CompletedNCT05450198Updated Jun 5, 2025Results posted

Multiple Rising Dose Study of MK-6194 in Participants With Atopic Dermatitis (MK-6194-008)

A Phase 1 interventional study of MK-6194 and Placebo in Dermatitis, Atopic, sponsored by Merck Sharp & Dohme LLC. Completed at 19 sites in 6 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 72
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

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.

Conditions studied

Dermatitis, Atopic

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In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 72 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion criteria

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 stable (≥1 month) regimen of medium to high potency topical corticosteroids or calcineurin inhibitors as treatment for atopic dermatitis within 6 months before the screening visit.
Body Mass Index (BMI) ≥18 and ≤38 kg/m2 at the screening visit.

Exclusion criteria

Exclusion Criteria:

Concurrent significant skin disease other than atopic dermatitis (such as psoriasis) or a concurrent clinically significant disease.
Significant organ dysfunction that is unstable or inadequately treated within 6 months prior to Screening.
History of cancer (malignancy), with the exceptions: of adequately treated nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or; other malignancies that have been successfully treated with appropriate follow up.
History of myocardial infarction, congestive heart failure, uncontrolled arrhythmias, cardiac revascularization, stroke, uncontrolled hypertension, or uncontrolled diabetes within 6 months of Screening.
History of organ or tissue allograft.
History of symptomatic herpes zoster within 16 weeks of randomization, or any history of disseminated herpes simplex, disseminated herpes zoster, ophthalmic zoster, or central nervous system (CNS) zoster.
Major surgery within 3 months prior to the screening visit or has a major surgery planned during the study.
Received a live or attenuated virus vaccine within 4 weeks prior to the Screening visit or intends to receive live or attenuated virus vaccination during the course of the study and for 12 weeks after the last dose of study drug.
Currently receiving any chronic systemic (oral or intravenous) anti-infective therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, or atypical mycobacteria).

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Double (Participant, Investigator)
Enrollment: 72 participants (actual)

Study arms

Experimental
Dose Escalation Panel A
Participants are randomized to low dose MK-6194 or placebo, administered every 2 weeks (q2w).
Biological: MK-6194 · Biological: Placebo
Experimental
Dose Escalation Panel B
Participants are randomized to medium dose MK-6194 or placebo administered q2w.
Biological: MK-6194 · Biological: Placebo
Experimental
Dose Escalation Panel C
Participants are randomized to high dose MK-6194 or placebo administered q2w.
Biological: MK-6194 · Biological: Placebo
Experimental
Expansion Panel D
Participants are randomized to medium dose MK-6194 or placebo administered q2w.
Biological: MK-6194 · Biological: Placebo
Experimental
Expansion Panel E
Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo administered q2w.
Biological: MK-6194 · Biological: Placebo
Experimental
Expansion Dose F
Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo q2w.
Biological: MK-6194 · Biological: Placebo

Interventions

BiologicalMK-6194
MK-6194 administered subcutaneously (SC)
BiologicalPlacebo
Placebo comparator to MK-6194 administered SC

What researchers measure

Primary outcomes

Number of Participants Who Experience One or More Adverse Events (AEs)
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 169 days
Number of Participants Who Discontinue Study Intervention Due to an AE
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: Up to approximately 85 days

Secondary outcomes

Area Under the Curve (AUC) From Days 1-15 (AUC1-15) of MK-6194
Blood samples were collected at pre-specified time points to determine the AUC1-15 of MK-6194 in plasma.
Time frame: Day 1 (Predose and 12 hours postdose), Day 8, and Day 15
AUC From Days 29-43 (AUC29-43) of MK-6194
Blood samples were collected at pre-specified time points to determine the AUC29-43 of MK-6194 in plasma.
Time frame: Day 29 (Predose and 12 hours postdose), Day 36, and Day 43
Peak Serum Concentration (Cmax) of MK-6194 (Day 1 to 29)
Blood samples were collected at pre-specified time points to determine the Cmax 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)
Minimum Serum Concentration (Ctrough) of MK-6194 (Day 1 to 29)
Blood samples were collected at pre-specified time points to determine the Ctrough of MK-6194 in plasma.
Time frame: Predose on Days 15 and 29
Time to Peak Serum Concentration (Tmax) of MK-6194 (Day 1 to 29)
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, and Day 29 (Predose and 12 hours postdose)
Geometric Mean Accumulation Ratio of AUC of MK-6194
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
Geometric Mean Accumulation Ratio of Cmax of MK-6194
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: Day 1 (Predose and 12 hours postdose), Day 8, Day 15, Day 29 (Predose and 12 hours postdose), Day 36, and Day 43
Fold Change From Baseline in Peak Regulatory T Cells (Tregs)
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.
Time frame: Baseline and Day 85

