Behcet SyndromePhase 2NCT07080346
Upadacitinib for Refractory Behcet's Syndrome
A Phase 2 study testing Upadacitinib 15 MG in people with Behcet Syndrome, run by Liu Tian at 1 site in China.
Trial summary
Behçet's syndrome (BS) is a systemic autoimmune vasculitis that can affect multiple organs, including the skin, eyes, and vascular system. Refractory BS poses significant treatment challenges, necessitating novel therapeutic approaches. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Behcet Syndrome
- What is being tested?
- Upadacitinib 15 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2024to 8 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Male or female aged 18-70 years at time of screening.
- Diagnosis of Behcet's syndrome (according to the International Criteria for Behçet's Disease) for ≥3 months before screening.
- Active Behcet's syndrome at time of screening (BDCAF≥2).
- Resistant to glucocorticoids, at least two traditional immunosuppressants (one of which must have been cyclophosphamide or mycophenolate mofetil) or biological agents (one of which must have been a TNF-α inhibitor or a JAK inhibitor) for at least 6 months.
- Given their written informed consent to participate in the trial and expected to be able to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- High-dose glucocorticoid (>1mg/kg/d) usage within 1 month.
- Severe comorbidities: including heart failure (≥ grade III NYHA), renal insufficiency (creatinine clearance ≤30 ml/min), hepatic insufficiency (serum ALT or AST >3 times the ULN, or total bilirubin >ULN for the central laboratory conducting the test). Other severe, progressive or uncontrolled hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis).
- Known allergies, hypersensitivity, or intolerance to Baricitinib or its excipients.
- Had a severe infection (including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis); had been hospitalized for an infection; or had been treated with IV antibiotics for an infection, within 2 months prior to the first administration of study agent.
- Chest radiograph within 3 months prior to the first administration of study agent that showed an abnormality suggestive of a malignancy or current active infection, including tuberculosis.
- Infected with HIV (positive serology for HIV antibody) or hepatitis C (positive serology for Hep C antibody). If seropositive, consultation with a physician with expertise in the treatment of HIV or hepatitis C virus infection was recommended.
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- Infected with hepatitis B virus. For patients who were not eligible for this study due to hepatitis B virus test results, consultation with a physician with expertise in the treatment of hepatitis B virus infection was recommended.
- Had any known malignancy or has a history of malignancy within the previous 5 years (with the exception of a nonmelanoma skin cancer that had been treated with no evidence of recurrence for ≥3 months before the first study agent administration or cervical neoplasia with surgical cure).
- Had uncontrolled psychiatric or emotional disorder, including a history of drug and alcohol abuse within the past 3 years that might prevent the successful completion of the study.
- Received, or was expected to receive, any live virus or bacterial vaccination within 3 months before the first administration of study agent, during the study, or within 4 months after the last administration of study agent. Had a BCG vaccination within 12 months of screening.
- Pregnancy, lactation or women of child-bearing potential (WCBP) unwilling to use medically approved contraception whilst receiving treatment and for 12 months after treatment has finished.
- Men whose partners are of child-bearing potential but who are unwilling to use appropriate medically approved contraception whilst receiving treatment and for 12 months after treatment has finished.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: Upadacitinib for Refractory Behcet's Syndrome: a Prospective Pilot Open-label Study
Behçet's syndrome (BS) is a systemic autoimmune vasculitis that can affect multiple organs, including the skin, eyes, and vascular system. Refractory BS poses significant treatment challenges, necessitating novel therapeutic approaches. Upadacitinib, a selective JAK1 inhibitor within the JAK-STAT pathway, has shown promise in modulating immune responses. This study aims to evaluate the efficacy and safety of upadacitinib in patients with refractory BS.
Read the detailed description
This multicenter, single-arm study investigates the efficacy and safety of upadacitinib (15 mg once daily) in refractory Behçet's syndrome (BS) patients. Adult patients had active BS with inadequate response to glucocorticoids and at least two conventional immunosuppressants or biologics over six months. Prior biologics were discontinued, and upadacitinib was added to ongoing glucocorticoids and immunosuppressants for 48 weeks. Clinical symptoms (oral/genital ulcers, skin lesions, uveitis), inflammatory markers (CRP, ESR), and medication usage were monitored. Adverse events were recorded to assess safety.
- Conditions
- Behcet Syndrome
- Being tested
- Upadacitinib 15 MG
- Keywords
- Behcet syndrome, Upadacitinib
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upadacitinib 15 MGDrug
All the BS patients discontinued other biologic agents and received oral upadacitinib treatment at a dose of 15mg per day with background glucocorticoids and immunosuppressants for 48 weeks. All the patients will be followed up prospectively for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treated with upadacitinib | Experimental | Refractory BS patients were treated with upadacitinib. Receives: Drug: Upadacitinib 15 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients getting improved condition
The primary endpoint was defined as the proportion(percent) of patients in the whole cohort getting improved condition by week 24. Improved condition was defined as BS-related manifestations resolved and no newly onset imaging/endoscopic findings observed.
