Trial Outcomes & Findings for A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD) (NCT NCT03921411)
NCT ID: NCT03921411
Last Updated: 2023-04-21
Results Overview
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
COMPLETED
PHASE2
20 participants
At week 1-2
2023-04-21
Participant Flow
A total of 31 participants were screened, of which 20 were enrolled and 18 participants were treated with study drug.
Participant milestones
| Measure |
Nemolizumab
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Overall Study
STARTED
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20
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Overall Study
Treated
|
18
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Overall Study
COMPLETED
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15
|
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Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Nemolizumab
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Overall Study
Protocol Deviation
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2
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|
Overall Study
Enrolled, but never treated
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2
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Baseline Characteristics
A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD)
Baseline characteristics by cohort
| Measure |
Nemolizumab
n=20 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Age, Continuous
|
14.8 Years
STANDARD_DEVIATION 1.59 • n=5 Participants
|
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Sex: Female, Male
Female
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12 Participants
n=5 Participants
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Sex: Female, Male
Male
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8 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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4 Participants
n=5 Participants
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|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
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2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
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10 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
White
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7 Participants
n=5 Participants
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Race/Ethnicity, Customized
Other: Hispanic
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1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At week 1-2Population: The pharmacokinetic (PK) population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Nemolizumab
n=17 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Nemolizumab Serum Concentrations at Week 1-2
|
6478.8 nanogram per milliliter (ng/mL)
Standard Deviation 2393.11
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PRIMARY outcome
Timeframe: At week 4Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Nemolizumab
n=17 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Nemolizumab Serum Concentrations at Week 4
|
2935.3 ng/mL
Standard Deviation 1029.41
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PRIMARY outcome
Timeframe: At week 8Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Nemolizumab
n=15 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Nemolizumab Serum Concentrations at Week 8
|
3292.3 ng/mL
Standard Deviation 2017.83
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PRIMARY outcome
Timeframe: At week 12Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Nemolizumab
n=14 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Nemolizumab Serum Concentrations at Week 12
|
3221.6 ng/mL
Standard Deviation 1781.15
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PRIMARY outcome
Timeframe: At week 16Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Nemolizumab
n=13 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Nemolizumab Serum Concentrations at Week 16
|
3010.0 ng/mL
Standard Deviation 1131.81
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PRIMARY outcome
Timeframe: At week 24Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Nemolizumab
n=8 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Nemolizumab Serum Concentrations at Week 24
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473.9 ng/mL
Standard Deviation 333.72
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PRIMARY outcome
Timeframe: Baseline to week 24Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value.
CL/F is apparent clearance of the drug from the serum, calculated as the drug dose divided area under the curve from time 0 extrapolated to infinite time \[AUC (0-inf)\].
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Apparent Clearance After Extravascular Administration (Cl/F) of Nemolizumab
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0.325 liter/day (L/day)
Standard Deviation 0.153
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PRIMARY outcome
Timeframe: Baseline to week 24Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Vd/F was calculated as dose divided by lambda\_z \*AUC(0-inf).
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Apparent Volume of Distribution After Extravascular Administration (Vd/F) of Nemolizumab
|
7.15 liter
Standard Deviation 2.24
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PRIMARY outcome
Timeframe: Baseline to week 24Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Lag time is defined as the time taken for a drug to appear in the systemic circulation following administration. The population Tlag value was estimated for the overall population and was reported in this endpoint.
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Population Lag Time (Tlag)
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1.0728 hours
Standard Deviation 0
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PRIMARY outcome
Timeframe: Baseline to week 24Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value
PK of Nemolizumab was evaluated in participants using Ka using PK samples collected on Weeks 1-2, 4, 8, 12, 16 and 24. Ka was evaluated by population PK (popPK) methods and mean and standard from the model has been tabulated.
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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First Order Constant of Absorption (ka)
|
0.402 1/day
Standard Deviation 0.145
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PRIMARY outcome
Timeframe: Baseline to week 12Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value.
Cmax was obtained from serum concentration time curve.
Outcome measures
| Measure |
Nemolizumab
n=12 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Maximum Observed Serum Concentration (Cmax) of Nemolizumab
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5975.5 ng/mL
Standard Deviation 2175.2
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PRIMARY outcome
Timeframe: Baseline to week 12Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value.
