Calcium Pyrophosphate Deposition DiseasePhase 2TociCCAreNCT07254637
Tocilizumab in Chronic Inflammatory CPPD Disease
A Phase 2 study testing Tocilizumab in people with Calcium Pyrophosphate Deposition Disease, run by Assistance Publique - Hôpitaux de Paris at 12 sites in France.
Trial summary
The aim of this clinical trial is to determine the efficacy of tocilizumab (an IL-6 inhibitor) in treatment-refractory chronic inflammatory forms of CPPD. The main questions this trial aims to answer are: Can tocilizumab improve joint pain in patients with chronic inflammatory CPPD disease? Does tocilizumab improve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcium Pyrophosphate Deposition Disease
- What is being tested?
- Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 12 sitesFrance
- Study dates
- Apr 2026to Nov 2029
- Phase
- Phase 2
- 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
- Adults > 18 years
- Diagnosis of CPPD according to ACR/EULAR 2023 classification criteria
- Persistent inflammatory pain (> 3 months) or ≥ 2 arthritics/month
- Number of painful joints (NAD) > 3
- Overall pain VAS (0_100) > 40 mm
- Failure, intolerance or impossibility of repeated use of usual treatments: colchicine, NSAIDs, corticosteroids and anakinra
- Use of an effective method of contraception in women of childbearing age until 3 months after the end of the study.
- Informed consent
Who cannot join
- Presence of anti-CPP antibodies > 50 IU/ml
- Recurrent or chronic infections
- History of severe infection (= requiring hospitalization)
- Active infection
- Vaccination with live or attenuated vaccine within 4 weeks prior to inclusion
- History of intestinal ulceration or diverticulitis Untreated latent tuberculosis
Show all 25Show fewer
- History of viral hepatitis B ou C
- Symptoms suggestive of demyelinating disease of the central nervous system
- History of cancer, active cancer, or suspected cancer
- Neutropenia < 2000 elements/mm3, thrombocytopenia < 100 000/mm3
- Elevated transaminases > 3 x ULN
- Known hypersensitivity to the active substance or one of the excipients;
- Known severe immune deficiency
- Patients not meeting classification criteria
- Concomitant treatment with biological or targeted therapies, or immunosuppressive therapy (including methotrexate, leflunomide, azathioprine), systemic corticosteroids, anakinra, IL-6 inhibitors in subcutaneous injection, anti-TNF agents, and JAK. If these treatments are used before inclusion, a washout period corresponding to at least five times their respective mean terminal half-life must be respected.
- inhibitors.
- Previous treatment with tocilizumab
- Concomitant treatment with methylprednisolone, dexamethasone, atorvastatin, calcium channel blockers, theophylline, warfarin, phenprocoumon, phenytoin, cyclosporine or benzodiazepines
- Dyslipidemia, hypertension or poorly controlled cardiovascular disease
- Scheduled surgery
- Difficulty to understand French, illiteracy
- Pregnant women, women in labor or nursing mothers
- Persons deprived of their liberty, adults under legal protection or unable to express their consent
- Persons not affiliated to a social security scheme or beneficiaries of such a scheme
- Participation in another interventional study
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
France12 sites
Centre Hospitalier Sud-Francilien
Corbeil-Essonnes, Paris, 91100
HILLIQUIN Pascal, Dr, 0161693128, pascal.hilliquin@chsf.fr
CHU de Dijon
Dijon, 21000
RAMON André, Dr, 0380293745, andre.ramon@chu-dijon.fr
Groupe Hospitalier de l'Institut Catholique de Lille
Lomme, Lille, 59462
PASCART Tristan, Dr, 0320225059, pascart.tristan@ghicl.net
CHU de Nantes
Nantes, 44000
LE GOFF Benoit, Dr, 0240083333, benoit.legoff@chu-nantes.fr
Lariboisière hospital
Paris, Paris Paris, 75010
Hôpital Bichat Claude-Bernard
Paris, 75018
OTTAVIANI Sébastien, 0140258739, sebastien.ottaviani@aphp.fr
Hôpital de la Croix Saint-Simon
Paris, 75020
CHAZERAIN Pascal, Dr, 0144641782, PChazerain@hopital-dcss.org
Hôpital Tenon
Paris, 75020
LETAVERNIER Emmanuel, Pr, 0156016773, emmanuel.letavernier@aphp.fr
Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
Paris, 93370
DELLAL Azzedine, Dr, 0141708766, azeddine.dellal@ght-gpne.fr
Hôpital Le Kremlin Bicêtre
Paris, 94270
CHU de Rennes
Rennes, 35200
CHOTARD Emilie, Dr, 0299267140, Emilie.CHOTARD@chu-rennes.fr
CHU de Saint-Étienne
Saint-Etienne, 42100
MAROTTE Hubert, Pr, 0477127643, hubert.marotte@chu-st-etienne.fr
About this study
Official title: Randomized, Double-blind, Multicentre Trial of Tocilizumab Versus Placebo in Chronic Polyarticular Inflammatory of Calcium Pyrophosphate Deposition Disease Refractory to Standard Treatments
The aim of this clinical trial is to determine the efficacy of tocilizumab (an IL-6 inhibitor) in treatment-refractory chronic inflammatory forms of CPPD.
