Kawasaki DiseasePhase 4NIKITANCT06697431

Non Inferiority KawasakI Trial With Anakinra

A Phase 4 study testing Anakinra and Intravenous Immunoglobulins, Human in people with Kawasaki Disease and Anakinra, run by Meyer Children's Hospital IRCCS.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This is a multicenter, open-label, randomized, controlled, interventional trial followed by a long-term observational extension period in patients with Kawasaki Disease (KD) to be treated eitherwith endovenous Immunoglobulins (IVIG-standard treatment) versus anakinra Aim of the study: to demonstrate that anakinra is… Read more about this study

Who is it for?: Ages 1 month to 16 years
Conditions the study is for: Kawasaki Disease, Anakinra
What is being tested?: Anakinra and Intravenous Immunoglobulins, Human
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 1 Apr 2026to 1 Apr 2027
Phase: Phase 4
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 1 month to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

KD defined in at least one of the three following ways as per American Heart Association (AHA) criteria: Fever for at least 5 days in addition to 4 of the following 5 clinical criteria:
bilateral non-purulent conjunctivitis
cervical lymphadenopathy
polymorphous skin rash
changes in lips or mucosa (strawberry tongue, red cracked lips, diffuse erythematous oropharynx)
extremity changes (erythema, oedema of palms and soles in initial phase, and at convalescent stage skin peeling)

Show all 14Show fewer

less than 5 days of fever but all 5 clinical criteria above
incomplete KD cases defined as:
children/adolescents (>1 year old) with fever greater than or equal to 5 days AND at least 2 other compatible clinical criteria as listed above;
OR infants ≤ 1 year old with fever greater than or equal to 7 days without other explanation;
AND for both age groups, CRP ≥30 mg/L or erythrocyte sedimentation rate (ESR) ≥40 mm/hr (or both) AND for both age groups EITHER the presence of any 3 or more of: anaemia for age (haemoglobin < lower limit of normal reference range for local laboratory); platelet count ≥450,000/L or <140,000/L; albumin <30 g/L; elevated ALT (> upper limit of normal reference range for local laboratory); white cell count ≥15,000/L; urine ≥10 white blood cells per high power field iv.
OR abnormal echocardiogram compatible with KD but without established CAA, with ≥ 3 of the following suggestive features: decreased left ventricular function, mitral regurgitation, pericardial effusion, or dilated but non-aneurysmal coronary arteries (internal diameter 2≤Z<2.5; and not meeting the exclusion criteria for aneurysmal change as defined below).
To be enrolled children need to show persistent fever ≤7 days
Written informed consent from an appropriate legal representative(s), and assent from patients older than 7 years

Who cannot join

Patients with KD and already established coronary artery aneurysms (CAA), as per AHA definition, at screening.
Clinical picture consistent with Kawasaki Shock Syndrome (KDSS) or Macrophage Activation Syndrome (MAS) OR Multisystem Inflammatory Syndrome in Children (MIS-C)
History or evidence of any previous heart disease
Known hypersensitivity to anakinra, IVIG and ASA or any medical condition that contraindicates the use of these treatments
Patients with KD receiving IVIG, corticosteroids, immunosuppressants, biologic treatments at the time of screening

About this study

Official title: A Randomized, Controlled, Open-label, Non Inferiority KawasakI Trial With Anakinra

Aim of the study: to demonstrate that anakinra is non-inferior to IVIG in KD, in terms of fever control in the acute phase and development of coronary artery dilation/aneurisms (CAA) within one year from the onset.

Read the detailed description

This is a multicenter national, open label, randomized, controlled, interventional trial followed by a long-term observational extension period. This is a non-inferiority study Patients who fulfill the eligibility criteria and whose parent/carer (legal representative) has provided informed consent will be randomized 1:1 to receive either

IVIG 2g/kg administered in 10-12 hours as per local standard of care (standard treatment) OR
Anakinra 2mg/kg intravenously, max 100 mg/dose 4 times/day (investigational treatment)

PLUS Aspirin (ASA) 50mg/kg QID until 36 hours from fever disappearance, then switched to low-dose (3-5 mg/Kg once a day) as per standard of care

