Trial Outcomes & Findings for Safety and Efficacy of Nemolizumab in PN (NCT NCT03181503)
NCT ID: NCT03181503
Last Updated: 2020-02-19
Results Overview
Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?"; 2) For maximum itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach.
COMPLETED
PHASE2
70 participants
Baseline, Week 4
2020-02-19
Participant Flow
The study was conducted at 16 sites in 4 countries.
A total of 100 participants were screened, out of which 70 participants were randomized and treated (36 participants in Placebo and 34 participants in Nemolizumab group). Total 60 participants completed the study.
Participant milestones
| Measure |
Placebo
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) every 4 weeks (Q4W) (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
Participants received 3 subcutaneous injections of 0.5 milligram per kilogram (mg/kg) of nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
34
|
|
Overall Study
Treated
|
36
|
34
|
|
Overall Study
COMPLETED
|
29
|
31
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) every 4 weeks (Q4W) (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
Participants received 3 subcutaneous injections of 0.5 milligram per kilogram (mg/kg) of nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy of Nemolizumab in PN
Baseline characteristics by cohort
| Measure |
Placebo
n=36 Participants
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
n=34 Participants
Participants received 3 subcutaneous injections of 0.5 mg/kg nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 17.47 • n=99 Participants
|
59.7 years
STANDARD_DEVIATION 13.16 • n=107 Participants
|
56.0 years
STANDARD_DEVIATION 15.85 • n=206 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Presence or absence of background of atopy
Presence
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Presence or absence of background of atopy
Absence
|
30 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: Intent-to-treat (ITT) population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?"; 2) For maximum itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
n=33 Participants
Participants received 3 subcutaneous injections of 0.5 mg/kg nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) Score at Week 4 Using Last Observation Carried Forward (LOCF) Approach
|
-13.8 Percent change
Standard Deviation 16.10
|
-52.6 Percent change
Standard Deviation 33.96
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received.
Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?"; 2) For maximum itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Where, higher score indicated worst imaginable itch. Multiple imputation generated twenty-five sets of data with missing values imputed from observed data using linear regression.
Outcome measures
| Measure |
Placebo
n=36 Participants
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
n=34 Participants
Participants received 3 subcutaneous injections of 0.5 mg/kg nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Multiple Imputation (MI) Method
|
-18.3 Percent change
Standard Deviation 22.39
|
-52.0 Percent change
Standard Deviation 33.94
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?"; 2) For maximum itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Where, higher score indicated worst imaginable itch.
Outcome measures
| Measure |
Placebo
n=32 Participants
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
n=31 Participants
Participants received 3 subcutaneous injections of 0.5 mg/kg nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Observed Data
|
-15.2 Percent change
Standard Deviation 17.42
|
-54.9 Percent change
Standard Deviation 33.80
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18Population: ITT population included all randomized participants analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for each time point.
Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?"; 2) For maximum itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
n=33 Participants
Participants received 3 subcutaneous injections of 0.5 mg/kg nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 1
|
-6.1 percent change
Standard Deviation 11.45
|
-26.0 percent change
Standard Deviation 21.93
|
|
Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 2
|
-7.4 percent change
Standard Deviation 14.85
|
-41.7 percent change
Standard Deviation 30.31
|
|
Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 4
|
-13.8 percent change
Standard Deviation 16.10
|
-52.6 percent change
Standard Deviation 33.96
|
|
Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 12
|
-18.7 percent change
Standard Deviation 22.80
|
-61.8 percent change
Standard Deviation 34.95
|
|
Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 18
|
-21.7 percent change
Standard Deviation 22.95
|
-59.6 percent change
Standard Deviation 35.89
|
|
Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 8
|
-19.7 percent change
Standard Deviation 20.03
|
-56.5 percent change
Standard Deviation 34.73
|
|
Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 16
|
-20.8 percent change
Standard Deviation 22.29
|
-61.1 percent change
Standard Deviation 35.35
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18Population: ITT population included all randomized participants analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.
Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?"; 2) For maximum itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
n=33 Participants
Participants received 3 subcutaneous injections of 0.5 mg/kg nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
|---|---|---|
|
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 1
|
-0.5 Units on a scale
Standard Deviation 0.87
|
-2.1 Units on a scale
Standard Deviation 1.66
|
|
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 8
|
-1.6 Units on a scale
Standard Deviation 1.62
|
-4.7 Units on a scale
Standard Deviation 2.90
|
|
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 12
|
-1.5 Units on a scale
Standard Deviation 1.84
|
-5.1 Units on a scale
Standard Deviation 2.95
|
|
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 16
|
-1.7 Units on a scale
Standard Deviation 1.81
|
-5.1 Units on a scale
Standard Deviation 3.00
|
|
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 18
|
-1.8 Units on a scale
Standard Deviation 1.87
|
-4.9 Units on a scale
Standard Deviation 3.07
|
|
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 2
|
-0.6 Units on a scale
Standard Deviation 1.21
|
-3.4 Units on a scale
Standard Deviation 2.38
|
|
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 4
|
-1.2 Units on a scale
Standard Deviation 1.33
|
-4.3 Units on a scale
Standard Deviation 2.77
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for each time point.
Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?"; 2) For maximum itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
n=32 Participants
Participants received 3 subcutaneous injections of 0.5 mg/kg nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 1
|
-7.5 Percent change
Standard Deviation 12.82
|
-26.6 Percent change
Standard Deviation 21.25
|
|
Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 2
|
-9.6 Percent change
Standard Deviation 15.28
|
-44.0 Percent change
Standard Deviation 29.54
|
|
Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 8
|
-24.6 Percent change
Standard Deviation 23.38
|
-57.3 Percent change
Standard Deviation 34.78
|
|
Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 12
|
-23.0 Percent change
Standard Deviation 26.31
|
-62.6 Percent change
Standard Deviation 34.98
|
|
Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 16
|
-25.9 Percent change
Standard Deviation 24.89
|
-62.4 Percent change
Standard Deviation 35.93
|
|
Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 18
|
-26.2 Percent change
Standard Deviation 25.39
|
-60.4 Percent change
Standard Deviation 36.15
|
|
Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 4
|
-16.5 Percent change
Standard Deviation 18.25
|
-53.4 Percent change
Standard Deviation 33.23
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.
Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?"; 2) For maximum itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
n=32 Participants
Participants received 3 subcutaneous injections of 0.5 mg/kg nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
|---|---|---|
|
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 1
|
-0.5 Units on a scale
Standard Deviation 0.82
|
-1.9 Units on a scale
Standard Deviation 1.47
|
|
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 2
|
-0.8 Units on a scale
Standard Deviation 1.14
|
-3.2 Units on a scale
Standard Deviation 2.03
|
|
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 4
|
-1.3 Units on a scale
Standard Deviation 1.41
|
-3.9 Units on a scale
Standard Deviation 2.44
|
|
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 8
|
-1.9 Units on a scale
Standard Deviation 1.80
|
-4.2 Units on a scale
Standard Deviation 2.60
|
|
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 12
|
-1.8 Units on a scale
Standard Deviation 2.05
|
-4.6 Units on a scale
Standard Deviation 2.71
|
|
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 16
|
-2.0 Units on a scale
Standard Deviation 1.97
|
-4.6 Units on a scale
Standard Deviation 2.86
|
|
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Week 18
|
-2.1 Units on a scale
Standard Deviation 2.02
|
-4.5 Units on a scale
Standard Deviation 2.94
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.
