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Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate

Phase 2

Rhinitis, Allergic, Seasonal | Monoclonal antibody | Respiratory |Dynavax Technologies Corporation|Last Updated: Apr 16, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment271

FDA Designations

No designations recorded

Clinical trial landscape

Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate · 1 trial · 1 indication

Phase 2 1
NCT00537355An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure ChamberRhinitis, Allergic, Seasonal
COMPLETED271 Analytics
PHASE2COMPLETED
An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber
Rhinitis, Allergic, SeasonalUnlock trial analytics

Study Endpoints

Primary Endpoints

Total Nasal Symptom Score (TNSS)
3 months

Secondary Endpoints

Total Non-Nasal Symptom Score (TNNSS)
3 months
Total Symptom Score (TSS)
3 months
quality of life questionnaire
3 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TOLAMBA™ACTIVE_COMPARATOR -
HistamineSHAM_COMPARATORHistamine simulates mild redness/swelling effect seen with active comparator, TOLAMBA™. Prevents study staff from easily identifying subjects who received active comparator.

Interventions

NameTypeDescription
Amb a 1 Immunostimulatory Oligoribonucleotide ConjugateBIOLOGICAL6 weekly subcutaneous injections (escalating doses of 3 mcg to 30 mcg)
HistamineDRUG6 weekly subcutaneous injections (escalating doses of 0.22 mcg to 1.1 mcg)
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Is willing and able to give signed informed consent, and must have provided this consent. * Has a clinical history of seasonal allergic rhinitis with seasonal nasal allergy symptoms during each of the last 2 ragweed allergy seasons. * Has documentation of a positive skin test ...

Countries:Canada
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