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

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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 Patients who are found to be non-aneurysmal following randomisation will be withdrawn from the study treatment.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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Manchester
• Collaborators: Manchester Academic Health Science Centre; National Institute for Health Research, United Kingdom; Salford Royal NHS Foundation Trust
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

1. 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.

2. 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.

3. 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.

4. Male or female aged 18 years or above.

Exclusion Criteria:

1. Unconfirmed or uncertain diagnosis of spontaneous SAH.

2. Known active tuberculosis or active hepatitis.

3. Known active malignancy.

4. Neutropenia (ANC <1.5 x 109/L ).

5. Abnormal renal function (creatinine clearance or estimated Glomerular Filtration Rate (eGFR) < 30 ml/minute) documented in the last 3 months prior to this SAH.

6. Live vaccinations within the last 10 days of this SAH.

7. Previous or concurrent treatment with IL-1Ra known at the time of trial entry or previous participation in this trial.

8. Previous or current treatment with medication suspected of interacting with IL-1Ra, listed in the drug SmPC

9. 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.

10. Known to be pregnant or breast feeding or inability to reliably confirm that the patient is not pregnant

11. 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.

12. Known allergy to IL-1Ra or any of the excipients listed in the drug SmPC

13. Known allergy to other products that are produced by DNA technology using the micro-organism E. coli (e.g. E.coli derived protein).