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A Study of Intravenous MK-8226 in Participants With Moderate-to-Severe Atopic Dermatitis (MK-8226-003)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01732510
Recruitment Status : Terminated (The study was prematurely stopped due to business reasons.)
First Posted : November 22, 2012
Results First Posted : June 9, 2016
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Drug: MK-8226
Drug: Placebo
Enrollment 65
Recruitment Details  
Pre-assignment Details Participants were screened for study eligibility over 4 weeks prior to first dosing. Additional inclusion and exclusion criteria applied.
Arm/Group Title Part 1: MK-8226 0.3 mg/kg Part 1: MK-8226 1 mg/kg Part 1: MK-8226 3 mg/kg Part 1: MK-8226 10 mg/kg Part 1: Placebo (Pooled) Part 2: MK-8226 3 mg/kg Part 2: Placebo
Hide Arm/Group Description MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks. MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks. MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. Placebo administered IV every 2 weeks for a period of 12 weeks.
Period Title: Overall Study
Started 9 9 8 10 8 13 8
Completed 8 4 4 5 3 0 0
Not Completed 1 5 4 5 5 13 8
Reason Not Completed
Adverse Event             0             1             1             0             0             0             1
Protocol Violation             0             0             0             1             0             0             0
Withdrawal by Subject             1             3             2             1             5             0             1
Lost to Follow-up             0             0             1             1             0             1             0
Physician Decision             0             1             0             0             0             0             0
Pregnancy             0             0             0             1             0             0             0
Study Terminated By Sponsor             0             0             0             1             0             12             6
Arm/Group Title Part 1: MK-8226 0.3 mg/kg Part 1: MK-8226 1 mg/kg Part 1: MK-8226 3 mg/kg Part 1: MK-8226 10 mg/kg Part 1: Placebo (Pooled) Part 2: MK-8226 3 mg/kg Part 2: Placebo Total
Hide Arm/Group Description MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks. MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks. MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. Placebo administered IV every 2 weeks for a period of 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 9 9 8 10 8 13 8 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 8 participants 10 participants 8 participants 13 participants 8 participants 65 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  88.9%
9
 100.0%
8
 100.0%
10
 100.0%
8
 100.0%
13
 100.0%
8
 100.0%
64
  98.5%
>=65 years
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 9 participants 8 participants 10 participants 8 participants 13 participants 8 participants 65 participants
49.0  (11.8) 30.8  (13.4) 41.6  (12.6) 34.7  (10.2) 37.8  (14.2) 38.3  (11.5) 33.9  (12.9) 38.0  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 8 participants 10 participants 8 participants 13 participants 8 participants 65 participants
Female
4
  44.4%
2
  22.2%
4
  50.0%
6
  60.0%
5
  62.5%
8
  61.5%
3
  37.5%
32
  49.2%
Male
5
  55.6%
7
  77.8%
4
  50.0%
4
  40.0%
3
  37.5%
5
  38.5%
5
  62.5%
33
  50.8%
1.Primary Outcome
Title Number of Participants Who Experienced at Least One Adverse Event
Hide Description 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 significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Time Frame Up to 32 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The All Subjects as Treated (ASaT) population defined as all participants who received at least one dose of investigational drug was used for analysis.
Arm/Group Title Part 1: MK-8226 0.3 mg/kg Part 1: MK-8226 1 mg/kg Part 1: MK-8226 3 mg/kg Part 1: MK-8226 10 mg/kg Part 1: Placebo (Pooled) Part 2: MK-8226 3 mg/kg Part 2: Placebo
Hide Arm/Group Description:
MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Placebo administered IV every 2 weeks for a period of 12 weeks.
Overall Number of Participants Analyzed 9 9 8 10 8 13 8
Measure Type: Number
Unit of Measure: participants
8 6 6 7 7 10 7
2.Primary Outcome
Title Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Hide Description 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 change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Time Frame Up to 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The ASaT population defined as all participants who received at least one dose of investigational drug was used for analysis.
Arm/Group Title Part 1: MK-8226 0.3 mg/kg Part 1: MK-8226 1 mg/kg Part 1: MK-8226 3 mg/kg Part 1: MK-8226 10 mg/kg Part 1: Placebo (Pooled) Part 2: MK-8226 3 mg/kg Part 2: Placebo
Hide Arm/Group Description:
MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Placebo administered IV every 2 weeks for a period of 12 weeks.
