Trial Outcomes & Findings for Study to Access the Relative Bioavailability of Subcutaneous Dose of Nemolizumab When Administered Via Auto-Injector Versus Dual-Chamber Syringe (NCT NCT05405985)
NCT ID: NCT05405985
Last Updated: 2025-01-03
Results Overview
Cmax was defined as the observed maximum serum concentration of nemolizumab. Cmax was used to measure the rate of absorption of nemolizumab.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
192 participants
Primary outcome timeframe
Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose
Results posted on
2025-01-03
Participant Flow
The study was conducted at 2 sites in United States from 11 August 2022 to 08 December 2022.
A total of 192 participants were randomized in two treatment group. 96 participants received nemolizumab with auto-injector (AI) and remaining 96 participants received nemolizumab with dual chamber syringe (DCS).
Participant milestones
| Measure |
Nemolizumab With Auto-Injector (AI)
Participants received a 60 milligrams (mg) dose of nemolizumab as 2 successive subcutaneous (SC) injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 centimeters \[cm\]) apart with AI on Day 0 (injection day).
|
Nemolizumab With Dual Chamber Syringe (DCS)
Participants received a 60-mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with DCS on Day 0 (injection day).
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
96
|
|
Overall Study
COMPLETED
|
95
|
96
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Nemolizumab With Auto-Injector (AI)
Participants received a 60 milligrams (mg) dose of nemolizumab as 2 successive subcutaneous (SC) injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 centimeters \[cm\]) apart with AI on Day 0 (injection day).
|
Nemolizumab With Dual Chamber Syringe (DCS)
Participants received a 60-mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with DCS on Day 0 (injection day).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Study to Access the Relative Bioavailability of Subcutaneous Dose of Nemolizumab When Administered Via Auto-Injector Versus Dual-Chamber Syringe
Baseline characteristics by cohort
| Measure |
Nemolizumab With AI
n=96 Participants
Participants received a 60 mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with AI on Day 0 (injection day).
|
Nemolizumab With DCS
n=96 Participants
Participants received a 60-mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with DCS on Day 0 (injection day).
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 11.71 • n=5 Participants
|
42.1 years
STANDARD_DEVIATION 12.52 • n=7 Participants
|
41.5 years
STANDARD_DEVIATION 12.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
53 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dosePopulation: Analysis was performed on pharmacokinetics (PK) population which included all randomized participants who received the dose of nemolizumab and provided evaluable data that can be used for the PK analyses.
Cmax was defined as the observed maximum serum concentration of nemolizumab. Cmax was used to measure the rate of absorption of nemolizumab.
Outcome measures
| Measure |
Nemolizumab With AI
n=96 Participants
Participants received a 60 mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with AI on Day 0 (injection day).
|
Nemolizumab With DCS
n=96 Participants
Participants received a 60-mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with DCS on Day 0 (injection day).
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Nemolizumab
|
8.00 micrograms per milliliter (mcg/mL)
Standard Deviation 2.34
|
7.51 micrograms per milliliter (mcg/mL)
Standard Deviation 2.31
|
PRIMARY outcome
Timeframe: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dosePopulation: Analysis was performed on PK population which included all randomized participants who received the dose of nemolizumab and provided evaluable data that can be used for the PK analyses. Here, 'overall number of participants analyzed, N' signifies participants who were evaluable for this outcome measure.
AUC0-inf was defined as area under the plasma concentration-time curve from time 0 to infinity according to the equation: AUC0-inf = AUClast + Clast/λz; where λz = slope of the regression line of the terminal phase of the plasma concentration versus time curve, in semi-logarithmic scale; and Clast = last measurable drug concentration.
Outcome measures
| Measure |
Nemolizumab With AI
n=95 Participants
Participants received a 60 mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with AI on Day 0 (injection day).
|
Nemolizumab With DCS
n=96 Participants
Participants received a 60-mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with DCS on Day 0 (injection day).
|
|---|---|---|
|
Area Under Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Nemolizumab
|
270 micrograms*day per milliliter
Standard Deviation 85.8
|
279 micrograms*day per milliliter
Standard Deviation 89.7
|
SECONDARY outcome
Timeframe: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22 and 29 post-dosePopulation: Analysis was performed on PK population which included all randomized participants who received the dose of nemolizumab and provided evaluable data that can be used for the PK analyses. Here, 'overall number of participants analyzed, N' signifies participants who were evaluable for this outcome measure.
AUC0-4 weeks was defined as area under the concentration-time curve from time 0 to 4 weeks after study drug administration calculated with the linear trapezoidal method.
Outcome measures
| Measure |
Nemolizumab With AI
n=95 Participants
Participants received a 60 mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with AI on Day 0 (injection day).
|
Nemolizumab With DCS
n=96 Participants
Participants received a 60-mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with DCS on Day 0 (injection day).
|
|---|---|---|
|
Area Under the Concentration-time Curve Over the Specified Interval (AUC0-4 Weeks) of Nemolizumab
|
157 micrograms*day per milliliter
Standard Deviation 37.9
|
155 micrograms*day per milliliter
Standard Deviation 39.8
|
SECONDARY outcome
Timeframe: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dosePopulation: Analysis was performed on PK population which included all randomized participants who received the dose of nemolizumab and provided evaluable data that can be used for the PK analyses.
AUC0-last was defined as area under the concentration-time curve from administration to the last observed concentration time t, calculated with the linear trapezoidal method.
