SC IL-1Ra in SAH - Phase III Trial (SCIL)
SCIL
Does Interleukin-1 Receptor Antagonist Improve Outcome Following Aneurysmal Subarachnoid Haemorrhage (aSAH)? A Phase III Trial
1 other identifier
interventional
612
1 country
17
Brief 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 Patients who are found to be non-aneurysmal following randomisation will be withdrawn from the study treatment.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2018
Longer than P75 for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2017
CompletedFirst Posted
Study publicly available on registry
August 15, 2017
CompletedStudy Start
First participant enrolled
October 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedNovember 21, 2023
October 1, 2023
5.5 years
August 9, 2017
November 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ordinal shift in modified Rankin Score (mRS)
6 months post randomisation
Secondary Outcomes (3)
Measurement of mood using HADS
6 months post randomisation
Measurement of fatigue using Fatigue score
6 months post randomisation
Measurement of quality of life using EQ-5D-5L score
6 months post randomisation
Study Arms (2)
IL-1Ra twice daily
ACTIVE COMPARATORPlacebo twice daily
PLACEBO COMPARATORInterventions
Doses to be administered subcutaneously (SC) twice daily (12 hourly) starting within 72 hours of ictus (onset of symptoms) for a maximum of 21 days from ictus (or sooner if discharged from neurosurgical centre).
Doses to be administered subcutaneously (SC) twice daily (12 hourly) starting within 72 hours of ictus (onset of symptoms) for a maximum of 21 days from ictus (or sooner if discharged from neurosurgical centre).
Eligibility Criteria
You may qualify if:
- 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.
- Male or female aged 18 years or above.
You may not qualify if:
- Unconfirmed or uncertain diagnosis of spontaneous SAH.
- Known active tuberculosis or active hepatitis.
- Known active malignancy.
- Known Still's Disease
- Neutropenia (ANC \<1.5 x 109/L ).
- 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 have participated in a clinical trial of an investigational agent or device in the 30 days prior to ictus.
- 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 to be pregnant or breast feeding or inability to reliably confirm that the patient is not pregnant
- 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 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).
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Manchesterlead
- National Institute for Health Research, United Kingdomcollaborator
- Clinical Trials Unit, Manchestercollaborator
- Northern Care Alliance NHS Foundation Trustcollaborator
Study Sites (17)
Derriford Hospital
Plymouth, Devon, PL6 8DH, United Kingdom
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF, United Kingdom
University Hospital of Wales
Cardiff, Wales, CF14 4XW, United Kingdom
Leeds General Infirmary
Leeds, Yorkshire, LS1 3EX, United Kingdom
Royal Sussex County Hospital
Brighton, BN2 5BE, United Kingdom
Southmead Hospital
Bristol, BS10 5NB, United Kingdom
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
The Walton Centre
Liverpool, L9 7LJ, United Kingdom
Royal London Hospital
London, E1 1FR, United Kingdom
St George's Hospital
London, SW17 0QT, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
National Hospital for Neurology and Neurosurgery, Queen Square
London, WC1N 3BG, United Kingdom
Northern Care Alliance NHS Foundation Trust
Manchester, United Kingdom
Queens Medical Centre
Nottingham, NG7 2UH, United Kingdom
Royal Preston Hospital
Preston, PR2 9HT, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew King
University of Manchester
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2017
First Posted
August 15, 2017
Study Start
October 11, 2018
Primary Completion
April 1, 2024
Study Completion
September 1, 2024
Last Updated
November 21, 2023
Record last verified: 2023-10