Safety and Efficacy of Baricitinib After Endovascular Treatment in Acute Anterior Circulation Large Vessel Occlusion: A Multicenter, Randomized Controlled Clinical Trial

Safety and Efficacy of Baricitinib Combined With Acute Large Vessel Occlusion Recanalization : A Multicenter, Randomized Controlled Clinical Trial

The primary purpose of this study is to evaluate the efficacy and safety of Baricitinib combined with endovascular therapy in patients with acute anterior circulation large vessel occlusion, to address futile recanalization with priority, and to elucidating the mechanism of JAK/STAT pathway inhibition on neuroprotection and inflammatory regulation.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ichemic Stroke; Anterior Cerebral Artery Stroke; Baricitinib
• Intervention / Treatment: Drug: 2mg Baricitinib; Other: Guideline-based therapy; Drug: 4mg Baricitinib; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Wei Hu, MD, PhD; Phone Number: +86 055162284313; Email: andinghu@ustc.edu.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • The First Affiliated Hospital of University of Science and Technology of China, Hefei, Recruiting
      • Contact: Wei Hu, MD, PhD; Phone Number: +86 115155510611; Email: andinghu@ustc.edu.cn

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age is 18 years old or above.
2. Diagnosed as anterior circulation large vessel occlusion stroke by CTA, MRA or DSA.
3. Randomized within 24h after the onset.
4. The NIHSS score is above 5 and the ASPECT score is above 3 points while receiving imaging examination;
5. The mTICI score after endovascular treatment (EVT) is above 2b.
6. informed consent.

Exclusion Criteria:

1. Intracranial hemorrhage confirmed by CT or MRI.
2. mRS score>2 for patients <80 years, or mRS score>1 for those ≥80 years before onset.
3. Pregnant or lactating women.
4. Allergic to contrast agents.
5. Allergic to baricitinib or having contraindications for using baricitinib.
6. Participating in other clinical studies.
7. Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, and unable to be controlled by oral antihypertensive drugs.
8. Genetic or acquired bleeding diathesis, lack of anticoagulant factors or having taken oral anticoagulants and INR >1.7.
9. Hemoglobin value <8g/L.
10. Recent history of using other JAK inhibitors or potent immunosuppressants, including but not limited to the combined use with potent immunosuppressive drugs such as azathioprine, tacrolimus, tofacitinib and fedratinib, etc. Tortuous arteries make the thrombectomy device unable to reach the target blood vessel.
11. Previous history of diagnosed viral hepatitis and tuberculosis.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2mg Baricitinib group+Guideline-based therapy; One 2mg Baricitinib tablet and one 2mg placebo tablet are given once daily for 5 to 7 days.	Drug: 2mg Baricitinib; One 2mg Baricitinib tablet and one 2mg placebo tablet are given three times a day, last for 5±2 days.; Other: Guideline-based therapy; Guideline-based therapy including EVT treatment is determined by the physician.
Experimental: Baricitinib 4mg group+Guideline-based therapy; Two 2mg Baricitinib tablets are given three once daily for 5 to 7 days.	Other: Guideline-based therapy; Guideline-based therapy including EVT treatment is determined by the physician.; Drug: 4mg Baricitinib; Two 2mg Baricitinib tablets are given three times a day, last for 5±2 days.
Active Comparator: Sham group+Guideline-based therapy; Two 2mg placebo tablets are given three times a day once daily for 5 to 7 days.	Other: Guideline-based therapy; Guideline-based therapy including EVT treatment is determined by the physician.; Drug: Placebo; Two 2mg placebo tablets are given three times a day, last for 5±2 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of 90-day mRS scores	The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.	90±14 days post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with functional independence outcome (mRS 0-2) at 90-day	modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death).	90±14 days post-procedure
Proportion of patients with functional independence outcome (mRS 0-1) at 90-day	modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death).	90±14 days post-procedure
Change in NIHSS score at 5-7 days post-procedure		5-7 days post-procedure
Any mortality at 90±14 days	Primary Safety Endpoints	90±14 days post-procedure
Any symptomatic intracranial hemorrhage within 48h	Secondary Safety Endpoints	48 hours post-procedure
Any asymptomatic intracranial hemorrhage within 48h	Secondary Safety Endpoints	48 hours post-procedure
Any adverse event	Asymptomatic intracranial hemorrhage	90±14 days post-procedure

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of University of Science and Technology of China

Study record dates

Study Major Dates

• Study Start (Estimated): March 17, 2026
• Primary Completion (Estimated): August 17, 2027
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Ischemia; Intracranial Arterial Diseases; Stroke; Cerebral Arterial Diseases; Cerebral Infarction; Pathological Conditions, Signs and Symptoms; Infarction, Anterior Cerebral Artery; baricitinib
• Other Study ID Numbers: BEACON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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