Results

Posted Jun 5, 2025

Participant flow

Participant flow — Overall Study
Milestone	Placebo	MK-6194 Low Dose (Panel A)	MK-6194 High Dose (Panel B-E)	MK-6194 High Dose (Panel F)
Started	18	6	36	12
Completed	16	5	32	11
Not completed	2	1	4	1
Withdrew: Withdrawal by subject	1	1	2	0
Withdrew: Lost to follow-up	1	0	2	1

Outcome measures

SecondaryArea Under the Curve (AUC) From Days 1-15 (AUC1-15) of MK-6194

Blood samples were collected at pre-specified time points to determine the AUC1-15 of MK-6194 in plasma.

Time frame:: Day 1 (Predose and 12 hours postdose), Day 8, and Day 15
Reported as:: Geometric least squares mean · day*ng/mL

Area Under the Curve (AUC) From Days 1-15 (AUC1-15) of MK-6194
day*ng/mL	Placebo	MK-6194 Low Dose (Panel A)	MK-6194 High Dose (Panel B-E)	MK-6194 High Dose (Panel F)
Area Under the Curve (AUC) From Days 1-15 (AUC1-15) of MK-6194	—	32.3 (13.9 to 75.1)	59.6 (43.8 to 81.1)	—

SecondaryAUC From Days 29-43 (AUC29-43) of MK-6194

Blood samples were collected at pre-specified time points to determine the AUC29-43 of MK-6194 in plasma.

Time frame:: Day 29 (Predose and 12 hours postdose), Day 36, and Day 43
Reported as:: Geometric least squares mean · day*ng/mL

AUC From Days 29-43 (AUC29-43) of MK-6194
day*ng/mL	Placebo	MK-6194 Low Dose (Panel A)	MK-6194 High Dose (Panel B-E)	MK-6194 High Dose (Panel F)
AUC From Days 29-43 (AUC29-43) of MK-6194	—	10.9 (4.13 to 28.7)	56.7 (41.7 to 77.0)	86.7 (47.0 to 160)

SecondaryPeak Serum Concentration (Cmax) of MK-6194 (Day 1 to 29)

Blood samples were collected at pre-specified time points to determine the Cmax 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)
Reported as:: Geometric least squares mean · ng/mL

Peak Serum Concentration (Cmax) of MK-6194 (Day 1 to 29)
ng/mL	Placebo	MK-6194 Low Dose (Panel A)	MK-6194 High Dose (Panel B-E)	MK-6194 High Dose (Panel F)
Peak Serum Concentration (Cmax) of MK-6194 (Day 1 to 29)	—	13.2 (6.34 to 27.3)	21.7 (16.8 to 27.9)	20.0 (12.9 to 31.1)

SecondaryMinimum Serum Concentration (Ctrough) of MK-6194 (Day 1 to 29)

Blood samples were collected at pre-specified time points to determine the Ctrough of MK-6194 in plasma.

Time frame:: Predose on Days 15 and 29
Reported as:: Geometric least squares mean · ng/mL

Minimum Serum Concentration (Ctrough) of MK-6194 (Day 1 to 29)
ng/mL	Placebo	MK-6194 Low Dose (Panel A)	MK-6194 High Dose (Panel B-E)	MK-6194 High Dose (Panel F)
Minimum Serum Concentration (Ctrough) of MK-6194 (Day 1 to 29)	—	—	0.210 (0.0141 to 3.13)	—

SecondaryTime to Peak Serum Concentration (Tmax) of MK-6194 (Day 1 to 29)

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, and Day 29 (Predose and 12 hours postdose)
Reported as:: Geometric least squares mean · day

Time to Peak Serum Concentration (Tmax) of MK-6194 (Day 1 to 29)
day	Placebo	MK-6194 Low Dose (Panel A)	MK-6194 High Dose (Panel B-E)	MK-6194 High Dose (Panel F)
Time to Peak Serum Concentration (Tmax) of MK-6194 (Day 1 to 29)	—	0.49 (0.48 to 0.49)	0.49 (0.48 to 0.51)	0.49 (0.42 to 0.50)

