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Histamine

Phase 2

Rhinitis, Allergic, Seasonal | Small molecule | 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

Histamine · 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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Frequently asked questions about Histamine

What is Histamine used for?

Histamine is an investigational small molecule being developed for the treatment of seasonal allergic rhinitis. It is currently in Phase 2 clinical development, meaning it has not yet been approved and is still being studied for safety and efficacy in patients.

Who makes Histamine?

Histamine is being developed by Dynavax Technologies Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol DVAX. The company is conducting clinical trials to evaluate the drug's potential in treating seasonal allergic rhinitis.

What phase is Histamine in?

Histamine is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the treatment of seasonal allergic rhinitis, and its safety and efficacy are still being evaluated in clinical trials.

What clinical trials is Histamine in?

Histamine has one completed Phase 2 clinical trial registered under NCT00537355. This study, titled 'An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber,' enrolled 271 participants in Canada and evaluated the drug's effects on seasonal allergic rhinitis.

Is Histamine the same as TOLAMBA?

Yes, Histamine is also known as TOLAMBA. In clinical trials, the drug has been referred to by this brand name, as seen in the study title for NCT00537355. Both names refer to the same investigational drug being developed for seasonal allergic rhinitis.