Trial Outcomes & Findings for Efficacy and Safety of MK-6194 in Adult Participants With Systemic Lupus Erythematosus (MK-6194-006) (NCT NCT06161116)
NCT ID: NCT06161116
Last Updated: 2026-08-10
Results Overview
The SRI was a composite index used to assess clinical improvement in participants with SLE. The SRI-4 response evaluated global improvement, any significant worsening in unaffected organ systems, and improvements in disease activity, without compromise to the participant's overall condition. SRI-4 response was binary and either achieved or not achieved by the participant, thus there was no associated score. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of counts calculated as percentages was reported.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
149 participants
Primary outcome timeframe
Week 28
Results posted on
2026-08-10
Participant Flow
During the main study, participants received MK-6194 (3 mg every 2 weeks \[q2w\] or every 4 weeks \[q4w\]) or placebo, administered subcutaneously (SC). Those who completed the main study entered the extension period. Participants who received MK-6194 continued their regimen, and participants who received placebo were re-randomized to MK-6194 3 mg q2w or MK-6194 3 mg q4w.
Participant milestones
| Measure |
MK-6194 3 mg Q2W
Participants received SC MK-6194 3 mg q2w.
|
MK-6194 3 mg Q4W
Participants received SC MK-6194 3 mg q4w.
|
Placebo
Participants received SC placebo q2w.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Main Study
STARTED
|
49
|
49
|
51
|
0
|
0
|
0
|
0
|
|
Main Study
Treated
|
49
|
49
|
51
|
0
|
0
|
0
|
0
|
|
Main Study
COMPLETED
|
2
|
4
|
6
|
0
|
0
|
0
|
0
|
|
Main Study
NOT COMPLETED
|
47
|
45
|
45
|
0
|
0
|
0
|
0
|
|
Extension Period
STARTED
|
0
|
0
|
0
|
2
|
4
|
2
|
4
|
|
Extension Period
Treated
|
0
|
0
|
0
|
2
|
4
|
2
|
4
|
|
Extension Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Extension Period
NOT COMPLETED
|
0
|
0
|
0
|
2
|
4
|
2
|
4
|
Reasons for withdrawal
| Measure |
MK-6194 3 mg Q2W
Participants received SC MK-6194 3 mg q2w.
|
MK-6194 3 mg Q4W
Participants received SC MK-6194 3 mg q4w.
|
Placebo
Participants received SC placebo q2w.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Main Study
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Main Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study
Physician Decision
|
1
|
3
|
1
|
0
|
0
|
0
|
0
|
|
Main Study
Study Terminated by Sponsor
|
39
|
39
|
41
|
0
|
0
|
0
|
0
|
|
Main Study
Withdrawal by Subject
|
3
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Main Study
Other
|
3
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Extension Period
Study Terminated by Sponsor
|
0
|
0
|
0
|
2
|
4
|
2
|
4
|
Baseline Characteristics
Efficacy and Safety of MK-6194 in Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)
Baseline characteristics by cohort
| Measure |
MK-6194 3 mg Q2W
n=49 Participants
Participants received SC MK-6194 3 mg q2w.
|
MK-6194 3 mg Q4W
n=49 Participants
Participants received SC MK-6194 3 mg q4w.
