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

NCT07449910 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: BEACON
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Ichemic Stroke; Anterior Cerebral Artery Stroke; Baricitinib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Proportion of patients with functional independence outcome (mRS 0-2) at 90-day

  90±14 days post-procedure

• Proportion of patients with functional independence outcome (mRS 0-1) at 90-day

  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

  90±14 days post-procedure

• Any symptomatic intracranial hemorrhage within 48h

  48 hours post-procedure

Study Arms (3)

2mg Baricitinib group+Guideline-based therapy

EXPERIMENTAL

One 2mg Baricitinib tablet and one 2mg placebo tablet are given once daily for 5 to 7 days.

Drug: 2mg Baricitinib; Other: Guideline-based therapy

Baricitinib 4mg group+Guideline-based therapy

EXPERIMENTAL

Two 2mg Baricitinib tablets are given three once daily for 5 to 7 days.

Drug: 4mg Baricitinib; Other: Guideline-based therapy

Sham group+Guideline-based therapy

ACTIVE COMPARATOR

Two 2mg placebo tablets are given three times a day once daily for 5 to 7 days.

Drug: Placebo; Other: Guideline-based therapy

Interventions

2mg Baricitinib DRUG

One 2mg Baricitinib tablet and one 2mg placebo tablet are given three times a day, last for 5±2 days.

2mg Baricitinib group+Guideline-based therapy

4mg Baricitinib DRUG

Two 2mg Baricitinib tablets are given three times a day, last for 5±2 days.

Baricitinib 4mg group+Guideline-based therapy

Placebo DRUG

Two 2mg placebo tablets are given three times a day, last for 5±2 days.

Sham group+Guideline-based therapy

Guideline-based therapy OTHER

Guideline-based therapy including EVT treatment is determined by the physician.

2mg Baricitinib group+Guideline-based therapy; Baricitinib 4mg group+Guideline-based therapy; Sham group+Guideline-based therapy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Intracranial hemorrhage confirmed by CT or MRI.
• mRS score\>2 for patients \<80 years, or mRS score\>1 for those ≥80 years before onset.
• Pregnant or lactating women.
• Allergic to contrast agents.
• Allergic to baricitinib or having contraindications for using baricitinib.
• Participating in other clinical studies.
• Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, and unable to be controlled by oral antihypertensive drugs.
• Genetic or acquired bleeding diathesis, lack of anticoagulant factors or having taken oral anticoagulants and INR \>1.7.
• Hemoglobin value \<8g/L.
• 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.
• Previous history of diagnosed viral hepatitis and tuberculosis.

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of University of Science and Technology of China, Hefei, Recruiting

Hefei, Anhui, 230001, China

Location

MeSH Terms

Conditions

Infarction, Anterior Cerebral Artery

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Wei Hu, MD, PhD

CONTACT

+86 055162284313; andinghu@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 4, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): August 17, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)