CompletedNCT00483184Updated Jun 16, 2009Results posted

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

A Phase 2 interventional study of Veldona, in Behcet Syndrome, Behcet Disease and Mucocutaneous Ulceration, sponsored by Nobel Pharmaceuticals. Completed at 4 sites in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2009-06-16.

Sponsored by Nobel Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 84
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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).

Read the detailed description

Behçet's disease is a severe chronic relapsing inflammatory disorder marked by oral and genital ulcers, uveitis and skin lesions, as well as varying multisystem involvement including the joints, blood vessels, central nervous system, and gastrointestinal tract. Oral ulcers are the initial symptom for most of Behçet's cases and are the single manifestation of the disease required for an official diagnosis, along with two other hallmark symptoms.

Ninety (90) patients will be enrolled in a randomized, parallel, double-blind, placebo-controlled study to evaluate the effectiveness of low dose natural human IFN α administered by the oral mucosal route in reducing the number, size, incidence and pain of oral ulcers in patients with Behçet's disease.

The clinical trial will consist of 3 groups of patients randomized in a 1:1:1 ratio to twice daily receive 2 lozenges containing 500 IU IFN α(2,000 IU daily, n=30), one active (500 IU) and one placebo lozenge (1,000 IU daily, n=30) or 2 placebo lozenges (n=30). Subjects will be monitored weekly over an initial 4 weeks of treatment and then bi-weekly over an additional 8 weeks of treatment. Medication will be self-administered as 2 lozenges taken twice daily (morning and evening). Oral lesions will be counted and measured at each study visit, and patients will answer a series of questionnaires. Results will be subjected to statistical analysis at the completion of the study, with change in total ulcer burden of a patient, a measurement of the total oral mucosal surface area involved with ulcerous lesions at each visit, serving as the primary endpoint. The total ulcer burden from each treated visit will be compared to the baseline total ulcer burden and the amount of change determined. Patients with a 75% decrease in total ulcer burden will be considered responders.

Conditions studied

Behcet Syndrome
Behcet Disease
Mucocutaneous Ulceration

Browse trials for

Behcet Syndrome 136

In context

Behcet Syndrome

136 studies on the registry are indexed under Behcet Syndrome; 43 are open to participants now.

This study's enrollment of 84 is above the median of 50 across 70 interventional studies indexed under Behcet Syndrome.

Browse Behcet Syndrome studies →

Lead sponsor

This is the only study on the registry with Nobel Pharmaceuticals as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 84 participants (actual)

Study arms

Placebo comparator
1
(placebo)0 IU IFNa
Biological: Veldona,
Experimental
2
(Veldona)500 IU IFNα bid
Biological: Veldona,
Experimental
3
(Veldona)1000 IU IFNα bid
Biological: Veldona,

Interventions

BiologicalVeldona,
Very low dose oral natural human interferon alpha lozenges

What researchers measure

Primary outcomes

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".
Time frame: (0-12 weeks)

Secondary outcomes

Time to Initial Response, Oral Ulcer Sustained Response, Oral Ulcer Recurrence, Time to Recurrence, Pain Associated With Oral Lesions, General Well-Being, Safety
Time frame: 12 weeks

Results

Posted Jun 16, 2009

Participant flow

Eighty four Behcet's Disease patients were followed at the rheumatology or dedicated BS outpatient clinics of 4 medical schools in Turkey.

Participant flow — Overall Study
Milestone	1	2	3
Started	27	31	26
Completed	22	27	23
Not completed	5	4	3
Withdrew: Withdrawal by subject	2	2	0
Withdrew: Lost to follow-up	1	0	0
Withdrew: Adverse event	1	2	2
Withdrew: Protocol violation	1	0	1

Outcome measures

PrimaryComparison 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".

Time frame:: (0-12 weeks)
Reported as:: Number · patients with sustained response

Comparison of Patients Experiencing a Sustained Response for Each Treatment Arm.
patients with sustained response	1	2	3
Comparison of Patients Experiencing a Sustained Response for Each Treatment Arm.	13	10	12

Statistical analysis

1 vs 2 vs 3 · ANOVA · p = 0.404

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

Time frame:: 12 weeks

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
1	—	—	—
2	—	—	—
3	—	—	—

Most frequent serious events

Most frequent serious events
Event	1	2	3
cervical intraepithelial neoplasiaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	—	1/1	—

Most frequent other events

Most frequent other events
Event	1	2	3
headacheGeneral disorders	2/2	4/4	2/2
nauseaGastrointestinal disorders	—	2/2	—

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	1	2	3	Total
<=18 years	0	0	0	0
Between 18 and 65 years	27	31	26	84
>=65 years	0	0	0	0

Age Continuous
Age Continuous(years)	1	2	3	Total
Mean	36 ± 8.6	37 ± 10.2	36 ± 9.4	37 ± 9.4

Sex: Female, Male
Sex: Female, Male(Participants)	1	2	3	Total
Female	20	20	19	59
Male	7	11	7	25

Region of Enrollment
Region of Enrollment(participants)	1	2	3	Total
Turkey	27	31	26	84

Study locations

4 sites

Gulhane Military Medical School
Ankara, Turkey
Osmangazi University Medical School, Dept of Rheumatology
Eskisehir, Turkey
Istanbul University Cerrahpasa Medical School Department of Internal Medicine
Istanbul, Turkey
Istanbul University Istanbul Medical School
Istanbul, Turkey

References and documents

Publications

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. PubMed 19717547 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00483184
Lead sponsor: Nobel Pharmaceuticals
Collaborators: Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
First posted: Jun 6, 2007
Start date: Apr 2006
Primary completion: Apr 2008
Completion: Apr 2008
Results posted: Jun 16, 2009
Last update: Jun 16, 2009

Study contacts

Hasan Yazici, MD

study director · Istanbul University Cerrahpaşa Medical School

Cem Mat, MD

principal investigator · Istanbul University Cerrahpasa Medical School

Cengiz Korkmaz, MD

principal investigator · Osmangazi University Medical School

Ayhan Dinc, MD

principal investigator · Gülhane Military Medical School

Ahmet Gul, MD

principal investigator · İstanbul University Istanbul Medical School

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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