|
Placebo
n=51 Participants
Participants received SC placebo q2w.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.9 Years
STANDARD_DEVIATION 13.8 • n=54 Participants
|
40.4 Years
STANDARD_DEVIATION 12.0 • n=54 Participants
|
41.2 Years
STANDARD_DEVIATION 14.0 • n=27 Participants
|
40.8 Years
STANDARD_DEVIATION 13.2 • n=26 Participants
|
|
Age, Customized
Adults (Between 18 and 64 Years)
|
48 Participants
n=54 Participants
|
48 Participants
n=54 Participants
|
49 Participants
n=27 Participants
|
145 Participants
n=26 Participants
|
|
Age, Customized
From 65 to 84 Years
|
1 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=26 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=54 Participants
|
46 Participants
n=54 Participants
|
45 Participants
n=27 Participants
|
139 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=54 Participants
|
3 Participants
n=54 Participants
|
6 Participants
n=27 Participants
|
10 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=54 Participants
|
25 Participants
n=54 Participants
|
29 Participants
n=27 Participants
|
83 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=54 Participants
|
24 Participants
n=54 Participants
|
22 Participants
n=27 Participants
|
66 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
15 Participants
n=54 Participants
|
10 Participants
n=54 Participants
|
12 Participants
n=27 Participants
|
37 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=54 Participants
|
13 Participants
n=54 Participants
|
15 Participants
n=27 Participants
|
36 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=54 Participants
|
3 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
7 Participants
n=26 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=54 Participants
|
21 Participants
n=54 Participants
|
20 Participants
n=27 Participants
|
61 Participants
n=26 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=54 Participants
|
2 Participants
n=54 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
|
Total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Score at Screening
<10
|
27 Participants
n=54 Participants
|
27 Participants
n=54 Participants
|
29 Participants
n=27 Participants
|
83 Participants
n=26 Participants
|
|
Total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Score at Screening
≥10
|
22 Participants
n=54 Participants
|
22 Participants
n=54 Participants
|
22 Participants
n=27 Participants
|
66 Participants
n=26 Participants
|
|
Oral Corticosteroid Dose (Prednisone or Equivalent) at Randomization
<10 mg/day
|
26 Participants
n=54 Participants
|
27 Participants
n=54 Participants
|
27 Participants
n=27 Participants
|
80 Participants
n=26 Participants
|
|
Oral Corticosteroid Dose (Prednisone or Equivalent) at Randomization
≥10 mg/day
|
23 Participants
n=54 Participants
|
22 Participants
n=54 Participants
|
24 Participants
n=27 Participants
|
69 Participants
n=26 Participants
|
|
Geographic Region
Latin America/Eastern Europe
|
24 Participants
n=54 Participants
|
24 Participants
n=54 Participants
|
26 Participants
n=27 Participants
|
74 Participants
n=26 Participants
|
|
Geographic Region
Rest of the World
|
25 Participants
n=54 Participants
|
25 Participants
n=54 Participants
|
25 Participants
n=27 Participants
|
75 Participants
n=26 Participants
|
PRIMARY outcome
Timeframe: Week 28Population: All randomized participants who received at least 1 dose of study treatment, had non-missing values at both baseline and Week 28, and did not discontinue study or treatment prior to Week 28 due to study termination. Participants who did not receive treatment at Week 28 due to study discontinuation but had efficacy assessment were also included.
The SRI was a composite index used to assess clinical improvement in participants with SLE. The SRI-4 response evaluated global improvement, any significant worsening in unaffected organ systems, and improvements in disease activity, without compromise to the participant's overall condition. SRI-4 response was binary and either achieved or not achieved by the participant, thus there was no associated score. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of counts calculated as percentages was reported.
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received SC placebo Q2W.
|
MK-6194 3 mg Q2W
n=30 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=29 Participants
Participants received SC MK-6194 3 mg Q4W.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28
|
10 Participants
|
15 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 16 monthsPopulation: All randomized participants who received at least 1 dose of study treatment.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs were reported based on study treatment received by the participant at time of event. The number of participants who experienced one or more AEs was reported.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants received SC placebo Q2W.
|
MK-6194 3 mg Q2W
n=49 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=49 Participants
Participants received SC MK-6194 3 mg Q4W.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
n=2 Participants
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
n=4 Participants
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
n=2 Participants
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
n=4 Participants
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
35 Participants
|
38 Participants
|
38 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 16 monthsPopulation: All randomized participants who received at least 1 dose of study treatment.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs were reported based on study treatment received by the participant at time of event. The number of participants who discontinued study treatment due to an AE was reported.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants received SC placebo Q2W.
|
MK-6194 3 mg Q2W
n=49 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=49 Participants
Participants received SC MK-6194 3 mg Q4W.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
n=2 Participants
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
n=4 Participants
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
n=2 Participants
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
n=4 Participants
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an AE
|
1 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 28Population: All randomized participants who received at least 1 dose of study treatment, had non-missing values at both baseline and Week 28, and did not discontinue study or treatment prior to Week 28 due to study termination. Participants who did not receive treatment at Week 28 due to study discontinuation but had efficacy assessment were also included.
