SC IL-1Ra in SAH - Phase III Trial (SCIL) (SCIL)

STATUS

Recruiting
End date

Sep 24, 2024
participants needed

1000
sponsor

University of Manchester

Updated on 24 August 2023

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Summary

This phase III trial will establish whether IL-1Ra, with sub-cutaneous (SC) administration twice daily for up to 21 days post aneurysmal subarachnoid haemorrhage (aSAH), improves clinical outcome as measured by ordinal shift in mRS at 6 months.

Patients with SAH transferred to a neurosurgical centre will be identified and approached for study participation. Following consent, patients will be randomised to receive either IL-1Ra or placebo for a maximum of 21 days from onset of symptoms. Patients who are found to be non-aneurysmal following randomisation will be withdrawn from the study treatment. Blood samples for plasma IL-6 will be obtained prior to randomisation and at day 3-5 post randomisation for IL-6 & IL-1 measurement. Safety will be measured at 30 days post randomisation and outcome assessed at 6 months post randomisation.

Details

Condition	Subarachnoid Hemorrhage
Treatment	IL-1Ra, IL-1Ra Placebo
Clinical Study Identifier	NCT03249207
Sponsor	University of Manchester
Last Modified on	24 August 2023

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Patients with CT positive spontaneous SAH admitted to a participating neurosurgical centre where written informed consent can be obtained and study drug can be administered within 72 hours of ictus
	No concomitant health problems that, in the opinion of the PI or designee, would interfere with participation, administration of study drug or assessment of outcomes including safety
	Willing and able to give informed consent or consent available from a patient representative for trial inclusion including agreement in principle to receive study drug and undergo all study assessments
	Male or female aged 18 years or above
Exclusion Criteria
	Unconfirmed or uncertain diagnosis of spontaneous SAH
	Known active tuberculosis or active hepatitis
	Known active malignancy
	Neutropenia (ANC <1.5 x 109/L )
	Known Still's Disease
	Abnormal renal function (creatinine clearance or estimated Glomerular Filtration Rate (eGFR) < 30 ml/minute) documented in the last 3 months prior to this SAH
	Live vaccinations within the last 10 days of this SAH
	Previous or concurrent treatment with IL-1Ra known at the time of trial entry or previous participation in this trial
	Current treatment with TNF antagonists
	Known to be pregnant or breast feeding or inability to reliably confirm that the patient is not pregnant
	Known to have participated in a clinical trial of an investigational agent or device in the 30 days prior to ictus
	Clinically significant serious concurrent medical condition, pre morbid illnesses, or concurrent serious infection, at the PI's (or designee's) discretion, which could affect the safety or tolerability of the intervention
	Known to have participated in a clinical trial of an investigational agent or device within 5 half-lives (of the previous agent or device) prior to ictus
	Known allergy to IL-1Ra or any of the excipients listed in the drug SmPC
	Known allergy to other products that are produced by DNA technology using the micro-organism E. coli (e.g. E.coli derived protein)
	Current treatment with IL-6 or IL-1 inhibitors or drugs affecting the IL-1 axis
	History of DRESS syndrome

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SC IL-1Ra in SAH - Phase III Trial (SCIL) (SCIL)