A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen; Celgene Corporation
• Treatments: Apremilast; Thalidomide

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)