SpondyloarthritisSpA23NCT05290363
The Role of IL-23 in Chronic Inflammatory Disease: Exploring the Cellular and Molecular Targets of IL-23 Signaling in Peripheral and Axial Spondyloarthritis
A study testing Blood sampling and synovial aspiration in people with Spondyloarthritis, run by Institut Pasteur at 4 sites in France.
Trial summary
This is a research study involving humans, of the interventional type with minimal risks and constraints (RIPH2). It is a multicentric, non randomized prospective study aiming to better understand the mechanisms of the response to anti-IL-23 biologics in Spondyloarthritis patients attending the rheumatology department… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthritis
- What is being tested?
- Blood sampling and synovial aspiration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesFrance
- Study dates
- 6 Oct 2022to 30 Sep 2027
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age : Adults (>18 years)
- Satisfying ASAS diagnostic criteria for SpA
- Patient has active disease, defined by the presence of active synovitis, tendinitis, or dactylitis or significant inflammatory pain of the spine, judged by the examining clinician to be due to SpA.
- Informed consent signed
- Beneficiary of health insurance, except for the AME
- Only for patients of Group 1 • Patient is naïve to biological therapies
Show all 21Show fewer
- Only for patients of Group 2
- Patient is affected by peripheral SpA (ASAS criteria) or psoriatic arthritis, with inflammation of peripheral joints
- Patient requires aspiration, as part of standard care
- Non inclusion criteria:
- Patient is minor
- Patient is pregnant or breastfeeding
- Patient is immunocompromised
- Patient has received biological therapy with 2 or more biologics
- Patient is receiving corticosteroid treatment > 10 mg per day
- Patient is under legal protection, curators, guardianship
- Patient refuses consent
- Previous history of alcoholism, drug addiction, psychological problems, severe concomitant conditions that could invalidate the patient's consent or limit the patient's compliance to the treatment protocol.
- Beneficiary of the AME
- Only for group 1
- Patient has received biological therapy
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Hôpital Henri-Mondor, AP-HP - Service de Rhumatologie
Créteil, 94000
Pascal CLAUDEPIERRE, Pr, +33149814704, pascal.claudepierre@aphp.fr
Pascal CLAUDEPIERRE, Pr
- Recruiting
Hôpital Cochin, AP-HP - Department of Dermatology B
Paris
Corinne MICELI-RICHARD, Pr, +33 6 1292 9487, corinne.miceli@aphp.fr
Corinne MICELI-RICHARD, Pr
- Recruiting
Hôpital Saint-Antoine, AP-HP - Service de Rhumatologie
Paris
Francis BERENBAUM, Pr, + 33 1 4928 2520, francis.berenbaum@aphp.fr
Francis BERENBAUM, Pr
- Not yet recruiting
Hôpital Maison Blanche - Service de Rhumatologie
Reims, 51092
Jean-Hugues SALMON, Pr, 33 3 26 78 43 73, jhsalmon@chu-reims.fr
Jean-Hugues SALMON, Pr
About this study
This is a research study involving humans, of the interventional type with minimal risks and constraints (RIPH2). It is a multicentric, non randomized prospective study aiming to better understand the mechanisms of the response to anti-IL-23 biologics in Spondyloarthritis patients attending the rheumatology department of Cochin, Saint-Antoine, Henri-Mondor hospitals (APHP) and Maison-Blanche Hospital (Reims).
Read the detailed description
The aim of this project is to improve our understanding of the role of IL-23 in the pathophysiology of axial SpA and peripheral SpA.
This objective is detailed in three specific aims:
- Define the effects of IL-23 on gene expression and cytokine production in innate and adaptive T lymphocytes from patients with SpA, and correlate them with the patient's genotype;
- Phenotypically characterize immune cell populations in peripheral blood and in synovial fluid from peripheral SpA patients and identify at the single cell level the cells expressing the IL-23 receptor and/or producing IL-17.
The study population to be included are patients affected by SpA, attended to in the Rheumatology Departments of Cochin Hospital, Saint-Antoine Hospital Henri-Mondor hospitals in Paris (APHP) and Maison-Blanche Hospital in Reims. Participants will be divided into two groups: Group 1 comprises patients diagnosed with axial SpA, Group 2 SpA patients with peripheral SpA or psoriatic arthritis.
