Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SCH 900237
MK-8237 6 DU · 2 trials · 2 indications
The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The 24-week TNSS was analyzed using the analysis of covariance (ANCOVA) model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.
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 |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks |
| MK-8237 6 Developmental Units (DU) | EXPERIMENTAL | MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks |
| MK-8237 12 DU | EXPERIMENTAL | MK-8237 12 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks |
| MK-8237 6 DU | EXPERIMENTAL | MK-8237 6 DU rapidly dissolving tablet administered sublingually once daily for 28 days |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo rapidly dissolving tablets administered sublingually once daily |
| MK-8237 6 DU | DRUG | MK-8237 6 DU rapidly dissolving tablets administered sublingually once daily |
| MK-8237 12 DU | DRUG | MK-8237 12 DU rapidly dissolving tablets administered sublingually once daily |
Inclusion Criteria: * History of allergic rhinitis/rhinoconjunctivitis to house dust of 1 year duration or more (with or without asthma) * If female of childbearing potential, has a negative urine pregnancy test at screening and agrees to remain abstinent or use (or have their partner use) 2 accept...
MK-8237 6 DU is being developed for perennial allergic rhinitis, a year-round allergic nasal condition. The clinical program has studied it in adults and adolescents with house dust mite induced allergic rhinitis and rhinoconjunctivitis, including nonseasonal allergic rhinitis.
MK-8237 6 DU is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the clinical studies of the asset in house dust mite allergic rhinitis, including a Phase 1 safety study in adolescents and a Phase 2 dose-ranging study in adults.
MK-8237 6 DU is in Phase 2 development. It is an investigational monoclonal antibody and has not been approved by the FDA. Two trials have been completed, a Phase 1 safety study and a Phase 2 dose-ranging study, and no trials are currently active.
MK-8237 6 DU has been evaluated in two completed trials. NCT01678807 was a Phase 1 safety study in house dust mite allergic adolescents, enrolling 195 participants. NCT01644617 was a Phase 2 dose-ranging study of safety and effectiveness in adults with house dust mite induced allergic rhinitis or rhinoconjunctivitis, enrolling 124 participants.
Both MK-8237 6 DU trials were randomized, double-blind, and placebo-controlled, together enrolling 319 participants. NCT01678807 enrolled adolescents aged 12 years and older, while NCT01644617 enrolled adults aged 18 years and older. Neither study selected participants based on a biomarker.