Using Baricitinib to Treat Lung Injury After Brain Bleeding

Efficacy and Safety Study of Baricitinib for Respiratory Injury in Patients With Intracerebral Hemorrhage

This study is testing if the medication baricitinib can help people with lung injuries after having a brain bleed.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital of Fujian Medical University (other)
• Drugs / interventions: adalimumab, infliximab, tocilizumab, secukinumab, Baricitinib, tofacitinib, abrocitinib, methotrexate, cyclophosphamide, baritinib
• Locations: 7 sites (Chongqing, Chongqing and 6 other locations)
• Trial ID: NCT06737705 on ClinicalTrials.gov

What this trial studies

This phase-2 clinical trial aims to evaluate the efficacy and safety of baricitinib for treating acute lung injury (ALI) in patients who have experienced spontaneous intracerebral hemorrhage (ICH). Approximately 100 patients will be recruited from various locations in China and randomly assigned to receive either baricitinib or standard treatment. The study will monitor the effects of baricitinib administered once daily for a specified duration, with a follow-up period to assess outcomes. An independent Data and Safety Monitoring Board will oversee the trial to ensure participant safety and data integrity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed spontaneous intracerebral hemorrhage and acute lung injury.

Not a fit: Patients with cerebellar or brainstem hemorrhages, or those with severe pre-existing cerebral comorbidities, are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from lung injury following brain hemorrhage.

How similar studies have performed: While this approach is novel in the context of treating lung injury post-ICH, similar studies using baricitinib for other conditions have shown promising results.

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.

Where this trial is running

Chongqing, Chongqing and 6 other locations

• The Southwest Hospital of Army Medical University — Chongqing, Chongqing, China (ACTIVE_NOT_RECRUITING)
• First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (RECRUITING)
• First Affiliated Hospital of Gannan Medical University — Ganzhou, Jiangxi, China (RECRUITING)
• Ganzhou People's Hospital — Ganzhou, Jiangxi, China (RECRUITING)
• Liaocheng People's Hospital, Liaocheng Brain Hospital — Liaocheng, Shandong, China (RECRUITING)
• Tianjin Medical University General Hospital — Tianjin, Tianjin, China (ACTIVE_NOT_RECRUITING)
• Tianjin Huanhu Hospital — Tianjin, Tianjin, China (RECRUITING)

Study contacts

• Principal investigator: De-zhi Kang, M.D. — First Affiliated Hospital of Fujian Medical University
• Study coordinator: De-zhi Kang, M.D.

Conditions: Intracerebral Hemorrhage, Acute Lung Injury, Baricitinib