VRS consists of a list of adjectives describing different levels of symptom intensity used by participants to report intensity of their pruritus (itch) over last 24 hours. Participants marked on a 5-point VRS (0=no itch, 1=mild itch, 2=moderate itch, 3=severe itch, 4=very severe itch), a response that best described their pruritus intensity in last 24 hours. Participants were asked following questions in their local language: 1) For average itch intensity: "on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your itch overall during previous 24 hours?"; 2) For maximum itch intensity: "on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your worst itch during previous 24 hours?". Where, higher score indicated very severe itch. Missing values including those who took rescue medication were replaced by LOCF approach.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
n=32 Participants
Participants received 3 subcutaneous injections of 0.5 mg/kg nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach
Week 1
|
-9.8 Percent change
Standard Deviation 14.24
|
-27.6 Percent change
Standard Deviation 17.21
|
|
Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach
Week 4
|
-15.6 Percent change
Standard Deviation 20.95
|
-50.7 Percent change
Standard Deviation 29.37
|
|
Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach
Week 8
|
-20.7 Percent change
Standard Deviation 21.22
|
-54.3 Percent change
Standard Deviation 30.61
|
|
Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach
Week 12
|
-19.4 Percent change
Standard Deviation 23.60
|
-56.9 Percent change
Standard Deviation 32.64
|
|
Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach
Week 16
|
-21.2 Percent change
Standard Deviation 22.24
|
-55.6 Percent change
Standard Deviation 34.48
|
|
Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach
Week 18
|
-23.0 Percent change
Standard Deviation 21.97
|
-53.4 Percent change
Standard Deviation 36.56
|
|
Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach
Week 2
|
-12.3 Percent change
Standard Deviation 17.64
|
-39.1 Percent change
Standard Deviation 25.38
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, 8, 12,16 and 18Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.
VRS consists of a list of adjectives describing different levels of symptom intensity used by participants to report intensity of their pruritus (itch) over last 24 hours. Participants marked on a 5-point VRS (0=no itch, 1=mild itch, 2=moderate itch, 3=severe itch, 4=very severe itch), a response that best described their pruritus intensity in last 24 hours. Participants were asked following questions in their local language: 1) For average itch intensity: "on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your itch overall during previous 24 hours?"; 2) For maximum itch intensity: "on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your worst itch during previous 24 hours?". Where, higher score indicated very severe itch. Missing values including those who took rescue medication were replaced by LOCF approach.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
n=32 Participants
Participants received 3 subcutaneous injections of 0.5 mg/kg nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
|---|---|---|
|
Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 1
|
-0.3 Units on a scale
Standard Deviation 0.47
|
-0.9 Units on a scale
Standard Deviation 0.57
|
|
Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 2
|
-0.4 Units on a scale
Standard Deviation 0.61
|
-1.3 Units on a scale
Standard Deviation 0.83
|
|
Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 4
|
-0.6 Units on a scale
Standard Deviation 0.74
|
-1.6 Units on a scale
Standard Deviation 1.00
|
|
Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 12
|
-0.7 Units on a scale
Standard Deviation 0.83
|
-1.8 Units on a scale
Standard Deviation 1.09
|
|
Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 16
|
-0.7 Units on a scale
Standard Deviation 0.78
|
-1.8 Units on a scale
Standard Deviation 1.16
|
|
Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 18
|
-0.8 Units on a scale
Standard Deviation 0.77
|
-1.7 Units on a scale
Standard Deviation 1.26
|
|
Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 8
|
-0.7 Units on a scale
Standard Deviation 0.74
|
-1.8 Units on a scale
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18Population: ITT population that included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.
VRS consists of a list of adjectives describing different levels of symptom intensity used by participants to report intensity of their pruritus (itch) over last 24 hours. Participants marked on a 5-point VRS (0=no itch, 1=mild itch, 2=moderate itch, 3=severe itch, 4=very severe itch), a response that best described their pruritus intensity in last 24 hours. Participants were asked following questions in their local language: 1) For average itch intensity: "on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your itch overall during previous 24 hours?"; 2) For maximum itch intensity: "on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your worst itch during previous 24 hours?". Where, higher score indicated very severe itch. Missing values including those who took rescue medication were replaced by LOCF approach.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
n=32 Participants
Participants received 3 subcutaneous injections of 0.5 mg/kg nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 1
|
-10.5 percent change
Standard Deviation 19.72
|
-29.6 percent change
Standard Deviation 16.90
|
|
Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 2
|
-13.0 percent change
Standard Deviation 19.20
|
-42.9 percent change
Standard Deviation 24.22
|
|
Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 4
|
-16.4 percent change
Standard Deviation 24.10
|
-52.1 percent change
Standard Deviation 27.63
|
|
Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 8
|
-23.5 percent change
Standard Deviation 22.89
|
-55.4 percent change
Standard Deviation 30.63
|
|
Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 12
|
-21.9 percent change
Standard Deviation 25.90
|
-62.1 percent change
Standard Deviation 29.98
|
|
Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 16
|
-25.1 percent change
Standard Deviation 24.15
|
-62.0 percent change
Standard Deviation 32.48
|
|
Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 18
|
-26.2 percent change
Standard Deviation 24.40
|
-58.7 percent change
Standard Deviation 34.81
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, 8, 12,16 and 18Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.
