18 and older, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Who Experienced at Least One Adverse EventPrimary· Up to 32 Weeks
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically sign
Group
Value
95% CI
Part 1: MK-8226 0.3 mg/kg
8
Part 1: MK-8226 1 mg/kg
6
Part 1: MK-8226 3 mg/kg
6
Part 1: MK-8226 10 mg/kg
7
Part 1: Placebo (Pooled)
7
Part 2: MK-8226 3 mg/kg
10
Part 2: Placebo
7
Number of Participants Who Discontinued Study Drug Due to an Adverse EventPrimary· Up to 12 Weeks
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse
Group
Value
95% CI
Part 1: MK-8226 0.3 mg/kg
0
Part 1: MK-8226 1 mg/kg
1
Part 1: MK-8226 3 mg/kg
1
Part 1: MK-8226 10 mg/kg
0
Part 1: Placebo (Pooled)
0
Part 2: MK-8226 3 mg/kg
0
Part 2: Placebo
1
Change From Baseline in the Eczema Area and Severity Index (EASI) for Study Part 1Primary· Baseline, Week 12
Reduction from baseline in EASI at Week 12 (interim analysis data). The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head \[10%\], trunk \[30%\], upper extremities \[20%\], and lower extremities \[40%\]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).
Group
Value
95% CI
Part 1: MK-8226 0.3 mg/kg
-5.77
± 6.17
Part 1: MK-8226 1 mg/kg
-8.40
± 9.39
Part 1: MK-8226 3 mg/kg
-10.20
± 7.23
Part 1: MK-8226 10 mg/kg
-7.78
± 8.35
Part 1: Placebo (Pooled)
-0.38
± 6.37
Area Under the Concentration-time Curve of MK-8226 From Time 0 to Tau (AUC0-tau) Following Multiple Intravenous Dose AdministrationSecondary· Days 1, 3, 5, 9, 14, 70, 72, 74, 84
AUC(0-tau) defined as AUC from time zero to tau where tau is the dosing interval (312 hours) was determined for the first and last periods of MK-8226 dosing. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 70 (incl. predose), 72, 74, 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect
Week 1 (n=9,7,8,10)
Group
Value
95% CI
Part 1: MK-8226 0.3 mg/kg
1000
± 18.2
Part 1: MK-8226 1 mg/kg
3300
± 29.3
Part 1: MK-8226 3 mg/kg
9300
± 19.1
Part 1: MK-8226 10 mg/kg
31400
± 11.2
Week 10 (n=8,5,6,6)
Group
Value
95% CI
Part 1: MK-8226 0.3 mg/kg
2310
± 11
Part 1: MK-8226 1 mg/kg
8530
± 15.4
Part 1: MK-8226 3 mg/kg
21100
± 28.8
Part 1: MK-8226 10 mg/kg
82100
± 16.2
AUC From Time 0 to Last Measurement (AUC0-last) of MK-8226 Following Multiple Intravenous Dose AdministrationSecondary· Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224
AUC0-last defined as AUC up to the last measured concentration was determined for the last period of dosing (starting Week 10 \[Day 70\]) up to the last measurement. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an
Group
Value
95% CI
Part 1: MK-8226 0.3 mg/kg
6460
± 34.3
Part 1: MK-8226 1 mg/kg
22600
± 65.8
Part 1: MK-8226 3 mg/kg
47100
± 97.2
Part 1: MK-8226 10 mg/kg
264000
± 25.2
Maximum Serum Concentration (Cmax) of MK-8226 Following Multiple Dose Intravenous AdministrationSecondary· Days 1, 3, 5, 9, 14, 70, 72, 74, 84
Cmax was determined for the first and last periods of MK-8226 dosing. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 70 (incl. predose), 72, 74, and 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.