Conditions: Kawasaki Disease, Anakinra
Being tested: Anakinra, Intravenous Immunoglobulins, Human
Medical subject headings: Mucocutaneous Lymph Node Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AnakinraDrug
Also called Kineret
Patients who fulfill the eligibility criteria a will be randomized 1:1 to receive either
1. IVIG 2g/kg administered in 10-12 hours as per local standard of care (standard treatment) OR
2. Anakinra 2mg/kg intravenously, max 100 mg/dose 4 times/day (investigational treatment)
Patients showing fever, between 36 hours and 72 hours from the end of first line treatment will be considered failures. Failures from the investigational treatment arm will receive a dose of IVIG and they will drop from the study.
Children who remained afebrile between the 36th and 72nd hour will be considered as responders, and they will proceed into the study.
Patients in the standard treatment arm will continue ancillary treatment and follow-up .
Patients in the investigational treatment arm will enter the tapering phase.
Intravenous Immunoglobulins, HumanDrug
Also called IVIG
see previous section

Study groups in NCT06697431
Study group	Role	What they receive
Anakinra	Experimental	Anakinra 2mg/kg intravenously, max 100 mg/dose 4 times/day Receives: Drug: Anakinra
Intravenous immunoglobulins	Active comparator	IVIG 2g/kg administered in 10-12 hours as per local standard of care Receives: Drug: Intravenous Immunoglobulins, Human

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of patients with treatment response in both treatment arms
Response rate
Measured: 12 months
Number of patients with CAA (as per Z-scores) at the end of the study period in both treatment arms
CAA rate in both arms. CAAs will be classified in accordance with the scheme based on Z scores proposed by AHA. No coronary involvement with Z score <2, dilation only with Z score > 2 to <2.5 or if initially <2 with a decrease during follow-up ≥1 3, small aneurysm with Z score ≥2.5 to <5, medium aneurysm with Z score ≥5 to <10 and absolute dimension <8 mm and large or giant aneurysm with Z score ≥10, or absolute dimension ≥8 mm
Measured: 12 months

Secondary outcomes (8)

Number of days with fever in both treatment arms
Fever as defined as T>38°C
Measured: 90 days
Time to reach CRP values<50% from the highest value and to normalize it in both treatment arms (days)
CRP values expressed in mg/dL
Measured: 90 days
Time to normalize coronary artery abnormalities (days)
CAAs will be classified in accordance with the scheme based on Z scores proposed by AHA. No coronary involvement with Z score <2, dilation only with Z score > 2 to <2.5 or if initially <2 with a decrease during follow-up ≥1 3, small aneurysm with Z score ≥2.5 to <5, medium aneurysm with Z score ≥5 to <10 and absolute dimension <8 mm and large or giant aneurysm with Z score ≥10, or absolute dimension ≥8 mm
Measured: 90 days
Severity of coronary artery abnormalities (as per Z-score) at the end of follow-up
CAAs will be classified in accordance with the scheme based on Z scores proposed by AHA. No coronary involvement with Z score <2, dilation only with Z score > 2 to <2.5 or if initially <2 with a decrease during follow-up ≥1 3, small aneurysm with Z score ≥2.5 to <5, medium aneurysm with Z score ≥5 to <10 and absolute dimension <8 mm and large or giant aneurysm with Z score ≥10, or absolute dimension ≥8 mm
Measured: 24 months
Length of hospitalization in both treatment arms (days)
Defined by days of hospitalization from disease onset to discharge
Measured: 90 days
Time to stop anakinra (days)
From the first administration iv to the last sc
Measured: 90 days
Adverse event and severe adverse event developed during the study and follow/up period
Medical Dictionary for Regulatory Activities (MeDRA) will be used for the description of adverse events (AEs), according to the regulatory requirements
Measured: 24 months
Cumulative drug exposure (mg/kg/day)
Calculated for both iv e sc administration
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20261 Apr 2027

First posted20 Nov 2024
Study start1 Apr 2026 (estimated)
Primary completion1 Apr 2026 (estimated)
Study completion1 Apr 2027 (estimated)