Overall Number of Participants Analyzed 9 9 8 10 8 13 8
Measure Type: Number
Unit of Measure: participants
0 1 1 0 0 0 1
3.Primary Outcome
Title Change From Baseline in the Eczema Area and Severity Index (EASI) for Study Part 1
Hide Description 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).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) defined as all randomized subjects who received at least one dose of study treatment with baseline and at least one post-dose assessment (EASI) was used for analysis.
Arm/Group Title Part 1: MK-8226 0.3 mg/kg Part 1: MK-8226 1 mg/kg Part 1: MK-8226 3 mg/kg Part 1: MK-8226 10 mg/kg Part 1: Placebo (Pooled)
Hide Arm/Group Description:
MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
Overall Number of Participants Analyzed 8 5 6 6 5
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-5.77  (6.17) -8.40  (9.39) -10.20  (7.23) -7.78  (8.35) -0.38  (6.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: MK-8226 3 mg/kg, Part 1: Placebo (Pooled)
Comments The reduction from baseline in EASI at week 12 for participants receiving MK-8226 3 mg/kg was compared to placebo (MK-8226 3 mg - Placebo). The constrained longitudinal data analysis model used variance component covariance matrix to model correlation among repeated visits, without adjustment for interaction of treatment group by visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method Constrained longitudinal data analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.82
Confidence Interval (2-Sided) 95%
-16.87 to -2.77
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Plasma Chemokine (C-C Motif) Ligand 17 (CCL17) Level in Study Part 2
Hide Description CCL17 is a pro-allergic chemokine that is assessed in human plasma. Levels of CCL17 are increased in allergic disease states.
Time Frame Baseline, 48 Hours, Week 2, Week 4, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from Baseline [BL] in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.
Arm/Group Title Part 2: MK-8226 3 mg/kg Part 2: Placebo
Hide Arm/Group Description:
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Placebo administered IV every 2 weeks for a period of 12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Plasma Chemokine (C-C Motif) Ligand 22 (CCL22) Level in Study Part 2
Hide Description CCL22 is a pro-allergic chemokine that is assessed in human plasma. Levels of CCL22 are increased in allergic disease states.
Time Frame Baseline, 48 Hours, Week 2, Week 4, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
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. The study was early terminated from a business perspective.
Arm/Group Title Part 2: MK-8226 3 mg/kg Part 2: Placebo
Hide Arm/Group Description:
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Placebo administered IV every 2 weeks for a period of 12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Area Under the Concentration-time Curve of MK-8226 From Time 0 to Tau (AUC0-tau) Following Multiple Intravenous Dose Administration
Hide Description 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 in an interim futility analysis.
Time Frame Days 1, 3, 5, 9, 14, 70, 72, 74, 84
Hide Outcome Measure Data
Hide Analysis Population Description
The Per-Protocol (PP) population defined as all participants compliant with study procedure with data available (AUC0-tau) from at least one treatment was used for analysis.
Arm/Group Title Part 1: MK-8226 0.3 mg/kg Part 1: MK-8226 1 mg/kg Part 1: MK-8226 3 mg/kg Part 1: MK-8226 10 mg/kg
Hide Arm/Group Description:
MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Overall Number of Participants Analyzed 9 7 8 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg*hr/mL
Week 1 (n=9,7,8,10)
1000
(18.2%)
3300
(29.3%)
9300
(19.1%)
31400
(11.2%)
Week 10 (n=8,5,6,6)
2310
(11%)
8530
(15.4%)
21100
(28.8%)
82100
(16.2%)
7.Secondary Outcome
Title AUC From Time 0 to Last Measurement (AUC0-last) of MK-8226 Following Multiple Intravenous Dose Administration
Hide Description 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 interim futility analysis.
Time Frame Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population defined as all participants compliant with study procedure with data available (AUC0-last) from at least one treatment was used for analysis.
Arm/Group Title Part 1: MK-8226 0.3 mg/kg Part 1: MK-8226 1 mg/kg Part 1: MK-8226 3 mg/kg Part 1: MK-8226 10 mg/kg
Hide Arm/Group Description:
MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Overall Number of Participants Analyzed 8 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg*hr/mL
6460
(34.3%)
22600
(65.8%)
47100
(97.2%)
264000
(25.2%)
8.Secondary Outcome
Title Maximum Serum Concentration (Cmax) of MK-8226 Following Multiple Dose Intravenous Administration
Hide Description 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.
Time Frame Days 1, 3, 5, 9, 14, 70, 72, 74, 84
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population defined as all participants compliant with study procedure with data available (Cmax) from at least one treatment was used for analysis.
