Behcet's SyndromePhase 2NCT07634848
Ivarmacitinib for Refractory Behcet's Syndrome
A Phase 2 study testing Ivarmacitinib in people with Behcet's Syndrome, run by Liu Tian at 1 site in China.
Trial summary
Behcet's syndrome (BS) is a multisystem autoimmune vasculitis. Current clinical treatment primarily includes glucocorticoids, immunosuppressants, and molecularly targeted drugs such as TNF-α and IL-6 inhibitors; however, some patients still respond poorly to existing treatment regimens. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Behcet's Syndrome
- What is being tested?
- Ivarmacitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 May 2027
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ① Meets the 1990 ISG diagnostic criteria for Behçet's syndrome [9];
- Aged 18-70 years; ③ Has shown an inadequate response to treatment after at least 6 months of therapy with glucocorticoids, at least two immunosuppressants, and/or biologics (including TNF-α inhibitors and IL-6 inhibitors);
- Agrees to receive treatment with a new targeted therapy
Who cannot join
- ① Patients with one or more other autoimmune diseases;
- Patients who have undergone major surgery within 4 weeks prior to enrollment, or who are scheduled to undergo elective surgery during the study; ③ Patients with a confirmed acute or chronic active infection (e.g., bacterial, viral [such as EBV, CMV, HIV, or active hepatitis virus]) within 4 weeks prior to enrollment; ④ Patients with a current or past history of any malignancy;
- Female patients who are pregnant or within 6 months postpartum;
- Patients with severe liver failure (Child-Pugh Class C) or end-stage renal disease (dialysis-dependent).
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality
About this study
Official title: Efficacy and Safety of the Novel, Highly Selective JAK Inhibitor Ivarmacitinib in the Treatment of Behçet's Disease: A Multicenter Prospective Study
Behcet's syndrome (BS) is a multisystem autoimmune vasculitis. Current clinical treatment primarily includes glucocorticoids, immunosuppressants, and molecularly targeted drugs such as TNF-α and IL-6 inhibitors; however, some patients still respond poorly to existing treatment regimens. The JAK-STAT signaling pathway serves as a common downstream signaling pathway for various cytokines involved in the pathogenesis of Behcet's syndrome. Upon binding to their receptors, cytokines activate JAK kinases, which in turn phosphorylate STAT proteins to regulate the expression of inflammation-related genes. Therefore, blocking the JAK-STAT pathway can simultaneously inhibit the signal transduction of multiple pathogenic cytokines, thereby exerting anti-inflammatory effects. Consequently, Ivarmacitinib-a highly selective JAK1 inhibitor-holds promise for improving the prognosis and quality of life of patients with refractory Behçet's syndrome.
This is a multi-center, single-arm trial conducted to evaluate the safety and efficacy of Ivarmacitinib in Behçet's syndrome (BS) . Patients with refractory Behçet's syndrome were enrolled . Patients received Ivarmacitinib for up to 24 weeks, which was added to the glucocorticoid and immunosuppressants. The clinical manifestations, inflammatory indicators, imaging and treatment of patients were recorded by investigators during the follow up.
- Conditions
- Behcet's Syndrome
- Being tested
- Ivarmacitinib
- Keywords
- Behçet's syndrome、Ivarmacitinib
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvarmacitinibDrug
The specific regimen was 4 mg of Ivarmacitinib administered daily for 24 weeks. All patients will undergo 24 weeks of prospective follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Ivarmacitinib for the Treatment of Refractory Behçet's Disease | Experimental | Not described Receives: Drug: Ivarmacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients achieving complete remission and partial remission
The primary endpoint was defined as the proportion(percent) of patients in the whole cohort achieving complete remission and partial remission by week 24.
Measured: Week 24
Secondary outcomes (3)
Changes of C-reactive protein
Blood samples were collected from all patients and the concentration of C-reactive protein (mg/L) were recorded.
Measured: Week 24
Changes of erythrocyte sedimentation rate
Blood samples were collected from all patients and the erythrocyte sedimentation rates (mm/h) were recorded.
Measured: week24
Changes of dosage of glucocorticoids from baseline.
The dosage of glucocorticoids (mg/day) of all patients were recorded during the follow-up.
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Why it stopped: Plans to rejoin a center
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet's 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
- 0 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
- NCT07634848
- Sponsor's protocol ID
- PKU People's Hospital SHR0302
- Status last verified
- May 2026
- First submitted
- 31 May 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Novel, Highly Selective JAK Inhibitor Ivarmacitinib in the Treatment of Behçet's Disease: A Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT07634848
- Acronym / sponsor ID
- PKU People's Hospital SHR0302
- Conditions
- Behcet's Syndrome
- Keywords
- Behçet's syndrome、Ivarmacitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Plans to rejoin a center
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Liu TianUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 9 Jun 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.
Behcet's syndrome (BS) is a multisystem autoimmune vasculitis. Current clinical treatment primarily includes glucocorticoids, immunosuppressants, and molecularly targeted drugs such as TNF-α and IL-6 inhibitors; however, some patients still respond poorly to existing treatment regimens. The JAK-STAT signaling pathway serves as a common downstream signaling pathway for various cytokines involved in the pathogenesis of Behcet's syndrome. Upon binding to their receptors, cytokines activate JAK kinases, which in turn phosphorylate STAT proteins to regulate the expression of inflammation-related genes. Therefore, blocking the JAK-STAT pathway can simultaneously inhibit the signal transduction of multiple pathogenic cytokines, thereby exerting anti-inflammatory effects. Consequently, Ivarmacitinib-a highly selective JAK1 inhibitor-holds promise for improving the prognosis and quality of life of patients with refractory Behçet's syndrome.
This is a multi-center, single-arm trial conducted to evaluate the safety and efficacy of Ivarmacitinib in Behçet's syndrome (BS) . Patients with refractory Behçet's syndrome were enrolled . Patients received Ivarmacitinib for up to 24 weeks, which was added to the glucocorticoid and immunosuppressants. The clinical manifestations, inflammatory indicators, imaging and treatment of patients were recorded by investigators during the follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ivarmacitinib for the Treatment of Refractory Behçet's Disease | Experimental | Drug: Ivarmacitinib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ① Meets the 1990 ISG diagnostic criteria for Behçet's syndrome [9];
Key exclusion criteria (4 listed)
- ① Patients with one or more other autoimmune diseases;
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 |
|---|---|---|
| IvarmacitinibThe specific regimen was 4 mg of Ivarmacitinib administered daily for 24 weeks. All patients will undergo 24 weeks of prospective follow-up. | Drug | Ivarmacitinib for the Treatment of Refractory Behçet's Disease |
Primary outcome
Patients achieving complete remission and partial remission
Time frame: Week 24
The primary endpoint was defined as the proportion(percent) of patients in the whole cohort achieving complete remission and partial remission by week 24.
3 secondary outcomes
Changes of C-reactive protein
Time frame: Week 24
Changes of erythrocyte sedimentation rate
Time frame: week24
Changes of dosage of glucocorticoids from baseline.
Time frame: week 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Behcet's Syndrome
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Corticotropin for Behçet's Disease: A Multicenter Randomized Controlled TrialAcronym.
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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 Ivarmacitinib in people with Behcet's 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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 10 Jul 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 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 was withdrawn before enrolling participants, so there are no results.
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 achieving complete remission and partial remission (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 10 Jul 2026.