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MK-8237 · 1 trial · 2 indications
Blood was collected from participants treated with Dermatophagoides (D.) farinae HDM and then with MK-8237 or placebo, and the amount of HDM-specific IgG4 antibodies in serum at baseline and at week 12 were measured. Fold change from baseline was evaluated based on constrained longitudinal data analysis (cLDA) method with log transformed data. The model included time (categorical variable), treatment, and time by treatment interaction as fixed effects and participants as random effect. Least squares geometric means are presented. It is hypothesized that the change from baseline is statistically greater with MK-8237 treatment than with placebo. This hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the geometric mean fold difference is \>1.0.
Blood was collected from participants treated with D. pteronyssinus HDM, and then with MK-8237 or placebo, and the amount of HDM-specific IgG4 antibodies in serum at baseline and at week 12 were measured. Fold change from baseline was evaluated based on cLDA method with log transformed data. The model included time (categorical variable), treatment, and time by treatment interaction as fixed effects and participants as random effect. Least squares geometric means are presented. It is hypothesized that the change from baseline is statistically greater with MK-8237 treatment than with placebo. This hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the geometric mean fold difference is \>1.0.
Blood was collected from participants treated with D. pteronyssinus and D.farinae HDM and then with either MK-8237 or placebo, and the amount of IgE-BF in serum was measured based on an Ordinary IgE measurement and an assay in the presence of Competitors; with IgE-BF = 1 - (Competitive IgE/Ordinary IgE). This ranges from 0 (no IgE blocked) to 1 (all IgE blocked); and as it is based on a ratio there are no units. Change from baseline (12 weeks minus baseline) was evaluated based on cLDA method, and was analyzed based on the original scale. The model included time (categorical variable), treatment, and time by treatment interaction as fixed effects and participants as random effect. It is hypothesized that the change from baseline is statistically greater with MK-8237 treatment than with placebo. This hypothesis is supported if the lower bound of the 1-tailed 95% CI around the 12 week mean difference in change from baseline in HDM-specific IgE blocking factor response excludes zero.
| Arm | Type | Description |
|---|---|---|
| NAC + MK-8237 (Part 2) | EXPERIMENTAL | Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days) |
| NAC + Placebo (Part 2) | PLACEBO_COMPARATOR | NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days) |
| NAC (Part 1) | EXPERIMENTAL | Nasal Allergen Challenge (NAC) consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1 |
| Name | Type | Description |
|---|---|---|
| MK-8237 | BIOLOGICAL | A single tablet of MK-8237 with 12 DU, administered sublingually, at approximately the same time each day for 84 days (+/- 5 days) |
| Placebo | OTHER | A single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days) |
| NAC | BIOLOGICAL | 0.1 mL fixed volume of 10,000 BU/mL of HDM extract is delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1; and in Part 2 on Days -14, 56 and 84 |
Inclusion Criteria: Part 1: * healthy participants * has a Body Mass Index (BMI) =\< 30 kg/m\^2 * female of reproductive potential remains abstinent or uses two acceptable methods of birth control from 2 weeks before first allergen challenge to 2 weeks after last allergen challenge; alternatively ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150, Standard therapy for INCS |
| Polyrizon Ltd. | PLRZ | 1 | N/A | Undisclosed |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | - | Undisclosed |
MK-8237 is an investigational monoclonal antibody being developed for allergic rhinitis and allergic rhinoconjunctivitis. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. A completed Phase 1 trial evaluated its effects in participants with these conditions.
MK-8237 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The drug is an investigational monoclonal antibody in Phase 1 clinical development for allergic rhinitis and allergic rhinoconjunctivitis.
MK-8237 is in Phase 1 clinical development. It is an investigational monoclonal antibody for allergic rhinitis and allergic rhinoconjunctivitis. The drug has not been approved by regulatory authorities and remains under clinical investigation.
MK-8237 has one completed Phase 1 clinical trial, identified as NCT01852825. This study, titled "MK-8237 (SCH900237) Biomarker Study in Participants With Allergic Rhinitis or Rhinoconjunctivitis (MK-8237-009)," enrolled 26 participants and was a randomized, double-blind, placebo-controlled trial.
Yes, MK-8237 is also known as SCH900237. The clinical trial NCT01852825 references both names in its title, indicating they refer to the same investigational monoclonal antibody being developed for allergic rhinitis and allergic rhinoconjunctivitis.