VRS consists of a list of adjectives describing different levels of symptom intensity used by participants to report intensity of their pruritus (itch) over last 24 hours. Participants marked on a 5-point VRS (0=no itch, 1=mild itch, 2=moderate itch, 3=severe itch, 4=very severe itch), a response that best described their pruritus intensity in last 24 hours. Participants were asked following questions in their local language: 1) For average itch intensity: "on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your itch overall during previous 24 hours?"; 2) For maximum itch intensity: "on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your worst itch during previous 24 hours?". Where, higher score indicated very severe itch. Missing values including those who took rescue medication were replaced by LOCF approach.
Outcome measures
| Measure |
Placebo
n=34 Participants
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
n=32 Participants
Participants received 3 subcutaneous injections of 0.5 mg/kg nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
|---|---|---|
|
Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 1
|
-0.4 Units on a scale
Standard Deviation 0.50
|
-0.9 Units on a scale
Standard Deviation 0.49
|
|
Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 2
|
-0.4 Units on a scale
Standard Deviation 0.61
|
-1.3 Units on a scale
Standard Deviation 0.68
|
|
Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 12
|
-0.7 Units on a scale
Standard Deviation 0.82
|
-1.9 Units on a scale
Standard Deviation 0.94
|
|
Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 16
|
-0.8 Units on a scale
Standard Deviation 0.78
|
-1.9 Units on a scale
Standard Deviation 1.06
|
|
Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 18
|
-0.8 Units on a scale
Standard Deviation 0.79
|
-1.8 Units on a scale
Standard Deviation 1.16
|
|
Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 4
|
-0.6 Units on a scale
Standard Deviation 0.73
|
-1.6 Units on a scale
Standard Deviation 0.84
|
|
Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach
Week 8
|
-0.7 Units on a scale
Standard Deviation 0.72
|
-1.7 Units on a scale
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: After 24, 48, 72 hours of first Injection and before second injection (Week 4)Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.
The 9-point DPS is a dynamic scale used by participants to evaluate the change of their pruritus compared with an earlier time point. The scale ranges from 0 (strongly worsened pruritus) to 8 (\[almost\] no pruritus anymore), including intermediate marks for slightly improved/worsened, moderately improved/worsened, and rather improved/worsened. Participants recorded their DPS score in their local language, and completed the assessment 24, 48 and 72 hours after the first injection at baseline and at week 4 before the second injection.
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
n=32 Participants
Participants received 3 subcutaneous injections of 0.5 mg/kg nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
|---|---|---|
|
Dynamic Pruritus Score (DPS) at 24, 48, and 72 Hours After First Injection and Before Second Injection (Week 4)
First injection, after 24 hours
|
4.3 Units on a scale
Standard Deviation 0.96
|
5.0 Units on a scale
Standard Deviation 1.20
|
|
Dynamic Pruritus Score (DPS) at 24, 48, and 72 Hours After First Injection and Before Second Injection (Week 4)
First injection, after 48 hours
|
4.0 Units on a scale
Standard Deviation 1.69
|
5.3 Units on a scale
Standard Deviation 1.40
|
|
Dynamic Pruritus Score (DPS) at 24, 48, and 72 Hours After First Injection and Before Second Injection (Week 4)
First injection, after 72 hours
|
4.0 Units on a scale
Standard Deviation 1.37
|
5.7 Units on a scale
Standard Deviation 1.34
|
|
Dynamic Pruritus Score (DPS) at 24, 48, and 72 Hours After First Injection and Before Second Injection (Week 4)
Before Second Injection (Week 4)
|
4.4 Units on a scale
Standard Deviation 1.07
|
6.3 Units on a scale
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received.
