MK-6194
BiologicalMK-6194 administered subcutaneously (SC)
NCT Number: NCT05450198
The primary objective of this study is to characterize the safety and tolerability of MK-6194 following multiple doses among participants with moderate to severe atopic dermatitis who are unresponsive to other therapies.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Anima ( Site 0013), Alken, Limburg, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion criteria
Exclusion criteria
MK-6194 administered subcutaneously (SC)
Placebo comparator to MK-6194 administered SC
Time frame: Up to approximately 169 days
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.
Time frame: Up to approximately 85 days
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.
Time frame: Day 1 (Predose and 12 hours postdose), Day 8, and Day 15
Blood samples were collected at pre-specified time points to determine the AUC1-15 of MK-6194 in plasma.
Time frame: Day 29 (Predose and 12 hours postdose), Day 36, and Day 43
Blood samples were collected at pre-specified time points to determine the AUC29-43 of MK-6194 in plasma.
Time frame: Day 1 (Predose and 12 hours postdose), Day 8, Day 15, and Day 29 (Predose and 12 hours postdose)
Blood samples were collected at pre-specified time points to determine the Cmax of MK-6194 in plasma.
Time frame: Predose on Days 15 and 29
Blood samples were collected at pre-specified time points to determine the Ctrough of MK-6194 in plasma.
Time frame: Day 1 (Predose and 12 hours postdose), Day 8, Day 15, and Day 29 (Predose and 12 hours postdose)
Blood samples were collected at pre-specified time points to determine the Tmax of MK-6194 in plasma.
Time frame: Day 1 (Predose and 12 hours postdose), Day 8, Day 15, Day 29 (Predose and 12 hours postdose), Day 36, and Day 43
Blood samples were collected at pre-specified time points to determine the geometric mean accumulation ratio of AUC of MK-6194. The accumulation ratio is defined as Day 29-43/ Day 1-15.
Time frame: Day 1 (Predose and 12 hours postdose), Day 8, Day 15, Day 29 (Predose and 12 hours postdose), Day 36, and Day 43
Blood samples were collected at pre-specified time points to determine the geometric mean accumulation ratio of Cmax of MK-6194. The accumulation ratio is defined as Day 29-43/ Day 1-15.
Time frame: Baseline and Day 85
Blood samples were collected to determine the fold change from baseline (FCB) in peak Tregs. The peak Treg FCB was evaluated after the last dose of MK-6194 on Day 85 using natural-log transformed values with a linear model containing fixed effects.
Merck Sharp & Dohme LLC
Industry
A Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Dose Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-6194 in Participants With Moderate to Severe Atopic Dermatitis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06324812
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Dermatitis
Beijing, Beijing Municipality, China
View Trial DetailsNCT04365387
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Dermatitis
Phoenix, Arizona, United States
View Trial DetailsNCT06173284
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Dermatitis
Beijing, Beijing Municipality, China
View Trial DetailsNCT03422822
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Dermatitis
Birmingham, Alabama, United States
View Trial Details