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Intracerebral HemorrhagePhase 2BRIGHTNCT06737705

Baricitinib for Patients With Intracerebral Hemorrhage

A Phase 2 study testing Baritinib in people with Intracerebral Hemorrhage, run by De-zhi Kang at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 spontaneous intracerebral hemorrhage (ICH). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracerebral Hemorrhage
What is being tested?
Baritinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
6 sitesChina
Study dates
1 Jan 2025to 18 Aug 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • The Southwest Hospital of Army Medical University

    Chongqing, Chongqing Municipality, 400038

  • First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350003

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi, 341000

  • Ganzhou People's Hospital

    Ganzhou, Jiangxi, 341000

  • Liaocheng People's Hospital, Liaocheng Brain Hospital

    Liaocheng, Shandong

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin Municipality

Other trials in China

About this study

Official title: 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.

Being tested
Baritinib
Keywords
Intracerebral Hemorrhage, Baricitinib
Medical subject headings
Cerebral Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BaritinibDrug

    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).

Study groups in NCT06737705
Study groupRoleWhat they receive
Standard careNo interventionStandardized treatment for ICH according to the related guidelines.
Standard care plus BaricitinibExperimentalBesides standardized treatment (background therapy) for ICH according to the related guidelines, participants will receive additional baritinib administration.
Receives: Drug: Baritinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At day 90 after randomization

Secondary outcomes (10)

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

    Measured: At day 90 after randomization

  2. Shift analysis in the mRS score

    Measured: At day 90 after randomization

  3. Peripheral blood lymphocyte count

    A key measure for immunosuppression.

    Measured: At days 7 and 14 after randomization

  4. 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.

    Measured: At days 7 and 14 after randomization

  5. 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.

    Measured: At days 7 and 14 after randomization

  6. 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).

    Measured: At day 90 after randomization

  7. Mortality (death event)

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

    Measured: At day 90 after randomization

  8. 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.

    Measured: At day 90 after randomization

  9. Peripheral blood exploratory biomarkers

    Exploratory biomarkers for evaluating immunosuppression, expressed as changes from baseline

    Measured: At days 7 and 14 after randomization

  10. Serious adverse event (SAE) occurrence

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

    Measured: At day 90 after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2024
  2. Study start1 Jan 2025
  3. Primary completion18 Aug 2025
  4. Study completion18 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06737705
Sponsor's protocol ID
MRCTA, ECFAH of FMU [2024] 556
Acronym
BRIGHT
Status last verified
Aug 2025
First submitted
10 Dec 2024
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Baritinib in people with Intracerebral Hemorrhage, run by De-zhi Kang at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Favorable neurological outcome defined by modified Rankin Scale (mRS) score of 0-2 (time frame: At day 90 after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06737705.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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Baricitinib for Patients With Intracerebral Hemorrhage | AzTrials