Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Short ragweed pollen allergen extract · 1 trial · 1 indication
TCS is daily symptom score (DSS) plus daily medication score (DMS), assessed in the peak RS (15 consecutive RS days with the highest 15-day average pollen count). The rhinoconjunctivitis (RC) DSS assesses 6 allergy symptoms measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Lower DSS indicates less RC symptoms. The RC DMS is based on use of RC rescue medications (loratadine, olopatadine, mometasone), with different rescue medications being assigned different scores/dose unit (score range: 0-20). Lower DMS indicates less RC medication use. Summed RC DSS+DMS could range from 0 to 38; a lower score indicates less RC symptoms and medication use. Components that contribute to DSS and DMS endpoints are collected in an electronic diary (e-diary) completed by the participant/parent/guardian. Evaluation is based on average TCS during peak RS.
| Arm | Type | Description |
|---|---|---|
| Short ragweed pollen allergen extract | EXPERIMENTAL | Participants receive one sublingual tablet containing 12 units of Ambrosia artemisiifolia major allergen number 1 (Amb a 1-U), once daily (QD) for up to 35 weeks. Participants may use study-provided rescue medication(s) as needed to treat rhinoconjunctivitis symptoms. |
| Placebo | PLACEBO_COMPARATOR | Participants receive one placebo sublingual tablet, QD for up to 35 weeks. Participants may use study-provided rescue medication(s) as needed to treat rhinoconjunctivitis symptoms. |
| Name | Type | Description |
|---|---|---|
| Short ragweed pollen allergen extract | BIOLOGICAL | One sublingual tablet containing 12 units of Amb a 1-U, once daily (QD) for up to 35 weeks. |
| Placebo | BIOLOGICAL | One placebo sublingual tablet, QD for up to 35 weeks. |
| Self-injectable epinephrine | DRUG | Intramuscular (IM) injection with suggested doses of 0.15 mg for participants weighing 15-30 kg (33-66 pounds) or 0.3 mg for participants weighing ≥30 kg (≥66 pounds), as needed for severe allergic reactions. Epinephrine was only provided in countries/study sites where it was a regulatory requirement. |
| Albuterol/Salbutamol | DRUG | Inhalation of albuterol 90 mcg/puff or salbutamol 100 mcg/puff metered dose inhaler (MDI), as needed as asthma rescue medication for those participants with asthma |
| Loratadine | DRUG | 5 mg (1 mg/mL syrup or 5 mg tablet) for participants 5 years old or 10 mg (1 mg/mL syrup or 10 mg tablet) for participants 6 to 17 years old, as needed for rhinoconjunctivitis symptoms |
| Olopatadine | DRUG | Opthalmic solution, 1 drop (0.1%) per affected eye twice daily (BID), as needed for rhinoconjunctivitis symptoms |
| Mometasone furoate monohydrate | DRUG | Intranasal spray, at doses of 1 spray (50 mcg/ spray) per nostril for participants 5 to 11 years old or 2 sprays (50 mcg/spray) per nostril for participants 12 to 17 years old, as needed for rhinoconjunctivitis symptoms |
Inclusion Criteria: * Is between the ages of 4 and 17 years (inclusive) at enrollment in this study and is at least 5 years old at randomization * Has a clinical history of significant ragweed pollen-induced allergic rhinitis/rhinoconjunctivitis of ≥1 year (at least 1 season for ages 4 to 6 years) ...
Short ragweed pollen allergen extract is used for seasonal allergic rhinitis, also called ragweed-induced rhinoconjunctivitis, with or without asthma. It is being developed as an investigational treatment for this respiratory condition.
Short ragweed pollen allergen extract targets the immune system's response to ragweed pollen allergens. It is designed to reduce allergic symptoms caused by exposure to short ragweed pollen in sensitized individuals.
Short ragweed pollen allergen extract is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the treatment for seasonal allergic rhinitis.
Short ragweed pollen allergen extract is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed.
Short ragweed pollen allergen extract has one completed Phase 3 trial, NCT02478398, which enrolled 1,025 children aged 4 years and older with ragweed-induced rhinoconjunctivitis with or without asthma. The trial was randomized, double-blind, and placebo-controlled.
Short ragweed pollen allergen extract is the same as RAGWITEK, also known as MK-3641. The Phase 3 trial NCT02478398 is titled 'Efficacy and Safety Study of RAGWITEK™ (MK-3641) in Children With Ragweed-Induced Rhinoconjunctivitis With or Without Asthma.'