Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease
Lead Sponsor:
Amgen
Conditions:
Behcet Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
- 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
- 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)
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00866359
Start Date
August 1 2009
End Date
May 1 2012
Last Update
June 19 2020
Active Locations (7)
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1
Mayo Clinic - Rheumatology and Internal Medicine
Jacksonville, Florida, United States, 32224
2
E5, Boston University School of Medicine
Boston, Massachusetts, United States, 02118
3
NYU Hospital for Joint Diseases
New York, New York, United States, 10003
4
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195