Arm/Group Title Part 1: MK-8226 0.3 mg/kg Part 1: MK-8226 1 mg/kg Part 1: MK-8226 3 mg/kg Part 1: MK-8226 10 mg/kg
Hide Arm/Group Description:
MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Overall Number of Participants Analyzed 9 8 8 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
Week 1 (n=9,8,8,10)
7.12
(21.9%)
21.6
(26.0%)
60.3
(18.0%)
200
(12.1%)
Week 10 (n=8,6,6,6)
11.7
(9.63%)
42.4
(20.1%)
106
(19.6%)
398
(17.1%)
9.Secondary Outcome
Title Clearance (CL) of MK-8226 Following Multiple Dose Intravenous Administration
Hide Description 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 endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.
Time Frame Days 1, 3, 5, 9, 14, 28, 42, 56, 70, 72, 74, 84
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population defined as all participants compliant with study procedure with data available (CL) from at least one treatment was used for analysis.
Arm/Group Title Part 1: MK-8226 0.3 mg/kg Part 1: MK-8226 1 mg/kg Part 1: MK-8226 3 mg/kg Part 1: MK-8226 10 mg/kg
Hide Arm/Group Description:
MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Overall Number of Participants Analyzed 8 5 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/day/kg
3.04
(11%)
2.81
(15.4%)
3.33
(28.8%)
2.9
(16.2%)
10.Secondary Outcome
Title Volume of Distribution (Vd) of MK-8226 Following Multiple Intravenous Administration
Hide Description 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 Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.
Time Frame Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population defined as all participants compliant with study procedure with data available (Vd) from at least one treatment was used for analysis.
Arm/Group Title Part 1: MK-8226 0.3 mg/kg Part 1: MK-8226 1 mg/kg Part 1: MK-8226 3 mg/kg Part 1: MK-8226 10 mg/kg
Hide Arm/Group Description:
MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Overall Number of Participants Analyzed 8 5 4 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/kg
103
(27.6%)
122
(26.8%)
102
(62.1%)
120
(25.3%)
11.Secondary Outcome
Title Terminal Half Life (t1/2) of MK-8226 Following Multiple Dose Intravenous Administration
Hide Description 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 demonstrate adequate effect in an interim futility analysis.
Time Frame Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population defined as all participants compliant with study procedure with data available (t1/2) from at least one treatment was used for analysis.
Arm/Group Title Part 1: MK-8226 0.3 mg/kg Part 1: MK-8226 1 mg/kg Part 1: MK-8226 3 mg/kg Part 1: MK-8226 10 mg/kg
Hide Arm/Group Description:
MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Overall Number of Participants Analyzed 8 5 4 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: days
23.6
(33.5%)
30
(15.9%)
24.7
(51.3%)
28.7
(15.7%)
12.Secondary Outcome
Title Change From Baseline in the Eczema Area and Severity Index (EASI) for Study Part 2
Hide Description 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).
Time Frame Baseline, Week 4, Week 8, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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. The study was early terminated from a business perspective.
Arm/Group Title Part 2: MK-8226 3 mg/kg Part 2: Placebo
Hide Arm/Group Description:
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Placebo administered IV every 2 weeks for a period of 12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Percentage of Participants With an Investigator Global Assessment (IGA) Score of Clear or Almost Clear in Study Part 2
Hide Description Percentage of participants achieving an IGA of atopic dermatitis of "clear-0" or "almost clear-1". The IGA is a six-point scale measuring the severity of disease at time of physical examination of the participant by the physician. The IGA is scored 0 (Clear) to 5 (Very severe disease).
Time Frame Baseline, Week 4, Week 8, Week 12, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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. The study was early terminated from a business perspective.
Arm/Group Title Part 2: MK-8226 3 mg/kg Part 2: Placebo
Hide Arm/Group Description:
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Placebo administered IV every 2 weeks for a period of 12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Change From Baseline in the Scoring Atopic Dermatitis Scale (SCORAD) in Study Part 2
Hide Description The SCORAD index scale combines 1) intensity of six lesion characteristics (erythema, edema/papulation, oozing/crusts, excoriations, lichenification, dryness) as assessed by the physician on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities) along with 2) subjective symptoms of pruritus and sleep disturbance as reported by the patient on a visual analog scale (VAS) from 1 to 10 cm (increasing severity). Physician assessment of affected areas in each region is made as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The final SCORAD index score, ranging from 0 (absent disease) to 103 (severe disease), is calculated according to the weighted formula: (0.2 x area) + (3.5 x [sum of intensity score for each of the 6 items]) + participant's subjective score.
