Phase
Condition
Lupus
Treatment
Dusquetide
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must have a clinical diagnosis of Behcet's Disease meeting theInternational Study Group criteria.
Participants must have at least two oral ulcers and/or one genital ulcer on the dayof randomization.
Participants willing to follow the clinical protocol and voluntarily give theirwritten informed consent.
Female participants not pregnant or nursing and willing to undergo a pregnancy testprior to treatment initiation and at the end of the treatment period.
Exclusion
Exclusion Criteria:
Pregnancy or mothers who are breast-feeding.
All women of childbearing potential (WOCBP) and males with female partners who areWOCBP 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 5pharmacokinetic/pharmacodynamic half-lives (whichever is longer).
Having received concomitant immune modulating therapy (except colchicine orazathioprine) 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 anddiscontinued 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 toenrollment 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 toenrollment.
Having received apremilast (Otezla) within 4 weeks prior to enrollment.
Presence of non- Behcet's Disease related genital ulcers, including both infectiousand non-infectious etiologies.
Active organ involvement requiring immunosuppressive treatment.
Study Design
Connect with a study center
Istanbul University - Cerrahpasa, Cerrahpasa School of Medicine
Istanbul,
TurkeyActive - Recruiting
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