- Conditions
- Spondyloarthritis
- Being tested
- Blood sampling, synovial aspiration
- Keywords
- interleukin-23, anti-IL-23 therapy, immune response, Spondyloarthritis
- Medical subject headings
- Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
A 51 mL blood sample will be collected during the study
synovial aspirationOther
If synovial aspiration is required in standard care for patients with peripheral spondylarthritis. Medical waste product will be collected for the study
| Study group | Role | What they receive |
|---|---|---|
| Patients with axial spondyloarthritis participating in the study | Experimental | People with axial spondylarthritis (60 participants), Receives: Other: Blood sampling |
| Patients with peripheral spondyloarthritis participating in the study | Experimental | People with peripheral spondylarthritis or psoriatic arthritis (30 participants). Receives: Other: Blood sampling; Other: synovial aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profiling of open chromatin regions
Profiling of open chromatin regions (ATAC seq) in T lymphocytes, cultured in the presence or absence of IL-23in order to define the effects of IL-23 on gene expression and cytokine production in innate and adaptive T lymphocytes from patients with SpA, and correlate them with the patient's genotype
Measured: 4 years
Profiling of transcriptome
Profiling of the transcriptome (RNA-seq) in T lymphocytes, cultured in the presence or absence of IL-23in order to define the effects of IL-23 on gene expression and cytokine production in innate and adaptive T lymphocytes from patients with SpA, and correlate them with the patient's genotype
Measured: 4 years
Profiling of the genome
Profiling of the genome (genotyping) in T lymphocytes, cultured in the presence or absence of IL-23in order to define the effects of IL-23 on gene expression and cytokine production in innate and adaptive T lymphocytes from patients with SpA, and correlate them with the patient's genotype
Measured: 4 years
Profiling of cytokine expression
Profiling of cytokine expression (Proximity Extension Assay technology) in T lymphocytes, cultured in the presence or absence of IL-23 in order to define the effects of IL-23 on gene expression and cytokine production in innate and adaptive T lymphocytes from patients with SpA, and correlate them with the patient's genotype
Measured: 4 years
Single cell transcriptome analysis
Single cell transcriptome analysis of cells from patients with peripheral SpA will be performed to characterize immune cell populations in peripheral blood and in synovial fluid and identify at the single cell level the cells expressing the IL-23 receptor and/or producing IL-17;
Measured: 4 years
Secondary outcomes (1)
Measure lymphocyte levels to explore the effects of anti-IL23 treatment on the immune responses of axSpA patients
Define the effects in vitro of IL-23 blockade on immune responses in the peripheral blood of axSpA patients, using whole blood culture assays to profile stimulated protein secretion and gene expression, in the presence or absence of IL-23 inhibitors.
As this therapy is not employed for the treatment of axSpA, we will characterize the in vitro effects of anti-IL-23 blockade on the immune responses of patients with axSpA, by analysing gene expression and protein secretion in whole blood cultures in the presence or absence of anti-IL-23 treatment.
We will isolate MAIT, γδ TCR+, CD4+CCR6+ and CD8+CCR6+ (enriched in IL-23R+) T cell populations from peripheral blood of psoriasis patients and stimulate them through the T cell receptor (TCR), in the presence or absence of IL-23.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start6 Oct 2022
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups are included Group 1: 60 patients with axial SpA Group 2 : 30 patients with SpA or psoriatic arthritis and peripheral joint involvement, with a medical decision to treat peripheral joint inflammation by arthrocentesis
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Biotech, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290363
- Sponsor's protocol ID
- 2021-087
- Other IDs
- 2021-A02801-40
- Acronym
- SpA23
- Status last verified
- Jan 2025
- First submitted
- 25 Feb 2022
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of IL-23 in Chronic Inflammatory Disease: Exploring the Cellular and Molecular Targets of IL-23 Signaling in Peripheral and Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT05290363
- Acronym / sponsor ID
- SpA23 / 2021-087
- Conditions
- Spondyloarthritis
- Keywords
- interleukin-23, anti-IL-23 therapy, immune response, Spondyloarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Biotech, Inc.
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 22 Mar 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.
This is a research study involving humans, of the interventional type with minimal risks and constraints (RIPH2). It is a multicentric, non randomized prospective study aiming to better understand the mechanisms of the response to anti-IL-23 biologics in Spondyloarthritis patients attending the rheumatology department of Cochin, Saint-Antoine, Henri-Mondor hospitals (APHP) and Maison-Blanche Hospital (Reims).
