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NCT Number: NCT06737705

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.

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Key information

Conditions

Intracerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Southwest Hospital of Army Medical University, Chongqing, Chongqing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion criteria
  • 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;
  • Exclusion criteria
  • 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 pulmonary or cardiac disorders, 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;
  • 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;
  • Are unlikely to finish the whole course of baricitinib administration in the opinion of the investigator (anticipated death or discharge);
  • Are pregnant, or intend to become pregnant or breastfeed during the study;
  • Are recruited for any other clinical trials;
  • Are unsuitable for inclusion in the study in the opinion of the investigator.

Treatment and study plan

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).

Primary outcomes

  1. Favorable neurological outcome defined by modified Rankin Scale (mRS) score of 0-2

    Time frame: 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.

Secondary outcomes

  1. Favorable neurological outcome defined by mRS score of 0-3

    Time frame: At day 90 after randomization

  2. Shift analysis in the mRS score

    Time frame: At day 90 after randomization

  3. Peripheral blood lymphocyte count

    Time frame: At days 7 and 14 after randomization

    A key measure for immunosuppression.

  4. New or exacerbated infection event

    Time frame: At days 7 and 14 after randomization

    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.

  5. Hemorrhage progression event

    Time frame: At days 7 and 14 after randomization

    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.

  6. Recurrent stroke event

    Time frame: At day 90 after randomization

    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).

  7. Mortality (death event)

    Time frame: At day 90 after randomization

    Mortality (death event) accounted for all-cause and is verified with medical certification or social identification system.

  8. Hierarchical composite event, including recurrent stroke and death

    Time frame: At day 90 after randomization

    The hierarchical composite includes aforementioned long-term neurological events of recurrent stroke and death, which death was prioritized over recurrent stroke.

  9. Peripheral blood exploratory biomarkers

    Time frame: At days 7 and 14 after randomization

    Exploratory biomarkers for evaluating immunosuppression, expressed as changes from baseline

  10. Serious adverse event (SAE) occurrence

    Time frame: At day 90 after randomization

    Local-reported SAE is adjudicated if it meets the criteria according to ICH GCP E6 (R2) guideline.

Sponsors and collaborators

Lead sponsor

De-zhi Kang

Other

Collaborators

  • Fujian Medical University
  • Tianjin Medical University General Hospital

Registry information

Official study title

Efficacy and Safety Study of Baricitinib for Patients With Intracerebral Hemorrhage

Acronym: BRIGHT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2024
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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