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

Primary Purpose

Dermatitis, Atopic

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MK-6194
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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:

  • 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).

Sites / Locations

  • Arkansas Research Trials-Clinical Trials ( Site 0002)Recruiting
  • Global Health Research Center, Inc. ( Site 0005)Recruiting
  • Miami Dermatology and Laser Research ( Site 0025)
  • Genesis Clinical Research, LLC ( Site 0004)Recruiting
  • ForCare Clinical Research ( Site 0003)Recruiting
  • Advanced Medical Research, PC. ( Site 0027)Recruiting
  • AXIS Clinicals ( Site 0029)Recruiting
  • Remington Davis Clinical Research ( Site 0021)Recruiting
  • Paddington Testing Company ( Site 0010)Recruiting
  • North Texas Center for Clinical Research ( Site 0028)Recruiting
  • Progressive Clinical Research ( Site 0022)Recruiting
  • Complete Dermatology ( Site 0023)Recruiting
  • Premier Clinical Research ( Site 0026)Recruiting
  • Anima ( Site 0013)Recruiting
  • ARENSIA Exploratory Medicine - Sofia ( Site 0018)Recruiting
  • Innovaderm Research Inc. ( Site 0019)Recruiting
  • ARENSIA Exploratory Medicine-SC ARENSIA Exploratory Medicine SRL with Monza Medical Center ( Site 00Recruiting
  • ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0017)Recruiting
  • Hospital Germans Trias i Pujol-CCEE Dermatologia ( Site 0012)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose Escalation Panel A

Dose Escalation Panel B

Dose Escalation Panel C

Expansion Panel D

Expansion Panel E

Expansion Dose F

Arm Description

Participants are randomized to low dose MK-6194 or placebo, administered every 2 weeks (q2w).

Participants are randomized to medium dose MK-6194 or placebo administered q2w.

Participants are randomized to high dose MK-6194 or placebo administered q2w.

Participants are randomized to medium dose MK-6194 or placebo administered q2w.

Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo administered q2w.

Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo q2w.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Area Under the Curve (AUC) from Days 1-15 (AUC1-15) of MK-6194
Blood samples will be collected at pre-specified time points to determine the AUC1-15 of MK-6194 in plasma.
AUC from Days 29-43 (AUC29-43) of MK-6194
Blood samples will be collected at pre-specified time points to determine the AUC29-43 of MK-6194 in plasma.
Peak Serum Concentration (Cmax) of MK-6194
Blood samples will be collected at pre-specified time points to determine the Cmax of MK-6194 in plasma.
Minimum Serum Concentration (Ctrough) of MK-6194
Blood samples will be collected at pre-specified time points to determine the Ctrough of MK-6194 in plasma.
Time to peak Serum Concentration (Tmax) of MK-6194
Blood samples will be collected at pre-specified time points to determine the Tmax of MK-6194 in plasma.
Geometric Mean Accumulation Ratio of AUC of MK-6194
Blood samples will be collected at pre-specified time points to determine the geometric mean accumulation ratio of AUC of MK-6194.
Geometric Mean Accumulation Ratio of Cmax of MK-6194
Blood samples will be collected at pre-specified time points to determine the geometric mean accumulation ratio of Cmax of MK-6194.
Fold Change from Baseline in Peak Regulatory T cells (Tregs)
Blood samples will be collected at baseline and at pre-specified timepoints up to day 169 to determine the fold change from baseline in peak Tregs.