The main questions this trial aims to answer are:
- Can tocilizumab improve joint pain in patients with chronic inflammatory CPPD disease?
- Does tocilizumab improve quality of life in patients with chronic inflammatory CPPD disease?
Participants will receive a monthly infusion of tocilizumab or placebo for three months.
Read the detailed description
Calcium pyrophosphate deposition (CPPD) disease affects 4 to 7% of the adult population. CPP crystals are responsible for inflammatory flares affecting one or more joints. The inflammation triggered by CPP crystals resembles that associated with sodium urate crystals in gout and depends on inflammatory cytokines such as interleukins (IL-) 1β and -6. The usual treatments are those used in gout flares (colchicine, NSAIDs, corticosteroids, IL-1β inhibitors), and most often control monoarticular involvement. The chronic inflammatory polyarticular form, on the other hand, is more difficult to treat, causing significant pain and disability, as well as joint destruction. In refractory forms, or in cases of intolerance to standard treatments, alternative therapies are required. In this context, the investigators treated 11 patients with refractory chronic inflammatory CPPD with tocilizumab (TCZ), an anti-IL-6 receptor (IL-6R) monoclonal antibody. After 3 monthly infusions, improvement was estimated at over 75% (PMID 2213498). Our hypothesis is that inhibiting IL-6 is an effective therapeutic option in chronic inflammatory CPPD refractory to conventional therapies.
Main objective and primary endpoint:
- To demonstrate the efficacy of IL-6 inhibition in treatment-refractory chronic inflammatory forms of CPPD disease.
- Our endpoint will be the change in global pain VAS between initiation and M4, i.e. one month after the 3rd infusion. VAS will be assessed after 24 hours off analgesics.
Secondary objectives and endpoints:
- Efficacy: DAS44, number of swollen, painful joints, overall disease activity VAS, fatigue VAS; overall effect on pain: area under the VAS curve (AUC); proportion of patients responding from M2 to M6 (improvement ≥ 50% of initial pain VAS) and complete response (improvement ≥ 80% of initial pain VAS); relapse rate; improvement in quality of life (SF-36, HAQ, EQ-5D-3L questionnaires)
- Tolerance: infusion reactions, infections, neutropenia, hepatic cytolysis, lipid profile
This is a phase III, multicentre, randomized, controlled, double-blind, superiority study, including 2 parallel groups with a 1:1 distribution. This trial will involve adults suffering from the chronic inflammatory polyarticular form of CPPD disease.
This study will involve 80 participants recruited in 12 centres in France.
- Conditions
- Calcium Pyrophosphate Deposition Disease
- Being tested
- Tocilizumab, Placebo
- Medical subject headings
- Chondrocalcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Tocilizumab, 8 mg/kg/month, IV infusion for 3 months
Tocilizumab, an anti-IL-6R monoclonal antibody, was approved in January 2009 for the treatment of rheumatoid arthritis. Its indications have since been extended, particularly for the treatment of giant cell arteritis, juvenile chronic arthritis, and severe cytokine release syndrome induced by chimeric antigen receptor T-cell (CAR-T) therapy.
PlaceboOther
Saline placebo, IV infusion / month for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab | Experimental | Not described Receives: Drug: Tocilizumab |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overall pain VAS
Overall pain will be assessed, after 24 hours of discontinuation of analgesics, using a visual analogue scale (VAS) ranging from 0 (no pain) to 100 mm (worst pain ever experienced), at inclusion, before each infusion at months M1, M2, M3, then at M4 (primary outcome) and M6.