Time Frame Baseline, Week 4, Week 12, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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. The study was early terminated from a business perspective.
Arm/Group Title Part 2: MK-8226 3 mg/kg Part 2: Placebo
Hide Arm/Group Description:
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Placebo administered IV every 2 weeks for a period of 12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Change From Baseline in Participant Pruritus in Study Part 2
Hide Description Skin pruritus (itching) is a typical characteristic of atopic dermatitis. Participant subjective assessment of pruritus (component of SCORAD) is rated on a VAS ranging from 1 to 10 cm (increasing severity).
Time Frame Baseline, Week 4, Week 12, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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. The study was early terminated from a business perspective.
Arm/Group Title Part 2: MK-8226 3 mg/kg Part 2: Placebo
Hide Arm/Group Description:
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Placebo administered IV every 2 weeks for a period of 12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Change From Baseline in Participant Sleep Disturbance in Study Part 2
Hide Description Sleep disturbance (sleep loss, disruption, or interference) due to unremitting pruritus and other causes is a quality of life issue in moderate to severe atopic dermatitis. Participant subjective assessment of sleep disturbance (component of SCORAD) over the past 3 days is rated on a VAS ranging from 1 to 10 cm (increasing severity).
Time Frame Baseline, Week 4, Week 12, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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. The study was early terminated from a business perspective.
Arm/Group Title Part 2: MK-8226 3 mg/kg Part 2: Placebo
Hide Arm/Group Description:
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Placebo administered IV every 2 weeks for a period of 12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Number of Participants Requiring As-Needed Oral Antihistamines as Rescue Medication in Study Part 2
Hide Description Oral antihistamines (i.e., diphenhydramine, acrivastine fenistil) were provided as as-needed rescue medication for severe pruritus.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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. The study was early terminated from a business perspective.
Arm/Group Title Part 2: MK-8226 3 mg/kg Part 2: Placebo
Hide Arm/Group Description:
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Placebo administered IV every 2 weeks for a period of 12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Percentage of Participants With >=50% Improvement in EASI Score
Hide Description 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).
Time Frame Baseline, Week 12, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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. The study was early terminated from a business perspective.
Arm/Group Title Part 2: MK-8226 3 mg/kg Part 2: Placebo
Hide Arm/Group Description:
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Placebo administered IV every 2 weeks for a period of 12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Number of Participants Positive for Anti-Drug Antibody (ADA) Formation
Hide Description 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).
Time Frame Days 1 (predose) and Days 14, 28, 42, 56, 74, 112, and 224
Hide Outcome Measure Data
Hide Analysis Population Description
The ADA evaluable population defined as all participants with at least one ADA sample available after treatment with MK-8226 or placebo was used for analysis.
Arm/Group Title Part 1: MK-8226 0.3 mg/kg Part 1: MK-8226 1 mg/kg Part 1: MK-8226 3 mg/kg Part 1: MK-8226 10 mg/kg Part 1: Placebo (Pooled) Part 2: MK-8226 3 mg/kg Part 2: Placebo
Hide Arm/Group Description:
MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks. No participant met criteria for inclusion in the evaluable population.
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Placebo administered IV every 2 weeks for a period of 12 weeks.
Overall Number of Participants Analyzed 9 8 8 9 0 12 2
Measure Type: Number
Unit of Measure: Participants
Non Treatment emergent ADA positive 0 1 0 0 0 0
Treatment emergent ADA positive 0 0 1 0 2 0
ADA positive: Max titer 1:10 0 0 0 0 0 0
ADA positive: Max titer 1:50 0 0 1 0 1 0
ADA positive: Neutralizing response positive 0 0 1 0 1 0
20.Other Pre-specified Outcome
Title Change From Baseline in the Participant's Global Impression of Disease Status in Study Part 2
Hide Description Participant subjective impression of improvement of his/her disease condition is scored on a six-point scale: 0 (Clear) to 5 (Very severe disease).
Time Frame Baseline, Week 4, Week 12, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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. The study was early terminated from a business perspective.
Arm/Group Title Part 2: MK-8226 3 mg/kg Part 2: Placebo
Hide Arm/Group Description:
MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
Placebo administered IV every 2 weeks for a period of 12 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 32 Weeks
Adverse Event Reporting Description 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.