Why it stopped: The study protocol was never submitted to the Ethics Committee because the study design was significantly modified and a new funding was secured.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
More trials run by Meyer Children's Hospital IRCCSThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Patients who fulfill the eligibility criteria and whose parent/carer (legal representative) have provided informed consent will be randomized 1:1 to receive standard of care IVIG and aspirin or anakinra and ASA. As epidemiological data suggest worse outcomes in terms of CAA for very young patients (age \<1 years), in this setting, proper randomisation 1:1 procedure will be matched for age \< or\> than 1 year
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06697431
Sponsor's protocol ID: NIKITA
Acronym: NIKITA
Status last verified: Oct 2026
First submitted: 1 Nov 2024
Last updated: 26 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Yang J, Jain S, Capparelli EV, Best BM, Son MB, Baker A, Newburger JW, Franco A, Printz BF, He F, Shimizu C, Hoshino S, Bainto E, Moreno E, Pancheri J, Burns JC, Tremoulet AH. Anakinra Treatment in Patients with Acute Kawasaki Disease with Coronary Artery Aneurysms: A Phase I/IIa Trial. J Pediatr. 2022 Apr;243:173-180.e8. doi: 10.1016/j.jpeds.2021.12.035. Epub 2021 Dec 23.
PubMed 34953816
Kone-Paut I, Tellier S, Belot A, Brochard K, Guitton C, Marie I, Meinzer U, Cherqaoui B, Galeotti C, Boukhedouni N, Agostini H, Arditi M, Lambert V, Piedvache C. Phase II Open Label Study of Anakinra in Intravenous Immunoglobulin-Resistant Kawasaki Disease. Arthritis Rheumatol. 2021 Jan;73(1):151-161. doi: 10.1002/art.41481. Epub 2020 Nov 17.
PubMed 32779863
Kessel C, Kone-Paut I, Tellier S, Belot A, Masjosthusmann K, Wittkowski H, Fuehner S, Rossi-Semerano L, Dusser P, Marie I, Boukhedouni N, Agostini H, Piedvache C, Foell D. An Immunological Axis Involving Interleukin 1beta and Leucine-Rich-alpha2-Glycoprotein Reflects Therapeutic Response of Children with Kawasaki Disease: Implications from the KAWAKINRA Trial. J Clin Immunol. 2022 Aug;42(6):1330-1341. doi: 10.1007/s10875-022-01301-w. Epub 2022 Jun 14.
PubMed 35699824
Blonz G, Lacroix S, Benbrik N, Warin-Fresse K, Masseau A, Trewick D, Hamidou M, Stephan JL, Neel A. Severe Late-Onset Kawasaki Disease Successfully Treated With Anakinra. J Clin Rheumatol. 2020 Mar;26(2):e42-e43. doi: 10.1097/RHU.0000000000000814. No abstract available.
PubMed 32073531
Bossi G, Codazzi AC, Vinci F, Clerici E, Regalbuto C, Crapanzano C, Veraldi D, Moiraghi A, Marseglia GL. Efficacy of Anakinra on Multiple Coronary Arteries Aneurysms in an Infant with Recurrent Kawasaki Disease, Complicated by Macrophage Activation Syndrome. Children (Basel). 2022 May 5;9(5):672. doi: 10.3390/children9050672.
PubMed 35626849
Maniscalco V, Abu-Rumeileh S, Mastrolia MV, Marrani E, Maccora I, Pagnini I, Simonini G. The off-label use of anakinra in pediatric systemic autoinflammatory diseases. Ther Adv Musculoskelet Dis. 2020 Oct 16;12:1759720X20959575. doi: 10.1177/1759720X20959575. eCollection 2020.
PubMed 33149772
Gambacorta A, Buonsenso D, De Rosa G, Lazzareschi I, Gatto A, Brancato F, Pata D, Valentini P. Resolution of Giant Coronary Aneurisms in a Child With Refractory Kawasaki Disease Treated With Anakinra. Front Pediatr. 2020 May 7;8:195. doi: 10.3389/fped.2020.00195. eCollection 2020.
PubMed 32457855
Mastrolia MV, Abbati G, Signorino C, Maccora I, Marrani E, Pagnini I, Simonini G. Early anti IL-1 treatment replaces steroids in refractory Kawasaki disease: clinical experience from two case reports. Ther Adv Musculoskelet Dis. 2021 Mar 29;13:1759720X211002593. doi: 10.1177/1759720X211002593. eCollection 2021.
PubMed 33854568

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 2/3
Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease
Kawasaki Disease
RecruitingPhase 4
Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease
Kawasaki Disease, Pilot Study
RecruitingObservational study
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension
RecruitingPhase 4
Rivaroxaban for Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease
Kawasaki Disease, Coronary Artery Aneurysm

All Kawasaki Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled, Open-label, Non Inferiority KawasakI Trial With Anakinra
ClinicalTrials.gov ID: NCT06697431
Acronym / sponsor ID: NIKITA / NIKITA
Conditions: Kawasaki Disease, Anakinra
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The study protocol was never submitted to the Ethics Committee because the study design was significantly modified and a new funding was secured.
Enrolment: 0 participants (actual)
Lead sponsor: Meyer Children's Hospital IRCCSUniversity, hospital or other
Collaborators: Asst Degli Spedali Civili Di Brescia, IRCCS Burlo Garofolo
Study start: 1 Apr 2026 (estimated)
Primary completion: 1 Apr 2026 (estimated)
Study completion: 1 Apr 2027 (estimated)
First posted: 20 Nov 2024 (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.

