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A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behcet Disease
This study is not yet open for participant recruitment.
Verified by Celgene Corporation, March 2009
First Received: March 18, 2009   Last Updated: March 19, 2009   History of Changes
Sponsored by: Celgene Corporation
Information provided by: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00866359
  Purpose

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


Condition Intervention Phase
Behcet Disease
Drug: Apremilast (CC-10004)
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • The change in the number of oral ulcers from Baseline to Day 85/Early Termination will be compared between the Apremilast and the placebo treatment groups.

Secondary Outcome Measures:
  • Painoforal/genitalulcersmeasuredbyVAS,AUC&Sumoforal/genitalulcers,#ofulcer freesubjects&thosewith>=50%reduction,BDCAForm score, SafetyAssessments,NewBDmanifestations,PtReportedOutcomes questionnaires,Systemic&populationPKAssessments

Estimated Enrollment: 156
Study Start Date: March 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator Drug: Apremilast (CC-10004)
Treatment Phase Days 1-7: Titration from 10 mg BID apremilast tablets (or matching placebo) to 30 mg BID apremilast (or matching placebo) Day 8-84: Maintenance of 30 mg BID apremilast (or matching placebo Dose reductions to 20 mg BID (or matching placebo) are permitted. Extension Phase All subjects will be given active drug
2: Placebo Comparator Drug: Apremilast (CC-10004)
Treatment Phase Days 1-7: Titration from 10 mg BID apremilast tablets (or matching placebo) to 30 mg BID apremilast (or matching placebo) Day 8-84: Maintenance of 30 mg BID apremilast (or matching placebo Dose reductions to 20 mg BID (or matching placebo) are permitted. Extension Phase All subjects will be given active drug

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866359

Contacts
Contact: Wayne R Hull, BS 908-860-7496 whull@celgene.com

Locations
United States, Florida
Mayo Clinic - Rheumatology and Internal Medicine
Jacksonville, Florida, United States, 32224
United States, Massachusetts
E5, Boston University School of Medicine
Boston, Massachusetts, United States, 02118
United States, New York
NYU Hospital for Joint Diseases
New York, New York, United States, 10003
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Turkey
University of Istanbul
Istanbul, Turkey, 34098
Eskişehir Osmangazi University
Eskişehir, Turkey, 26480
Selçuk University
Konya, Turkey, 42080
Sponsors and Collaborators
Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation ( Wayne Hull )
Study ID Numbers: CC-10004-BCT-001, EudraCT#: 2008-002722-11
Study First Received: March 18, 2009
Last Updated: March 19, 2009
ClinicalTrials.gov Identifier: NCT00866359     History of Changes
Health Authority: United States: Food and Drug Administration;   Turkey: The Republic of Turkey Ministry of Health, Pharmaceutical General Directorate Central Ethics Committee

Study placed in the following topic categories:
Panuveitis
Uveitis, Anterior
Mouth Diseases
Behcet Syndrome
Uveal Diseases
Vasculitis
Skin Diseases
Uveitis
Eye Diseases
Vascular Diseases
Stomatognathic Diseases

Additional relevant MeSH terms:
Mouth Diseases
Uveitis, Anterior
Panuveitis
Uveal Diseases
Skin Diseases, Vascular
Vasculitis
Skin Diseases
Eye Diseases
Vascular Diseases
Behcet Syndrome
Uveitis
Cardiovascular Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 25, 2009