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Also known as TOLAMBA™
Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| TOLAMBA™ | ACTIVE_COMPARATOR | - |
| Histamine | SHAM_COMPARATOR | Histamine simulates mild redness/swelling effect seen with active comparator, TOLAMBA™. Prevents study staff from easily identifying subjects who received active comparator. |
| Name | Type | Description |
|---|---|---|
| Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate | BIOLOGICAL | 6 weekly subcutaneous injections (escalating doses of 3 mcg to 30 mcg) |
| Histamine | DRUG | 6 weekly subcutaneous injections (escalating doses of 0.22 mcg to 1.1 mcg) |
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 ...
Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate is an investigational immunotherapy developed by Dynavax Technologies Corporation for seasonal allergic rhinitis. It combines the ragweed allergen protein Amb a 1 with an immunostimulatory oligoribonucleotide designed to redirect the immune response to the allergen. It is not approved and remains in clinical development.
Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate is being studied for the treatment of seasonal allergic rhinitis, specifically ragweed-allergic rhinitis. The only reported clinical trial enrolled adults aged 18 years and older with this condition. It is an investigational product and has not been approved for any use.
Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate is being developed by Dynavax Technologies Corporation, which trades on Nasdaq under the ticker DVAX. Dynavax is the sponsor of the clinical program for this ragweed allergy immunotherapy candidate.
Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA or any other regulatory agency.
Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate has been evaluated in one completed Phase 2 trial, NCT00537355, titled an evaluation of the efficacy and safety of TOLAMBA for ragweed-allergic rhinitis in an environmental exposure chamber. The trial enrolled 271 participants in Canada, was randomized, double-blind, and actively controlled.
Yes, TOLAMBA is the alternative name used for Amb a 1 Immunostimulatory Oligoribonucleotide Conjugate. The completed Phase 2 trial NCT00537355 was conducted under the TOLAMBA name, evaluating the same ragweed allergy immunotherapy candidate developed by Dynavax Technologies Corporation.