A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease
Condition: Behcet Syndrome
MeSH terms: Behcet Syndrome
Intervention: Apremilast (CC-10004); Placebo
Intervention description: Treatment Phase Days 1-7: Titration from 10 mg BID apremilast tablets arm A (or matching placebo arm B) to 30 mg BID apremilast arm A(or matching placebo arm B) Day 8-84: Maintenance of 30 mg BID apremilast arm A (or matching placebo arm B) Dose reductions to 20 mg BID apremilast arm A (or matching placebo arm B) are permitted.
Extension Phase All subjects will be given active drug Days 85-91: All placebo subjects from Treatment phase will be dose titrated from 10 mg BID apremilast tablets arm A to 30 mg BID Apremilast.
Day 92-169: Maintenance of 30 mg BID apremilast arm A or dose reductions to 20 mg BID apremilast arm A (if not previously down titrated); Treatment Phase Days 1-7: Titration from 10mg BID matching placebo (arm B) to 30mg BID placebo (arm B) Day 8-84: Maintenance of 30mg BID placebo (arm B). Dose reductions to 20 mg BID matching placebo (arm B) are permitted.
Extension Phase All subjects will be given active drug Days 85-91: All placebo subjects from Treatment phase will be dose titrated from 10 mg BID apremilast tablets arm A to 30 mg BID Apremilast.
Day 92-169: Maintenance of 30 mg BID apremilast or dose reductions to 20 mg BID apremilast (if not previously down titrated)
Intervention MeSH terms: Apremilast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess whether Apremilast is safe and effective in the
      treatment of patients with Behcet Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Behçet Disease. At the time of diagnosis, subjects must meet the
             international study group criteria for Behçet Disease

          -  Females of childbearing potential (FCBP) must have negative pregnancy tests and agree
             to use two forms of contraception throughout the study.

          -  Males must use barrier contraception (latex condoms) when engaging in reproductive
             sexual activity with FCBP

          -  Laboratory criteria: Hgb ≥ 9 g/dL, WBC count ≥ 3000 /microL and ≤14,000/microL,
             platelet count ≥ 100,000 /microL,, serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L),
             total bilirubin ≤ 2.0 mg/dL, AST and ALT ≤ 1.5 X ULN

          -  Two or more oral ulcers over the 28 day period before screening, with or without
             current treatment

          -  Two or more oral ulcers at the time of randomization (Visit 2, Baseline)

        Exclusion Criteria:

          -  Pregnant or breast feeding

          -  Any condition which places the subject at risk

          -  Systemic fungal infection

          -  History of TB infection within 3 years

          -  History of recurrent bacterial infection

          -  Mycobacterium TB as indicated by a positive PPD skin test

          -  History of incompletely treated Mycobacterium tuberculosis

          -  Clinically significant chest x-ray abnormality at screening.

          -  Clinically significant ECG abnormality at screening

          -  History of HIV infection

          -  History of congenital or acquired immunodeficiency

          -  Hepatitis B surface antigen positive or Hepatitis B core antibody positive at
             screening

          -  Antibodies to Hepatitis C at screening

          -  History of malignancy (except for treated basal-cell skin carcinomas > 3 years prior
             to screening)

          -  Any active major organ involvement of Behçet Disease

          -  Use of concomitant immune modulating therapy or topical corticosteroids.

          -  Use of ocular corticosteroids

          -  Use of any investigational medication within 4 weeks prior to randomization or 5 PK/PD
             half-lives (whichever is longer)