 
Arm/Group Title Part 1: MK-8226 0.3 mg/kg Part 1: MK-8226 1 mg/kg Part 1: MK-8226 3 mg/kg Part 1: MK-8226 10 mg/kg Part 1: Placebo (Pooled) Part 2: MK-8226 3 mg/kg Part 2: Placebo
Hide Arm/Group Description MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks. MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. Placebo administered IV every 2 weeks for a period of 12 weeks.
All-Cause Mortality
Part 1: MK-8226 0.3 mg/kg Part 1: MK-8226 1 mg/kg Part 1: MK-8226 3 mg/kg Part 1: MK-8226 10 mg/kg Part 1: Placebo (Pooled) Part 2: MK-8226 3 mg/kg Part 2: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Part 1: MK-8226 0.3 mg/kg Part 1: MK-8226 1 mg/kg Part 1: MK-8226 3 mg/kg Part 1: MK-8226 10 mg/kg Part 1: Placebo (Pooled) Part 2: MK-8226 3 mg/kg Part 2: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/9 (0.00%)      0/8 (0.00%)      1/10 (10.00%)      0/8 (0.00%)      0/13 (0.00%)      1/8 (12.50%)    
Infections and infestations               
Erysipelas  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 1/8 (12.50%)  1
Surgical and medical procedures               
Abortion induced  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1: MK-8226 0.3 mg/kg Part 1: MK-8226 1 mg/kg Part 1: MK-8226 3 mg/kg Part 1: MK-8226 10 mg/kg Part 1: Placebo (Pooled) Part 2: MK-8226 3 mg/kg Part 2: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/9 (88.89%)      6/9 (66.67%)      6/8 (75.00%)      7/10 (70.00%)      7/8 (87.50%)      10/13 (76.92%)      7/8 (87.50%)    
Ear and labyrinth disorders               
Hypoacusis  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Eye disorders               
Blepharitis  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Conjunctivitis allergic  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 1/13 (7.69%)  1 0/8 (0.00%)  0
Gastrointestinal disorders               
Abdominal pain  1  0/9 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Diarrhoea  1  1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Dry mouth  1  1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Food poisoning  1  1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Nausea  1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 1/10 (10.00%)  1 0/8 (0.00%)  0 1/13 (7.69%)  1 0/8 (0.00%)  0
Oral mucosal blistering  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 1/13 (7.69%)  1 0/8 (0.00%)  0
Palatal swelling  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 1/13 (7.69%)  1 0/8 (0.00%)  0
General disorders               
Asthenia  1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Chills  1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Fatigue  1  1/9 (11.11%)  1 1/9 (11.11%)  1 1/8 (12.50%)  1 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Gravitational oedema  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  2 0/13 (0.00%)  0 0/8 (0.00%)  0
Peripheral swelling  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1 0/13 (0.00%)  0 0/8 (0.00%)  0
Pyrexia  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 1/13 (7.69%)  1 0/8 (0.00%)  0
Infections and infestations               
Bacterial infection  1  1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Bronchitis  1  1/9 (11.11%)  1 1/9 (11.11%)  2 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 1/8 (12.50%)  1
Cellulitis  1  1/9 (11.11%)  1 0/9 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 1/8 (12.50%)  1 0/13 (0.00%)  0 0/8 (0.00%)  0
Conjunctivitis  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/8 (0.00%)  0 0/13 (0.00%)  0 1/8 (12.50%)  1
Folliculitis  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Furuncle  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1 0/13 (0.00%)  0 0/8 (0.00%)  0
Gastroenteritis viral  1  1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Herpes ophthalmic  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Herpes simplex  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1 0/13 (0.00%)  0 0/8 (0.00%)  0
Nasopharyngitis  1  4/9 (44.44%)  5 1/9 (11.11%)  1 1/8 (12.50%)  1 3/10 (30.00%)  6 2/8 (25.00%)  3 4/13 (30.77%)  5 2/8 (25.00%)  3
Oral herpes  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/8 (0.00%)  0 0/13 (0.00%)  0 1/8 (12.50%)  1
Rash pustular  1  0/9 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Skin infection  1  0/9 (0.00%)  0 0/9 (0.00%)  0 2/8 (25.00%)  2 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Superinfection bacterial  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 1/8 (12.50%)  1
Tonsillitis  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Upper respiratory tract infection  1  0/9 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Urinary tract infection  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 2/8 (25.00%)  2
Vulvovaginal candidiasis  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1 0/13 (0.00%)  0 0/8 (0.00%)  0
Wound infection  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  2 0/13 (0.00%)  0 0/8 (0.00%)  0
Injury, poisoning and procedural complications               
