Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's Disease
Condition: Behcet Syndrome; Behcet Disease; Mucocutaneous Ulceration
MeSH terms: Behcet Syndrome
Intervention: Veldona,
Intervention description: Very low dose oral natural human interferon alpha lozenges
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety and efficacy of natural human interferon
      alpha (IFN alpha) on size, number, incidence and pain of oral ulcers associated with Behçet's
      Disease (BD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is a male or a non-pregnant, non-lactating female.

          -  Has a history and clinical presentation consistent with a diagnosis of Behçet's
             Disease and meets International Study Group criteria (Appendix B).

          -  Has a history of oral ulcers for at least 12 months.

          -  Has a history of monthly episodes of multiple oral ulcers.

          -  Has the presence of at least 2 oral ulcers at study entry, both of which are
             accessible to measurement, with a total diameter of at least 4 mm.

          -  Has signed an IRB approved subject consent form.

          -  Has completed all screening procedures satisfactorily, is deemed to be an acceptable
             subject and is otherwise eligible for entry into the study.

          -  Is willing and able to comply with the protocol.

        Exclusion Criteria:

          -  Has a severe, acute, or chronic systemic disease other than Behçet's Disease such as
             congestive heart failure, hepatic failure, renal failure, Systemic Lupus Erythematosus
             (SLE), Stevens-Johnson syndrome, ulcerative colitis, cancer, leukemia, diabetes, AIDS
             or ARC, or any other condition for which they are immunocompromised.

          -  Is under active treatment for dental conditions, such that multiple dental office
             visits would be required during the study period, or presents with oral conditions
             which are not thought to be related to Behçet's Disease and, in the judgment of a
             qualified dentist, will require treatment during the study period.

          -  Is suffering from any medical condition other than Behçet's Disease known to cause
             oral ulcerations, such as erosive lichen planus, benign mucous membrane pemphigoid,
             SLE, Crohn's disease, Reiter's syndrome, or AIDS.

          -  Has an eating disorder and/or psychiatric illness requiring treatment.

          -  Has hypersensitivity to interferon-alpha.

          -  Is a pregnant or lactating female, or is of childbearing potential and is not using a
             medically acceptable contraceptive method throughout the study.

          -  Has had previous exposure to any parenteral interferon therapy.

          -  Has had exposure to IFNα lozenges within 30 days of screening.

          -  Has had exposure to thalidomide within 30 days of screening.

          -  Has had exposure to methotrexate within 30 days of screening.

          -  Has had exposure to any immune-suppressive medication within 30 days of screening.

          -  Has a history of, or is currently exhibiting, any disease or condition which, in the
             opinion of the Principal Investigator, would place the subject at increased risk
             during study therapy.

          -  Has any abnormality in a hematological or biochemical variable which, in the opinion
             of the Principal Investigator, would place the subject at increased risk during study
             therapy.