PAS includes 7-descriptive items; 1) lesions type (papules nodules/plaques/umbilicated ulcers/ulcers/hypo-/hyperpigmented maculae); 2) number (prurigo lesions on whole body); 3) distribution (disseminated/localized \[only 1/2 areas affected\]/neither of them); 4) affected areas (forearm/upper arm/lower and upper leg/trunk/head); 5) number of prurigo lesions in selected area; 6) activity (prurigo lesions with excoriations/crusts and healed prurigo lesions compared to all prurigo lesions) and 7) front and back, areas of marked monitor lesions to recognize on next visit.
Outcome measures
| Measure |
Placebo
n=36 Participants
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
n=34 Participants
Participants received 3 subcutaneous injections of 0.5 mg/kg nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
|---|---|---|
|
Prurigo Activity Score (PAS) Item 5: Overall Number of Prurigo Lesions at Week 12
Baseline
|
87.1 Prurigo Lesions
Standard Error 5.42
|
84.9 Prurigo Lesions
Standard Error 5.50
|
|
Prurigo Activity Score (PAS) Item 5: Overall Number of Prurigo Lesions at Week 12
Week 12
|
74.2 Prurigo Lesions
Standard Error 6.83
|
54.8 Prurigo Lesions
Standard Error 6.42
|
SECONDARY outcome
Timeframe: Day 1 (Baseline), Weeks 4, 8, 12 and 18Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here 'n' (number analyzed) signifies number of participants evaluable at each time point for specified category.
PAS includes 7-descriptive items; 1) lesions type (papules nodules/plaques/umbilicated ulcers/ulcers/hypo-/hyperpigmented maculae); 2) number (prurigo lesions on whole body); 3) distribution (disseminated/localized \[only 1/2 areas affected\]/neither of them); 4) affected areas (forearm/upper arm/lower and upper leg/trunk/head); 5) number of prurigo lesions in selected area; 6) activity (prurigo lesions with excoriations/crusts and healed prurigo lesions compared to all prurigo lesions) and 7) front and back, areas of marked monitor lesions to recognize on next visit. Item 6 has 5 stages (0-4) where each stage represents percentage of prurigo lesions with excoriations/crusts and healed prurigo lesions compared to all prurigo lesions: excoriations/crusts lesions; stage 0=0%, 1=1-25%, 2=26-50%, 3=51-75%, 4=76-100%; for healed lesions; stage 0=100%, 1=75-99%, 2=50-74%, 3=25-49%, 4=0-24%.
Outcome measures
| Measure |
Placebo
n=36 Participants
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
n=34 Participants
Participants received 3 subcutaneous injections of 0.5 mg/kg nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
|---|---|---|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Week 12: Stage 1
|
2 Participants
|
9 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Week 12: Stage 2
|
7 Participants
|
16 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Day 1: Stage 0
|
0 Participants
|
0 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Day 1: Stage 1
|
2 Participants
|
4 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Day 1: Stage 2
|
7 Participants
|
5 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Day 1: Stage 3
|
14 Participants
|
12 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Day 1: Stage 4
|
13 Participants
|
13 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Week 4: Stage 0
|
2 Participants
|
2 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Week 4: Stage 1
|
6 Participants
|
10 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Week 4: Stage 2
|
7 Participants
|
9 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Week 4: Stage 3
|
10 Participants
|
9 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Week 4: Stage 4
|
9 Participants
|
3 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Week 8: Stage 0
|
2 Participants
|
4 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Week 8: Stage 1
|
5 Participants
|
13 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Week 8: Stage 2
|
7 Participants
|
6 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Week 8: Stage 3
|
11 Participants
|
9 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Week 8: Stage 4
|
7 Participants
|
0 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/CrustsWeek 12: Stage 0
|
1 Participants
|
3 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Week 12: Stage 1
|
7 Participants
|
17 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Week 12: Stage 2
|
5 Participants
|
9 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Week 12: Stage 3
|
12 Participants
|
3 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Week 12: Stage 4
|
5 Participants
|
0 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Week 18: Stage 0
|