Measured: 6 months
Secondary outcomes (14)
Change in the number of swollen and tender joints
Disease Activity Score (DAS44), number of swollen and painful joints, Patient assessment of overall disease activity by a visual analogue scale (VAS) ranging from 0 (no activity) to 100 mm (maximal activity). Those outcomes will be assessed at inclusion, before each infusion at months M1, M2, M3, then at M4 (primary outcome) and M6
Measured: 6 months
Overall effect on pain
Area under the curve (AUC) of the overall pain visual analogue scale (VAS) ranging from 0 (no pain) to 100 mm (worst pain ever experienced) based on assessments at baseline, before each infusion at months M1, M2, M3 and at M4 and M6 (end of the study). Overall pain VAS will be collected after a 24-hour washout of analgesics.
Measured: 6 months
Response to treatment / relapse
Response to treatment will be defined as an improvement ≥ 50% of initial pain visual analogue scale (VAS) ranging from 0 (no pain) to 100 mm (worst pain ever experienced) Complete response will be defined as an improvement ≥ 80% of initial pain VAS This outcome will be assessed from M2 to M6.
Relapse will be assessed in responders at 6 months, and the time from response to relapse will be determined.
Measured: 6 months
Flares (ESR)
Outcome Measures - Inflammatory Biomarkers
Erythrocyte Sedimentation Rate (ESR) Unit: millimeters (mm) Frequency: measured at each visit
No aggregation of this measure is planned to produce a composite value. If aggregation is considered (e.g., to generate an overall inflammation score), a validated statistical method will be specified.
Measured: 6 months
Flares (CRP)
Outcome Measures - Inflammatory Biomarkers
C-reactive Protein (CRP) Unit: milligrams per liter (mg/L) Frequency: measured at each visit
No aggregation of this measure is planned to produce a composite value. If aggregation is considered (e.g., to generate an overall inflammation score), a validated statistical method will be specified.
Measured: 6 months
Flares (IL-6)
Outcome Measures - Inflammatory Biomarkers
Interleukin-6 (IL-6) Unit: picograms per milliliter (pg/mL) Frequency: measured at each visit
No aggregation of this measure is planned to produce a composite value. If aggregation is considered (e.g., to generate an overall inflammation score), a validated statistical method will be specified.
Measured: 6 months
Quality of life's Questionnaires (SF-36)
Full Title: Short Form 36 Health Survey (SF-36) Scale Range: 0 to 100 per subscale Interpretation: Higher scores indicate better health status or quality of life Time Points: Baseline, prior to each infusion, and at Months 4 and 6 (M4 and M6) Unit: Score
This questionnaire will be analyzed and reported as a distinct outcome measure, in accordance with its specific scoring system.
Measured: 6 months
Quality of life's Questionnaires (HAQ)
Full Title: Health Assessment Questionnaire (HAQ) Scale Range: 0 to 3 Interpretation: Higher scores indicate worse functional ability (i.e., more disability) Time Points: Baseline, prior to each infusion, and at Months 4 and 6 (M4 and M6) Unit: Score
This questionnaire will be analyzed and reported as a distinct outcome measure, in accordance with its specific scoring system.
Measured: 6 months
Quality of life's Questionnaires (EQ-5D-3L)
Full Title: EuroQol Five Dimensions Three Levels (EQ-5D-3L) Scale Range: 0 to 100 Interpretation: Higher scores indicate better health-related quality of life Time Points: Baseline, prior to each infusion, and at Months 4 and 6 (M4 and M6) Unit: Index value
This questionnaire will be analyzed and reported as a distinct outcome measure, in accordance with its specific scoring system.
Measured: 6 months
Patient Safety - Number of Participants with Adverse Events
Outcome Measure - Number of Participants with Adverse Events
Description: Number of participants experiencing any of the following safety-related events at each visit:
- Infusion reactions
- Neutropenia
- Thrombocytopenia
- Hepatic cytolysis
- Severe infections
- Treatment-related adverse events
- Abnormal changes in lipid profile
Unit of Measure: Count (participants) Time Points: Each visit Note: Each event type will be recorded and analyzed separately but reported under a unified outcome measure to reflect overall safety.
