A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet D… (NCT00866359) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease
United States, Turkey (Türkiye)111 participantsStarted 2009-08-01
Plain-language summary
The purpose of this study is to assess whether Apremilast is safe and effective in the treatment of patients with Behcet Disease.
Who can participate
Age range18 Years
SexALL
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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 …