A Phase 2 interventional study of Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate and Histamine base in Rhinitis, Allergic, Seasonal, sponsored by Dynavax Technologies Corporation. Terminated at 28 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Dynavax Technologies Corporation · Phase 2, Interventional, and Prevention
The purpose of this study is to find out if a new investigational vaccine, TOLAMBA™, is safe and effective in reducing the symptoms of ragweed allergy.
Ragweed allergy is the most common seasonal allergy in North America. Allergen immunotherapy is a therapeutic option for patients who have allergy symptoms that cannot be adequately controlled by avoidance of the allergen or medication. It may also be appropriate for those who cannot tolerate their medications due to side effects or have difficulties with medication compliance. This study compares the safety and efficacy of two different dosing regimens of TOLAMBA™ with placebo in reducing the symptoms of ragweed-allergic adults over two consecutive ragweed pollen seasons.
Comparison(s): Subject-rated allergy symptoms of subjects treated with TOLAMBA™ dose-intense regimen or TOLAMBA™ lower-dose regimen, compared with subjects treated with placebo.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 738 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Dynavax Technologies Corporation is the lead sponsor of 25 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
TOLAMBA™ dose-intense regimen
Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate
TOLAMBA™ lower-dose regimen
Biological: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate
Biological: Histamine base
Escalating doses, 6 weekly subcutaneous (under the skin) injections
Also known as: TOLAMBA™
Escalating doses, 6 weekly subcutaneous (under the skin) injections
Change from baseline in total nasal symptom score during the peak period of the ragweed pollen season.
Time frame: Two years
Plan to share: No — The IND for Tolamba was withdrawn, it was reported to the agency that there was no plan to conduct clinical studies with this compound. \[per email from EA 18Dec2015. 3/1/2017 - No update
This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Dynavax Technologies Corporation