SecondaryGeometric Mean Accumulation Ratio of AUC of MK-6194

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
Reported as:: Geometric least squares mean · Ratio

Geometric Mean Accumulation Ratio of AUC of MK-6194
Ratio	Placebo	MK-6194 Low Dose (Panel A)	MK-6194 High Dose (Panel B-E)	MK-6194 High Dose (Panel F)
Geometric Mean Accumulation Ratio of AUC of MK-6194	—	0.35 (0.13 to 0.96)	0.98 (0.70 to 1.38)	—

SecondaryGeometric Mean Accumulation Ratio of Cmax of MK-6194

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:: Day 1 (Predose and 12 hours postdose), Day 8, Day 15, Day 29 (Predose and 12 hours postdose), Day 36, and Day 43
Reported as:: Geometric least squares mean · Ratio

Geometric Mean Accumulation Ratio of Cmax of MK-6194
Ratio	Placebo	MK-6194 Low Dose (Panel A)	MK-6194 High Dose (Panel B-E)	MK-6194 High Dose (Panel F)
Geometric Mean Accumulation Ratio of Cmax of MK-6194	—	0.84 (0.41 to 1.72)	0.98 (0.79 to 1.20)	1.35 (0.94 to 1.94)

SecondaryFold Change From Baseline in Peak Regulatory T Cells (Tregs)

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.

Time frame:: Baseline and Day 85
Reported as:: Geometric least squares mean · Fold change from baseline

Fold Change From Baseline in Peak Regulatory T Cells (Tregs)
Fold change from baseline	Placebo	MK-6194 Low Dose of (Panel A)	MK-6194 High Dose (Panel B-E)	MK-6194 High Dose (Panel F)
Fold Change From Baseline in Peak Regulatory T Cells (Tregs)	1.15 (0.83 to 1.59)	1.86 (0.95 to 3.66)	1.69 (1.27 to 2.24)	1.58 (1.05 to 2.38)

PrimaryNumber of Participants Who Experience One or More Adverse Events (AEs)

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 169 days
Reported as:: Count of participants · Participants

Number of Participants Who Experience One or More Adverse Events (AEs)
Participants	Placebo	MK-6194 Low Dose (Panel A)	MK-6194 High Dose (Panel B-E)	MK-6194 High Dose (Panel F)	MK-6194 Total
Number of Participants Who Experience One or More Adverse Events (AEs)	13	6	30	9	45

PrimaryNumber of Participants Who Discontinue Study Intervention Due to an AE

Time frame:: Up to approximately 85 days
Reported as:: Count of participants · Participants

Number of Participants Who Discontinue Study Intervention Due to an AE
Participants	Placebo	MK-6194 Low Dose (Panel A)	MK-6194 High Dose (Panel B-E)	MK-6194 High Dose (Panel F)	MK-6194 Total
Number of Participants Who Discontinue Study Intervention Due to an AE	0	1	2	0	3

Adverse events

Collected over Up to approximately 169 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	0/18 (0%)	0/18 (0%)	13/18 (72.2%)
MK-6194 Low Dose (Panel A)	0/6 (0%)	0/6 (0%)	6/6 (100%)
MK-6194 High Dose (Panels B-E)	0/36 (0%)	2/36 (5.6%)	30/36 (83.3%)
MK-6194 High Dose (Panel F)	0/12 (0%)	0/12 (0%)	9/12 (75%)
MK-6194 Total	0/54 (0%)	2/54 (3.7%)	45/54 (83.3%)

Most frequent serious events

Most frequent serious events
Event	Placebo	MK-6194 Low Dose (Panel A)	MK-6194 High Dose (Panels B-E)	MK-6194 High Dose (Panel F)	MK-6194 Total
Inguinal herniaGastrointestinal disorders	0/18	0/6	1/36	0/12	1/54
MalaiseGeneral disorders	0/18	0/6	1/36	0/12	1/54

