Baricitinib for moderate-to-severe intracerebral bleeding and contusions after head injury

A Randomized Control Trial of Baricitinib Administration in Patients With Moderate and Severe Traumatic Intracerebral Hemorrhage/Contusions

This will test whether giving baricitinib soon after a head injury helps adults with moderate to severe brain bleeding or contusions recover better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Tang-Du Hospital (Academic / other)
• Drugs / interventions: abroctinib, baricitinib
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT06065046 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, phase 2 trial comparing oral baricitinib plus standard treatment versus standard treatment alone in adults with CT-confirmed traumatic intracerebral hemorrhage or contusions. Eligible patients have closed head injury, a Glasgow Coma Scale score of 5–12, and are enrolled within 24 hours of injury. The intervention uses baricitinib 4 mg in addition to routine care, and outcomes compare clinical recovery and neurologic status between groups. The study is grounded in preclinical data showing JAK1/2 inhibition reduces post‑traumatic neuroinflammation and edema, and in clinical experience with baricitinib in other inflammatory conditions.

Who should consider this trial

Good fit: Adults aged 18 to 79 with a closed-head injury, CT-proven intracerebral hemorrhage or contusions, GCS 5–12, admitted within 24 hours, without active infection and meeting other inclusion/exclusion criteria are ideal candidates.

Not a fit: Patients with open head injuries, those requiring immediate surgical intervention, recent use of JAK inhibitors, pregnancy or active lactation, or severe pre-existing organ failure or dementia are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, baricitinib could reduce neuroinflammation and brain swelling after traumatic hemorrhage and improve neurological recovery.

How similar studies have performed: Preclinical TBI studies of JAK1/2 inhibitors showed reduced edema and improved function in animals, and baricitinib has proven anti-inflammatory benefits in other human diseases, but clinical evidence in traumatic brain injury is limited.

Eligibility criteria

Inclusion Criteria:

1. Age 18 years older and younger than 80 years old.
2. Definite history of traumatic brain injury.
3. Admission within≤24 hours after the traumatic brain injury.
4. CT scans demonstrate intracerebral hemorrhage/contusions with and without extracerebral hemorrhage (epi- and sub- dural hemorrhage)
5. GCS score of 5 or greater and no more than 12 at time of enrollment.
6. Closed head injury.
7. Admission without infections
8. Signed and dated informed consent by the subject, legally authorized representative, or surrogate obtained.

Exclusion Criteria:

1. Time of head injury cannot be reliably assessed.
2. Subjects is considered a candidate for immediate surgical intervention because of severe extracranial injury.
3. Open head injury.
4. Pregnancy or parturition within previous 30 days or active lactation.
5. Use of Janus kinase inhibitors (baricinitib,abroctinib, AG490 and etc.)
6. Pre-traumatic dementia or disability.
7. With severe liver, kidney disease, or malignancy, life expectancy is less than 14 days.
8. Severe pulmonary infection.
9. Severe or acute heart failure.
10. Severe infections within previous 30 days.
11. History of myocardial infarction.
12. Known sensitivity to baricinitib.
13. Severe decreases in neutrophil, lymphocyte and platelet counts, severe decrease in hemoglobin.
14. Severe liver and kidney dysfunction.
15. Currently participating in other interventional clinical trials.

Where this trial is running

Xi'an, Shaanxi

• Tandu Hospital, Fourth Military Medical University — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Study coordinator: Shunnan Ge, M.D,Ph.D

Conditions Traumatic Brain Injury; traumatic intracerebral Hemorrhage; traumatic intracerebral Contusions; baricitinib; Janus kinase inhibitor; neuro-inflammatory responses