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Veldona

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

Veldona · 1 trial · 3 indications

Phase 2 1
NCT00483184Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's DiseaseBehcet Syndrome
COMPLETED84 Analytics
PHASE2COMPLETED
Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's Disease
Behcet SyndromeUnlock trial analytics

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 to 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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Frequently asked questions about Veldona

What is Veldona used for in Behcet Syndrome?

Veldona is an investigational monoclonal antibody being studied for the treatment of Behcet Syndrome, specifically for oral ulcers associated with the condition. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Veldona?

Veldona is being developed by Ainos, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol AIMD.

What phase is Veldona in?

Veldona is in Phase 2 clinical development. It is an investigational drug and has not yet received regulatory approval. A Phase 2 clinical trial for Veldona in Behcet Syndrome has been completed.

What clinical trials is Veldona in?

Veldona has one completed Phase 2 clinical trial registered under NCT00483184, titled 'Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's Disease.' The trial enrolled 84 participants with Behcet Syndrome and mucocutaneous ulceration in Turkey.

Is Veldona the same as interferon alpha?

Veldona is a monoclonal antibody, not interferon alpha. The completed clinical trial NCT00483184 evaluated low-dose interferon alpha treatment for oral ulcers in Behcet's disease, but Veldona itself is a distinct investigational monoclonal antibody.