Time to reach maximum observed serum concentration (Tmax) for Nemolizumab was derived from serum concentrations versus time data.
Outcome measures
| Measure |
Nemolizumab
n=12 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Time to Reach Maximum Observed Serum Concentration (Tmax) of Nemolizumab
|
5.862 days
Standard Deviation 1.669
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PRIMARY outcome
Timeframe: At week 4Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Ctrough is the concentration prior to study drug administration.
Outcome measures
| Measure |
Nemolizumab
n=17 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Trough Serum Concentration (Ctrough) of Nemolizumab at Week 4
|
3271.859 ng/mL
Standard Deviation 1268.612
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PRIMARY outcome
Timeframe: At week 8Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Ctrough is the concentration prior to study drug administration.
Outcome measures
| Measure |
Nemolizumab
n=14 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Trough Serum Concentration (Ctrough) of Nemolizumab at Week 8
|
3056.496 ng/mL
Standard Deviation 1367.884
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PRIMARY outcome
Timeframe: At week 12Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Ctrough is the concentration prior to study drug administration.
Outcome measures
| Measure |
Nemolizumab
n=14 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
|
Trough Serum Concentration (Ctrough) of Nemolizumab at Week 12
|
2886.796 ng/mL
Standard Deviation 1441.998
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PRIMARY outcome
Timeframe: At week 16Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Ctrough is the concentration prior to study drug administration.
Outcome measures
| Measure |
Nemolizumab
n=12 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Trough Serum Concentration (Ctrough) of Nemolizumab at Week 16
|
2981.792 ng/mL
Standard Deviation 1166.871
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PRIMARY outcome
Timeframe: Pre-dose through 4 weeks post-dosePopulation: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Area under the drug concentration-time curve from 0 to 4 week post dosing for Nemolizumab. AUC(0-4w) was calculated according to the mixed log-linear trapezoidal rule.
Outcome measures
| Measure |
Nemolizumab
n=17 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Area Under the Serum Concentration-Time Curve From Zero to 4 Week Post-dose (AUC0-4w)
|
144046.235 nanogram*day per milliliter (ng*day/mL)
Standard Deviation 50800.805
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PRIMARY outcome
Timeframe: Pre-dose through 8 weeks post-dosePopulation: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Area under the drug concentration-time curve from 0 to 8 week post dosing for Nemolizumab. AUC(0-8w) was calculated according to the mixed log-linear trapezoidal rule.
Outcome measures
| Measure |
Nemolizumab
n=14 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Area Under the Serum Concentration-Time Curve From Time Zero to 8 Week Post-dose (AUC0-8w)
|
284397.143 ng*day/mL
Standard Deviation 97105.285
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PRIMARY outcome
Timeframe: Pre-dose through 12 week post-dosePopulation: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Area under the drug concentration-time curve from 0 to 12 week post dosing for Nemolizumab. AUC(0-12w) was calculated according to the mixed log-linear trapezoidal rule.
Outcome measures
| Measure |
Nemolizumab
n=14 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Area Under the Serum Concentration-Time Curve From Time Zero to 12 Week Post-dose (AUC0-12w)
|
411707.857 ng*day/mL
Standard Deviation 142851.408
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PRIMARY outcome
Timeframe: Pre-dose through 16 weeks post-dosePopulation: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Area under the drug concentration-time curve from 0 to 16 week post dosing for Nemolizumab. AUC(0-16w) was calculated according to the mixed log-linear trapezoidal rule.
Outcome measures
| Measure |
Nemolizumab
n=12 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
|
Area Under the Serum Concentration-Time Curve From Time Zero to 16 Week Post-dose (AUC0-16w)
|
549489.167 ng*day/mL
Standard Deviation 184483.765
|
PRIMARY outcome
Timeframe: Baseline to week 24Population: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value.
Apparent Terminal Half-life (t1/2) is the time required for a given drug concentration in the serum to decrease by 50%.
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
|
Apparent Terminal Half-life (t1/2)
|
16.666 day
Standard Deviation 4.115
|
PRIMARY outcome
Timeframe: At week 4Population: The Safety population included all participants in ITT population who were administered at least 1 dose of study medication.
Antidrug antibodies were determined using a validated enzyme-linked immunosorbent assay (ELISA) assay. Number of participants with positive ADA in Serum were reported.