Detailed description

IVIG 2g/kg administered in 10-12 hours as per local standard of care (standard treatment) OR
Anakinra 2mg/kg intravenously, max 100 mg/dose 4 times/day (investigational treatment)

PLUS Aspirin (ASA) 50mg/kg QID until 36 hours from fever disappearance, then switched to low-dose (3-5 mg/Kg once a day) as per standard of care

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Patients who fulfill the eligibility criteria and whose parent/carer (legal representative) have provided informed consent will be randomized 1:1 to receive standard of care IVIG and aspirin or anakinra and ASA. As epidemiological data suggest worse outcomes in terms of CAA for very young patients (age <1 years), in this setting, proper randomisation 1:1 procedure will be matched for age < or> than 1 year

Arm	Type	Receives
Anakinra	Experimental	Drug: AnakinraAnakinra 2mg/kg intravenously, max 100 mg/dose 4 times/day
Intravenous immunoglobulins	Active comparator	Drug: Intravenous Immunoglobulins, HumanIVIG 2g/kg administered in 10-12 hours as per local standard of care

Who may qualify

Ages: 1 month to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (14 listed)

KD defined in at least one of the three following ways as per American Heart Association (AHA) criteria: Fever for at least 5 days in addition to 4 of the following 5 clinical criteria:
less than 5 days of fever but all 5 clinical criteria above
incomplete KD cases defined as:
AND for both age groups, CRP ≥30 mg/L or erythrocyte sedimentation rate (ESR) ≥40 mm/hr (or both) AND for both age groups EITHER the presence of any 3 or more of: anaemia for age (haemoglobin < lower limit of normal reference range for local laboratory); platelet count ≥450,000/L or <140,000/L; albumin <30 g/L; elevated ALT (> upper limit of normal reference range for local laboratory); white cell count ≥15,000/L; urine ≥10 white blood cells per high power field iv.
OR abnormal echocardiogram compatible with KD but without established CAA, with ≥ 3 of the following suggestive features: decreased left ventricular function, mitral regurgitation, pericardial effusion, or dilated but non-aneurysmal coronary arteries (internal diameter 2≤Z<2.5; and not meeting the exclusion criteria for aneurysmal change as defined below).

Key exclusion criteria (5 listed)

Patients with KD and already established coronary artery aneurysms (CAA), as per AHA definition, at screening.
Clinical picture consistent with Kawasaki Shock Syndrome (KDSS) or Macrophage Activation Syndrome (MAS) OR Multisystem Inflammatory Syndrome in Children (MIS-C)
History or evidence of any previous heart disease
Known hypersensitivity to anakinra, IVIG and ASA or any medical condition that contraindicates the use of these treatments
Patients with KD receiving IVIG, corticosteroids, immunosuppressants, biologic treatments at the time of screening

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
AnakinraAlso: KineretPatients who fulfill the eligibility criteria a will be randomized 1:1 to receive either 1. IVIG 2g/kg administered in 10-12 hours as per local standard of care (standard treatment) OR 2. Anakinra 2mg/kg intravenously, max 100 mg/dose 4 times/day (investigational treatment) Patients showing fever, between 36 hours and 72 hours from the end of first line treatment will be considered failures. Failures from the investigational treatment arm will receive a dose of IVIG and they will drop from the study. Children who remained afebrile between the 36th and 72nd hour will be considered as responders, and they will proceed into the study. Patients in the standard treatment arm will continue ancillary treatment and follow-up . Patients in the investigational treatment arm will enter the tapering phase.	Drug	Anakinra
Intravenous Immunoglobulins, HumanAlso: IVIGsee previous section	Drug	Intravenous immunoglobulins

Primary outcome

Number of patients with treatment response in both treatment arms
Time frame: 12 months
Response rate
Number of patients with CAA (as per Z-scores) at the end of the study period in both treatment arms
Time frame: 12 months
CAA rate in both arms. CAAs will be classified in accordance with the scheme based on Z scores proposed by AHA. No coronary involvement with Z score <2, dilation only with Z score > 2 to <2.5 or if initially <2 with a decrease during follow-up ≥1 3, small aneurysm with Z score ≥2.5 to <5, medium aneurysm with Z score ≥5 to <10 and absolute dimension <8 mm and large or giant aneurysm with Z score ≥10, or absolute dimension ≥8 mm

8 secondary outcomes

Number of days with fever in both treatment arms
Time frame: 90 days
Time to reach CRP values<50% from the highest value and to normalize it in both treatment arms (days)
Time frame: 90 days
Time to normalize coronary artery abnormalities (days)
Time frame: 90 days
Severity of coronary artery abnormalities (as per Z-score) at the end of follow-up
Time frame: 24 months
Length of hospitalization in both treatment arms (days)
Time frame: 90 days
Time to stop anakinra (days)
Time frame: 90 days
Adverse event and severe adverse event developed during the study and follow/up period
Time frame: 24 months
Cumulative drug exposure (mg/kg/day)
Time frame: 12 months

