Phase 3 Vasculitis Trial, Recruiting (NCT04656184)

Phase 3 Vasculitis Trial, Recruiting NCT04656184 Sponsor: Assistance Publique - Hôpitaux de Paris Condition: Vasculitis

Printed from Voxsanity (voxsanity.com.au) — NCT04656184 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Vasculitis

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Children (both boys and girls) between 3 months and under 18 years of age
Children who weigh at least 5 kg (about 11 pounds)
Children diagnosed with Kawasaki Disease (KD) — either the full or incomplete form — based on American Heart Association guidelines, which includes having a fever for 5 or more days (or at least 3 days in some cases) plus 4 or more of 5 specific symptoms such as changes to the hands/feet, a rash, red eyes, red lips or mouth, or swollen neck lymph nodes
Children whose fever has not gone away or has come back (38°C/100.4°F or higher) at least 48 hours after receiving the standard treatment (an IV immunoglobulin infusion at 2g/kg); screening may begin 24 hours after the infusion if the child still has a fever
Written consent from the patient, parent, or legal guardian is provided
The child has health insurance coverage
Girls of childbearing age must be using effective contraception for the duration of the trial

Who may not be able to join:

Babies born prematurely or newborns, or anyone who is pregnant or breastfeeding
Children where another diagnosis is suspected instead of Kawasaki Disease
Children who currently have a bacterial, viral, or fungal infection alongside their condition
Children who have already been treated with steroids or certain other biologic medications
Children considered at increased risk of tuberculosis, or who have had a recent or currently active tuberculosis infection
Children with any type of immune system disorder or cancer
Children with severely reduced kidney function (confirm with trial site)
Children with liver insufficiency
Children with a low level of a type of white blood cell called neutrophils (confirm with trial site)
Children already taking part in another interventional clinical trial
Children currently taking certain fever-reducing medications (such as paracetamol or anti-inflammatory drugs other than aspirin used for Kawasaki Disease) while on the study medication
Children who have recently taken certain immune-suppressing medications (such as steroids, cyclosporine, or certain biologic drugs) within a specific time window before the study medication is given (confirm with trial site)
Children with a known allergy or sensitivity to anakinra or any of its ingredients (citric acid, sodium chloride, disodium EDTA, polysorbate 80, sodium hydroxide)
Children with a known allergy or sensitivity to IV immunoglobulin or its ingredients (L-proline), or who have antibodies against IgA (a type of immune protein)
Children with a condition called type I or type II hyperprolinemia (a rare metabolic disorder)
Children who have received a live vaccine within 1 month before joining the trial
Children with any other allergy to the study drugs (Kineret® or Privigen®) or to E. coli proteins
Children taking medications that are known to interact with a specific liver enzyme pathway (cytochrome P450) (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 28 July 2026

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 00 33 1 45 21 32 46

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT04656184

Sponsor: Assistance Publique - Hôpitaux de Paris

Phase: Phase 3

Status: Recruiting

Condition: Vasculitis

Trial contact: 00 33 1 45 21 32 46

More information: https://clinicaltrials.gov/study/NCT04656184

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Children (both boys and girls) between 3 months and under 18 years of age
Children who weigh at least 5 kg (about 11 pounds)
Children diagnosed with Kawasaki Disease (KD) — either the full or incomplete form — based on American Heart Association guidelines, which includes having a fever for 5 or more days (or at least 3 days in some cases) plus 4 or more of 5 specific symptoms such as changes to the hands/feet, a rash, red eyes, red lips or mouth, or swollen neck lymph nodes
Children whose fever has not gone away or has come back (38°C/100.4°F or higher) at least 48 hours after receiving the standard treatment (an IV immunoglobulin infusion at 2g/kg); screening may begin 24 hours after the infusion if the child still has a fever
Written consent from the patient, parent, or legal guardian is provided
The child has health insurance coverage
Girls of childbearing age must be using effective contraception for the duration of the trial

Who may not be able to join:

Babies born prematurely or newborns, or anyone who is pregnant or breastfeeding
Children where another diagnosis is suspected instead of Kawasaki Disease
Children who currently have a bacterial, viral, or fungal infection alongside their condition
Children who have already been treated with steroids or certain other biologic medications
Children considered at increased risk of tuberculosis, or who have had a recent or currently active tuberculosis infection
Children with any type of immune system disorder or cancer
Children with severely reduced kidney function (confirm with trial site)
Children with liver insufficiency
Children with a low level of a type of white blood cell called neutrophils (confirm with trial site)
Children already taking part in another interventional clinical trial
Children currently taking certain fever-reducing medications (such as paracetamol or anti-inflammatory drugs other than aspirin used for Kawasaki Disease) while on the study medication
Children who have recently taken certain immune-suppressing medications (such as steroids, cyclosporine, or certain biologic drugs) within a specific time window before the study medication is given (confirm with trial site)
Children with a known allergy or sensitivity to anakinra or any of its ingredients (citric acid, sodium chloride, disodium EDTA, polysorbate 80, sodium hydroxide)
Children with a known allergy or sensitivity to IV immunoglobulin or its ingredients (L-proline), or who have antibodies against IgA (a type of immune protein)
Children with a condition called type I or type II hyperprolinemia (a rare metabolic disorder)
Children who have received a live vaccine within 1 month before joining the trial
Children with any other allergy to the study drugs (Kineret® or Privigen®) or to E. coli proteins
Children taking medications that are known to interact with a specific liver enzyme pathway (cytochrome P450) (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 3

Sponsor

Assistance Publique - Hôpitaux de Paris

Registry

ClinicalTrials.gov

Start date

20 October 2023

Est. completion

1 March 2027

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Fever

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov