Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's Disease

NCT00483184 | Completed Phase 2 Results

• 1 other identifier: 04HUBD01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Behcet Syndrome; Behcet Disease; Mucocutaneous Ulceration

Outcome Measures

Primary Outcomes (1)

• Comparison of Patients Experiencing a Sustained Response for Each Treatment Arm.

  A patient with a 75% or greater decrease in total OU for three visits was considered a "sustained responder".

  (0-12 weeks)

Secondary Outcomes (1)

• Time to Initial Response, Oral Ulcer Sustained Response, Oral Ulcer Recurrence, Time to Recurrence, Pain Associated With Oral Lesions, General Well-Being, Safety

  12 weeks

Study Arms (3)

1

PLACEBO COMPARATOR

(placebo)0 IU IFNa

Biological: Veldona,

2

EXPERIMENTAL

(Veldona)500 IU IFNα bid

Biological: Veldona,

3

EXPERIMENTAL

(Veldona)1000 IU IFNα bid

Biological: Veldona,

Interventions

Veldona, BIOLOGICAL

Very low dose oral natural human interferon alpha lozenges

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nobel Pharmaceuticals: lead
• Ainos, Inc. (f/k/a Amarillo Biosciences Inc.: collaborator

Study Sites (4)

Gulhane Military Medical School

Ankara, Turkey (Türkiye)

Location

Osmangazi University Medical School, Dept of Rheumatology

Eskişehir, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa Medical School Department of Internal Medicine

Istanbul, Turkey (Türkiye)

Location

Istanbul University Istanbul Medical School

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Kilic H, Zeytin HE, Korkmaz C, Mat C, Gul A, Cosan F, Dinc A, Simsek I, Sut N, Yazici H. Low-dose natural human interferon-alpha lozenges in the treatment of Behcet's syndrome. Rheumatology (Oxford). 2009 Nov;48(11):1388-91. doi: 10.1093/rheumatology/kep237. Epub 2009 Aug 28.

  PMID: 19717547 DERIVED

MeSH Terms

Conditions

Behcet Syndrome

Interventions

Interferon-alpha

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Hasan Zeytin MD., Ph.D.
• Organization: Nobel Ilac San ve Tic. A.S.

hasan.zeytin@nobel.com.tr

+90 216 6336012

Study Officials

• Hasan Yazici, MD

  Istanbul University Cerrahpaşa Medical School

  STUDY DIRECTOR

• Cem Mat, MD

  Istanbul University Cerrahpasa Medical School

  PRINCIPAL INVESTIGATOR

• Cengiz Korkmaz, MD

  Osmangazi University Medical School

  PRINCIPAL INVESTIGATOR

• Ayhan Dinc, MD

  Gülhane Military Medical School

  PRINCIPAL INVESTIGATOR

• Ahmet Gul, MD

  İstanbul University Istanbul Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 5, 2007
• First Posted: June 6, 2007
• Study Start: April 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 16, 2009
• Results First Posted: June 16, 2009

Record last verified: 2009-04

Locations

TU (4)