Detailed description
The aim of this project is to improve our understanding of the role of IL-23 in the pathophysiology of axial SpA and peripheral SpA.
This objective is detailed in three specific aims:
- Define the effects of IL-23 on gene expression and cytokine production in innate and adaptive T lymphocytes from patients with SpA, and correlate them with the patient's genotype;
- Phenotypically characterize immune cell populations in peripheral blood and in synovial fluid from peripheral SpA patients and identify at the single cell level the cells expressing the IL-23 receptor and/or producing IL-17.
The study population to be included are patients affected by SpA, attended to in the Rheumatology Departments of Cochin Hospital, Saint-Antoine Hospital Henri-Mondor hospitals in Paris (APHP) and Maison-Blanche Hospital in Reims. Participants will be divided into two groups: Group 1 comprises patients diagnosed with axial SpA, Group 2 SpA patients with peripheral SpA or psoriatic arthritis.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups are included Group 1: 60 patients with axial SpA Group 2 : 30 patients with SpA or psoriatic arthritis and peripheral joint involvement, with a medical decision to treat peripheral joint inflammation by arthrocentesis
| Arm | Type | Receives |
|---|---|---|
| Patients with axial spondyloarthritis participating in the study | Experimental | Other: Blood samplingPeople with axial spondylarthritis (60 participants), |
| Patients with peripheral spondyloarthritis participating in the study | Experimental | Other: Blood sampling, Other: synovial aspirationPeople with peripheral spondylarthritis or psoriatic arthritis (30 participants). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age : Adults (>18 years)
- Satisfying ASAS diagnostic criteria for SpA
- Patient has active disease, defined by the presence of active synovitis, tendinitis, or dactylitis or significant inflammatory pain of the spine, judged by the examining clinician to be due to SpA.
- Informed consent signed
- Beneficiary of health insurance, except for the AME
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Blood samplingA 51 mL blood sample will be collected during the study | Other | Patients with axial spondyloarthritis participating in the study, Patients with peripheral spondyloarthritis participating in the study |
| synovial aspirationIf synovial aspiration is required in standard care for patients with peripheral spondylarthritis. Medical waste product will be collected for the study | Other | Patients with peripheral spondyloarthritis participating in the study |
Primary outcome
Profiling of open chromatin regions
Time frame: 4 years
Profiling of open chromatin regions (ATAC seq) in T lymphocytes, cultured in the presence or absence of IL-23in order to define the effects of IL-23 on gene expression and cytokine production in innate and adaptive T lymphocytes from patients with SpA, and correlate them with the patient's genotype
Profiling of transcriptome
Time frame: 4 years
Profiling of the transcriptome (RNA-seq) in T lymphocytes, cultured in the presence or absence of IL-23in order to define the effects of IL-23 on gene expression and cytokine production in innate and adaptive T lymphocytes from patients with SpA, and correlate them with the patient's genotype
Profiling of the genome
Time frame: 4 years
Profiling of the genome (genotyping) in T lymphocytes, cultured in the presence or absence of IL-23in order to define the effects of IL-23 on gene expression and cytokine production in innate and adaptive T lymphocytes from patients with SpA, and correlate them with the patient's genotype
Profiling of cytokine expression
Time frame: 4 years
Profiling of cytokine expression (Proximity Extension Assay technology) in T lymphocytes, cultured in the presence or absence of IL-23 in order to define the effects of IL-23 on gene expression and cytokine production in innate and adaptive T lymphocytes from patients with SpA, and correlate them with the patient's genotype
Single cell transcriptome analysis
Time frame: 4 years
Single cell transcriptome analysis of cells from patients with peripheral SpA will be performed to characterize immune cell populations in peripheral blood and in synovial fluid and identify at the single cell level the cells expressing the IL-23 receptor and/or producing IL-17;
1 secondary outcome
Measure lymphocyte levels to explore the effects of anti-IL23 treatment on the immune responses of axSpA patients
Time frame: 4 years
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 23 Jan 2025.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling and synovial aspiration in people with Spondyloarthritis, run by Institut Pasteur at 4 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 21 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
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 Lars ROGGE, Dr (+33140613822, lars.rogge@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profiling of open chromatin regions (time frame: 4 years). The study lists 5 primary outcomes in all. 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 23 Jan 2025.