The Role of IL-23 in Chronic Inflammatory Disease: Exploring the Cellular and Molecular Targets of IL-23 Signaling in Peripheral and Axial Spondyloarthritis

NCT05290363 | Recruiting

• 2 other identifiers: 2021-0872021-A02801-40
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

Brief 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 of Cochin, Saint-Antoine, Henri-Mondor hospitals (APHP) and Maison-Blanche Hospital (Reims).

Conditions

Spondyloarthritis

Keywords

interleukin-23; anti-IL-23 therapy; immune response; Spondyloarthritis

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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;

  4 years

Secondary Outcomes (1)

• Measure lymphocyte levels to explore the effects of anti-IL23 treatment on the immune responses of axSpA patients

  4 years

Study Arms (2)

Patients with axial spondyloarthritis participating in the study

EXPERIMENTAL

People with axial spondylarthritis (60 participants),

Other: Blood sampling

Patients with peripheral spondyloarthritis participating in the study

EXPERIMENTAL

People with peripheral spondylarthritis or psoriatic arthritis (30 participants).

Other: Blood sampling; Other: synovial aspiration

Interventions

Blood sampling OTHER

A 51 mL blood sample will be collected during the study

Patients with axial spondyloarthritis participating in the study; Patients with peripheral spondyloarthritis participating in the study

synovial aspiration OTHER

If synovial aspiration is required in standard care for patients with peripheral spondylarthritis. Medical waste product will be collected for the study

Patients with peripheral spondyloarthritis participating in the study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Institut Pasteur: lead
• Janssen Biotech, Inc.: collaborator

Study Sites (4)

Hôpital Henri-Mondor, AP-HP - Service de Rhumatologie

Créteil, 94000, France

NOT YET RECRUITING

Hôpital Cochin, AP-HP - Department of Dermatology B

Paris, France

RECRUITING

Hôpital Saint-Antoine, AP-HP - Service de Rhumatologie

Paris, France

RECRUITING

Hôpital Maison Blanche - Service de Rhumatologie

Reims, 51092, France

NOT YET RECRUITING

MeSH Terms

Conditions

Spondylarthritis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Lars ROGGE, Dr

CONTACT

+33140613822; lars.rogge@pasteur.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 22, 2022
• Study Start: October 6, 2022
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

FR (4)