NCT05845723

Brief Summary

This project aims to evaluate the efficacy and safety of the combination of glucocorticoids with tocilizumab or tofacitinib, compared to the traditional combination of glucocorticoids with cyclophosphamide in the treatment of vascular Behçet's syndrome.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Timeline
13mo left

Started Jun 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Jun 2023Jun 2027

First Submitted

Initial submission to the registry

April 26, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

August 19, 2024

Status Verified

July 1, 2024

Enrollment Period

3 years

First QC Date

April 26, 2023

Last Update Submit

August 16, 2024

Conditions

AneurysmBehcet Syndrome, Vascular Type

Keywords

TocilizumabTofacitinibVascular Behçet's Syndrome

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is the complete response (CR) rate at week 12.

    CR: the resolution of VBS-related symptoms and abnormal acute phase reactants including erythrocyte sedimentation rate (ESR) and high-sensitivity C reactive protein (hs-CRP), no progression or new occurrence of vascular lesions compared to baseline.

    Baseline to week 12

Secondary Outcomes (8)

  • The secondary endpoints include CR rate at week 24, and partial response (PR) rate at week 12/24.

    Baseline to week 24

  • Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF).

    BDCAF were assessed at weeks 0, 4, 8, 12, 18, and 24

  • Change From Baseline in the degree of vasculitis damage as Measured by Behçet's syndrome Overall Damage Index (BODI).

    BODI were assessed at weeks 0 and 24

  • 4.Change From Baseline in the degree of vasculitis damage as Measured by Vasculitis Damage Index (VDI).

    Time Frame: VDI were assessed at weeks 0, 12, and 24

  • Change From Baseline in ESR and hs-CRP.

    ESR and hs-CRP were assessed at weeks 0, 4, 8, 12, 18, and 24

  • +3 more secondary outcomes

Study Arms (3)

Tocilizumab+GCS for VBS

EXPERIMENTAL

Participants randomized to this arm will receive prednisone 1mg/kg/d, gradually tapered to 10mg/d at week 12, combined with intravenous infusion of tocilizumab 8mg/kg every 4 weeks for 24 weeks.

Drug: tocilizumab

Tofacitinib+GCS for VBS

EXPERIMENTAL

Participants randomized to this arm will receive prednisone 1mg/kg/d, gradually tapered to 10mg/d at week 12, combined with oral tofacitinib 5mg twice a day for 24 weeks of treatment.

Drug: tofacitinib

Cyclophosphamide+GCS for VBS

EXPERIMENTAL

Participants randomized to this arm will receive prednisone 1mg/kg/d, gradually tapered to 10mg/d at week 12, combined with intravenous infusion of cyclophosphamide 0.5g biweekly for 24 weeks.

Drug: cyclophosphamide

Interventions

tocilizumabDRUG

Participants will receive intravenous infusion of tocilizumab 8mg/kg every 4 weeks for 24 weeks.

Also known as: ACTEMRA®
Tocilizumab+GCS for VBS
tofacitinibDRUG

Participants will receive tofacitinib 5mg twice a day for 24 weeks of treatment.

Also known as: Xeljanz®
Tofacitinib+GCS for VBS
cyclophosphamideDRUG

Participants will receive intravenous infusion of cyclophosphamide 0.5g biweekly for 24 weeks.

Also known as: Endoxana
Cyclophosphamide+GCS for VBS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ． Understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures being conducted.
  • \. Male and female subjects aged 18-65 years.
  • ． Fulfill the 2013 International Classification Criteria for Behcet's Disease (ICBD).
  • ． Patients with aneurysmal dilatation/aneurysm of the descending aorta and/or peripheral arteries confirmed by ultrasonography and/or computed tomography angiography (CTA).
  • \. Elevated acute phase reactants ESR and hs-CRP.

You may not qualify if:

  • Cardiovascular manifestations that cannot be distinguished from giant cell arteritis, Burger's disease, or atherosclerotic aneurysm; infectious aneurysm;
  • Other active organ involvement related to BS that requires intensified immunosuppressive treatment, including gastrointestinal ulcers, uveitis, and parenchymal neurological involvement;
  • Severe organ dysfunction, including ALT, AST, and TBIL exceeding the upper limit of normal by more than 2 times, serum creatinine ≥ 133 mmol/L, white blood cell count \< 3×10\^9/L, ANC \< 2×10\^9/L, hemoglobin \< 80g/L, platelet count \< 100×10\^9/L;
  • Active infection such as active tuberculosis, hepatitis B or C, syphilis, chronic EBV infection, persistent or severe bacterial or viral infection;
  • Primary or secondary immunodeficiency;
  • Malignant tumor;
  • Use of immunosuppressants such as Cyclosporin A (CsA), Azathioprine (AZA), Tacrolimus (TAC), Mycophenolate Mofetil (MMF), or Cyclophosphamide (CTX) within 1 month;
  • Use of biologics/small molecule drugs within 5 half-lives (baricitinib within 10 days; etanercept within 4 weeks; infliximab within 8 weeks; adalimumab, golimumab, ustekinumab, and abatacept within 10 weeks, secukinumab within 6 months, and previously use of tocilizumab and tofacitinib);
  • Pregnant, lactating, or planning a recent pregnancy;
  • Subjects who do not agree to or are unable to comply with regular visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

AneurysmBehcet Syndrome

Interventions

tocilizumabtofacitinibCyclophosphamide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesMouth DiseasesStomatognathic DiseasesUveitis, AnteriorPanuveitisUveitisUveal DiseasesEye DiseasesVasculitisHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Vascular

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Central Study Contacts

Jinjing Liu, M.D.

CONTACT

8613581605769wingsforjane@163.com

Wenjie Zheng, M.D.

CONTACT

8613661281939wenjzheng@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2023

First Posted

May 6, 2023

Study Start

June 1, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

August 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)