Baricitinib for Respiratory Injury in Patients With Intracerebral Hemorrhage

Phase 2

Recruiting

• Conditions: Intracerebral Hemorrhage; Acute Lung Injury(ALI)
• Interventions: Drug: Baritinib

• Registration Number: NCT06737705
• Lead Sponsor: De-zhi Kang

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-16
• Study First Posted: 2024-12-17
• Study Start: 2025-01-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-24
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care plus Baricitinib	Baritinib	Besides standardized treatment (background therapy) for respiratory protection and/or ALI after ICH according to the related guidelines, participants will receive additional baritinib administration.

Primary Outcome Measures

Name	Time	Method
The score shift on the radiologic scoring system for lung injury involvement from baseline to day 14 after randomization	From baseline to day 14 after randomization	This radiologic scoring system for lung injury involvement was assessed with the chest CT scan, ranging from 0 to 10. The lower score indicated less lung injury while the higher represented more.

Secondary Outcome Measures

Name	Time	Method
The modified Rankin Scale (mRS) score at day 90 after randomization	At day 90 after randomization	The mRS ranged from 0 to 6 and usually was adopted for neurological assessment. The lower score indicated favorable outcome while the higher represented worse or even death.
Time from randomization to the day of at least 1-point improvement on the National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS)	From randomization to the presence of clinical end-point (NIAID-OS improvement ≥ 1 point, discharge, or death) or the end of observation (up to 90 days after randomization), whichever comes first	The NIAID-OS was for respiratory assessment, ranging from 1 to 8 in the original version. In this trial, the NIAID-OS was measured ranging from 3 to 8 (inclusive). The lower score indicated mild symptoms while the higher represented more critical or even death.
Peripheral blood interleukin-6 (IL-6) level at day 14 after randomization	At day 14 after randomization
Peripheral blood interleukin-8 (IL-8) level at day 14 after randomization	At day 14 after randomization
Peripheral blood C-reactive protein (CRP) level at day 14 after randomization	At day 14 after randomization

Trial Locations

Locations (7)

The Southwest Hospital of Army Medical University; 🇨🇳 Chongqing, Chongqing, China

First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

First Affiliated Hospital of Gannan Medical University; 🇨🇳 Ganzhou, Jiangxi, China

Ganzhou People's Hospital; 🇨🇳 Ganzhou, Jiangxi, China

Liaocheng People's Hospital, Liaocheng Brain Hospital; 🇨🇳 Liaocheng, Shandong, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China

Tianjin Huanhu Hospital; 🇨🇳 Tianjin, Tianjin, China