The BICLA response was a composite global measure of SLE disease activity. It distinguished between partial and complete improvement in all body systems. BICLA response was binary and either achieved or not achieved by the participant, thus there was no associated score. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of counts calculated as percentages was reported.
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received SC placebo Q2W.
|
MK-6194 3 mg Q2W
n=30 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=29 Participants
Participants received SC MK-6194 3 mg Q4W.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 28
|
6 Participants
|
12 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized participants who received at least 1 dose of study treatment, had non-missing values at both baseline and Week 52, and did not discontinue study or treatment prior to Week 52 due to study termination. Participants who did not receive treatment at Week 52 due to study discontinuation but had efficacy assessment were also included.
The SRI was a composite index used to assess clinical improvement in participants with SLE. The SRI-4 response evaluated global improvement, any significant worsening in unaffected organ systems, and improvements in disease activity, without compromise to the participant's overall condition. SRI-4 response was binary and either achieved or not achieved by the participant, thus there was no associated score. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of counts calculated as percentages was reported.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received SC placebo Q2W.
|
MK-6194 3 mg Q2W
n=14 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=14 Participants
Participants received SC MK-6194 3 mg Q4W.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Achieving SRI-4 Response at Week 52
|
4 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized participants who received at least 1 dose of study treatment, had non-missing values at both baseline and Week 52, and did not discontinue study or treatment prior to Week 52 due to study termination. Participants who did not receive treatment at Week 52 due to study discontinuation but had efficacy assessment were also included.
The BICLA response was a composite global measure of SLE disease activity. It distinguished between partial and complete improvement in all body systems. BICLA response was binary and either achieved or not achieved by the participant, thus there was no associated score. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of counts calculated as percentages was reported.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received SC placebo Q2W.
|
MK-6194 3 mg Q2W
n=14 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=14 Participants
Participants received SC MK-6194 3 mg Q4W.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Achieving BICLA Response at Week 52
|
4 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 28Population: All randomized participants who received at least 1 dose of study treatment, had non-missing values at both baseline and Week 28, and did not discontinue study or treatment prior to Week 28 due to study termination. Participants who did not receive treatment at Week 28 due to study discontinuation but had efficacy assessment were also included.
The CLASI-A score was used to evaluate lupus skin manifestations, with higher scores indicating increased disease severity and lower scores indicating less disease severity. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represented disease severity of mild, moderate, and severe, respectively. CLASI-50 was 50% improvement from baseline in the CLASI-A score. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of counts calculated as percentages was reported.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received SC placebo Q2W.
|
MK-6194 3 mg Q2W
n=8 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=6 Participants
Participants received SC MK-6194 3 mg Q4W.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50 Response at Week 28
|
0 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized participants who received at least 1 dose of study treatment, had non-missing values at both baseline and Week 52, and did not discontinue study or treatment prior to Week 52 due to study termination. Participants who did not receive treatment at Week 52 due to study discontinuation but had efficacy assessment were also included.
The CLASI-A score was used to evaluate lupus skin manifestations, with higher scores indicating increased disease severity and lower scores indicating less disease severity. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represented disease severity of mild, moderate, and severe, respectively. CLASI-50 was 50% improvement from baseline in the CLASI-A score. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of counts calculated as percentages was reported.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received SC placebo Q2W.
|
MK-6194 3 mg Q2W
n=4 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=2 Participants
Participants received SC MK-6194 3 mg Q4W.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With a CLASI-50 Response at Week 52
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 28Population: All randomized participants who received at least 1 dose of study treatment, had non-missing values at both baseline and Week 28, had ≥3 swollen joints, ≥3 tender joints, and ≥3 swollen and tender joints at baseline, and did not discontinue study or treatment prior to Week 28 due to study termination. Participants who did not receive treatment at Week 28 due to study discontinuation but had efficacy assessment were also included.
