Baricitinib for Patients With Intracerebral Hemorrhage (BRIGHT)

Efficacy and Safety Study of Baricitinib for Patients With Intracerebral Hemorrhage

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 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 ICH 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.

Study Overview

• Status: Completed
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: Drug: Baritinib

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400038
      • The Southwest Hospital of Army Medical University
  • Fujian
    • Fuzhou, Fujian, China, 350003
      • First Affiliated Hospital of Fujian Medical University
  • Jiangxi
    • Ganzhou, Jiangxi, China, 341000
      • First Affiliated Hospital of Gannan Medical University
    • Ganzhou, Jiangxi, China, 341000
      • Ganzhou People's Hospital
  • Shandong
    • Liaocheng, Shandong, China
      • Liaocheng People's Hospital, Liaocheng Brain Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • Tianjin Huanhu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• 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;

• 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 pulmonary or cardiac disorders, 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care; Standardized treatment for ICH according to the related guidelines.
Experimental: Standard care plus Baricitinib; Besides standardized treatment (background therapy) for ICH according to the related guidelines, participants will receive additional baritinib administration.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Favorable neurological outcome defined by modified Rankin Scale (mRS) score of 0-2	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.	At day 90 after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Favorable neurological outcome defined by mRS score of 0-3		At day 90 after randomization
Shift analysis in the mRS score		At day 90 after randomization
Peripheral blood lymphocyte count	A key measure for immunosuppression.	At days 7 and 14 after randomization
New or exacerbated infection event	Infection is a clinical event, defined as an infection which is new or significantly exacerbated after randomization, adjudicated according to the modified CDC diagnostic criteria.	At days 7 and 14 after randomization
Hemorrhage progression event	Hemorrhage progression is a clinical event, including hematoma expansion or postoperative cerebral rebleeding after randomization, adjudicated with criteria of the hemorrhage growth > 6 mL or 33%, and postoperative growth ≥ 5mL or significant morphological difference in CT scans.	At days 7 and 14 after randomization
Recurrent stroke event	A recurrent stroke is defined as an acute disturbance of focal neurologic function resulting in death or symptoms lasting more than 24 hours, including both ischemic and hemorrhagic stroke (excluding the index hemorrhage).	At day 90 after randomization
Mortality (death event)	Mortality (death event) accounted for all-cause and is verified with medical certification or social identification system.	At day 90 after randomization
Hierarchical composite event, including recurrent stroke and death	The hierarchical composite includes aforementioned long-term neurological events of recurrent stroke and death, which death was prioritized over recurrent stroke.	At day 90 after randomization
Peripheral blood exploratory biomarkers	Exploratory biomarkers for evaluating immunosuppression, expressed as changes from baseline	At days 7 and 14 after randomization
Serious adverse event (SAE) occurrence	Local-reported SAE is adjudicated if it meets the criteria according to ICH GCP E6 (R2) guideline.	At day 90 after randomization

Collaborators and Investigators

• Sponsor: De-zhi Kang
• Collaborators: Fujian Medical University; Tianjin Medical University General Hospital
• Investigators: Principal Investigator: De-zhi Kang, M.D., First Affiliated Hospital of Fujian Medical University; Study Director: Ying Fu, Ph.D., First Affiliated Hospital of Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): August 18, 2025
• Study Completion (Actual): August 18, 2025

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 17, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Baricitinib; Intracerebral Hemorrhage
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Cerebral Hemorrhage
• Other Study ID Numbers: MRCTA, ECFAH of FMU [2024] 556

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes