Baricitinib for Moderate and Severe Traumatic Intracerebral Hemorrhage/Contusions

NCT06065046 | Recruiting Phase 2 DMC

• 1 other identifier: TDSJWK-TBI-Baritinib
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study is to study the effect of baricitinib administration on outcome of participants with moderate and severe traumatic intracerebral hemorrhage/contusions. A multi-center randomized control trial will be conducted. Participants with a radiological diagnosis of traumatic intracerebral hemorrhage/contusions and an initial GCS score of 5-12 will be screened and enrolled in the first 24 hours after traumatic brain injury.

Conditions

Traumatic Brain Injury

Keywords

traumatic intracerebral Hemorrhage; traumatic intracerebral Contusions; baricitinib; Janus kinase inhibitor; neuro-inflammatory responses

Outcome Measures

Primary Outcomes (1)

• Clinical improvement

  Glasgow Outcome Scale at 180 days after brain trauma

  up to 180 days

Secondary Outcomes (7)

• Mortality rate

  up to 180 days

• Coma severity

  up to 2 weeks

• Glasgow Outcome Scale

  up to 90 days

• Serum inflammatory factors

  up to 7 days

• Volume of edema around intracerebral hemorrhage/contusions

  up to 7 days

Study Arms (2)

Control group

SHAM COMPARATOR

Participants will receive standard treatment and care according to the current management guidelines for traumatic brain injury, e.g. the guideline made by U.S. Brain Trauma Foundation (BTF)

Other: Standard treatment

Baricitinib group

EXPERIMENTAL

Besides receiving standard treatment and care, baricitinib will be administrated orally (or crushed for nasogastric tube delivery) and given daily at the dosage of 4mg, for consecutive 14 days after patients' brain injury.

Drug: Baricitinib 4 MG

Interventions

Standard treatment OTHER

Patients will receive standard treatment and care according to the current management guidelines for traumatic brain injury.

Also known as: Blank control

Control group

Baricitinib 4 MG DRUG

Baricitinib with be be administrated orally (or crushed for nasogastric tube delivery) and given daily at the dosage of 4mg for consecutive 14 days

Also known as: Baricitinib

Baricitinib group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years older and younger than 80 years old.
• Definite history of traumatic brain injury.
• Admission within≤24 hours after the traumatic brain injury.
• CT scans demonstrate intracerebral hemorrhage/contusions with and without extracerebral hemorrhage (epi- and sub- dural hemorrhage)
• GCS score of 5 or greater and no more than 12 at time of enrollment.
• Closed head injury.
• Admission without infections
• Signed and dated informed consent by the subject, legally authorized representative, or surrogate obtained.

You may not qualify if:

• Time of head injury cannot be reliably assessed.
• Subjects is considered a candidate for immediate surgical intervention because of severe extracranial injury.
• Open head injury.
• Pregnancy or parturition within previous 30 days or active lactation.
• Use of Janus kinase inhibitors (baricinitib,abroctinib, AG490 and etc.)
• Pre-traumatic dementia or disability.
• With severe liver, kidney disease, or malignancy, life expectancy is less than 14 days.
• Severe pulmonary infection.
• Severe or acute heart failure.
• Severe infections within previous 30 days.
• History of myocardial infarction.
• Known sensitivity to baricinitib.
• Severe decreases in neutrophil, lymphocyte and platelet counts, severe decrease in hemoglobin.
• Severe liver and kidney dysfunction.
• Currently participating in other interventional clinical trials.

Sponsors & Collaborators

• The First Hospital of Yulin: collaborator
• Xidian Group Hospital: collaborator
• Chongqing University Central Hospital & Chongqing Emergency Medical Center: collaborator
• The People's Hospital of Jiaozuo City: collaborator
• First People's Hospital of Xianyang: collaborator
• The 987th Hospital of the Joint Logistics Support Force of the People's Liberation Army of China: collaborator
• Baoji Fengxiang District Hospital: collaborator
• Tang-Du Hospital: lead
• Qianxian People's Hospital: collaborator
• Chongqing Hospital of PAP: collaborator
• Weinan Central Hospital: collaborator
• Second Affiliated Hospital of Xi'an Jiaotong University: collaborator
• GEM Flower Xian Changqing Staff Hospital: collaborator

Study Sites (1)

Tandu Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710038, China

RECRUITING

Related Publications (7)

• Begemann M, Leon M, van der Horn HJ, van der Naalt J, Sommer I. Drugs with anti-inflammatory effects to improve outcome of traumatic brain injury: a meta-analysis. Sci Rep. 2020 Sep 30;10(1):16179. doi: 10.1038/s41598-020-73227-5.

  PMID: 32999392 BACKGROUND

• Jorgensen SCJ, Tse CLY, Burry L, Dresser LD. Baricitinib: A Review of Pharmacology, Safety, and Emerging Clinical Experience in COVID-19. Pharmacotherapy. 2020 Aug;40(8):843-856. doi: 10.1002/phar.2438. Epub 2020 Jul 27.

  PMID: 32542785 BACKGROUND

• Taylor PC, Keystone EC, van der Heijde D, Weinblatt ME, Del Carmen Morales L, Reyes Gonzaga J, Yakushin S, Ishii T, Emoto K, Beattie S, Arora V, Gaich C, Rooney T, Schlichting D, Macias WL, de Bono S, Tanaka Y. Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis. N Engl J Med. 2017 Feb 16;376(7):652-662. doi: 10.1056/NEJMoa1608345.

  PMID: 28199814 BACKGROUND

• DU AL, Ji TL, Yang B, Cao JF, Zhang XG, Li Y, Pan S, Zhang B, Hu ZB, Zeng XW. Neuroprotective effect of AG490 in experimental traumatic brain injury of rats. Chin Med J (Engl). 2013;126(15):2934-7.

  PMID: 23924471 BACKGROUND

• Li T, Li L, Peng R, Hao H, Zhang H, Gao Y, Wang C, Li F, Liu X, Chen F, Zhang S, Zhang J. Abrocitinib Attenuates Microglia-Mediated Neuroinflammation after Traumatic Brain Injury via Inhibiting the JAK1/STAT1/NF-kappaB Pathway. Cells. 2022 Nov 13;11(22):3588. doi: 10.3390/cells11223588.

  PMID: 36429017 BACKGROUND

• Messenger A, Harries M. Baricitinib in Alopecia Areata. N Engl J Med. 2022 May 5;386(18):1751-1752. doi: 10.1056/NEJMe2203440. No abstract available.

  PMID: 35507486 BACKGROUND

• Marconi VC, Ramanan AV, de Bono S, Kartman CE, Krishnan V, Liao R, Piruzeli MLB, Goldman JD, Alatorre-Alexander J, de Cassia Pellegrini R, Estrada V, Som M, Cardoso A, Chakladar S, Crowe B, Reis P, Zhang X, Adams DH, Ely EW; COV-BARRIER Study Group. Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): a randomised, double-blind, parallel-group, placebo-controlled phase 3 trial. Lancet Respir Med. 2021 Dec;9(12):1407-1418. doi: 10.1016/S2213-2600(21)00331-3. Epub 2021 Sep 1.

  PMID: 34480861 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Cerebral Hemorrhage, Traumatic

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Hemorrhage, Traumatic; Cerebral Hemorrhage; Intracranial Hemorrhages; Cerebrovascular Disorders; Intracranial Hemorrhage, Traumatic; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yan Qu, M.D,Ph.D

  Tang-Du Hospital

  STUDY CHAIR

• Shunnan Ge, M.D,Ph.D

  Tang-Du Hospital

  STUDY DIRECTOR

Central Study Contacts

Shunnan Ge, M.D,Ph.D

CONTACT

+8618165295569; gesn8561@fmmu.edu.cn

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

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: October 3, 2023
• Study Start: November 24, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)