1 Participants
|
6 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Week 18: Stage 1
|
4 Participants
|
12 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Week 18: Stage 3
|
11 Participants
|
5 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Week 18: Stage 4
|
6 Participants
|
4 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Day 1: Stage 0
|
1 Participants
|
0 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Day 1: Stage 1
|
0 Participants
|
1 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Day 1: Stage 2
|
3 Participants
|
5 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Day 1: Stage 3
|
13 Participants
|
9 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Week 4: Stage 0
|
2 Participants
|
3 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Week 4: Stage 2
|
6 Participants
|
5 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Week 8: Stage 1
|
3 Participants
|
8 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Week 8: Stage 2
|
7 Participants
|
8 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Week 8: Stage 4
|
11 Participants
|
1 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Week 12: Stage 0
|
1 Participants
|
2 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Week 12: Stage 3
|
8 Participants
|
5 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Excoriation/Crusts: Week 18: Stage 2
|
8 Participants
|
4 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Day 1: Stage 4
|
19 Participants
|
19 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Week 4: Stage 1
|
2 Participants
|
5 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Week 4: Stage 3
|
11 Participants
|
14 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Week 4: Stage 4
|
13 Participants
|
6 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Week 8: Stage 0
|
2 Participants
|
3 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Week 8: Stage 3
|
9 Participants
|
12 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Week 12: Stage 4
|
12 Participants
|
0 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Week 18: Stage 0
|
1 Participants
|
3 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Week 18: Stage 1
|
2 Participants
|
12 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Week 18: Stage 2
|
7 Participants
|
7 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Week 18: Stage 3
|
8 Participants
|
5 Participants
|
|
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
Healed Lesions: Week 18: Stage 4
|
12 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline), Weeks 4, 8, 12 and 18Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here, 'n' (number analyzed) signifies number of participants evaluable for each time point.
IGA is a 5-point scale used by the investigator or trained designee to evaluate the severity of the disease ranging from 0 to 4 where, 0 = clear, 1= almost clear, 2 = mild, 3 = moderate and 4 severe. IGA corresponds to the overall assessment of the severity of prurigo including presence of crust and nodules or skin bleeding. Higher score indicated greater severity of disease.
Outcome measures
| Measure |
Placebo
n=36 Participants
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
n=34 Participants
Participants received 3 subcutaneous injections of 0.5 mg/kg nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
|---|---|---|
|
Investigator Global Assessment (IGA) Score at Each Visit
Week 8
|
3.1 Units on a scale
Standard Deviation 0.67
|
2.4 Units on a scale
Standard Deviation 0.80
|
|
Investigator Global Assessment (IGA) Score at Each Visit
Week 12
|
2.8 Units on a scale
Standard Deviation 0.82
|
2.0 Units on a scale
Standard Deviation 0.80
|
|
Investigator Global Assessment (IGA) Score at Each Visit
Day 1 (Baseline)
|
3.4 Units on a scale
Standard Deviation 0.49
|
3.5 Units on a scale
Standard Deviation 0.51
|
|
Investigator Global Assessment (IGA) Score at Each Visit
Week 4
|
3.3 Units on a scale
Standard Deviation 0.61
|
2.8 Units on a scale
Standard Deviation 0.81
|
|
Investigator Global Assessment (IGA) Score at Each Visit
Week 18
|
3.0 Units on a scale
Standard Deviation 0.93
|
2.0 Units on a scale
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: Week 12Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received.
IGA is a 5-point scale used by the investigator or trained designee to evaluate the severity of the disease ranging from 0 to 4 where, 0 = clear, 1= almost clear, 2 = mild, 3 = moderate and 4 severe. IGA corresponds to the overall assessment of the severity of prurigo including presence of crust and nodules or skin bleeding. Higher score indicated greater severity of disease.