Measured: 6 months
Patient Safety - Number of patients with abnormal laboratory tests results - Mean Neutrophil Count
Description: Mean neutrophil count measured from blood samples collected at each visit.
Unit of Measure: normal: 2500-8000/μL; AE: <1500/μL
Measured: 6 months
Patient Safety - Number of patients with abnormal laboratory tests results - Mean Platelet Count
Description: Mean platelet count measured from blood samples collected at each visit.
Unit of Measure: normal: 150,000-400,000/μL; AE: <75,000/μL
Measured: 6 months
Patient Safety - Number of patients with abnormal laboratory tests results - Mean Transaminase Levels
Description: Mean levels of transaminases (e.g., ALT, AST) measured to assess hepatic cytolysis.
Unit of Measure: ALT/AST normal: <40 U/L; AE: >3×ULN
Measured: 6 months
Patient Safety - Number of patients with abnormal laboratory tests results - Mean Lipid Profile Values
Description: Mean values of lipid profile components (e.g., total cholesterol, LDL, HDL, triglycerides) measured at each visit.
Unit of Measure: normal: TC <200, LDL <130, HDL >45/55, TG <150 mg/dL
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study startApr 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcium Pyrophosphate Deposition DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- TociCCAre is a phase II, randomised, double-blind, placebo-controlled comparative study. The study aims to demonstrate the efficacy of tocilizumab in treating chronic polyarticular inflammation associated with CPP crystals. It is a superiority study with 1:1 randomisation into two parallel groups. This multicentre study has 12 participating centres, including centres specialising in microcrystalline diseases and a reference centre for Gitelman syndrome (one of whose complications is extensive PPC crystal deposition), located at the HEGP hospital in Paris. Patients will be enrolled during consultations and hospitalisations by the principal investigator or their co-investigators.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254637
- Sponsor's protocol ID
- APHP220790
- Acronym
- TociCCAre
- Status last verified
- Nov 2025
- First submitted
- 14 Aug 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Multicentre Trial of Tocilizumab Versus Placebo in Chronic Polyarticular Inflammatory of Calcium Pyrophosphate Deposition Disease Refractory to Standard Treatments
- ClinicalTrials.gov ID
- NCT07254637
- Acronym / sponsor ID
- TociCCAre / APHP220790
- Conditions
- Calcium Pyrophosphate Deposition Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fresenius AG
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 28 Nov 2025 (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 aim of this clinical trial is to determine the efficacy of tocilizumab (an IL-6 inhibitor) in treatment-refractory chronic inflammatory forms of CPPD.
The main questions this trial aims to answer are:
- Can tocilizumab improve joint pain in patients with chronic inflammatory CPPD disease?
- Does tocilizumab improve quality of life in patients with chronic inflammatory CPPD disease?
Participants will receive a monthly infusion of tocilizumab or placebo for three months.
Detailed description
Calcium pyrophosphate deposition (CPPD) disease affects 4 to 7% of the adult population. CPP crystals are responsible for inflammatory flares affecting one or more joints. The inflammation triggered by CPP crystals resembles that associated with sodium urate crystals in gout and depends on inflammatory cytokines such as interleukins (IL-) 1β and -6. The usual treatments are those used in gout flares (colchicine, NSAIDs, corticosteroids, IL-1β inhibitors), and most often control monoarticular involvement. The chronic inflammatory polyarticular form, on the other hand, is more difficult to treat, causing significant pain and disability, as well as joint destruction. In refractory forms, or in cases of intolerance to standard treatments, alternative therapies are required. In this context, the investigators treated 11 patients with refractory chronic inflammatory CPPD with tocilizumab (TCZ), an anti-IL-6 receptor (IL-6R) monoclonal antibody. After 3 monthly infusions, improvement was estimated at over 75% (PMID 2213498). Our hypothesis is that inhibiting IL-6 is an effective therapeutic option in chronic inflammatory CPPD refractory to conventional therapies.
Main objective and primary endpoint:
- To demonstrate the efficacy of IL-6 inhibition in treatment-refractory chronic inflammatory forms of CPPD disease.
- Our endpoint will be the change in global pain VAS between initiation and M4, i.e. one month after the 3rd infusion. VAS will be assessed after 24 hours off analgesics.
