for Crohn's, endoscopic Mayo score) in whom a de-escalation of treatment is scheduled.
- Agrrement of treatment discontinuation between patient and clinician before inclusion in this study.
- Informed Consent Form signed
Exclusion Criteria:
- Uncertain diagnosis
- Local immunomodulatory treatment for psoriasis ongoing or stopped for less than three weeks
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Presence and activation of tissue-resident memory [TRM] lymphocytes
Assessment of predictive abilities of TRM lymphocytes in psoriasis relapse through transcriptomic analysis
Secondary Outcome Measures
Full Information
NCT ID
NCT04848649
First Posted
April 1, 2021
Last Updated
April 15, 2021
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT04848649
Brief Title
Shortening Treatments Of Chronic Inflammatory Conditions
Acronym
STOIC
Official Title
Etude Pilote Exploratoire Des capacités Pronostiques de Rechute et Des Facteurs de Persistance de la mémoire Lymphocytaire T Dans Les Maladies Inflammatoires Chroniques
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background Psoriasis is a common disease which is a source of major distress for patients and costs for the society. Treatments are effective but temporary and relapses occur, preferentially at sites previously involved. Locally, tissue resident memory T cells (TRM) cells prone to produce pathogenic cytokines accumulate in the outer layers of the resolved skin of psoriasis patients under treatment, and can trigger strong inflammatory responses upon reactivation, thus starting the cascade of the relapse. We have recently shown that the skin transcriptional responses after TRM cell activation in healed skin biopsies of patients could predict the time until the disease relapse. How to modify the local pool of TRM cells in the human skin is not known, but several factors leading to the establishment and the persistence of the TRM cells in the skin are suggested. First, the skin microbiota has emerged as a potent actor of the skin immunity, with the capacity to shape the pool of skin T cells in mice. Second, after TRM cells are settled in the skin, their lipid intake will impact their local survival. Last, in addition to these local factors, the gut subclinical inflammation that lead to bacterial translocation can trigger a more global state of inflammation in the body and could drive the local survival of the TRM cells in the skin.
Aims Our first aim in this project is to validate a tool to predict psoriasis relapse upon treatment withdrawal in a cohort of patients treated with systemic drugs- the STOPso cohort (Shortening Treatments Of Psoriasis). We will correlate the skin reaction to local TRM activation in resolved lesions to the time before relapse.
In parallel, we will characterize several factors likely to participate to the establishment, function and survival of the TRM cells in the skin. We will decipher the skin microbiota and mycobiota; the lipid composition of the outer layer of the skin; the presence of lipopolysaccharide in the blood, in order to better understand what factors should be targeted to modify the skin populations of TRM cells.
Methods Patients will be recruited through the Dermatology department of the university hospital of Besançon. We will use skin biopsies from resolved lesions to perform the characterization of the skin responses at the transcriptional level after local TRM activation with OKT-3 antibody compared to control. RNA will be analyzed with Nanostring technologies. For the microbiota analysis, we will use wet swabs and later DNA sequencing. The lipid composition and the circulating LPS will be analyzed after tape stripping, through the LabEx LipSTIC lipidomic platform of the region Bourgogne Franche-Comté. Patients will be followed up at Month 1, Month 6, Month 12 and Month 18 and at time of relapse if it occurs in between those intervals. Data about the disease activity (PASI, quality of life scores) and inter-current events will be registered at each time point.
Expected results and Perspectives The final aim of this project is to validate a tool available to clinicians to guide them in their decision to withdraw an efficient treatment in psoriasis, based on the skin reactivity to the resident T cells left locally after resolution of the inflammation. This would help reduce treatment length, and thus toxicities and costs to the health care systems. To open future perspectives, we also want to better understand the reasons why TRM populations tend to be retained in the skin, in order to develop remodeling strategies of the skin TRM populations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Inflammatory Bowel Diseases
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Study arm
Intervention Description
Questionnaires, blood sample, skin (for psoriasis patients) or digestive (for IBD patients) biopsy and swab testing
Primary Outcome Measure Information:
Title
Presence and activation of tissue-resident memory [TRM] lymphocytes
Description
Assessment of predictive abilities of TRM lymphocytes in psoriasis relapse through transcriptomic analysis
Time Frame
Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Psoriasis under systemic treatment for more than a year and in remission for at least 12 weeks: Physician Global Assessment [PGA] score 0-1, Psoriasis Area and Severity Index [PASI] score ≤ 3 OR inflammatory Bowel Disease [IBD] (Crohn's disease or ulcerative colitis) under systemic treatment for more than a year and in deep remission (clinical and endoscopic = SES CD 0-2 score for Crohn's, endoscopic Mayo score) in whom a de-escalation of treatment is scheduled.
Agrrement of treatment discontinuation between patient and clinician before inclusion in this study.
Informed Consent Form signed
Exclusion Criteria:
Uncertain diagnosis
Local immunomodulatory treatment for psoriasis ongoing or stopped for less than three weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irène SEREZAL-GALLAIS, MD
Phone
0033381218097
Email
igallaisserezal@chu-besancon.fr
12. IPD Sharing Statement
Learn more about this trial
Shortening Treatments Of Chronic Inflammatory Conditions
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