Behcet SyndromePhase 2NCT00483184
Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's Disease
A Phase 2 study testing Veldona, in people with Behcet Syndrome and Behcet Disease, run by Nobel Pharmaceuticals at 4 sites in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Behcet Syndrome, Behcet Disease, Mucocutaneous Ulceration
- What is being tested?
- Veldona,
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- Apr 2006to Apr 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites
Gulhane Military Medical School
Ankara
Osmangazi University Medical School, Dept of Rheumatology
Eskişehir
Istanbul University Cerrahpasa Medical School Department of Internal Medicine
Istanbul
Istanbul University Istanbul Medical School
Istanbul
About this study
Official title: Phase II Study, Evaluation of Low Dose Natural Human Interferon Alpha Administered by the Oral Mucosal Route in the Treatment of Behçet's Disease
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
- Behcet Syndrome, Behcet Disease, Mucocutaneous Ulceration
- Being tested
- Veldona,
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veldona,Biological
Very low dose oral natural human interferon alpha lozenges
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | (placebo)0 IU IFNa Receives: Biological: Veldona, |
| 2 | Experimental | (Veldona)500 IU IFNα bid Receives: Biological: Veldona, |
| 3 | Experimental | (Veldona)1000 IU IFNα bid Receives: Biological: Veldona, |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: (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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2007 (estimated)
- Study startApr 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behcet SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
- Investigators
- Hasan Yazici, MD, Study director, Istanbul University Cerrahpaşa Medical SchoolCem Mat, MD, Principal investigator, Istanbul University Cerrahpasa Medical SchoolCengiz Korkmaz, MD, Principal investigator, Osmangazi University Medical SchoolAyhan Dinc, MD, Principal investigator, Gülhane Military Medical SchoolAhmet Gul, MD, Principal investigator, İstanbul University Istanbul Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483184
- Sponsor's protocol ID
- 04HUBD01
- Status last verified
- Apr 2009
- First submitted
- 5 Jun 2007
- Last updated
- 16 Jun 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study, Evaluation of Low Dose Natural Human Interferon Alpha Administered by the Oral Mucosal Route in the Treatment of Behçet's Disease
- ClinicalTrials.gov ID
- NCT00483184
- Acronym / sponsor ID
- 04HUBD01
- Conditions
- Behcet Syndrome, Behcet Disease, Mucocutaneous Ulceration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Nobel PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
- Study start
- Apr 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 6 Jun 2007 (estimated)
- Results
- Posted 16 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Biological: Veldona,(placebo)0 IU IFNa |
| 2 | Experimental | Biological: Veldona,(Veldona)500 IU IFNα bid |
| 3 | Experimental | Biological: Veldona,(Veldona)1000 IU IFNα bid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Veldona,Very low dose oral natural human interferon alpha lozenges | Biological | 1, 2, 3 |
Primary outcome
Comparison of Patients Experiencing a Sustained Response for Each Treatment Arm.
Time frame: (0-12 weeks)
A patient with a 75% or greater decrease in total OU for three visits was considered a "sustained responder".
1 secondary outcome
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 and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19717547Kilic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Veldona, in people with Behcet Syndrome and Behcet Disease, run by Nobel Pharmaceuticals at 4 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Patients Experiencing a Sustained Response for Each Treatment Arm. (time frame: (0-12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00483184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2009.