Full Information

First Posted
July 5, 2022
Last Updated
October 15, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05450198
Brief Title
Multiple Rising Dose Study of MK-6194 in Participants With Atopic Dermatitis (MK-6194-008)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2022 (Actual)
Primary Completion Date
June 4, 2024 (Anticipated)
Study Completion Date
June 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation Panel A
Arm Type
Experimental
Arm Description
Participants are randomized to low dose MK-6194 or placebo, administered every 2 weeks (q2w).
Arm Title
Dose Escalation Panel B
Arm Type
Experimental
Arm Description
Participants are randomized to medium dose MK-6194 or placebo administered q2w.
Arm Title
Dose Escalation Panel C
Arm Type
Experimental
Arm Description
Participants are randomized to high dose MK-6194 or placebo administered q2w.
Arm Title
Expansion Panel D
Arm Type
Experimental
Arm Description
Participants are randomized to medium dose MK-6194 or placebo administered q2w.
Arm Title
Expansion Panel E
Arm Type
Experimental
Arm Description
Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo administered q2w.
Arm Title
Expansion Dose F
Arm Type
Experimental
Arm Description
Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo q2w.
Intervention Type
Biological
Intervention Name(s)
MK-6194
Intervention Description
MK-6194 administered subcutaneously (SC)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator to MK-6194 administered SC
Primary Outcome Measure Information:
Title
Number of Participants who Experience One or More Adverse Events (AEs)
Description
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.
Time Frame
Up to approximately 169 days
Title
Number of Participants who Discontinue Study Intervention Due to an AE
Description
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.
Time Frame
Up to approximately 85 days
Secondary Outcome Measure Information:
Title
Area Under the Curve (AUC) from Days 1-15 (AUC1-15) of MK-6194
Description
Blood samples will be collected at pre-specified time points to determine the AUC1-15 of MK-6194 in plasma.
Time Frame
At protocol specific time points from Day 1 to Day 15
Title
AUC from Days 29-43 (AUC29-43) of MK-6194
Description
Blood samples will be collected at pre-specified time points to determine the AUC29-43 of MK-6194 in plasma.
Time Frame
At protocol specific time points from Day 29 to Day 43
Title
Peak Serum Concentration (Cmax) of MK-6194
Description
Blood samples will be collected at pre-specified time points to determine the Cmax of MK-6194 in plasma.
Time Frame
At protocol specific time points from Day 1 to Day 29
Title
Minimum Serum Concentration (Ctrough) of MK-6194
Description
Blood samples will be collected at pre-specified time points to determine the Ctrough of MK-6194 in plasma.
Time Frame
Days 15, 29, 43, and 85: Predose
Title
Time to peak Serum Concentration (Tmax) of MK-6194
Description
Blood samples will be collected at pre-specified time points to determine the Tmax of MK-6194 in plasma.
Time Frame
At protocol specific time points from Day 1 to Day 29
Title
Geometric Mean Accumulation Ratio of AUC of MK-6194
Description
Blood samples will be collected at pre-specified time points to determine the geometric mean accumulation ratio of AUC of MK-6194.
Time Frame
At protocol specific time points from Day 1 to Day 15 and Day 29 to Day 43
Title
Geometric Mean Accumulation Ratio of Cmax of MK-6194
Description
Blood samples will be collected at pre-specified time points to determine the geometric mean accumulation ratio of Cmax of MK-6194.
Time Frame
At protocol specific time points from Day 1 to Day 15 and Day 29 to Day 43
Title
Fold Change from Baseline in Peak Regulatory T cells (Tregs)
Description
Blood samples will be collected at baseline and at pre-specified timepoints up to day 169 to determine the fold change from baseline in peak Tregs.
Time Frame
Baseline and up to approximately 169 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Arkansas Research Trials-Clinical Trials ( Site 0002)
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
501-621-1100
Facility Name
Global Health Research Center, Inc. ( Site 0005)
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
305-824-0026
Facility Name
Miami Dermatology and Laser Research ( Site 0025)
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Completed
Facility Name
Genesis Clinical Research, LLC ( Site 0004)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
813-755-4403
Facility Name
ForCare Clinical Research ( Site 0003)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
813-960-2400
Facility Name
Advanced Medical Research, PC. ( Site 0027)
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
404-939-9220
Facility Name
AXIS Clinicals ( Site 0029)
City
Dilworth
State/Province
Minnesota
ZIP/Postal Code
56529
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
701-630-3246
Facility Name
Remington Davis Clinical Research ( Site 0021)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
614-487-2560
Facility Name
Paddington Testing Company ( Site 0010)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
215-563-7330
Facility Name
North Texas Center for Clinical Research ( Site 0028)
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
682-718-1778
Facility Name
Progressive Clinical Research ( Site 0022)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
210-614-5557
Facility Name
Complete Dermatology ( Site 0023)
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
281-757-6351
Facility Name
Premier Clinical Research ( Site 0026)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
509-343-3710
Facility Name
Anima ( Site 0013)
City
Alken
State/Province
Limburg
ZIP/Postal Code
3570
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3211949115
Facility Name
ARENSIA Exploratory Medicine - Sofia ( Site 0018)
City
Sofia
State/Province
Sofia (stolitsa)
ZIP/Postal Code
1618
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+359878334990
Facility Name
Innovaderm Research Inc. ( Site 0019)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+1 514 521 4285
Facility Name
ARENSIA Exploratory Medicine-SC ARENSIA Exploratory Medicine SRL with Monza Medical Center ( Site 00
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
11658
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40746262328
Facility Name
ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0017)
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400006
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40746262328
Facility Name
Hospital Germans Trias i Pujol-CCEE Dermatologia ( Site 0012)
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34934978849

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information

Learn more about this trial

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

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