Measured: Week 24
Secondary outcomes (4)
Changes of Behcet's Disease Current Activity Form (BDCAF) score of patients
The clinical manifestation of patients were recorded during the follow-up. The disease activity of patients was accessed by Behcet's Disease Current Activity Form (BDCAF) score and the BDCAF scores (Range: 0~12, higher scores mean higher disease activity) at week 24, week 48 and the baseline scores were compared.
Measured: Week 24 and week 48
Changes of C-reactive protein
Blood samples were collected from all patients and the concentration of C-reactive protein (mg/L) were recorded. C-reactive protein at 24 weeks, 48 weeks and the baseline were compared.
Measured: Week 24 and week 48
Changes of erythrocyte sedimentation rate
Blood samples were collected from all patients and the erythrocyte sedimentation rates (mm/h) were recorded. Erythrocyte sedimentation rates at 24 weeks, 48 weeks and the baseline were compared.
Measured: Week 24 and week 48
Changes of dosage of glucocorticoids from baseline
The dosage of glucocorticoids (mg/day) of all patients were recorded during the follow-up. The dosage of glucocorticoids at 24 weeks, 48 weeks and the baseline were compared.
Measured: Week 24 and week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start25 Jan 2024
- Primary completion20 Dec 2024
- Study completion8 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet SyndromeStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liu Tian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Tian, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080346
- Sponsor's protocol ID
- PKU People's Hospital UPA
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upadacitinib for Refractory Behcet's Syndrome: a Prospective Pilot Open-label Study
- ClinicalTrials.gov ID
- NCT07080346
- Acronym / sponsor ID
- PKU People's Hospital UPA
- Conditions
- Behcet Syndrome
- Keywords
- Behcet syndrome, Upadacitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Liu TianUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 8 Jul 2025 (actual)
- First posted
- 23 Jul 2025 (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.
Behçet's syndrome (BS) is a systemic autoimmune vasculitis that can affect multiple organs, including the skin, eyes, and vascular system. Refractory BS poses significant treatment challenges, necessitating novel therapeutic approaches. Upadacitinib, a selective JAK1 inhibitor within the JAK-STAT pathway, has shown promise in modulating immune responses. This study aims to evaluate the efficacy and safety of upadacitinib in patients with refractory BS.
Detailed description
This multicenter, single-arm study investigates the efficacy and safety of upadacitinib (15 mg once daily) in refractory Behçet's syndrome (BS) patients. Adult patients had active BS with inadequate response to glucocorticoids and at least two conventional immunosuppressants or biologics over six months. Prior biologics were discontinued, and upadacitinib was added to ongoing glucocorticoids and immunosuppressants for 48 weeks. Clinical symptoms (oral/genital ulcers, skin lesions, uveitis), inflammatory markers (CRP, ESR), and medication usage were monitored. Adverse events were recorded to assess safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated with upadacitinib | Experimental | Drug: Upadacitinib 15 MGRefractory BS patients were treated with upadacitinib. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Male or female aged 18-70 years at time of screening.
Key exclusion criteria (12 listed)
- High-dose glucocorticoid (>1mg/kg/d) usage within 1 month.
- Severe comorbidities: including heart failure (≥ grade III NYHA), renal insufficiency (creatinine clearance ≤30 ml/min), hepatic insufficiency (serum ALT or AST >3 times the ULN, or total bilirubin >ULN for the central laboratory conducting the test). Other severe, progressive or uncontrolled hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis).
- Known allergies, hypersensitivity, or intolerance to Baricitinib or its excipients.
- Had a severe infection (including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis); had been hospitalized for an infection; or had been treated with IV antibiotics for an infection, within 2 months prior to the first administration of study agent.
- Chest radiograph within 3 months prior to the first administration of study agent that showed an abnormality suggestive of a malignancy or current active infection, including tuberculosis.
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 |
|---|---|---|
| Upadacitinib 15 MGAll the BS patients discontinued other biologic agents and received oral upadacitinib treatment at a dose of 15mg per day with background glucocorticoids and immunosuppressants for 48 weeks. All the patients will be followed up prospectively for 48 weeks. | Drug | Treated with upadacitinib |
Primary outcome
Patients getting improved condition
Time frame: Week 24
The primary endpoint was defined as the proportion(percent) of patients in the whole cohort getting improved condition by week 24. Improved condition was defined as BS-related manifestations resolved and no newly onset imaging/endoscopic findings observed.
4 secondary outcomes
Changes of Behcet's Disease Current Activity Form (BDCAF) score of patients
Time frame: Week 24 and week 48
Changes of C-reactive protein
Time frame: Week 24 and week 48
Changes of erythrocyte sedimentation rate
Time frame: Week 24 and week 48
Changes of dosage of glucocorticoids from baseline
Time frame: Week 24 and week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Upadacitinib 15 MG in people with Behcet Syndrome, run by Liu Tian 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 2 Dec 2025. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients getting improved condition (time frame: Week 24). 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 2 Dec 2025.