Phase 2
Completed N=111
A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease
Behcet Syndrome
Source: ClinicalTrials.gov NCT00866359 ↗
Enrolled (actual)
111
Serious AEs
5.2%
Results posted
Aug 2014
Primary outcomePrimary: Number of Oral Ulcers at Day 85 — 2.0; 0.4 ulcers/participants — p=<0.0001
Summary
The purpose of this study is to assess whether Apremilast is safe and effective in the treatment of patients with Behcet Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Oral Ulcers at Day 85 |
2.0; 0.4 | <0.0001 sig |
| SECONDARY Pain of Oral Ulcers as Measured by Visual Analog Scale (VAS) at Day 85 |
36.7; 9.9 | <0.0001 sig |
| SECONDARY Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) Scores at Day 85 |
— | — |
| SECONDARY Area Under the Curve (AUC) for the Number of Oral Ulcers From Day 1 to 85 |
157.82; 67.74 | <0.0001 sig |
| SECONDARY Area Under the Curve for the Number of Genital Ulcers From Day 1 to 85 |
— | — |
| SECONDARY Area Under the Curve (AUC) for the Number of Oral Plus Genital Ulcers From Day 1 to 85 |
193.95; 65.79 | — |
| SECONDARY Sum of the Number Oral Ulcers, Genital Ulcers or Oral Plus Genital Ulcers at Day 85 |
2.3; 0.6 | 0.0007 sig |
| SECONDARY Percentage of Participants Who Were Oral Ulcer-free (Complete Response), or Whose Oral Ulcers Were Reduced by ≥ 50%, (Partial Response) |
28.6; 70.9; 50.0; 89.1 | <0.0001 sig |
| SECONDARY Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 85 |
-0.1; -1.2 | 0.0007 sig |
| SECONDARY Number of Treatment Emergent Adverse Events (TEAE) During the Placebo Controlled Treatment Phase |
50; 49; 24; 30; 5; 5 | — |
| SECONDARY Number of New Manifestations of Behçet's Disease or Flare During the Placebo Controlled Treatment Phase |
27; 12; 3; 0 | — |
| SECONDARY Number of Oral Ulcers at Day 169 |
0.4; 0.6 | — |
| SECONDARY Pain of Oral Ulcers as Measured by VAS (VAS Score) at Day 169 |
9.6; 9.7 | — |
| SECONDARY Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) at Day 169 |
— | — |
| SECONDARY Behçet's Disease (BD) Current Activity Index Form Score at Day 169 |
1.4; 1.6 | — |
| SECONDARY Number of New Manifestations of Behçet's Disease or Flare That Were Not Present at Day 1 |
15; 19; 1; 2 | — |
| SECONDARY Number of Oral Ulcers at Day 197 |
1.6; 1.7 | — |
| SECONDARY Pain of Oral Ulcers as Measured by VAS (VAS Score) at Day 197 |
21.0; 27.2 | — |
| SECONDARY Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) at Day 197 |
— | — |
| SECONDARY Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 197 |
-0.6; -1.2 | — |
| SECONDARY Summary of Treatment Emergent Adverse Events During the Active Treatment-Extension Phase |
39; 50; 20; 33; 1; 11 | — |
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)
Data sourced from ClinicalTrials.gov (NCT00866359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.