Acute Ichemic StrokePhase 2/3NCT07449910
Safety and Efficacy of Baricitinib After Endovascular Treatment in Acute Anterior Circulation Large Vessel Occlusion: A Multicenter, Randomized Controlled Clinical Trial
A Phase 2/3 study testing 2mg Baricitinib, 4mg Baricitinib and Guideline-based therapy in people with Acute Ichemic Stroke and Anterior Cerebral Artery Stroke, run by The First Affiliated Hospital of University of Science and Technology of China at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ichemic Stroke, Anterior Cerebral Artery Stroke, Baricitinib
- What is being tested?
- 2mg Baricitinib, 4mg Baricitinib and Guideline-based therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 750 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2026to 31 Jan 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of University of Science and Technology of China, Hefei, Recruiting
Hefei, Anhui, 230001
Wei Hu, MD, PhD, +86 115155510611, andinghu@ustc.edu.cn
About this study
Official title: 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.
- Being tested
- 2mg Baricitinib, 4mg Baricitinib, Placebo, Guideline-based therapy
- Medical subject headings
- Infarction, Anterior Cerebral Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2mg BaricitinibDrug
One 2mg Baricitinib tablet and one 2mg placebo tablet are given three times a day, last for 5±2 days.
4mg BaricitinibDrug
Two 2mg Baricitinib tablets are given three times a day, last for 5±2 days.
PlaceboDrug
Two 2mg placebo tablets are given three times a day, last for 5±2 days.
Guideline-based therapyOther
Guideline-based therapy including EVT treatment is determined by the physician.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Placebo; Other: Guideline-based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90±14 days post-procedure
Secondary outcomes (7)
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).
Measured: 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).
Measured: 90±14 days post-procedure
Change in NIHSS score at 5-7 days post-procedure
Measured: 5-7 days post-procedure
Any mortality at 90±14 days
Primary Safety Endpoints
Measured: 90±14 days post-procedure
Any symptomatic intracranial hemorrhage within 48h
Secondary Safety Endpoints
Measured: 48 hours post-procedure
Any asymptomatic intracranial hemorrhage within 48h
Secondary Safety Endpoints
Measured: 48 hours post-procedure
Any adverse event
Asymptomatic intracranial hemorrhage
Measured: 90±14 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start17 Mar 2026 (estimated)
- Primary completion17 Aug 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ichemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Hu, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449910
- Sponsor's protocol ID
- BEACON
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Baricitinib Combined With Acute Large Vessel Occlusion Recanalization : A Multicenter, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07449910
- Acronym / sponsor ID
- BEACON
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of ChinaUniversity, hospital or other
- Study start
- 17 Mar 2026 (estimated)
- Primary completion
- 17 Aug 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2mg Baricitinib group+Guideline-based therapy | Experimental | Drug: 2mg Baricitinib, Other: Guideline-based therapyOne 2mg Baricitinib tablet and one 2mg placebo tablet are given once daily for 5 to 7 days. |
| Baricitinib 4mg group+Guideline-based therapy | Experimental | Drug: 4mg Baricitinib, Other: Guideline-based therapyTwo 2mg Baricitinib tablets are given three once daily for 5 to 7 days. |
| Sham group+Guideline-based therapy | Active comparator | Drug: Placebo, Other: Guideline-based therapyTwo 2mg placebo tablets are given three times a day once daily for 5 to 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2mg BaricitinibOne 2mg Baricitinib tablet and one 2mg placebo tablet are given three times a day, last for 5±2 days. | Drug | 2mg Baricitinib group+Guideline-based therapy |
| 4mg BaricitinibTwo 2mg Baricitinib tablets are given three times a day, last for 5±2 days. | Drug | Baricitinib 4mg group+Guideline-based therapy |
| PlaceboTwo 2mg placebo tablets are given three times a day, last for 5±2 days. | Drug | Sham group+Guideline-based therapy |
| Guideline-based therapyGuideline-based therapy including EVT treatment is determined by the physician. | Other | 2mg Baricitinib group+Guideline-based therapy, Baricitinib 4mg group+Guideline-based therapy, Sham group+Guideline-based therapy |
Primary outcome
Distribution of 90-day mRS scores
Time frame: 90±14 days post-procedure
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.
7 secondary outcomes
Proportion of patients with functional independence outcome (mRS 0-2) at 90-day
Time frame: 90±14 days post-procedure
Proportion of patients with functional independence outcome (mRS 0-1) at 90-day
Time frame: 90±14 days post-procedure
Change in NIHSS score at 5-7 days post-procedure
Time frame: 5-7 days post-procedure
Any mortality at 90±14 days
Time frame: 90±14 days post-procedure
Any symptomatic intracranial hemorrhage within 48h
Time frame: 48 hours post-procedure
Any asymptomatic intracranial hemorrhage within 48h
Time frame: 48 hours post-procedure
Any adverse event
Time frame: 90±14 days post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 2mg Baricitinib, 4mg Baricitinib and Guideline-based therapy in people with Acute Ichemic Stroke and Anterior Cerebral Artery Stroke, run by The First Affiliated Hospital of University of Science and Technology of China at 1 site 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 6 inclusion and 11 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: opening soon, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Hu, MD, PhD (+86 055162284313, andinghu@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of 90-day mRS scores (time frame: 90±14 days post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2026.