Secondary objectives and endpoints:
- Efficacy: DAS44, number of swollen, painful joints, overall disease activity VAS, fatigue VAS; overall effect on pain: area under the VAS curve (AUC); proportion of patients responding from M2 to M6 (improvement ≥ 50% of initial pain VAS) and complete response (improvement ≥ 80% of initial pain VAS); relapse rate; improvement in quality of life (SF-36, HAQ, EQ-5D-3L questionnaires)
- Tolerance: infusion reactions, infections, neutropenia, hepatic cytolysis, lipid profile
This is a phase III, multicentre, randomized, controlled, double-blind, superiority study, including 2 parallel groups with a 1:1 distribution. This trial will involve adults suffering from the chronic inflammatory polyarticular form of CPPD disease.
This study will involve 80 participants recruited in 12 centres in France.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- TociCCAre is a phase II, randomised, double-blind, placebo-controlled comparative study. The study aims to demonstrate the efficacy of tocilizumab in treating chronic polyarticular inflammation associated with CPP crystals. It is a superiority study with 1:1 randomisation into two parallel groups. This multicentre study has 12 participating centres, including centres specialising in microcrystalline diseases and a reference centre for Gitelman syndrome (one of whose complications is extensive PPC crystal deposition), located at the HEGP hospital in Paris. Patients will be enrolled during consultations and hospitalisations by the principal investigator or their co-investigators.
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab | Experimental | Drug: Tocilizumab |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults > 18 years
- Diagnosis of CPPD according to ACR/EULAR 2023 classification criteria
- Persistent inflammatory pain (> 3 months) or ≥ 2 arthritics/month
- Number of painful joints (NAD) > 3
- Overall pain VAS (0_100) > 40 mm
Key exclusion criteria (25 listed)
- Presence of anti-CPP antibodies > 50 IU/ml
- Recurrent or chronic infections
- History of severe infection (= requiring hospitalization)
- Active infection
- Vaccination with live or attenuated vaccine within 4 weeks prior to inclusion
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 |
|---|---|---|
| TocilizumabTocilizumab, 8 mg/kg/month, IV infusion for 3 months Tocilizumab, an anti-IL-6R monoclonal antibody, was approved in January 2009 for the treatment of rheumatoid arthritis. Its indications have since been extended, particularly for the treatment of giant cell arteritis, juvenile chronic arthritis, and severe cytokine release syndrome induced by chimeric antigen receptor T-cell (CAR-T) therapy. | Drug | Tocilizumab |
| PlaceboSaline placebo, IV infusion / month for 3 months | Other | Placebo |
Primary outcome
Change in overall pain VAS
Time frame: 6 months
Overall pain will be assessed, after 24 hours of discontinuation of analgesics, using a visual analogue scale (VAS) ranging from 0 (no pain) to 100 mm (worst pain ever experienced), at inclusion, before each infusion at months M1, M2, M3, then at M4 (primary outcome) and M6.
14 secondary outcomes
Change in the number of swollen and tender joints
Time frame: 6 months
Overall effect on pain
Time frame: 6 months
Response to treatment / relapse
Time frame: 6 months
Flares (ESR)
Time frame: 6 months
Flares (CRP)
Time frame: 6 months
Flares (IL-6)
Time frame: 6 months
Quality of life's Questionnaires (SF-36)
Time frame: 6 months
Quality of life's Questionnaires (HAQ)
Time frame: 6 months
Quality of life's Questionnaires (EQ-5D-3L)
Time frame: 6 months
Patient Safety - Number of Participants with Adverse Events
Time frame: 6 months
Patient Safety - Number of patients with abnormal laboratory tests results - Mean Neutrophil Count
Time frame: 6 months
Patient Safety - Number of patients with abnormal laboratory tests results - Mean Platelet Count
Time frame: 6 months
Patient Safety - Number of patients with abnormal laboratory tests results - Mean Transaminase Levels
Time frame: 6 months
Patient Safety - Number of patients with abnormal laboratory tests results - Mean Lipid Profile Values
Time frame: 6 months
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 14 Jan 2026.
- Individual participant dataSharing planned: No
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tocilizumab in people with Calcium Pyrophosphate Deposition Disease, run by Assistance Publique - Hôpitaux de Paris at 12 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 8 inclusion and 25 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: opening soon, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Augustin Latourte, Associate Professor (+33 1 49 95 62 90, augustin.latourte@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in overall pain VAS (time frame: 6 months). 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 14 Jan 2026.