Clinical trial NCT00866359: A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Behcet Syndrome
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2009-03-20
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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)

Primary outcomes:
measure: Number of Oral Ulcers at Day 85
timeFrame: Day 85
Secondary outcomes:
measure: Pain of Oral Ulcers as Measured by Visual Analog Scale (VAS) at Day 85
timeFrame: Day 85
measure: Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) Scores at Day 85
timeFrame: Baseline to Day 85
measure: Area Under the Curve (AUC) for the Number of Oral Ulcers From Day 1 to 85
timeFrame: Day 1 to Day 85
measure: Area Under the Curve for the Number of Genital Ulcers From Day 1 to 85
timeFrame: Day 1 to Day 85
measure: Area Under the Curve (AUC) for the Number of Oral Plus Genital Ulcers From Day 1 to 85
timeFrame: Day 1 to Day 85
measure: Sum of the Number Oral Ulcers, Genital Ulcers or Oral Plus Genital Ulcers at Day 85
timeFrame: Day 85
measure: Percentage of Participants Who Were Oral Ulcer-free (Complete Response), or Whose Oral Ulcers Were Reduced by ≥ 50%, (Partial Response)
timeFrame: Baseline and Day 85
measure: Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 85
timeFrame: Day 1 to Day 85 or to early termination visit
measure: Number of Treatment Emergent Adverse Events (TEAE) During the Placebo Controlled Treatment Phase
timeFrame: Day 1 to Day 85; maximum exposure to study drug was 13 weeks during treatment phase
measure: Number of New Manifestations of Behçet's Disease or Flare During the Placebo Controlled Treatment Phase
timeFrame: Day 1 to Day 85
measure: Number of Oral Ulcers at Day 169
timeFrame: Day 169
measure: Pain of Oral Ulcers as Measured by VAS (VAS Score) at Day 169
timeFrame: Day 169
measure: Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) at Day 169
timeFrame: Day 1 to Day 169
measure: Behçet's Disease (BD) Current Activity Index Form Score at Day 169
timeFrame: Day 169
measure: Number of New Manifestations of Behçet's Disease or Flare That Were Not Present at Day 1
timeFrame: Day 1 to Day 169
measure: Number of Oral Ulcers at Day 197
timeFrame: Day 197
measure: Pain of Oral Ulcers as Measured by VAS (VAS Score) at Day 197
timeFrame: Day 197
measure: Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) at Day 197
timeFrame: Day 1 to Day 197
measure: Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 197
timeFrame: Day 1 to Day 197
measure: Summary of Treatment Emergent Adverse Events During the Active Treatment-Extension Phase
timeFrame: Day 1 to Day 197; maximum exposure was 25.1 weeks
Other outcomes:
measure: Percentage of Participants Who Were Genital Ulcer-free (Complete Response) at Day 85
timeFrame: Baseline to Day 85
measure: Percentage of Participants Who Were Genital Ulcer-free (Complete Response) at Day 169
timeFrame: Day 1 to Day 169
measure: Percentage of Participants Who Were Genital Ulcer-free (Complete Response)
timeFrame: Day 1 to Day 197
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic - Rheumatology and Internal Medicine
state: Florida
city: Boston
country: United States
facility: E5, Boston University School of Medicine
state: Massachusetts
city: New York
country: United States
facility: NYU Hospital for Joint Diseases
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi University
city: Istanbul
country: Turkey
facility: University of Istanbul
city: Konya
country: Turkey
facility: Selçuk University
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Hatemi G, Melikoglu M, Tunc R, Korkmaz C, Turgut Ozturk B, Mat C, Merkel PA, Calamia KT, Liu Z, Pineda L, Stevens RM, Yazici H, Yazici Y. Apremilast for Behcet's syndrome--a phase 2, placebo-controlled study. N Engl J Med. 2015 Apr 16;372(16):1510-8. doi: 10.1056/NEJMoa1408684.