Outcome measures
| Measure |
Placebo
n=36 Participants
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
n=34 Participants
Participants received 3 subcutaneous injections of 0.5 mg/kg nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Investigator Global Assessment Success (Defined as IGA= 0 [Clear] or IGA = 1 [Almost Clear] With Two-point Improvement From Baseline) at Week 12
|
2.8 percentage of participants
|
20.6 percentage of participants
|
Adverse Events
Placebo
Nemolizumab 0.5 mg/kg
Serious adverse events
| Measure |
Placebo
n=36 participants at risk
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W for 12 weeks (Baseline, Week 4 and Week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
n=34 participants at risk
Participants received 3 subcutaneous injections of nemolizumab 0.5 mg/kg Q4W for 12 weeks (Baseline, Week 4 and Week 8). Participants were further followed up for 6 weeks.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
8.3%
3/36 • Up to 18 Weeks
|
0.00%
0/34 • Up to 18 Weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis Psoriasiform
|
0.00%
0/36 • Up to 18 Weeks
|
2.9%
1/34 • Up to 18 Weeks
|
|
Skin and subcutaneous tissue disorders
Eczema Nummular
|
0.00%
0/36 • Up to 18 Weeks
|
2.9%
1/34 • Up to 18 Weeks
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.00%
0/36 • Up to 18 Weeks
|
2.9%
1/34 • Up to 18 Weeks
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
2.8%
1/36 • Up to 18 Weeks
|
0.00%
0/34 • Up to 18 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.8%
1/36 • Up to 18 Weeks
|
0.00%
0/34 • Up to 18 Weeks
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/36 • Up to 18 Weeks
|
2.9%
1/34 • Up to 18 Weeks
|
|
Renal and urinary disorders
Calculus Bladder
|
0.00%
0/36 • Up to 18 Weeks
|
2.9%
1/34 • Up to 18 Weeks
|
Other adverse events
| Measure |
Placebo
n=36 participants at risk
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W for 12 weeks (Baseline, Week 4 and Week 8). Participants were further followed up for 6 weeks.
|
Nemolizumab 0.5 mg/kg
n=34 participants at risk
Participants received 3 subcutaneous injections of nemolizumab 0.5 mg/kg Q4W for 12 weeks (Baseline, Week 4 and Week 8). Participants were further followed up for 6 weeks.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
11.1%
4/36 • Up to 18 Weeks
|
14.7%
5/34 • Up to 18 Weeks
|
|
Infections and infestations
Conjunctivitis
|
5.6%
2/36 • Up to 18 Weeks
|
8.8%
3/34 • Up to 18 Weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/36 • Up to 18 Weeks
|
5.9%
2/34 • Up to 18 Weeks
|
|
Infections and infestations
Cystitis
|
5.6%
2/36 • Up to 18 Weeks
|
0.00%
0/34 • Up to 18 Weeks
|
|
Infections and infestations
Postoperative Wound Infection
|
5.6%
2/36 • Up to 18 Weeks
|
0.00%
0/34 • Up to 18 Weeks
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
13.9%
5/36 • Up to 18 Weeks
|
5.9%
2/34 • Up to 18 Weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.00%
0/36 • Up to 18 Weeks
|
8.8%
3/34 • Up to 18 Weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
2/36 • Up to 18 Weeks
|
0.00%
0/34 • Up to 18 Weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/36 • Up to 18 Weeks
|
5.9%
2/34 • Up to 18 Weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
2/36 • Up to 18 Weeks
|
0.00%
0/34 • Up to 18 Weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/36 • Up to 18 Weeks
|
5.9%
2/34 • Up to 18 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/36 • Up to 18 Weeks
|
5.9%
2/34 • Up to 18 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
2/36 • Up to 18 Weeks
|
2.9%
1/34 • Up to 18 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
2/36 • Up to 18 Weeks
|
0.00%
0/34 • Up to 18 Weeks
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/36 • Up to 18 Weeks
|
5.9%
2/34 • Up to 18 Weeks
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.00%
0/36 • Up to 18 Weeks
|
5.9%
2/34 • Up to 18 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place