Ustekinumab for Intestinal Behçet's Syndrome With Myelodysplastic Syndrome

Sponsor
Liu Tian
Study ID
NCT07582991
Phase
PHASE2
Status
Completed

Conditions

  • Behcet's Syndrome, Intestinal Type
  • Myelodysplastic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab 90 mg — DRUG
    Ustekinumab will be administered subcutaneously at a dose of 90 mg at weeks 0, 4, and 8, followed by a maintenance dose of 90 mg every 12 weeks (every 3 months).

Study Details

Behçet's syndrome is a systemic vasculitis. Gastrointestinal involvement in Behçet's syndrome complicated by myelodysplastic syndrome represents a rare and severe subtype for which no standardized treatment guidelines currently exist, posing significant challenges in clinical practice. Ustekinumab, a biologic agent targeting IL-12/IL-23, has demonstrated favorable efficacy in both gastrointestinal Behçet's syndrome and inflammatory bowel disease. This study aims to evaluate the efficacy and safety of ustekinumab in patients with intestinal Behçet's syndrome and coexisting myelodysplastic syndrome.

Key Dates

Start date
Mar 24, 2024
Status verified
Mar 2026
Primary completion
Feb 23, 2026
Completion
Feb 23, 2026

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treated with ustekinumab
    Eight patients with intestinal Behçet's syndrome complicated by myelodysplastic syndrome were treated with ustekinumab.

Primary Outcome Measure

Patients achieving complete remission, marked improvement, and improvement [ Time Frame: Week 24 ]

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