Outcome measures
| Measure |
Nemolizumab With AI
n=96 Participants
Participants received a 60 mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with AI on Day 0 (injection day).
|
Nemolizumab With DCS
n=96 Participants
Participants received a 60-mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with DCS on Day 0 (injection day).
|
|---|---|---|
|
Area Under Concentration-time Curve From Administration to the Last Observed Concentration Time t (AUC0-last) of Nemolizumab
|
250 micrograms*day per milliliter
Standard Deviation 73.6
|
260 micrograms*day per milliliter
Standard Deviation 75.4
|
SECONDARY outcome
Timeframe: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dosePopulation: Analysis was performed on PK population which included all randomized participants who received the dose of nemolizumab and provided evaluable data that can be used for the PK analyses.
Tmax was defined as the time taken to reach the maximum observed serum concentration.
Outcome measures
| Measure |
Nemolizumab With AI
n=96 Participants
Participants received a 60 mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with AI on Day 0 (injection day).
|
Nemolizumab With DCS
n=96 Participants
Participants received a 60-mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with DCS on Day 0 (injection day).
|
|---|---|---|
|
Time to Reach Maximum Observed Serum Concentration (Tmax) of Nemolizumab
|
4.99 days
Interval 1.0 to 21.99
|
5.99 days
Interval 1.0 to 22.0
|
SECONDARY outcome
Timeframe: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dosePopulation: Analysis was performed on PK population which included all randomized participants who received the dose of nemolizumab and provided evaluable data that can be used for the PK analyses. Here, 'overall number of participants analyzed, N' signifies participants who were evaluable for this outcome measure.
t1/2 is defined as time required for the concentration of the drug to reach half of its original value.
Outcome measures
| Measure |
Nemolizumab With AI
n=95 Participants
Participants received a 60 mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with AI on Day 0 (injection day).
|
Nemolizumab With DCS
n=96 Participants
Participants received a 60-mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with DCS on Day 0 (injection day).
|
|---|---|---|
|
Half-life (t1/2) of Nemolizumab
|
18.0 days
Standard Deviation 5.91
|
18.5 days
Standard Deviation 4.52
|
SECONDARY outcome
Timeframe: Pre-dose, Day 29 and 85 post-dosePopulation: Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data. Here, 'overall number of participants analyzed, N' signifies participants who were evaluable for this outcome measure.
ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result.
Outcome measures
| Measure |
Nemolizumab With AI
n=95 Participants
Participants received a 60 mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with AI on Day 0 (injection day).
|
Nemolizumab With DCS
n=96 Participants
Participants received a 60-mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with DCS on Day 0 (injection day).
|
|---|---|---|
|
Number of Participants With Positive Anti-drug Antibodies (ADA) Response Against Nemolizumab
Day 85: ADA positive
|
2 Participants
|
8 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies (ADA) Response Against Nemolizumab
Pre-dose: ADA postive
|
6 Participants
|
8 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies (ADA) Response Against Nemolizumab
Day 29: ADA positive
|
2 Participants
|
4 Participants
|
Adverse Events
Nemolizumab With AI
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Nemolizumab With DCS
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nemolizumab With AI
n=96 participants at risk
Participants received a 60 mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with AI on Day 0.
|
Nemolizumab With DCS
n=96 participants at risk
Participants received a 60-mg dose of nemolizumab as 2 successive SC injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with DCS on Day 0.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
2.1%
2/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Eye disorders
Conjunctival hyperaemia
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Eye disorders
Eye irritation
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Eye disorders
Ocular discomfort
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Gastrointestinal disorders
Lip pruritus
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
2/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
4.2%
4/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Gastrointestinal disorders
Palatal disorder
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Gastrointestinal disorders
Toothache
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
General disorders
Asthenia
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
General disorders
Chills
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
General disorders
Hunger
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
General disorders
Injection site bruising
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
2.1%
2/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
General disorders
Injection site erythema
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
General disorders
Injection site pain
|
2.1%
2/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
General disorders
Injection site pruritus
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
General disorders
Injection site reaction
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
General disorders
Nodule
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
General disorders
Pain
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
General disorders
Peripheral swelling
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
General disorders
Procedural failure
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
General disorders
Vaccination site pain
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Infections and infestations
COVID-19
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
2.1%
2/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Infections and infestations
Viral infection
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
3.1%
3/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.1%
2/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Investigations
Bacterial test
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Investigations
Blood pressure increased
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Investigations
Heart rate increased
|
2.1%
2/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Investigations
Weight decreased
|
2.1%
2/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Investigations
Weight increased
|
7.3%
7/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
5.2%
5/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
2.1%
2/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Metabolism and nutrition disorders
Increased appetite
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
3.1%
3/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
5.2%
5/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
2.1%
2/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
2.1%
2/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Nervous system disorders
Dizziness
|
2.1%
2/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Nervous system disorders
Headache
|
8.3%
8/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
22.9%
22/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Nervous system disorders
Migraine
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Nervous system disorders
Paraesthesia
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Nervous system disorders
Sensory disturbance
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Nervous system disorders
Somnolence
|
2.1%
2/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Psychiatric disorders
Procedural anxiety
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Renal and urinary disorders
Dysuria
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.1%
2/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.1%
2/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
2.1%
2/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.1%
3/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Skin and subcutaneous tissue disorders
Papule
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
4.2%
4/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
5.2%
5/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
2.1%
2/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
2.1%
2/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Skin and subcutaneous tissue disorders
Scab
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
1.0%
1/96 • From Baseline up to Week 12
Analysis was performed on safety population that included all randomized participants who received the single dose of nemolizumab and was the primary population for all safety data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place