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Also known as PT101
MK-6194 · 2 trials · 2 indications
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study intervention due to an AE is presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to thestudy intervention
| Arm | Type | Description |
|---|---|---|
| Dose Escalation Panel A | EXPERIMENTAL | Participants are randomized to low dose MK-6194 or placebo, administered every 2 weeks (q2w). |
| Dose Escalation Panel B | EXPERIMENTAL | Participants are randomized to medium dose MK-6194 or placebo administered q2w. |
| Dose Escalation Panel C | EXPERIMENTAL | Participants are randomized to high dose MK-6194 or placebo administered q2w. |
| Expansion Panel D | EXPERIMENTAL | Participants are randomized to medium dose MK-6194 or placebo administered q2w. |
| Expansion Panel E | EXPERIMENTAL | Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo administered q2w. |
| Expansion Dose F | EXPERIMENTAL | Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo q2w. |
| MK-6194 Low Dose - Interval 1 (Less Frequent) | EXPERIMENTAL | Participants received low dose of MK-6194 at specified less frequent intervals |
| MK-6194 Medium Dose- Interval 2 (More Frequent) | EXPERIMENTAL | Participants received medium dose of MK-6194 at specified more frequent intervals |
| MK-6194 High Dose- Interval 2 (More Frequent) | EXPERIMENTAL | Participants received high dose of MK-6194 at specified more frequent intervals |
| MK-6194 High Dose- Interval 1 (Less Frequent) | EXPERIMENTAL | Participants received high dose MK-6194 at specified less frequent intervals |
| Placebo | PLACEBO_COMPARATOR | Participants received MK- 6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2 |
| Name | Type | Description |
|---|---|---|
| MK-6194 | BIOLOGICAL | MK-6194 administered subcutaneously (SC) |
| Placebo | BIOLOGICAL | Placebo comparator to MK-6194 administered SC |
| MK-6194-matching placebo | DRUG | Subcutaneous injection |
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Clinical diagnosis of atopic dermatitis for at least 6 months prior to the Screening visit. * Atopic dermatitis is of at least moderate severity. * History of inadequate response to a stab...
MK-6194 is an investigational monoclonal antibody being developed by Merck & Company, Inc. (ticker MRK). It is in Phase 1 clinical development for atopic dermatitis and ulcerative colitis. It has been studied in two completed Phase 1 trials, one in atopic dermatitis and one in ulcerative colitis, with a combined enrollment of 129 participants.
MK-6194 is being studied for the treatment of atopic dermatitis and ulcerative colitis. It is an investigational therapy and has not been approved for any indication. Clinical development remains in Phase 1, with completed trials in both atopic dermatitis and ulcerative colitis.
MK-6194 is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the clinical program evaluating MK-6194 in atopic dermatitis and ulcerative colitis.
MK-6194 is in Phase 1 clinical development. Two Phase 1 trials have been completed: one in atopic dermatitis and one in ulcerative colitis. The drug remains investigational and has not been approved for any indication.
MK-6194 has been evaluated in two completed Phase 1 trials. NCT05450198 was a multiple rising dose study in participants with atopic dermatitis, enrolling 72 participants across the United States, Belgium, Bulgaria, Canada, Romania, and Spain. NCT04924114 studied MK-6194 in participants with active ulcerative colitis, enrolling 57 participants across the United States, Georgia, Germany, Hungary, Moldova, Poland, Ukraine, and the United Kingdom.
Yes, MK-6194 is also known as PT101. The ulcerative colitis trial NCT04924114 is titled as a study of MK-6194 (PT101) in participants with active ulcerative colitis, confirming that the two names refer to the same investigational monoclonal antibody.