Dusquetide for the Treatment of Behcet's Disease

Inclusion criteria

• Participants must have a clinical diagnosis of Behcet's Disease meeting the International Study Group criteria.
• Participants must have at least two oral ulcers and/or one genital ulcer on the day of randomization.
• Participants willing to follow the clinical protocol and voluntarily give their written informed consent.
• Female participants not pregnant or nursing and willing to undergo a pregnancy test prior to treatment initiation and at the end of the treatment period.

Exclusion criteria

• Pregnancy or mothers who are breast-feeding.
• All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to agree to the use of effective contraception during the trial.
• Evidence of significant renal, hepatic, hematologic or immunologic disease.
• Use of any investigational medication within 4 weeks prior to enrollment or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer).
• Having received concomitant immune modulating therapy (except colchicine or azathioprine) within:

• Ten days prior to enrollment for mycophenolate mofetil
• Four weeks (28 days) prior to enrollment for cyclosporine, methotrexate, cyclophosphamide, thalidomide and dapsone
• Oral and topical corticosteroids must have been tapered as appropriate and discontinued 3 days prior to day of enrollment
• At least 5 terminal half-lives for all biologics including, but not limited to, those listed below; within: i. Four weeks prior to enrollment for etanercept; ii. Eight weeks prior to enrollment for infliximab; iii. Ten weeks prior to enrollment for adalimumab, golimumab, certolizumab, abatacept, and tocilizumab; iv. Six months prior to enrollment for secukinumab.
• Having received oral or parenteral corticosteroids within 6 weeks (42 days) prior to enrollment.
• Having received apremilast (Otezla) within 4 weeks prior to enrollment.
• Presence of non- Behcet's Disease related genital ulcers, including both infectious and non-infectious etiologies.
• Active organ involvement requiring immunosuppressive treatment.