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
Background: PubMed 34953816Yang J, Jain S, Capparelli EV, Best BM, Son MB, Baker A, Newburger JW, Franco A, Printz BF, He F, Shimizu C, Hoshino S, Bainto E, Moreno E, Pancheri J, Burns JC, Tremoulet AH. Anakinra Treatment in Patients with Acute Kawasaki Disease with Coronary Artery Aneurysms: A Phase I/IIa Trial. J Pediatr. 2022 Apr;243:173-180.e8. doi: 10.1016/j.jpeds.2021.12.035. Epub 2021 Dec 23.
Background: PubMed 32779863Kone-Paut I, Tellier S, Belot A, Brochard K, Guitton C, Marie I, Meinzer U, Cherqaoui B, Galeotti C, Boukhedouni N, Agostini H, Arditi M, Lambert V, Piedvache C. Phase II Open Label Study of Anakinra in Intravenous Immunoglobulin-Resistant Kawasaki Disease. Arthritis Rheumatol. 2021 Jan;73(1):151-161. doi: 10.1002/art.41481. Epub 2020 Nov 17.
Background: PubMed 35699824Kessel C, Kone-Paut I, Tellier S, Belot A, Masjosthusmann K, Wittkowski H, Fuehner S, Rossi-Semerano L, Dusser P, Marie I, Boukhedouni N, Agostini H, Piedvache C, Foell D. An Immunological Axis Involving Interleukin 1beta and Leucine-Rich-alpha2-Glycoprotein Reflects Therapeutic Response of Children with Kawasaki Disease: Implications from the KAWAKINRA Trial. J Clin Immunol. 2022 Aug;42(6):1330-1341. doi: 10.1007/s10875-022-01301-w. Epub 2022 Jun 14.
Background: PubMed 32073531Blonz G, Lacroix S, Benbrik N, Warin-Fresse K, Masseau A, Trewick D, Hamidou M, Stephan JL, Neel A. Severe Late-Onset Kawasaki Disease Successfully Treated With Anakinra. J Clin Rheumatol. 2020 Mar;26(2):e42-e43. doi: 10.1097/RHU.0000000000000814. No abstract available.
Background: PubMed 35626849Bossi G, Codazzi AC, Vinci F, Clerici E, Regalbuto C, Crapanzano C, Veraldi D, Moiraghi A, Marseglia GL. Efficacy of Anakinra on Multiple Coronary Arteries Aneurysms in an Infant with Recurrent Kawasaki Disease, Complicated by Macrophage Activation Syndrome. Children (Basel). 2022 May 5;9(5):672. doi: 10.3390/children9050672.
Background: PubMed 33149772Maniscalco V, Abu-Rumeileh S, Mastrolia MV, Marrani E, Maccora I, Pagnini I, Simonini G. The off-label use of anakinra in pediatric systemic autoinflammatory diseases. Ther Adv Musculoskelet Dis. 2020 Oct 16;12:1759720X20959575. doi: 10.1177/1759720X20959575. eCollection 2020.
Background: PubMed 32457855Gambacorta A, Buonsenso D, De Rosa G, Lazzareschi I, Gatto A, Brancato F, Pata D, Valentini P. Resolution of Giant Coronary Aneurisms in a Child With Refractory Kawasaki Disease Treated With Anakinra. Front Pediatr. 2020 May 7;8:195. doi: 10.3389/fped.2020.00195. eCollection 2020.
Background: PubMed 33854568Mastrolia MV, Abbati G, Signorino C, Maccora I, Marrani E, Pagnini I, Simonini G. Early anti IL-1 treatment replaces steroids in refractory Kawasaki disease: clinical experience from two case reports. Ther Adv Musculoskelet Dis. 2021 Mar 29;13:1759720X211002593. doi: 10.1177/1759720X211002593. eCollection 2021.
Individual participant dataSharing planned: No

Related trials for Kawasaki Disease

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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.

Gabriele Simonini, Prof principal investigator

Meyer Children's Hospital IRCCS

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Anakinra and Intravenous Immunoglobulins, Human in people with Kawasaki Disease and Anakinra, run by Meyer Children's Hospital IRCCS.

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 14 inclusion and 5 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: withdrawn, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Number of patients with treatment response in both treatment arms (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT06697431, which also lists 8 linked publications.

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 26 Oct 2026.