Most frequent other events

Showing 10 of 92

Most frequent other events
Event	Placebo	MK-6194 Low Dose (Panel A)	MK-6194 High Dose (Panels B-E)	MK-6194 High Dose (Panel F)	MK-6194 Total
Injection site erythemaGeneral disorders	0/18	6/6	25/36	6/12	37/54
Injection site indurationGeneral disorders	0/18	3/6	8/36	0/12	11/54
Injection site painGeneral disorders	0/18	3/6	6/36	2/12	11/54
NasopharyngitisInfections and infestations	2/18	0/6	3/36	5/12	8/54
NauseaGastrointestinal disorders	0/18	2/6	0/36	0/12	2/54
PruritusSkin and subcutaneous tissue disorders	0/18	2/6	0/36	0/12	2/54
EosinophiliaBlood and lymphatic system disorders	0/18	1/6	7/36	3/12	11/54
Injection site swellingGeneral disorders	0/18	1/6	7/36	3/12	11/54
HeadacheNervous system disorders	4/18	1/6	4/36	0/12	5/54
DiarrhoeaGastrointestinal disorders	1/18	0/6	0/36	2/12	2/54

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Placebo	MK-6194 Low Dose (Panel A)	MK-6194 High Dose (Panel B-E)	MK-6194 High Dose (Panel F)	Total
Mean	37.2 ± 11.0	46.5 ± 11.3	42.8 ± 16.8	42.0 ± 16.5	41.6 ± 15.0

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	MK-6194 Low Dose (Panel A)	MK-6194 High Dose (Panel B-E)	MK-6194 High Dose (Panel F)	Total
Female	5	2	18	5	30
Male	13	4	18	7	42

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Placebo	MK-6194 Low Dose (Panel A)	MK-6194 High Dose (Panel B-E)	MK-6194 High Dose (Panel F)	Total
Hispanic or Latino	3	0	6	1	10
Not Hispanic or Latino	15	6	30	11	62
Unknown or Not Reported	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Placebo	MK-6194 Low Dose (Panel A)	MK-6194 High Dose (Panel B-E)	MK-6194 High Dose (Panel F)	Total
American Indian or Alaska Native	1	0	0	0	1
Asian	0	0	1	0	1
Native Hawaiian or Other Pacific Islander	1	0	0	0	1
Black or African American	2	0	3	2	7
White	14	6	31	10	61
More than one race	0	0	1	0	1
Unknown or Not Reported	0	0	0	0	0

Study locations

19 sites

Arkansas Research Trials-Clinical Trials ( Site 0002)
North Little Rock, Arkansas 72117, United States
Global Health Research Center, Inc. ( Site 0005)
Miami Lakes, Florida 33016, United States
Miami Dermatology and Laser Research ( Site 0025)
Miami, Florida 33173, United States
Genesis Clinical Research, LLC ( Site 0004)
Tampa, Florida 33603, United States
ForCare Clinical Research ( Site 0003)
Tampa, Florida 33613, United States
Advanced Medical Research, PC. ( Site 0027)
Sandy Springs, Georgia 30328, United States
AXIS Clinicals ( Site 0029)
Dilworth, Minnesota 56529, United States
Remington Davis Clinical Research ( Site 0021)
Columbus, Ohio 43215, United States
Paddington Testing Company ( Site 0010)
Philadelphia, Pennsylvania 19103, United States
North Texas Center for Clinical Research ( Site 0028)
Frisco, Texas 75034, United States
Progressive Clinical Research ( Site 0022)
San Antonio, Texas 78213, United States
Complete Dermatology ( Site 0023)
Sugar Land, Texas 77478, United States
Premier Clinical Research ( Site 0026)
Spokane, Washington 99202, United States
Anima ( Site 0013)
Alken, Limburg 3570, Belgium
ARENSIA Exploratory Medicine - Sofia ( Site 0018)
Sofia, Sofia (stolitsa) 1618, Bulgaria
Innovaderm Research Inc. ( Site 0019)
Montréal, Quebec H2X 2V1, Canada
ARENSIA Exploratory Medicine-SC ARENSIA Exploratory Medicine SRL with Monza Medical Center ( Site 00
Bucharest, Bucuresti 11658, Romania
ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0017)
Cluj-Napoca, Cluj 400006, Romania
Hospital Germans Trias i Pujol-CCEE Dermatologia ( Site 0012)
Badalona, Barcelona 08916, Spain

References and documents

Study documents

Protocol and statistical analysis plan · Dec 12, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05450198
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Jul 8, 2022
Start date: Aug 8, 2022
Primary completion: May 22, 2024
Completion: May 22, 2024
Results posted: Jun 5, 2025
Last update: Jun 5, 2025

Study contacts

Medical Director

study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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