Ivarmacitinib for Refractory Behcet's Syndrome

NCT07634848 | Withdrawn Phase 2

• 1 other identifier: PKU People's Hospital SHR0302
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Behçet's syndrome、Ivarmacitinib

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 24

Secondary Outcomes (3)

• Changes of C-reactive protein

  Week 24

• Changes of erythrocyte sedimentation rate

  week24

• Changes of dosage of glucocorticoids from baseline.

  week 24

Study Arms (1)

Ivarmacitinib for the Treatment of Refractory Behçet's Disease

EXPERIMENTAL

Drug: Ivarmacitinib

Interventions

Ivarmacitinib DRUG

The specific regimen was 4 mg of Ivarmacitinib administered daily for 24 weeks. All patients will undergo 24 weeks of prospective follow-up.

Ivarmacitinib for the Treatment of Refractory Behçet's Disease

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Liu Tian: lead

Study Sites (1)

Department of Rheumatology and Immunology, Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Behcet Syndrome

Interventions

ivarmacitinib

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)