Axial Spondyloarthritis (axSpA)KIR3DL2NCT03322618
Evaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 in Blood Samples
A study testing blood samples in people with Axial Spondyloarthritis (axSpA) and Ankylosing Spondylitis (AS), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
the main objectives are 1. to study the pathophysiological role of KIR3DL2 in axSpA and its relationship with Th17 immunity in HLA-B27 + and HLA-B27- patients and 2. to assess the effect on the pro-inflammatory immune response of a cytotoxic monoclonal antibody IPH4102 (anti-KIR3DL2) in these patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Axial Spondyloarthritis (axSpA), Ankylosing Spondylitis (AS)
- What is being tested?
- blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 18 Dec 2017to 17 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent of the patient signed before any procedure planned to the protocol
- SPA axial according to the criteria of the ASAS (international Assessment of SpondyloArthritis Society)
- Known Status HLA B27
- Disease activates with a score of BASDAI = 4/10. The BASDAI (Bath Ankylosing Spondylitis Disease Activity Score) is a composite indication(index), validated, used in the therapeutic essays and in current practice for the evaluation of the activity of the SPA.
- Naive Patients of thorough treatment
- Patients of 18 and more years old
Who cannot join
- Minors
- Pregnant or breast-feeding Women
- Adults under guardianship
- People staying in a sanitary or social establishment
- People in emergency situation
- Not profitable People of a national insurance scheme
Show all 13Show fewer
- Private persons of freedom
- Treatment by corticoids during the last 30 days before the inclusion
- Treatment by anti-TNF or quite different biomedicine
- Treatment by sulfasalazine
- Reached concomitant by another active chronic inflammatory disease
- Infection chronicles by VHB, VHC or HIV
- Patients included in another study of clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 (Monoclonal Antibody IPH4102 Targeting KIR3DL2) in Blood Samples Taken From Patients With Axial Spondyloarthritis and Healthy Volunteers
the main objectives are
- to study the pathophysiological role of KIR3DL2 in axSpA and its relationship with Th17 immunity in HLA-B27 + and HLA-B27- patients and
- to assess the effect on the pro-inflammatory immune response of a cytotoxic monoclonal antibody IPH4102 (anti-KIR3DL2) in these patients.
The study will be carried out on blood samples from 24 patients with axSpA, 12 HLA-B27 + and 12 HLA-B27-, without any drug injection nor direct therapeutic benefit for the participating patients and 12 healthy controls.
- Being tested
- blood samples
- Medical subject headings
- Axial Spondyloarthritis, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesBiological
7 tubes of 6 ml (42 ml of blood )
| Study group | Role | What they receive |
|---|---|---|
| SpA HLA-B27 +, | Experimental | Not described Receives: Biological: blood samples |
| SpA HLA-B27- | Experimental | Not described Receives: Biological: blood samples |
| healthy subject | Active comparator | Not described Receives: Biological: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the present various immunizing populations in patients' blood SPA HLA-B27 + and HLA-B27-(Lymphocytes T CD4 (Th1 Th2, Th17, Tregs), lymphocytes T CD8, cells NK, lymphocytes B, monocytes)
by flow cytometry.
Measured: 12 MONTHS
Secondary outcomes (2)
Expression of the receivers involved in SPA on lymphocytes T CD4 in percentage of cells T CD4 expressing this markers
Measured: 12 MONTHS
Dosage of cytokines
Measured: 12 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start18 Dec 2017
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Axial Spondyloarthritis (axSpA)Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jean olivier ARNAUD, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322618
- Sponsor's protocol ID
- 2017-33
- Other IDs
- 2017-A01705-48
- Acronym
- KIR3DL2
- Status last verified
- Aug 2022
- First submitted
- 17 Oct 2017
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Larid G, Trijau S, Barral C, Lafforgue P, Pham T. Absence of overexpression of KIR3DL2 on CD4+ T cells and NK cells in patients with axial spondyloarthritis. Rheumatology (Oxford). 2023 Apr 3;62(4):e114-e116. doi: 10.1093/rheumatology/keac546. No abstract available.
PubMed 36124947
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 (Monoclonal Antibody IPH4102 Targeting KIR3DL2) in Blood Samples Taken From Patients With Axial Spondyloarthritis and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03322618
- Acronym / sponsor ID
- KIR3DL2 / 2017-33
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 26 Oct 2017 (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 main objectives are
- to study the pathophysiological role of KIR3DL2 in axSpA and its relationship with Th17 immunity in HLA-B27 + and HLA-B27- patients and
- to assess the effect on the pro-inflammatory immune response of a cytotoxic monoclonal antibody IPH4102 (anti-KIR3DL2) in these patients.
The study will be carried out on blood samples from 24 patients with axSpA, 12 HLA-B27 + and 12 HLA-B27-, without any drug injection nor direct therapeutic benefit for the participating patients and 12 healthy controls.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SpA HLA-B27 +, | Experimental | Biological: blood samples |
| SpA HLA-B27- | Experimental | Biological: blood samples |
| healthy subject | Active comparator | Biological: blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent of the patient signed before any procedure planned to the protocol
- SPA axial according to the criteria of the ASAS (international Assessment of SpondyloArthritis Society)
- Known Status HLA B27
- Disease activates with a score of BASDAI = 4/10. The BASDAI (Bath Ankylosing Spondylitis Disease Activity Score) is a composite indication(index), validated, used in the therapeutic essays and in current practice for the evaluation of the activity of the SPA.
- Naive Patients of thorough treatment
Key exclusion criteria (13 listed)
- Minors
- Pregnant or breast-feeding Women
- Adults under guardianship
- People staying in a sanitary or social establishment
- People in emergency situation
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 samples7 tubes of 6 ml (42 ml of blood ) | Biological | SpA HLA-B27 +,, SpA HLA-B27-, healthy subject |
Primary outcome
Characterize the present various immunizing populations in patients' blood SPA HLA-B27 + and HLA-B27-(Lymphocytes T CD4 (Th1 Th2, Th17, Tregs), lymphocytes T CD8, cells NK, lymphocytes B, monocytes)
Time frame: 12 MONTHS
by flow cytometry.
2 secondary outcomes
Expression of the receivers involved in SPA on lymphocytes T CD4 in percentage of cells T CD4 expressing this markers
Time frame: 12 MONTHS
Dosage of cytokines
Time frame: 12 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Results publication: PubMed 36124947Larid G, Trijau S, Barral C, Lafforgue P, Pham T. Absence of overexpression of KIR3DL2 on CD4+ T cells and NK cells in patients with axial spondyloarthritis. Rheumatology (Oxford). 2023 Apr 3;62(4):e114-e116. doi: 10.1093/rheumatology/keac546. No abstract available.
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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. This study is not recruiting at the moment.
jean olivier ARNAUD study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples in people with Axial Spondyloarthritis (axSpA) and Ankylosing Spondylitis (AS), run by Assistance Publique Hopitaux De Marseille at 1 site 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 6 inclusion and 13 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: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the present various immunizing populations in patients' blood SPA HLA-B27 + and HLA-B27-(Lymphocytes T CD4 (Th1 Th2, Th17, Tregs), lymphocytes T CD8, cells NK, lymphocytes B, monocytes) (time frame: 12 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03322618, which also lists 1 linked publication.
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 8 May 2026.