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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT00866359
Date of registration: 18/03/2009
Prospective Registration: Yes
Primary sponsor: Amgen
Public title: A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease
Scientific title: A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Followed by an Active-Treatment Extension to Evaluate the Efficacy and Safety of Apremilast(CC-10004) in the Treatment of Behçet Disease
Date of first enrolment: August 1, 2009
Target sample size: 111
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00866359
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
Turkey United States
Contacts
Name:     MD
Address: 
Telephone:
Email:
Affiliation:  Amgen
Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Behcet Syndrome
Intervention(s)
Drug: Apremilast (CC-10004)
Drug: Placebo
Primary Outcome(s)
Number of Oral Ulcers at Day 85 [Time Frame: Day 85]
Secondary Outcome(s)
Area Under the Curve (AUC) for the Number of Oral Plus Genital Ulcers From Day 1 to 85 [Time Frame: Day 1 to Day 85]
Area Under the Curve (AUC) for the Number of Oral Ulcers From Day 1 to 85 [Time Frame: Day 1 to Day 85]
Area Under the Curve for the Number of Genital Ulcers From Day 1 to 85 [Time Frame: Day 1 to Day 85]
Behçet's Disease (BD) Current Activity Index Form Score at Day 169 [Time Frame: Day 169]
Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 197 [Time Frame: Day 1 to Day 197]
Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 85 [Time Frame: Day 1 to Day 85 or to early termination visit]
Number of New Manifestations of Behçet's Disease or Flare During the Placebo Controlled Treatment Phase [Time Frame: Day 1 to Day 85]
Number of New Manifestations of Behçet's Disease or Flare That Were Not Present at Day 1 [Time Frame: Day 1 to Day 169]
Number of Oral Ulcers at Day 169 [Time Frame: Day 169]
Number of Oral Ulcers at Day 197 [Time Frame: Day 197]
Number of Treatment Emergent Adverse Events (TEAE) During the Placebo Controlled Treatment Phase [Time Frame: Day 1 to Day 85; maximum exposure to study drug was 13 weeks during treatment phase]
Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) at Day 169 [Time Frame: Day 1 to Day 169]
Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) at Day 197 [Time Frame: Day 1 to Day 197]
Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) Scores at Day 85 [Time Frame: Baseline to Day 85]
Pain of Oral Ulcers as Measured by VAS (VAS Score) at Day 169 [Time Frame: Day 169]
Pain of Oral Ulcers as Measured by VAS (VAS Score) at Day 197 [Time Frame: Day 197]
Pain of Oral Ulcers as Measured by Visual Analog Scale (VAS) at Day 85 [Time Frame: Day 85]
Percentage of Participants Who Were Oral Ulcer-free (Complete Response), or Whose Oral Ulcers Were Reduced by = 50%, (Partial Response) [Time Frame: Baseline and Day 85]
Sum of the Number Oral Ulcers, Genital Ulcers or Oral Plus Genital Ulcers at Day 85 [Time Frame: Day 85]
Summary of Treatment Emergent Adverse Events During the Active Treatment-Extension Phase [Time Frame: Day 1 to Day 197; maximum exposure was 25.1 weeks]
Secondary ID(s)
CC-10004-BCT-001
EudraCT#: 2008-002722-11
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 27/08/2014
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00866359
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