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Veldona,

Phase 2

Behcet Syndrome | Monoclonal antibody | Other |Ainos, Inc.|Last Updated: Jun 16, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment84
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00483184Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's DiseasePHASE2 COMPLETED 84Apr 1, 2006Apr 1, 2008Jun 16, 20094 Turkey (Türkiye)
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Study Endpoints
Primary Endpoints
Comparison of Patients Experiencing a Sustained Response for Each Treatment Arm.
(0-12 weeks)

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

Secondary Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1PLACEBO_COMPARATOR(placebo)0 IU IFNa
2EXPERIMENTAL(Veldona)500 IU IFNα bid
3EXPERIMENTAL(Veldona)1000 IU IFNα bid
Interventions
NameTypeDescription
Veldona,BIOLOGICALVery low dose oral natural human interferon alpha lozenges
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites4

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 mon...

Countries:Turkey (Türkiye)
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