Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bezlotoxumab · 1 trial · 1 indication
Blood samples were collected at specified intervals for the determination of AUC0-inf. AUC0-inf was defined as the area under the concentration-time curve of bezlotoxumab from time zero to infinity. Per protocol, AUC0-inf of bezlotoxumab was determined for each age cohort.
An AE was defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product and does not imply any judgment about causality. Per protocol, percentage of participants with AEs in the bezlotoxumab and placebo groups were presented.
An AE was defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product and does not imply any judgment about causality. Per protocol, percentage of participants who discontinued study due to AEs in the bezlotoxumab and placebo groups were presented.
| Arm | Type | Description |
|---|---|---|
| Bezlotoxumab | EXPERIMENTAL | Participants receive 10 mg of bezlotoxumab per kg body weight via a single 60-minute (±10 minutes) intravenous (IV) infusion on Day 1. Additionally, participants receive background antibacterial drug treatment (ABD) for 10-21 days per institutional guidelines, at the investigator's discretion. Dose may then be changed based on results from initial 12 participants. |
| Placebo | PLACEBO_COMPARATOR | Participants receive placebo for bezlotoxumab consisting of either 0.9% sodium chloride or 5% dextrose via a single 60-minute (±10 minutes) IV infusion on Day 1. Additionally, participants receive background ABD for 10-21 days per institutional guidelines, at the investigator's discretion. |
| Name | Type | Description |
|---|---|---|
| Bezlotoxumab | BIOLOGICAL | A single intravenous (IV) infusion of 10 mg of bezlotoxumab per kg body weight. Dose may then be changed based on results from initial 12 participants. |
| Placebo | DRUG | A single IV infusion of placebo for bezlotoxumab consisting of either 0.9% sodium chloride or 5% dextrose. |
| Antibacterial drug treatment (ABD) | DRUG | ABD will be administered for 10-21 days including the duration of ABD prior to the screening visit, during the screening period, and after the infusion of study treatment, per institutional guidelines, at the investigator's discretion. ABD is defined as the receipt of oral metronidazole, oral vancomycin, intravenous (IV) metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole. |
Inclusion Criteria: * At screening has suspected or confirmed Clostridium difficile infection (CDI), and is receiving or is planning to receive a 10- to 21-day course of antibacterial drug treatment for CDI * At study infusion has a diagnosis of CDI confirmed by a diagnostic assay which detects the...
Bezlotoxumab is a monoclonal antibody being developed for Clostridium Difficile Infection (CDI). It is an investigational therapy studied in a Phase 3 clinical trial in children with CDI. The drug is not approved and remains in clinical development.
Bezlotoxumab is a monoclonal antibody that targets Clostridium Difficile Infection. It is designed to bind to the C. difficile toxin B, neutralizing its effects. This mechanism is intended to help treat the infection by blocking the toxin's activity.
Bezlotoxumab is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker MRK. Merck is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Clostridium Difficile Infection.
Bezlotoxumab is in Phase 3 clinical development. It has completed one Phase 3 trial in children with Clostridium Difficile Infection. The drug is investigational and has not been approved by regulatory authorities.
Bezlotoxumab has one completed Phase 3 trial, NCT03182907, titled 'Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)'. The trial enrolled 148 participants across multiple countries and was placebo-controlled, randomized, and double-blind.
Yes, Bezlotoxumab is also known as MK-6072. The clinical trial NCT03182907 refers to the drug as MK-6072, confirming that both names refer to the same investigational monoclonal antibody for Clostridium Difficile Infection.