The joint count score was an evaluation of 28 joints in which joints were assessed for presence or absence of swelling. The number of affected joints could have ranged from 0 to 28; with higher values corresponding to higher disease activity and lower values to less disease activity. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of means and standard deviations was reported.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received SC placebo Q2W.
|
MK-6194 3 mg Q2W
n=22 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=20 Participants
Participants received SC MK-6194 3 mg Q4W.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Swollen Joint Count at Week 28
|
-5.6 Score on a scale
Standard Deviation 5.0
|
-6.9 Score on a scale
Standard Deviation 5.1
|
-7.4 Score on a scale
Standard Deviation 4.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: All randomized participants who received at least 1 dose of study treatment, had non-missing values at both baseline and Week 52, had ≥3 swollen joints, ≥3 tender joints, and ≥3 swollen and tender joints at baseline, and did not discontinue study or treatment prior to Week 52 due to study termination. Participants who did not receive treatment at Week 52 due to study discontinuation but had efficacy assessment were also included.
The joint count score was an evaluation of 28 joints in which joints were assessed for presence or absence of swelling. The number of affected joints could have ranged from 0 to 28; with higher values corresponding to higher disease activity and lower values to less disease activity. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of means and standard deviations was reported.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received SC placebo Q2W.
|
MK-6194 3 mg Q2W
n=4 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=5 Participants
Participants received SC MK-6194 3 mg Q4W.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Swollen Joint Count at Week 52
|
-5.9 Score on a scale
Standard Deviation 3.8
|
1.3 Score on a scale
Standard Deviation 11.3
|
-6.2 Score on a scale
Standard Deviation 3.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 28Population: All randomized participants who received at least 1 dose of study treatment, had non-missing values at both baseline and Week 28, had ≥3 swollen joints, ≥3 tender joints, and ≥3 swollen and tender joints at baseline, and did not discontinue study or treatment prior to Week 28 due to study termination. Participants who did not receive treatment at Week 28 due to study discontinuation but had efficacy assessment were also included.
The joint count score was an evaluation of 28 joints in which joints were assessed for presence or absence of tenderness. The number of affected joints could have ranged from 0 to 28; with higher values corresponding to higher disease activity and lower values to less disease activity. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of means and standard deviations was reported.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received SC placebo Q2W.
|
MK-6194 3 mg Q2W
n=22 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=20 Participants
Participants received SC MK-6194 3 mg Q4W.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Tender Joint Count at Week 28
|
-9.4 Score on a scale
Standard Deviation 6.7
|
-10.8 Score on a scale
Standard Deviation 7.9
|
-10.2 Score on a scale
Standard Deviation 6.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: All randomized participants who received at least 1 dose of study treatment, had non-missing values at both baseline and Week 52, had ≥3 swollen joints, ≥3 tender joints, and ≥3 swollen and tender joints at baseline, and did not discontinue study or treatment prior to Week 52 due to study termination. Participants who did not receive treatment at Week 52 due to study discontinuation but had efficacy assessment were also included.
The joint count score was an evaluation of 28 joints in which joints were assessed for presence or absence of tenderness. The number of affected joints could have ranged from 0 to 28; with higher values corresponding to higher disease activity and lower values to less disease activity. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of means and standard deviations was reported.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received SC placebo Q2W.
|
MK-6194 3 mg Q2W
n=4 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=5 Participants
Participants received SC MK-6194 3 mg Q4W.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Tender Joint Count at Week 52
|
-9.6 Score on a scale
Standard Deviation 6.7
|
-1.8 Score on a scale
Standard Deviation 7.9
|
-7.0 Score on a scale
Standard Deviation 3.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 28Population: All randomized participants who received at least 1 dose of study treatment, had non-missing values at both baseline and Week 28, had ≥3 swollen joints, ≥3 tender joints, and ≥3 swollen and tender joints at baseline, and did not discontinue study or treatment prior to Week 28 due to study termination. Participants who did not receive treatment at Week 28 due to study discontinuation but had efficacy assessment were also included.
