Baricitinib for Respiratory Injury in Patients With Intracerebral Hemorrhage

NCT ID: NCT06737705

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-08-18

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.

Conditions

Intracerebral Hemorrhage; Acute Lung Injury(ALI)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard care

Standardized treatment for respiratory protection and/or ALI after ICH according to the related guidelines.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Standard care plus Baricitinib

Besides standardized treatment (background therapy) for respiratory protection and/or ALI after ICH according to the related guidelines, participants will receive additional baritinib administration.

Group Type: EXPERIMENTAL

Baritinib

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Participant (or legally authorized representative) who gives informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol;

2. Are male or female patients from 18 years of age (inclusive), at the time of enrollment;

3. Have acute, spontaneous, primary, supratentorial intracerebral hemorrhage (ICH), confirmed by head CT scan, at the time of enrollment;

4. Complicated with acute lung injury (ALI), confirmed by chest CT scan, at the time of enrollment.

Exclusion Criteria

1. Have cerebellar or brainstem ICH;

2. Have secondary ICH due to known or suspected structural abnormality in the brain, i.e., trauma, aneurysm, arteriovenous malformation, tumor;

3. Have severe cerebral comorbidities, i.e., historical severe stroke, hydrocephalus, epilepsy;

4. Have known advanced dementia or significant pre-stroke disability (modified Rankin Scale score of > 1);

5. Have comorbidities might result in ALI, i.e., interstitial lung disease, chronic obstructive pulmonary disease, lung tumor, asthma, chronic respiratory failure, chronic heart failure;

6. Have severe immunosuppression, defined as neutropenia (absolute neutrophil count < 1.0×10^9 cells/L) or lymphopenia (absolute lymphocyte count < 0.2×10^9 cells/L);

7. Have chronic autoimmune disease, i.e., neuromyelitis optica spectrum disorders, multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus;

8. Have ever received attenuated live vaccination or immunological treatments (see below) within 4 weeks prior to the enrollment, or intend to receive measures above;

• Cytotoxic treatments: cyclophosphamide, methotrexate, sulfasalazine, leflunomide, etc.;
• Biological treatments: adalimumab, infliximab, etanercept (TNF-α inhibitors), tocilizumab (anti-IL-6), secukinumab (anti-IL-17), etc.;
• Baricitinib and other JAK inhibitors: tofacitinib, abrocitinib, etc.;
• Other treatments: convalescent plasma or intravenous immunoglobulin (IVIg), corticosteroids with dosage over alternative purpose, etc.;
• Note: Non-steroid anti-inflammatory drugs (NSAID) are allowed;

9. Have current or historical infections within 2 weeks prior to the enrollment, i.e., pneumonia, SARS-CoV-2 infections, current active tuberculosis; or have ever received antibiotics within 2 weeks prior to the enrollment;

10. Have contraindications for baricitinib, i.e., severe anemia (hemoglobulin < 80g/L), decompensated kidney disease (eGFR < 30mL/min/1.73m^2), or severe liver injury with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times ULN;

11. Have a current diagnosis of active malignancy, history of deep vein thrombosis (DVT) and/or pulmonary embolism (PE) within 12 weeks prior to the enrollment or have a history of recurrent DVT/PE (≥ 2 times in total), which could constitute a risk when taking baricitinib in the opinion of the investigator;

12. Are unlikely to finish the whole course of baricitinib administration in the opinion of the investigator (anticipated death or discharge);

13. Are pregnant, or intend to become pregnant or breastfeed during the study;

14. Are recruited for any other clinical trials;

15. Are unsuitable for inclusion in the study in the opinion of the investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University

OTHER

Sponsor Role: collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role: collaborator

De-zhi Kang

OTHER

Sponsor Role: lead

Responsible Party

De-zhi Kang

Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

De-zhi Kang, M.D.

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Fujian Medical University

Ying Fu, Ph.D.

Role: STUDY_DIRECTOR

First Affiliated Hospital of Fujian Medical University

Locations

The Southwest Hospital of Army Medical University

Chongqing, Chongqing Municipality, 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 Huanhu Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

MRCTA, ECFAH of FMU [2024] 556

Identifier Type: -

Identifier Source: org_study_id