Dermatitis, AtopicPhase 1NCT05450198
Multiple Rising Dose Study of MK-6194 in Participants With Atopic Dermatitis (MK-6194-008)
A Phase 1 study testing MK-6194 in people with Dermatitis, Atopic, run by Merck Sharp & Dohme LLC at 19 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- MK-6194
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 19 sitesin 6 countries
- Study dates
- 8 Aug 2022to 22 May 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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).
Trial locations and contacts
19 sites in 6 countries.
19 sites in 6 countries
United States13 sites
Remington Davis Clinical Research ( Site 0021)
Columbus, Ohio, 43215
AXIS Clinicals ( Site 0029)
Dilworth, Minnesota, 56529
North Texas Center for Clinical Research ( Site 0028)
Frisco, Texas, 75034
Miami Dermatology and Laser Research ( Site 0025)
Miami, Florida, 33173
Global Health Research Center, Inc. ( Site 0005)
Miami Lakes, Florida, 33016
Arkansas Research Trials-Clinical Trials ( Site 0002)
North Little Rock, Arkansas, 72117
Paddington Testing Company ( Site 0010)
Philadelphia, Pennsylvania, 19103
Progressive Clinical Research ( Site 0022)
San Antonio, Texas, 78213
Advanced Medical Research, PC. ( Site 0027)
Sandy Springs, Georgia, 30328
Premier Clinical Research ( Site 0026)
Spokane, Washington, 99202
Complete Dermatology ( Site 0023)
Sugar Land, Texas, 77478
Genesis Clinical Research, LLC ( Site 0004)
Tampa, Florida, 33603
ForCare Clinical Research ( Site 0003)
Tampa, Florida, 33613
Romania2 sites
ARENSIA Exploratory Medicine-SC ARENSIA Exploratory Medicine SRL with Monza Medical Center ( Site 00
Bucharest, Bucharest, 11658
ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0017)
Cluj-Napoca, Cluj, 400006
Bulgaria1 site
ARENSIA Exploratory Medicine - Sofia ( Site 0018)
Sofia, Sofia (stolitsa), 1618
Spain1 site
Hospital Germans Trias i Pujol-CCEE Dermatologia ( Site 0012)
Badalona, Barcelona, 08916
About this study
Official title: 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
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
- Dermatitis, Atopic
- Being tested
- MK-6194, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-6194Biological
MK-6194 administered subcutaneously (SC)
PlaceboBiological
Placebo comparator to MK-6194 administered SC
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Panel A | Experimental | Participants are randomized to low dose MK-6194 or placebo, administered every 2 weeks (q2w). Receives: Biological: MK-6194; Biological: Placebo |
| Dose Escalation Panel B | Experimental | Participants are randomized to medium dose MK-6194 or placebo administered q2w. Receives: Biological: MK-6194; Biological: Placebo |
| Dose Escalation Panel C | Experimental | Participants are randomized to high dose MK-6194 or placebo administered q2w. Receives: Biological: MK-6194; Biological: Placebo |
| Expansion Panel D | Experimental | Participants are randomized to medium dose MK-6194 or placebo administered q2w. Receives: Biological: MK-6194; Biological: Placebo |
| Expansion Panel E | Experimental | Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo administered q2w. Receives: Biological: MK-6194; Biological: Placebo |
| Expansion Dose F | Experimental | Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo q2w. Receives: Biological: MK-6194; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to approximately 85 days
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start8 Aug 2022
- Primary completion22 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450198
- Sponsor's protocol ID
- 6194-008
- Other IDs
- MK-6194-008, 2022-001011-12
- Status last verified
- May 2025
- First submitted
- 5 Jul 2022
- Last updated
- 5 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05450198
- Acronym / sponsor ID
- 6194-008
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 8 Jul 2022 (actual)
- Results
- Posted 5 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Panel A | Experimental | Biological: MK-6194, Biological: PlaceboParticipants are randomized to low dose MK-6194 or placebo, administered every 2 weeks (q2w). |
| Dose Escalation Panel B | Experimental | Biological: MK-6194, Biological: PlaceboParticipants are randomized to medium dose MK-6194 or placebo administered q2w. |
| Dose Escalation Panel C | Experimental | Biological: MK-6194, Biological: PlaceboParticipants are randomized to high dose MK-6194 or placebo administered q2w. |
| Expansion Panel D | Experimental | Biological: MK-6194, Biological: PlaceboParticipants are randomized to medium dose MK-6194 or placebo administered q2w. |
| Expansion Panel E | Experimental | Biological: MK-6194, Biological: PlaceboParticipants are randomized to a dose less than or equal to high dose MK-6194 or placebo administered q2w. |
| Expansion Dose F | Experimental | Biological: MK-6194, Biological: PlaceboParticipants are randomized to a dose less than or equal to high dose MK-6194 or placebo q2w. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-6194MK-6194 administered subcutaneously (SC) | Biological | Dose Escalation Panel A, Dose Escalation Panel B, Dose Escalation Panel C, Expansion Dose F, Expansion Panel D, Expansion Panel E |
| PlaceboPlacebo comparator to MK-6194 administered SC | Biological | Dose Escalation Panel A, Dose Escalation Panel B, Dose Escalation Panel C, Expansion Dose F, Expansion Panel D, Expansion Panel E |
Primary outcome
Number of Participants Who Experience One or More Adverse Events (AEs)
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.
Number of Participants Who Discontinue Study Intervention Due to an AE
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.
8 secondary outcomes
Area Under the Curve (AUC) From Days 1-15 (AUC1-15) of MK-6194
Time frame: Day 1 (Predose and 12 hours postdose), Day 8, and Day 15
AUC From Days 29-43 (AUC29-43) of MK-6194
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)
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)
Time frame: Predose on Days 15 and 29
Time to Peak Serum Concentration (Tmax) of MK-6194 (Day 1 to 29)
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
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
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)
Time frame: Baseline and Day 85
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
19 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-6194 in people with Dermatitis, Atopic, run by Merck Sharp & Dohme LLC at 19 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Romania, Belgium, Bulgaria, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience One or More Adverse Events (AEs) (time frame: Up to approximately 169 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.