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Number of Participants With Treatment-Related Positive Anti-Drug Antibodies (ADA) in Serum at Week 4
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 24Population: The safety population included all participants in the ITT who were administered at least 1 dose of study medication.
The number of participants with neutralizing antibodies response at time of baseline up to week 24 has been presented. Neutralizing antibodies response assay result have been only presented for participants with positive anti-drug antibody assay.
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Number of Participants With Neutralizing Antibodies
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline through week 24Population: The Safety population included all participants in the ITT who were administered at least 1 dose of study medication.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAE was defined as AEs starting/worsening after first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs. An AESI is a noteworthy event for study drug that should be monitored closely and reported immediately. The following AEs will be considered AESIs: Anaphylactic reactions, Acute allergic reactions requiring treatment, Severe injection site reaction, Newly-diagnosed asthma or worsening of asthma, Peripheral edema: limbs, bilateral and Facial edema.
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Adverse Event of Special Interests (AESI) and Serious Adverse Events (SAEs)
TEAEs
|
6 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Adverse Event of Special Interests (AESI) and Serious Adverse Events (SAEs)
TE-AESIs
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Adverse Event of Special Interests (AESI) and Serious Adverse Events (SAEs)
SAEs
|
2 Participants
|
PRIMARY outcome
Timeframe: At week 1-2Population: Safety population included all participants in the ITT set who were administered at least 1 dose of study medication. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
The ACT is a participant-completed assessment consisting of 5 questions health survey for measuring asthma control. Each question is answered with a score in a range of 1 to 5 and lower score represents the more severe condition. The scale range for Question 1 is "all the time" (1) to "none of the time" (5); Question 2 range: "more than once a day" (1) to "not at all" (5); Question 3 range: "4 or more nights a week" (1) to "not at all" (5); Question 4 range: "3 or more times per day" (1) to "not at all" (5); Question 5 range: "not controlled at all" (1) to "completely controlled" (5). A total ACT score is obtained as the sum of the 5 individual question scores that is from 5 to 25, where Higher scores mean that asthma is more controlled.
Outcome measures
| Measure |
Nemolizumab
n=10 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 1-2
|
0 Participants
|
PRIMARY outcome
Timeframe: At week 4Population: Safety population included all participants in the ITT set who were administered at least 1 dose of study medication. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
The ACT is a participant-completed assessment consisting of 5 questions health survey for measuring asthma control. Each question is answered with a score in a range of 1 to 5 and lower score represents the more severe condition. The scale range for Question 1 is "all the time" (1) to "none of the time" (5); Question 2 range: "more than once a day" (1) to "not at all" (5); Question 3 range: "4 or more nights a week" (1) to "not at all" (5); Question 4 range: "3 or more times per day" (1) to "not at all" (5); Question 5 range: "not controlled at all" (1) to "completely controlled" (5). A total ACT score is obtained as the sum of the 5 individual question scores that is from 5 to 25, where Higher scores mean that asthma is more controlled.
Outcome measures
| Measure |
Nemolizumab
n=8 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 4
|
0 Participants
|
PRIMARY outcome
Timeframe: At week 8Population: Safety population included all participants in the ITT set who were administered at least 1 dose of study medication. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
The ACT is a participant-completed assessment consisting of 5 questions health survey for measuring asthma control. Each question is answered with a score in a range of 1 to 5 and lower score represents the more severe condition. The scale range for Question 1 is "all the time" (1) to "none of the time" (5); Question 2 range: "more than once a day" (1) to "not at all" (5); Question 3 range: "4 or more nights a week" (1) to "not at all" (5); Question 4 range: "3 or more times per day" (1) to "not at all" (5); Question 5 range: "not controlled at all" (1) to "completely controlled" (5). A total ACT score is obtained as the sum of the 5 individual question scores that is from 5 to 25, where Higher scores mean that asthma is more controlled.
Outcome measures
| Measure |
Nemolizumab
n=7 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 8
|
0 Participants
|
PRIMARY outcome
Timeframe: At week 12Population: Safety population included all participants in the ITT set who were administered at least 1 dose of study medication. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
The ACT is a participant-completed assessment consisting of 5 questions health survey for measuring asthma control. Each question is answered with a score in a range of 1 to 5 and lower score represents the more severe condition. The scale range for Question 1 is "all the time" (1) to "none of the time" (5); Question 2 range: "more than once a day" (1) to "not at all" (5); Question 3 range: "4 or more nights a week" (1) to "not at all" (5); Question 4 range: "3 or more times per day" (1) to "not at all" (5); Question 5 range: "not controlled at all" (1) to "completely controlled" (5). A total ACT score is obtained as the sum of the 5 individual question scores that is from 5 to 25, where Higher scores mean that asthma is more controlled.
