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Veldona

Phase 2

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

Veldona development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jun 2001

Veldona target and mechanism

ModalityMonoclonal antibody

Also known as Interferon-alpha, IFN-alpha lozenge, low dose IFN lozenge

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment84

FDA Designations

No designations recorded

Veldona clinical trials

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?

Veldona is being developed for Behcet syndrome, a condition that involves mucocutaneous ulceration, including oral ulcers. It is an immunology asset studied in adults 18 years and older. The clinical program has focused on low dose interferon alpha treatment for the oral ulcers associated with Behcet's disease.

Who makes Veldona?

Veldona is developed by Ainos, Inc., which trades under the ticker AIMD. The company is the sponsor of the clinical program for the asset in Behcet syndrome.

What phase is Veldona in?

Veldona is in Phase 2 development. It is investigational and has not been approved by the FDA. One Phase 2 trial has been completed, and no trials are currently active.

What clinical trials is Veldona in?

Veldona has been studied in one completed Phase 2 trial, NCT00483184, titled Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's Disease. The trial enrolled 84 participants in Turkey, was randomized, double blind, and placebo controlled, and included adults 18 years and older of all sexes.