Approval Probability
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Adjusted LOA
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MK-3415 · 1 trial · 1 indication
CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic Clostridium (C.) difficile following clinical cure of the initial CDI episode
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. A drug-related AE was an AE determined by the investigator to be related to the drug.
A SAE is any AE occurring at any dose or during any use of Sponsor's product that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer, or is associated with an overdose (whether accidental or intentional); or is other important medical events.
A SAE is any AE occurring at any dose or during any use of Sponsor's product that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer, or is associated with an overdose (whether accidental or intentional); or is other important medical events. A serious drug-related AE was a SAE determined by the investigator to be related to the drug.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol-specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Infusion-specific AEs included local infusion site AEs; and systemic AEs which include nausea, vomiting, chills, fatigue, feeling hot, infusion site conditions (bruising, coldness, erythema, extravasation, pain, phlebitis, pruritus), pyrexia, arthralgia, musculoskeletal pain, myalgia, dizziness, headache, dysphonia, nasal congestion, pruritus, rash, pruritic rash, urticaria, flushing, hot flush, hypertension, and hypotension.
| Arm | Type | Description |
|---|---|---|
| MK-3415 + SOC | EXPERIMENTAL | Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI |
| MK-6072 + SOC | EXPERIMENTAL | Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI |
| MK-3415A + SOC | EXPERIMENTAL | Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI |
| Placebo + SOC | PLACEBO_COMPARATOR | Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI |
| Name | Type | Description |
|---|---|---|
| MK-3415 | BIOLOGICAL | A single IV infusion of MK-3415 (10 mg/kg of monoclonal antibody to Clostridium difficile Toxin A) |
| MK-6072 | BIOLOGICAL | A single infusion of MK-6072 (10 mg/kg of monoclonal antibody to Clostridium difficile Toxin B) |
| MK-3415A | BIOLOGICAL | A single IV infusion of MK-3415A (10 mg/kg of monoclonal antibody to Clostridium difficile Toxin A and 10mg/kg of monoclonal antibody to Clostridium difficile Toxin B) |
| Placebo | BIOLOGICAL | A single IV infusion of normal saline (0.9% sodium chloride) |
| SOC | DRUG | Standard of care (SOC) for CDI will be prescribed for 10 to 14 days and can begin on the day of study drug infusion; but the first dose must have been administered prior to or within a few hours following study drug infusion. SOC is defined as the receipt of oral metranidazole, oral vancomycin, IV metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole. |
Inclusion Criteria: * participant has a confirmed diagnosis of CDI as defined by: a. diarrhea, as defined by passage of 3 or more loose stools in 24 or fewer hours, AND b. A positive test for toxigenic C. difficile from a stool collected no more than 7 days before study infusion. * participant must...
MK-3415 is a monoclonal antibody being developed by Merck & Company, Inc. for the treatment of Clostridium difficile infection. It is administered to participants who are also receiving antibiotic therapy for this condition. The drug is currently in Phase 3 clinical development.
MK-3415 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being studied for its ability to treat Clostridium difficile infection when given alongside antibiotic therapy. Its mechanism of action is not publicly detailed.
MK-3415 is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Clostridium difficile infection.
MK-3415 is in Phase 3 clinical development. It has completed one Phase 3 trial, which was a randomized, double-blind, placebo-controlled study. The drug is investigational and has not been approved by regulatory authorities.
MK-3415 has been studied in one clinical trial, identified as NCT01241552. This Phase 3 study enrolled 1,452 participants with Clostridium difficile infection and evaluated the drug in combination with antibiotic therapy. The trial has been completed.
MK-3415 is not the same as MK-3415A. MK-3415A is a combination product that includes MK-3415 along with another monoclonal antibody, MK-6072. The clinical trial NCT01241552 studied MK-3415, MK-6072, and MK-3415A in participants with Clostridium difficile infection.