Outcome measures
| Measure |
Nemolizumab
n=7 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Number of Participants With Asthma Control Test (ACT) Score Less Than or Equal to (=<) 19 at Week 12
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 24Population: Safety population included all participants in the ITT set who were administered at least 1 dose of study medication.
A complete PE included assessments of the head, ears, eyes, nose, throat, neck (including thyroid), skin/integumentary system, cardiovascular system, respiratory system, gastrointestinal system, musculoskeletal system, lymph nodes, and nervous system. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Physical Examination (PE) Findings
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 24Population: Safety population included all participants in the ITT set who were administered at least 1 dose of study medication.
Laboratory investigation included hematology, biochemistry, and urinalysis. Clinical significance was determined by the investigator. The number of participants with clinically significant abnormalities in laboratory parameters were reported.
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Laboratory Values
Urinalyses
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Laboratory Values
Hematology
|
6 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Laboratory Values
Biochemistry
|
5 Participants
|
PRIMARY outcome
Timeframe: At week 16Population: Safety population included all participants in the ITT set who were administered at least 1 dose of study medication.
The ECG recordings were obtained after 10 minutes of rest in a semi-supine position. Number of participants with clinically significant change from baseline in ECG findings were reported. Clinically significance was decided by investigator.
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings at Week 16
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 24Population: Safety population included all participants in the ITT set who were administered at least 1 dose of study medication.
Vital signs included pulse rate, systolic and diastolic blood pressure (after the participant had been sitting for at least 5 minutes), and body temperature. Clinically significance was decided by investigator..
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs
|
5 Participants
|
PRIMARY outcome
Timeframe: At week 1-2Population: Safety population included all participants in the ITT set who were administered at least 1 dose of study medication. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
PEF was the maximum speed of expiration measured using spirometer. A participant took rest just before the measurement. At each time of measurement, a participant expired for at least 6 seconds wherever possible. At each time of measurement, at least 3 readings were obtained, and three readings which were obtained in an appropriate manner were stored. PEF \<80% of predictive value is considered as abnormal.
Outcome measures
| Measure |
Nemolizumab
n=10 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Number of Participants With Abnormal Peak Expiratory Flow (PEF) <80% of Predicted Value at Week 1-2
|
1 Participants
|
PRIMARY outcome
Timeframe: At week 4Population: Safety population included all participants in the ITT set who were administered at least 1 dose of study medication. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
PEF was the maximum speed of expiration measured using spirometer. A participant took rest just before the measurement. At each time of measurement, a participant expired for at least 6 seconds wherever possible. At each time of measurement, at least 3 readings were obtained, and three readings which were obtained in an appropriate manner were stored. PEF \<80% of predictive value is considered as abnormal.
Outcome measures
| Measure |
Nemolizumab
n=8 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Number of Participants With Abnormal Peak Expiratory Flow (PEF) <80% Predicted Value at Week 4
|
1 Participants
|
SECONDARY outcome
Timeframe: Pre-dose through 4 weeks post-dosePopulation: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Area under the drug concentration-time curve from 0 to 4 week post dosing for Nemolizumab. AUC(0-4w) was calculated according to the mixed log-linear trapezoidal rule.
Outcome measures
| Measure |
Nemolizumab
n=17 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Non-Compartmental Analysis: Area Under the Serum Concentration-time Curve From Time Zero to 4 Weeks Post-dose AUC(0-4w)
|
122286.736 ng*day/mL
Standard Deviation 44081.623
|
SECONDARY outcome
Timeframe: Pre-dose through 8 weeks post-dosePopulation: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Area under the drug concentration-time curve from 0 to 8 week post dosing for Nemolizumab. AUC(0-8w) was calculated according to the mixed log-linear trapezoidal rule.