Contusion  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Joint dislocation  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 1/13 (7.69%)  1 0/8 (0.00%)  0
Laceration  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 1/8 (12.50%)  2
Muscle strain  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 1/13 (7.69%)  1 0/8 (0.00%)  0
Investigations               
Blood creatine phosphokinase increased  1  1/9 (11.11%)  1 1/9 (11.11%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 1/8 (12.50%)  1
Heart rate irregular  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1 0/13 (0.00%)  0 0/8 (0.00%)  0
Streptococcus test positive  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 1/13 (7.69%)  1 0/8 (0.00%)  0
Metabolism and nutrition disorders               
Abnormal weight gain  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Musculoskeletal and connective tissue disorders               
Arthralgia  1  1/9 (11.11%)  1 0/9 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 1/8 (12.50%)  1 1/13 (7.69%)  1 0/8 (0.00%)  0
Back pain  1  1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Bursitis  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1 0/13 (0.00%)  0 0/8 (0.00%)  0
Fracture pain  1  1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Musculoskeletal pain  1  1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Myalgia  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/8 (0.00%)  0 1/13 (7.69%)  1 0/8 (0.00%)  0
Pain in extremity  1  1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1 0/13 (0.00%)  0 0/8 (0.00%)  0
Nervous system disorders               
Carpal tunnel syndrome  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1 0/13 (0.00%)  0 0/8 (0.00%)  0
Dizziness  1  0/9 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 1/8 (12.50%)  1 0/13 (0.00%)  0 0/8 (0.00%)  0
Dysgeusia  1  1/9 (11.11%)  2 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Headache  1  2/9 (22.22%)  2 0/9 (0.00%)  0 1/8 (12.50%)  1 1/10 (10.00%)  3 1/8 (12.50%)  2 3/13 (23.08%)  4 2/8 (25.00%)  2
Presyncope  1  0/9 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Syncope  1  0/9 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Psychiatric disorders               
Anxiety  1  0/9 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Depression  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1 0/13 (0.00%)  0 0/8 (0.00%)  0
Insomnia  1  0/9 (0.00%)  0 1/9 (11.11%)  1 1/8 (12.50%)  1 0/10 (0.00%)  0 1/8 (12.50%)  1 0/13 (0.00%)  0 0/8 (0.00%)  0
Reproductive system and breast disorders               
Amenorrhoea  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1 0/13 (0.00%)  0 0/8 (0.00%)  0
Vulvovaginal pruritus  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1 0/13 (0.00%)  0 0/8 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Asthma  1  1/9 (11.11%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Cough  1  0/9 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 1/8 (12.50%)  1 0/13 (0.00%)  0 0/8 (0.00%)  0
Dyspnoea  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 1/8 (12.50%)  1
Nasal congestion  1  0/9 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  2 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Rhinorrhoea  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 1/8 (12.50%)  1
Skin and subcutaneous tissue disorders               
Alopecia areata  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1 0/13 (0.00%)  0 0/8 (0.00%)  0
Blister  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 1/13 (7.69%)  2 0/8 (0.00%)  0
Dermal cyst  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1 0/13 (0.00%)  0 0/8 (0.00%)  0
Dermatitis atopic  1  0/9 (0.00%)  0 1/9 (11.11%)  1 1/8 (12.50%)  1 1/10 (10.00%)  2 0/8 (0.00%)  0 3/13 (23.08%)  3 1/8 (12.50%)  1
Dermatitis contact  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1 0/13 (0.00%)  0 0/8 (0.00%)  0
Dyshidrotic eczema  1  0/9 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1 0/13 (0.00%)  0 0/8 (0.00%)  0
Erythema  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 1/13 (7.69%)  1 0/8 (0.00%)  0
Pruritus  1  1/9 (11.11%)  1 0/9 (0.00%)  0 1/8 (12.50%)  1 1/10 (10.00%)  1 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Rash  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0 1/13 (7.69%)  1 0/8 (0.00%)  0
Skin mass  1  0/9 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  2 0/13 (0.00%)  0 0/8 (0.00%)  0
Urticaria  1  0/9 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Vascular disorders               
Hypotension  1  0/9 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/8 (0.00%)  0 0/13 (0.00%)  0 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01732510    
Other Study ID Numbers: 8226-003
2012-005560-95 ( EudraCT Number )
First Submitted: November 19, 2012
First Posted: November 22, 2012
Results First Submitted: February 26, 2016
Results First Posted: June 9, 2016
Last Update Posted: March 15, 2019