The joint count score was an evaluation of 28 joints in which joints were assessed for presence or absence of swelling and presence or absence of tenderness. The number of affected joints could have ranged from 0 to 28; with higher values corresponding to higher disease activity and lower values to less disease activity. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of means and standard deviations was reported.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received SC placebo Q2W.
|
MK-6194 3 mg Q2W
n=22 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=20 Participants
Participants received SC MK-6194 3 mg Q4W.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Swollen and Tender Joint Count at Week 28
|
-5.6 Score on a scale
Standard Deviation 5.0
|
-6.9 Score on a scale
Standard Deviation 5.2
|
-7.4 Score on a scale
Standard Deviation 4.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: All randomized participants who received at least 1 dose of study treatment, had non-missing values at both baseline and Week 52, had ≥3 swollen joints, ≥3 tender joints, and ≥3 swollen and tender joints at baseline, and did not discontinue study or treatment prior to Week 52 due to study termination. Participants who did not receive treatment at Week 52 due to study discontinuation but had efficacy assessment were also included.
The joint count score was an evaluation of 28 joints in which joints were assessed for presence or absence of swelling and presence or absence of tenderness. The number of affected joints could have ranged from 0 to 28; with higher values corresponding to higher disease activity and lower values to less disease activity. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of means and standard deviations was reported.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received SC placebo Q2W.
|
MK-6194 3 mg Q2W
n=4 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=5 Participants
Participants received SC MK-6194 3 mg Q4W.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Swollen and Tender Joint Count at Week 52
|
-5.9 Score on a scale
Standard Deviation 3.8
|
1.3 Score on a scale
Standard Deviation 11.3
|
-6.6 Score on a scale
Standard Deviation 3.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 28Population: All randomized participants who received at least 1 dose of study treatment and completed Week 28 assessments.
Participants were assessed for corticosteroid dose change. Oral corticosteroid dose was based on prednisone or prednisone-equivalent dose. The oral corticosteroid dose at Week 28 was determined by the visit window of Week 28 (±7 days). Missing Week 28 dose was imputed with 0 if the participant completed Week 28 efficacy assessments. Oral corticosteroid doses as the weighted average of all doses taken at Week 28, weighted by the number of days each oral corticosteroid dose was administered was reported. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of means and standard deviations were reported.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants received SC placebo Q2W.
|
MK-6194 3 mg Q2W
n=22 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=22 Participants
Participants received SC MK-6194 3 mg Q4W.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Oral Corticosteroid Dose at Week 28
|
-4.2 mg
Standard Deviation 5.9
|
-3.5 mg
Standard Deviation 7.4
|
-5.2 mg
Standard Deviation 5.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: All randomized participants who received at least 1 dose of study treatment and completed Week 52 assessments.
Participants were assessed for corticosteroid dose change. Oral corticosteroid dose was based on prednisone or prednisone-equivalent dose. The oral corticosteroid dose at Week 52 was determined by the visit window of Week 52 (±7 days). Missing Week 52 dose was imputed with 0 if the participant completed Week 52 efficacy assessments. Oral corticosteroid doses as the weighted average of all doses taken at Week 52, weighted by the number of days each oral corticosteroid dose was administered was reported. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of means and standard deviations were reported.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants received SC placebo Q2W.
|
MK-6194 3 mg Q2W
n=5 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=5 Participants
Participants received SC MK-6194 3 mg Q4W.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Oral Corticosteroid Dose at Week 52
|
-8.3 mg
Standard Deviation 4.9
|
-5.5 mg
Standard Deviation 2.7
|
-8.5 mg
Standard Deviation 7.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 28 weeksPopulation: All randomized participants who received at least 1 dose of study treatment and completed Week 28 assessments.
Participants were assessed for cumulative oral corticosteroid dose. Oral corticosteroid dose was based on prednisone or prednisone-equivalent dose. The cumulative oral corticosteroid dose at Week 28, calculated from Week 0 (Day 1) to Week 28 was reported. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of means and standard deviations were reported.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants received SC placebo Q2W.
|
MK-6194 3 mg Q2W
n=22 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=22 Participants
Participants received SC MK-6194 3 mg Q4W.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Cumulative Oral Corticosteroid Use Between Week 0 and Week 28
|
1622.7 mg
Standard Deviation 822.0
|
1509.3 mg
Standard Deviation 947.4
|
1540.8 mg
Standard Deviation 758.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 52 weeksPopulation: All randomized participants who received at least 1 dose of study treatment and completed Week 52 assessments.
