NCT06737705

Baricitinib for Respiratory Injury in Patients With Intracerebral Hemorrhage

Efficacy and Safety Study of Baricitinib for Respiratory Injury in Patients With Intracerebral Hemorrhage

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: De-zhi Kang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an investigator-initiated, prospective, randomized, open-label, blind end-point (PROBE) phase-2 clinical trial, to preliminarily evaluate the efficacy and safety of baritinib for the treatment of acute lung injury (ALI) after spontaneous intracerebral hemorrhage (ICH). Approximately 100 patients from different geographic sites across China will be recruited and randomized to 2 parallel arms in a 1:1 ratio to the intervention arm or control arm. The study will compare early additional baritinib 4-mg once daily (QD) administration to control arm with standardized treatments (background therapy), as novel agents for ALI in aimed subjects in immunological approach; and provide cortical evidence for further phase-3 clinical trials. The trial will be across up to approximately 15-month scope (12-month enrollment period and 3-month follow-up period). One independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data in all stages to make recommendations about early study closure or changes to study protocol.

Conditions

• Intracerebral Hemorrhage
• Acute Lung Injury(ALI)

Interventions

Type	Name	Description
DRUG	Baritinib	Participants will receive additional baritinib administration with 4-mg dosage once daily (QD) for consecutive 14 days after randomization (adjusted dosage of 2-mg QD for participants with eGFR between 30-60 mL/min/1.73m\^2).

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-08-18
• Completion: 2025-08-18
• First posted: 2024-12-17
• Last updated: 2025-08-22

Locations

6 sites across 1 country: China

Regulatory

• FDA-regulated drug study