None listed
Conditions
Interventions
Drug : This is a single-arm, open-label, exploratory clinical study targeting patients aged 19 to 75 years with Behçet’s disease who present with recurrent oral ulcers. Eligibility will be assessed ba
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged =19 years and <75 years with active mucocutaneous Behçet’s disease who are resistant or intolerant to colchicine and meet all of the following inclusion criteria: ? Adult patients (=19 years old) diagnosed with Behçet’s disease according to clinical diagnostic criteria (ISGBD or Japanese diagnostic criteria) by the Department of Dermatology at this institution during the clinical study period. ? Patients who fully understand the details of this clinical study and voluntarily agree to participate. ? Patients with Behçet’s disease who are resistant or intolerant to colchicine: i. Patients who, despite receiving a therapeutic dose of colchicine (=0.6 mg daily) for at least 8 weeks, continue to experience recurrent oral ulcers at least once per month. ii. Patients who are intolerant to colchicine due to adverse drug reactions (e.g., diarrhea, loose stools) even at low doses (=0.6 mg daily). Patients who meet the following disease severity criteria prior to administration of the investigational drug: At screening, a history of at least one recurrence of oral ulcers within the past month, and at the time of randomization, at least two painful oral ulcers present. Contraception requirements: All women of childbearing potential must agree to use and consistently practice appropriate contraception (as listed below) during the clinical study period and for at least 90 days after the last administration of the investigational drug: i. Intrauterine device (IUD), tubal ligation, or partner’s vasectomy. ii. Hormonal contraception (oral, injectable, implantable, transdermal patch, or vaginal ring). iii. Double-barrier method [male condom combined with a female barrier method (spermicides, diaphragm, contraceptive vaginal sponge, or cervical cap)]. iv. Complete sexual abstinence.
Exclusion criteria
Exclusion criteria: (1)Patients with prior exposure to guselkumab or other agents with similar mechanisms of action, such as ustekinumab, risankizumab, tildrakizumab, or mirikizumab, for any reason. (2)Patients currently receiving other biologics (e.g., anti-TNF agents, anti-IL-1 agents, anti-IL-23 agents such as ustekinumab or risankizumab, or anti-IL-17 agents such as secukinumab or ixekizumab). (3)Patients who, within the past 6 months, experienced the occurrence or worsening of major organ involvement other than mucocutaneous symptoms of Behçet’s disease (such as uveitis, vascular Behçet’s disease, intestinal Behçet’s disease, or neuro-Behçet’s disease), requiring an increased dose of systemic corticosteroids (equivalent to =20 mg/day of prednisolone) or initiation of a new immunosuppressant. However, patients with inactive intestinal Behçet’s disease without clinical symptoms (e.g., abdominal pain or diarrhea) or those with arthralgia without physical signs of inflammation may participate in the study. (4)Patients currently receiving or having received any of the following systemic immunosuppressants (oral or injectable) within the wash-out period: cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, tacrolimus, cyclophosphamide, etc. However, patients who have been on a stable dose of =100 mg/day of azathioprine or =10 mg/week of methotrexate for at least 4 weeks may participate. (5)Patients with uncontrolled systemic infections (e.g., active viral hepatitis, tuberculosis). (6)Patients with clinically significant abnormalities on chest radiography or ECG. (7)Patients with latent tuberculosis confirmed by IGRA testing prior to administration of the study drug. However, patients may participate if appropriate anti-tuberculosis treatment, as recommended, has been initiated before administration of the investigational drug. (8)Individuals unable to read or understand the informed consent form. (9)Patients who do not consent to participate in the study. (10)Patients with any of the following abnormal laboratory test results at Visit 1: ? Hemoglobin 14,000/µL ? AST or ALT > 3 × the upper limit of normal (ULN) ? Serum creatinine > 2 × ULN ? Total bilirubin > 2.0 mg/dL ? Positive pregnancy test (11)Patients with a history of hypersensitivity to the investigational drug or any of its components. (12)Patients who, within 4 weeks prior to Visit 1, participated in another clinical study and received an investigational drug or medical device. (13)Pregnant or breastfeeding women. (14)Patients who have received a live vaccine within 4 weeks prior to study enrollment or who are scheduled to receive a live vaccine during the study period. (15)Patients with other clinically significant findings that, in the judgment of the investigator, would make them unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total oral ulcer count at Week 16 compared to baseline;umber of oral ulcers and genital ulcers separately;VAS for Oral and Genital Ulcer Pain;PGA of Skin Lesions | — |
Secondary
| Measure | Time frame |
|---|---|
| Health-Related Quality of Life assessed by SF-36 questionnaire | — |
Countries
Korea, Republic of
Contacts
Public ContactKim DoYoung
Yonsei University Health System, Severance Hospital
Outcome results
None listed