SC IL-1Ra in SAH - Phase III Trial (SCIL) (SCIL)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03249207 |
Recruitment Status :
Recruiting
First Posted : August 15, 2017
Last Update Posted : July 29, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 Patients who are found to be non-aneurysmal following randomisation will be withdrawn from the study treatment.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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Subarachnoid Hemorrhage | Drug: IL-1Ra Drug: IL-1Ra Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Does Interleukin-1 Receptor Antagonist Improve Outcome Following Aneurysmal Subarachnoid Haemorrhage (aSAH)? A Phase III Trial |
Actual Study Start Date : | October 11, 2018 |
Estimated Primary Completion Date : | October 2022 |
Estimated Study Completion Date : | October 2022 |

Arm | Intervention/treatment |
---|---|
Active Comparator: IL-1Ra twice daily |
Drug: IL-1Ra
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). |
Placebo Comparator: Placebo twice daily |
Drug: IL-1Ra Placebo
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). |
- Ordinal shift in modified Rankin Score (mRS) [ Time Frame: 6 months post randomisation ]
- Measurement of mood using HADS [ Time Frame: 6 months post randomisation ]
- Measurement of fatigue using Fatigue score [ Time Frame: 6 months post randomisation ]
- Measurement of quality of life using EQ-5D-5L score [ Time Frame: 6 months post randomisation ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 ).
- 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.
- Previous or current treatment with medication suspected of interacting with IL-1Ra, listed in the drug SmPC
- Known to have participated in a clinical trial of an investigational agent or device in the previous 30 days or 5 half-lives of enrolment (whichever is longer) of ictus, or for the period determined by the protocol of the trial / study the patient has taken part in.
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249207
Contact: Helen Bradley, BSc, PhD | 0161 306 3196 | scil@manchester.ac.uk | |
Contact: Sharon Hulme | 0161 206 5755 | sharon.hulme@manchester.ac.uk |
United Kingdom | |
Derriford Hospital | Recruiting |
Plymouth, Devon, United Kingdom, PL6 8DH | |
Contact: Peter Whitfield | |
Royal Hallamshire Hospital | Recruiting |
Sheffield, South Yorkshire, United Kingdom, S10 2JF | |
Contact: Yahia Al-Tamimi | |
University Hospital of Wales | Recruiting |
Cardiff, Wales, United Kingdom, CF14 4XW | |
Contact: James Galea | |
Leeds General Infirmary | Recruiting |
Leeds, Yorkshire, United Kingdom, LS1 3EX | |
Contact: Ian Anderson | |
Royal Sussex County Hospital | Recruiting |
Brighton, United Kingdom, BN2 5BE | |
Contact: Giles Critchley | |
The Walton Centre | Recruiting |
Liverpool, United Kingdom, L9 7LJ | |
Contact: Catherine McMahon | |
St George's Hospital | Recruiting |
London, United Kingdom, SW17 0QT | |
Contact: Marios Papadopoulos | |
National Hospital for Neurology and Neurosurgery, Queen Square | Recruiting |
London, United Kingdom, WC1N 3BG | |
Contact: Ahmed Toma | |
Salford Royal NHS Foundation Trust | Recruiting |
Manchester, United Kingdom | |
Contact: Hiren Patel, MBBS FRCS hiren.patel@srft.nhs.uk | |
Queens Medical Centre | Recruiting |
Nottingham, United Kingdom, NG7 2UH | |
Contact: Surajit Basu | |
Southampton General Hospital | Recruiting |
Southampton, United Kingdom, SO16 6YD | |
Contact: Mukul Arora |
Principal Investigator: | Andrew King | University of Manchester |
Responsible Party: | Helen Bradley, Clinical Trials Manager, University of Manchester |
ClinicalTrials.gov Identifier: | NCT03249207 |
Other Study ID Numbers: |
R121178 |
First Posted: | August 15, 2017 Key Record Dates |
Last Update Posted: | July 29, 2020 |
Last Verified: | July 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Aneurysmal |
Subarachnoid Hemorrhage Hemorrhage Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Interleukin 1 Receptor Antagonist Protein Antirheumatic Agents |