Week 1 (n=9,8,8,10)
Group
Value
95% CI
Part 1: MK-8226 0.3 mg/kg
7.12
± 21.9
Part 1: MK-8226 1 mg/kg
21.6
± 26.0
Part 1: MK-8226 3 mg/kg
60.3
± 18.0
Part 1: MK-8226 10 mg/kg
200
± 12.1
Week 10 (n=8,6,6,6)
Group
Value
95% CI
Part 1: MK-8226 0.3 mg/kg
11.7
± 9.63
Part 1: MK-8226 1 mg/kg
42.4
± 20.1
Part 1: MK-8226 3 mg/kg
106
± 19.6
Part 1: MK-8226 10 mg/kg
398
± 17.1
Clearance (CL) of MK-8226 Following Multiple Dose Intravenous AdministrationSecondary· Days 1, 3, 5, 9, 14, 28, 42, 56, 70, 72, 74, 84
CL, the volume of plasma cleared of drug per unit time, was determined for the last period of dosing (starting Week 10 \[Day 70\]) in the treatment period. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 28 (incl. predose), 42 (incl. predose), 56 (incl. predose), 70 (incl. predose), 72, 74, and 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoin
Group
Value
95% CI
Part 1: MK-8226 0.3 mg/kg
3.04
± 11
Part 1: MK-8226 1 mg/kg
2.81
± 15.4
Part 1: MK-8226 3 mg/kg
3.33
± 28.8
Part 1: MK-8226 10 mg/kg
2.9
± 16.2
Volume of Distribution (Vd) of MK-8226 Following Multiple Intravenous AdministrationSecondary· Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224
Vd, a theoretical approximation of degree to which the drug distributes in body tissue rather than plasma (higher Vd indicates greater tissue distribution), was determined for the last period of dosing (starting Week 10 \[Day 70\]) in the treatment period. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the
Group
Value
95% CI
Part 1: MK-8226 0.3 mg/kg
103
± 27.6
Part 1: MK-8226 1 mg/kg
122
± 26.8
Part 1: MK-8226 3 mg/kg
102
± 62.1
Part 1: MK-8226 10 mg/kg
120
± 25.3
Terminal Half Life (t1/2) of MK-8226 Following Multiple Dose Intravenous AdministrationSecondary· Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224
t1/2, the time needed for the concentration of drug to reach half the initial concentration, was determined for the last period of dosing (starting Week 10 \[Day 70\]) up to the last measurement. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demo
Group
Value
95% CI
Part 1: MK-8226 0.3 mg/kg
23.6
± 33.5
Part 1: MK-8226 1 mg/kg
30
± 15.9
Part 1: MK-8226 3 mg/kg
24.7
± 51.3
Part 1: MK-8226 10 mg/kg
28.7
± 15.7
Number of Participants Positive for Anti-Drug Antibody (ADA) FormationSecondary· Days 1 (predose) and Days 14, 28, 42, 56, 74, 112, and 224
Testing for ADA positivity and neutralizing response and antibody titre quantification are performed with blood (serum) samples collected at baseline (Day 1 predose) and Days 14, 28, 42, 56, 74, 112, and 224. Neutralizing response refers to ADA neutralizing interference with study drug assessed in vitro. Non-Treatment emergent ADA refers to presence of ADAs (as determined by assay) in the absence of treatment with study drug (i.e., at predose).
Non Treatment emergent ADA positive
Group
Value
95% CI
Part 1: MK-8226 0.3 mg/kg
0
Part 1: MK-8226 1 mg/kg
1
Part 1: MK-8226 3 mg/kg
0
Part 1: MK-8226 10 mg/kg
0
Part 2: MK-8226 3 mg/kg
0
Part 2: Placebo
0
Treatment emergent ADA positive
Group
Value
95% CI
Part 1: MK-8226 0.3 mg/kg
0
Part 1: MK-8226 1 mg/kg
0
Part 1: MK-8226 3 mg/kg
1
Part 1: MK-8226 10 mg/kg
0
Part 2: MK-8226 3 mg/kg
2
Part 2: Placebo
0
ADA positive: Max titer 1:10
Group
Value
95% CI
Part 1: MK-8226 0.3 mg/kg
0
Part 1: MK-8226 1 mg/kg
0
Part 1: MK-8226 3 mg/kg
0
Part 1: MK-8226 10 mg/kg
0
Part 2: MK-8226 3 mg/kg
0
Part 2: Placebo
0
ADA positive: Max titer 1:50
Group
Value
95% CI
Part 1: MK-8226 0.3 mg/kg
0
Part 1: MK-8226 1 mg/kg
0
Part 1: MK-8226 3 mg/kg
1
Part 1: MK-8226 10 mg/kg
0
Part 2: MK-8226 3 mg/kg
1
Part 2: Placebo
0
ADA positive: Neutralizing response positive
Group
Value
95% CI
Part 1: MK-8226 0.3 mg/kg
0
Part 1: MK-8226 1 mg/kg
0
Part 1: MK-8226 3 mg/kg
1
Part 1: MK-8226 10 mg/kg
0
Part 2: MK-8226 3 mg/kg
1
Part 2: Placebo
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 32 Weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a 3-part study to assess the safety, tolerability, efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of MK-8226 in participants with moderate to severe atopic dermatitis. Part 1 (multiple rising dose study) objectives were to find the maximum tolerated dose (MTD) of MK-8226 and to assess safety and PK. Part 2 objectives were to determine safety, PK, and preliminary efficacy. Part 3 objectives were to further define safety and PK, and explore MK-8226 PK/PD to model the optimal dose range for future studies. The study was terminated early due to business reasons on 08 May 2014; final results from an analysis for Part 1 (efficacy, PK, safety, immunogenicity) and Part 2 (safety, immunogenicity) are summarized.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 15 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01732510.