Participants were assessed for cumulative oral corticosteroid dose. Oral corticosteroid dose was based on prednisone or prednisone-equivalent dose. The cumulative oral corticosteroid dose at Week 52, calculated from Week 0 (Day 1) to Week 52 was reported. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of means and standard deviations were reported.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants received SC placebo Q2W.
|
MK-6194 3 mg Q2W
n=4 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=5 Participants
Participants received SC MK-6194 3 mg Q4W.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Cumulative Oral Corticosteroid Use Between Week 0 and Week 52
|
2047.5 mg
Standard Deviation 1089.3
|
1355.6 mg
Standard Deviation 919.4
|
2268.1 mg
Standard Deviation 710.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 28Population: All randomized participants who received at least 1 dose of study treatment, had non-missing values at both baseline and Week 28, and did not discontinue study or treatment prior to Week 28 due to study termination. Participants who did not receive treatment at Week 28 due to study discontinuation but had efficacy assessment were also included.
LLDAS was a low disease activity state associated with significant protection against flares and organ damage accrual. It included both the measurement of disease activity and maintenance of immunosuppressive medications. LLDAS response was defined as hybrid SLEDAI ≤4 (with no activity in major organ systems), no new features of SLE activity compared with previous assessment, physician's global assessment (PGA) ≤1.0, current prednisone (or equivalent) dose ≤7.5 mg daily, and well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents, excluding investigational drugs. LLDAS response was binary and was either achieved or not achieved by the participant, thus there was no associated score. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of counts calculated as percentages was reported.
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received SC placebo Q2W.
|
MK-6194 3 mg Q2W
n=30 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=29 Participants
Participants received SC MK-6194 3 mg Q4W.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Achieved Low Level of Disease Activity (LLDAS) at Week 28
|
2 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized participants who received at least 1 dose of study treatment, had non-missing values at both baseline and Week 52, and did not discontinue study or treatment prior to Week 52 due to study termination. Participants who did not receive treatment at Week 52 due to study discontinuation but had efficacy assessment were also included.
LLDAS was a low disease activity state associated with significant protection against flares and organ damage accrual. It included both the measurement of disease activity and maintenance of immunosuppressive medications. LLDAS response was defined as hybrid SLEDAI ≤4 (with no activity in major organ systems), no new features of SLE activity compared with previous assessment, physician's global assessment (PGA) ≤1.0, current prednisone (or equivalent) dose ≤7.5 mg daily, and well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents, excluding investigational drugs. LLDAS response was binary and was either achieved or not achieved by the participant, thus there was no associated score. Due to insufficient sample size, no statistical analysis was performed. Descriptive statistics in the form of counts calculated as percentages was reported.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received SC placebo Q2W.
|
MK-6194 3 mg Q2W
n=14 Participants
Participants received SC MK-6194 3 mg Q2W.
|
MK-6194 3 mg Q4W
n=14 Participants
Participants received SC MK-6194 3 mg Q4W.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Achieved LLDAS at Week 52
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
MK-6194 3 mg Q2W
Serious events: 5 serious events
Other events: 29 other events
Deaths: 0 deaths
MK-6194 3 mg Q4W
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 22 other events
Deaths: 1 deaths
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo (Main Study) / MK-6194 3 mg Q2W (Extension Period)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (Main Study) / MK-6194 3 mg Q4W (Extension Period)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-6194 3 mg Q2W
n=49 participants at risk
Participants received SC MK-6194 3 mg q2w.
|
MK-6194 3 mg Q4W
n=49 participants at risk
Participants received SC MK-6194 3 mg q4w.
