Baricitinib for Respiratory Injury in Patients With Intracerebral Hemorrhage

NCT06737705 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: MRCTA, ECFAH of FMU [2024] 556
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 6

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)

Keywords

Intracerebral Hemorrhage; Acute Lung Injury; Baricitinib

Outcome Measures

Primary Outcomes (1)

• The score shift on the radiologic scoring system for lung injury involvement 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.

  From baseline to day 14 after randomization

Secondary Outcomes (5)

• The modified Rankin Scale (mRS) score at day 90 after randomization

  At day 90 after randomization

• 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

• 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

Study Arms (2)

Standard care

NO INTERVENTION

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

Standard care plus Baricitinib

EXPERIMENTAL

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

Drug: Baritinib

Interventions

Baritinib 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).

Standard care plus Baricitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Are male or female patients from 18 years of age (inclusive), at the time of enrollment;
• Have acute, spontaneous, primary, supratentorial intracerebral hemorrhage (ICH), confirmed by head CT scan, at the time of enrollment;
• Complicated with acute lung injury (ALI), confirmed by chest CT scan, at the time of enrollment.

You may not qualify if:

• Have cerebellar or brainstem ICH;
• Have secondary ICH due to known or suspected structural abnormality in the brain, i.e., trauma, aneurysm, arteriovenous malformation, tumor;
• Have severe cerebral comorbidities, i.e., historical severe stroke, hydrocephalus, epilepsy;
• Have known advanced dementia or significant pre-stroke disability (modified Rankin Scale score of \> 1);
• Have comorbidities might result in ALI, i.e., interstitial lung disease, chronic obstructive pulmonary disease, lung tumor, asthma, chronic respiratory failure, chronic heart failure;
• 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);
• Have chronic autoimmune disease, i.e., neuromyelitis optica spectrum disorders, multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus;
• 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;
• 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;
• 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;

Sponsors & Collaborators

• De-zhi Kang: lead
• Fujian Medical University: collaborator
• Tianjin Medical University General Hospital: collaborator

Study Sites (6)

The Southwest Hospital of Army Medical University

Chongqing, Chongqing Municipality, 400038, China

Location

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350003, China

Location

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, 341000, China

Location

Ganzhou People's Hospital

Ganzhou, Jiangxi, 341000, China

Location

Liaocheng People's Hospital, Liaocheng Brain Hospital

Liaocheng, Shandong, China

Location

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Cerebral Hemorrhage; Acute Lung Injury

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• De-zhi Kang, M.D.

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

• Ying Fu, Ph.D.

  First Affiliated Hospital of Fujian Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 17, 2024
• Study Start: January 1, 2025
• Primary Completion: August 18, 2025
• Study Completion: August 18, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

CN (6)