Wir untersuchen die Wirksamkeit und Sicherheit von Apremilast bei pädiatrischen Patienten mit aktiven Mundgeschwüren in Verbindung mit der Behçet-Krankheit.

Drug: Apremilast;Drug: Placebo

Gender: All
Maximum age: 17 Years
Minimum age: 2 Years

Key Inclusion Criteria

- Male or Female participants 2 to < 18 years of age at randomization.

- Diagnosed with beh?et's disease (BD) meeting the International Study Group for Beh?et
Disease (ISGBD) criteria at any time prior to the screening visit.

- Oral ulcers that occurred = 3 times within the 12-month period prior to the screening
visit.

- Participant must have = 2 oral ulcers at both the screening visit and on day 1.

- Participant has had prior treatment with = 1 non-biologic BD therapy, such as, but not
limited to, topical corticosteroids or systemic treatment.

Key Exclusion Criteria

- Behcet's disease-related active major organ involvement - pulmonary (eg, pulmonary
artery aneurysm), vascular (eg, thrombophlebitis), gastrointestinal (eg, ulcers along
the gastrointestinal tract), and central nervous system (CNS) (eg,
meningoencephalitis) manifestations, and ocular lesions (eg, uveitis) requiring
immunosuppressive therapy; however:

- Previous major organ involvement is allowed if it occurred =1 year prior to the
screening visit and is not active at time of enrollment

- Participants with mild BD-related ocular lesions not requiring systemic
immunosuppressive therapy are allowed

- Participants with BD-related arthritis and BD-skin manifestations are also
allowed.

- Previous exposure to biologic therapies for the treatment of BD oral ulcers, previous
biologic exposure is allowed for other indications (including other manifestations of
BD).