|
Placebo
n=51 participants at risk
Participants received SC placebo q2w.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
n=2 participants at risk
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
n=4 participants at risk
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study) / MK-6194 3 mg Q2W (Extension Period)
n=2 participants at risk
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study) / MK-6194 3 mg Q4W (Extension Period)
n=4 participants at risk
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/51 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/49 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Infections and infestations
Bacteraemia
|
2.0%
1/49 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/51 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Infections and infestations
Gastroenteritis viral
|
2.0%
1/49 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Infections and infestations
Herpes zoster
|
2.0%
1/49 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/49 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/49 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/49 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/49 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Infections and infestations
Sepsis
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/51 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/49 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/51 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
2.0%
1/49 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
25.0%
1/4 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/51 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/49 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Vascular disorders
Distributive shock
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/51 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Vascular disorders
Peripheral vein thrombosis
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/51 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
Other adverse events
| Measure |
MK-6194 3 mg Q2W
n=49 participants at risk
Participants received SC MK-6194 3 mg q2w.
|
MK-6194 3 mg Q4W
n=49 participants at risk
Participants received SC MK-6194 3 mg q4w.
|
Placebo
n=51 participants at risk
Participants received SC placebo q2w.
|
MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
n=2 participants at risk
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continued to receive SC MK-6194 3 mg q2w in the extension period.
|
MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
n=4 participants at risk
After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continued to receive SC MK-6194 3 mg q4w in the extension period.
|
Placebo (Main Study) / MK-6194 3 mg Q2W (Extension Period)
n=2 participants at risk
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
|
Placebo (Main Study) / MK-6194 3 mg Q4W (Extension Period)
n=4 participants at risk
After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants were re-randomized to receive SC MK-6194 3 mg q4w in the extension period.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
3/49 • Number of events 5 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
4.1%
2/49 • Number of events 2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/51 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.1%
3/49 • Number of events 3 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
4.1%
2/49 • Number of events 2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
3.9%
2/51 • Number of events 2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Gastrointestinal disorders
Gastritis
|
8.2%
4/49 • Number of events 4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/49 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
3/49 • Number of events 6 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
General disorders
Fatigue
|
4.1%
2/49 • Number of events 3 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
3.9%
2/51 • Number of events 2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
25.0%
1/4 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
General disorders
Injection site erythema
|
12.2%
6/49 • Number of events 18 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
4.1%
2/49 • Number of events 2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
General disorders
Injection site pruritus
|
8.2%
4/49 • Number of events 9 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/49 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
General disorders
Injection site rash
|
4.1%
2/49 • Number of events 3 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
6.1%
3/49 • Number of events 3 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
General disorders
Injection site reaction
|
12.2%
6/49 • Number of events 6 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
4.1%
2/49 • Number of events 5 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
25.0%
1/4 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
10.2%
5/49 • Number of events 5 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/51 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Infections and infestations
Nasopharyngitis
|
4.1%
2/49 • Number of events 3 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
6.1%
3/49 • Number of events 4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
3.9%
2/51 • Number of events 2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Infections and infestations
Oral herpes
|
6.1%
3/49 • Number of events 3 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
5.9%
3/51 • Number of events 3 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.3%
8/49 • Number of events 9 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
10.2%
5/49 • Number of events 6 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
3.9%
2/51 • Number of events 2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Infections and infestations
Urinary tract infection
|
10.2%
5/49 • Number of events 7 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
4.1%
2/49 • Number of events 2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/51 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
6.1%
3/49 • Number of events 3 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
6.1%
3/49 • Number of events 4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
7.8%
4/51 • Number of events 4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
50.0%
1/2 • Number of events 2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
3/49 • Number of events 5 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
6.1%
3/49 • Number of events 5 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
7.8%
4/51 • Number of events 8 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.1%
3/49 • Number of events 4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Nervous system disorders
Headache
|
6.1%
3/49 • Number of events 3 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
12.2%
6/49 • Number of events 8 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
15.7%
8/51 • Number of events 15 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/49 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
3.9%
2/51 • Number of events 2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
25.0%
1/4 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.1%
3/49 • Number of events 3 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/49 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/51 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.1%
3/49 • Number of events 3 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/49 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
2.0%
1/51 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/49 • Number of events 1 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
6.1%
3/49 • Number of events 3 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
3.9%
2/51 • Number of events 2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/2 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
|
0.00%
0/4 • Up to approximately 19 months
The population for all-cause mortality included all randomized participants. The population for serious and nonserious AEs included all participants who received ≥1 dose of study treatment. AEs were reported based on study treatment received by the participant at time of event.
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Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER