A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease
Completed · Phase 2 · Has a placebo group
Conditions studied: Behcet Syndrome
In brief
The purpose of this study is to assess whether Apremilast is safe and effective in the treatment of patients with Behcet Disease.
Key facts
- Study ID
- NCT00866359
- Run by
- Amgen
- People needed
- 111
- Starts
- 2009-08-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2020-06-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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)
Where it is running
- Mayo Clinic - Rheumatology and Internal Medicine — Jacksonville, Florida, United States
- E5, Boston University School of Medicine — Boston, Massachusetts, United States
- NYU Hospital for Joint Diseases — New York, New York, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Eskişehir Osmangazi University — Eskişehir, Turkey (Türkiye)
- University of Istanbul — Istanbul, Turkey (Türkiye)
- Selçuk University — Konya, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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