NCT03737344: BLOC-ICH

BLOC-ICH: Interleukin-1 Receptor Antagonist in Intracerebral Haemorrhage

Completed Phase 2 Last updated 5 October 2021

What this trial tests

Phase 2 trial testing IL-1Ra Kineret® in Intracerebral Haemorrhage in 25 participants. Completed in 30 April 2021.

Timeline

17 May 2019

Primary endpoint
19 February 2021

30 April 2021

Quick facts

Lead sponsor	Adrian Parry-Jones
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	25
Start date	17 May 2019
Primary completion	19 February 2021
Estimated completion	30 April 2021
Sites	1 location across United Kingdom

Drugs / interventions tested

• IL-1Ra Kineret® — full drug profile →
• IL-1Ra Placebo

Conditions studied

• Intracerebral Haemorrhage — all drugs for Intracerebral Haemorrhage →

Sponsor

Adrian Parry-Jones — full company profile →

Who can join

18 and older, any sex, with Intracerebral Haemorrhage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial will help inform the development of a new treatment for intracerebral haemorrhage (ICH; also known as haemorrhagic stroke). ICH is a type of stroke caused by spontaneous bleeding into the brain. In the hours to days after bleeding occurs, inflammation develops in the brain around the haematoma (collection of blood in the brain). Inflammation is the body's natural response to injury, however when it continues unchecked there is a risk that the brain tissue around the haematoma will become swollen. This type of swelling can worsen existing stroke symptoms or cause new deficits such as speech disturbance and limb weakness, which can lead to long term disability.

The level of inflammation in the blood is high after ICH. The investigators want to investigate whether blocking this inflammation can improve overall recovery. The investigators research group has extensively investigated the use of a well-established anti-inflammatory drug, Kineret® in trials with patients who have suffered a stroke or brain haemorrhage. Kineret® is similar to a naturally-produced protein called interleukin-1 receptor antagonist (IL-1Ra) and is already licensed to treat patients with rheumatoid arthritis. The investigators have evidence from these previous studies that Kineret® reduced levels of inflammation in the blood after ischaemic stroke (caused by a blockage in an artery). However, in order to develop Kineret® as a treatment for ICH, the investigators need to know if it reduces levels of inflammation present in the blood following ICH and if it reduces swelling in the brain.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Signaling pathways involved in ischemic stroke: molecular mechanisms and therapeutic interventions.
   Qin C, Yang S, Chu YH, Zhang H, et al · · 2022 · cited 591× · PMID 35794095 · DOI 10.1038/s41392-022-01064-1
2. Cerebral Hemorrhage: Pathophysiology, Treatment, and Future Directions.
   Magid-Bernstein J, Girard R, Polster S, Srinath A, et al · · 2022 · cited 408× · PMID 35420918 · DOI 10.1161/circresaha.121.319949
3. IL-1 Family Cytokine Regulation of Vascular Permeability and Angiogenesis.
   Fahey E, Doyle SL. · · 2019 · cited 215× · PMID 31293586 · DOI 10.3389/fimmu.2019.01426
4. Brain edema formation and therapy after intracerebral hemorrhage.
   Wan Y, Holste KG, Hua Y, Keep RF, et al · · 2023 · cited 115× · PMID 36481437 · DOI 10.1016/j.nbd.2022.105948
5. Advances in Therapeutic Approaches for Spontaneous Intracerebral Hemorrhage.
   Al-Kawaz MN, Hanley DF, Ziai W. · · 2020 · cited 79× · PMID 32720246 · DOI 10.1007/s13311-020-00902-w
6. Distinct peripheral blood monocyte and neutrophil transcriptional programs following intracerebral hemorrhage and different etiologies of ischemic stroke.
   Carmona-Mora P, Ander BP, Jickling GC, Dykstra-Aiello C, et al · · 2021 · cited 49× · PMID 32960689 · DOI 10.1177/0271678x20953912
7. The Therapeutic Prospects of Targeting IL-1R1 for the Modulation of Neuroinflammation in Central Nervous System Disorders.
   Luís JP, Simões CJV, Brito RMM. · · 2022 · cited 41× · PMID 35163653 · DOI 10.3390/ijms23031731
8. CNS-peripheral immune interactions in hemorrhagic stroke.
   Li X, Chen G. · · 2023 · cited 37× · PMID 36476130 · DOI 10.1177/0271678x221145089