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

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Amgen

Status and phase

Completed
Phase 2

Conditions

Behcet Syndrome

Treatments

Drug: Apremilast (CC-10004)
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00866359
EudraCT#: 2008-002722-11
CC-10004-BCT-001

Details and patient eligibility

About

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

Enrollment

111 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

111 participants in 2 patient groups, including a placebo group

A. Apremilast
Active Comparator group
Treatment:
Drug: Apremilast (CC-10004)
B. Placebo Comparator
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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