Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-8237 6 DU · 1 trial · 2 indications
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.
The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment.
| Arm | Type | Description |
|---|---|---|
| MK-8237 6 DU | EXPERIMENTAL | MK-8237 6 DU rapidly dissolving tablet administered sublingually once daily for 28 days |
| MK-8237 12 DU | EXPERIMENTAL | MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily for 28 days |
| Placebo | PLACEBO_COMPARATOR | Placebo rapidly dissolving tablet administered sublingually once daily for 28 days |
| Name | Type | Description |
|---|---|---|
| MK-8237 6 DU | BIOLOGICAL | - |
| MK-8237 12 DU | BIOLOGICAL | - |
| Placebo | BIOLOGICAL | - |
Inclusion Criteria: * History of physician-diagnosed allergic rhinitis/rhinoconjunctivitis to house dust of at least 6 months duration (with or without asthma) * History of controlled asthma for the prior 1 month if participant has asthma, defined by not exceeding 2 days of symptoms per week; not m...
MK-8237 6 DU is an investigational monoclonal antibody being developed for perennial allergic rhinitis, a condition also referred to as nonseasonal allergic rhinitis. It is intended for use in adolescents and is currently in Phase 1 clinical development.
MK-8237 6 DU is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being studied for its potential to treat perennial allergic rhinitis, which is typically triggered by allergens such as house dust mites.
MK-8237 6 DU is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical trials.
MK-8237 6 DU is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is not currently in any active clinical trials.
MK-8237 6 DU has one completed clinical trial, NCT01678807, titled "Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (MK-8237-008)." This was a Phase 1, randomized, double-blind, placebo-controlled study that enrolled 195 participants aged 12 years and older.
MK-8237 6 DU is a specific formulation or dosage of the investigational drug MK-8237. The clinical trial NCT01678807 refers to the treatment as MK-8237, and the "6 DU" designation indicates a particular dose unit used in the study.