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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-01

Study Completion Date

2012-05-01

Brief Summary

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

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Detailed Description

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Conditions

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Behcet Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A. Apremilast

Group Type ACTIVE_COMPARATOR

Apremilast (CC-10004)

Intervention Type DRUG

Treatment Phase Days 1-7: Titration from 10 mg BID apremilast tablets arm A (or matching placebo arm B) to 30 mg BID apremilast arm A(or matching placebo arm B) Day 8-84: Maintenance of 30 mg BID apremilast arm A (or matching placebo arm B) Dose reductions to 20 mg BID apremilast arm A (or matching placebo arm B) are permitted.

Extension Phase All subjects will be given active drug Days 85-91: All placebo subjects from Treatment phase will be dose titrated from 10 mg BID apremilast tablets arm A to 30 mg BID Apremilast.

Day 92-169: Maintenance of 30 mg BID apremilast arm A or dose reductions to 20 mg BID apremilast arm A (if not previously down titrated)

B. Placebo Comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Treatment Phase Days 1-7: Titration from 10mg BID matching placebo (arm B) to 30mg BID placebo (arm B) Day 8-84: Maintenance of 30mg BID placebo (arm B). Dose reductions to 20 mg BID matching placebo (arm B) are permitted.

Extension Phase All subjects will be given active drug Days 85-91: All placebo subjects from Treatment phase will be dose titrated from 10 mg BID apremilast tablets arm A to 30 mg BID Apremilast.

Day 92-169: Maintenance of 30 mg BID apremilast or dose reductions to 20 mg BID apremilast (if not previously down titrated)

Interventions

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Apremilast (CC-10004)

Treatment Phase Days 1-7: Titration from 10 mg BID apremilast tablets arm A (or matching placebo arm B) to 30 mg BID apremilast arm A(or matching placebo arm B) Day 8-84: Maintenance of 30 mg BID apremilast arm A (or matching placebo arm B) Dose reductions to 20 mg BID apremilast arm A (or matching placebo arm B) are permitted.

Extension Phase All subjects will be given active drug Days 85-91: All placebo subjects from Treatment phase will be dose titrated from 10 mg BID apremilast tablets arm A to 30 mg BID Apremilast.

Day 92-169: Maintenance of 30 mg BID apremilast arm A or dose reductions to 20 mg BID apremilast arm A (if not previously down titrated)

Intervention Type DRUG

Placebo

Treatment Phase Days 1-7: Titration from 10mg BID matching placebo (arm B) to 30mg BID placebo (arm B) Day 8-84: Maintenance of 30mg BID placebo (arm B). Dose reductions to 20 mg BID matching placebo (arm B) are permitted.

Extension Phase All subjects will be given active drug Days 85-91: All placebo subjects from Treatment phase will be dose titrated from 10 mg BID apremilast tablets arm A to 30 mg BID Apremilast.

Day 92-169: Maintenance of 30 mg BID apremilast or dose reductions to 20 mg BID apremilast (if not previously down titrated)

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No