Outcome measures
| Measure |
Nemolizumab
n=13 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 8 Week Post-dose (AUC0-8w)
|
233258.841 ng*day/mL
Standard Deviation 80113.408
|
SECONDARY outcome
Timeframe: Pre-dose through 12 week post-dosePopulation: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Area under the drug concentration-time curve from 0 to 12 week post dosing for Nemolizumab. AUC(0-12w) was calculated according to the mixed log-linear trapezoidal rule
Outcome measures
| Measure |
Nemolizumab
n=13 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 12 Week Post-dose (AUC0-12w)
|
332928.434 ng*day/mL
Standard Deviation 121739.832
|
SECONDARY outcome
Timeframe: Pre-dose through 16 weeks post-dosePopulation: PK population included all participants in the Safety population who provided at least 1 post-baseline evaluable drug concentration value. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Area under the drug concentration-time curve from 0 to 16 week post dosing for Nemolizumab. AUC(0-16w) was calculated according to the mixed log-linear trapezoidal rule.
Outcome measures
| Measure |
Nemolizumab
n=12 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Non-Compartmental Analysis: Area Under the Serum Concentration-Time Curve From Time Zero to 16 Week Post-dose (AUC0-16w)
|
372858.017 ng*day/mL
Standard Deviation 149908.126
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: ITT population included all enrolled participants who signed informed consent form. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
EASI assesses severity and extent of atopic dermatitis (AD) signs through a composite score of erythema, induration/population, excoriation, and lichenification. Each characteristic was assessed for severity on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs. The total EASI score range from 0 to 72 with higher scores representing greater severity of AD.
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16
|
-15.994 units on a scale
Standard Deviation 9.9413
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: ITT population included all enrolled participants who signed informed consent form. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. Each characteristic was assessed for severity on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs. The EASI score can range from 0 to 72 with higher scores representing greater severity of AD.
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16
|
-66.52 Percent change
Standard Deviation 32.461
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: ITT population included all enrolled participants who signed informed consent form.
IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of AD. Ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), where higher score indicated higher severity. IGA success is defined as participants with 0 (clear) or 1 (almost clear) and at least 2 -grade improvement from baseline. Number of Participants who achieved Investigator's Global Assessment (IGA) Success from baseline to week 16 were reported.
Outcome measures
| Measure |
Nemolizumab
n=20 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Number of Participants Who Achieved Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) From Baseline to Week 16
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1-2, 4, 8, 12, 14, 16 and 24Population: ITT population included all enrolled participants who signed informed consent form. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck \[9%\], anterior trunk \[18%\], back \[18%\], upper limbs \[18%\], lower limbs \[36%\], and genitals \[1%\]) and reported as a percentage of all major body sections combined. The reported percentage of BSA was combined percentage of all major body sections.
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Change From Baseline in the Percentage of Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD) at Each Visit up to Week 24
Week 1 to 2
|
-1.9 Percentage of BSA
Standard Deviation 6.33
|
|
Change From Baseline in the Percentage of Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD) at Each Visit up to Week 24
Week 4
|
-7.1 Percentage of BSA
Standard Deviation 15.90
|
|
Change From Baseline in the Percentage of Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD) at Each Visit up to Week 24
Week 8
|
-11.2 Percentage of BSA
Standard Deviation 15.48
|
|
Change From Baseline in the Percentage of Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD) at Each Visit up to Week 24
Week 12
|
-17.2 Percentage of BSA
Standard Deviation 17.94
|
|
Change From Baseline in the Percentage of Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD) at Each Visit up to Week 24
Week 16
|
-19.9 Percentage of BSA
Standard Deviation 17.04
|
|
Change From Baseline in the Percentage of Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD) at Each Visit up to Week 24
Week 24
|
-14.7 Percentage of BSA
Standard Deviation 17.88
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: ITT population included all enrolled participants who signed informed consent form. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]), higher scores indicated greater severity.
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (NRS) Score at Week 16
|
-3.122 score on a scale
Standard Deviation 2.8216
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: ITT population included all enrolled participants who signed informed consent form. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]), higher scores indicated greater severity.
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Percent Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (NRS) Score at Week 16
|
-43.21 Percent of change
Standard Deviation 36.970
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: ITT population included all enrolled participants who signed informed consent form. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]), higher scores indicated greater severity.
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Absolute Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Week 16
|
-2.610 score on a scale
Standard Deviation 2.6148
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: ITT population included all enrolled participants who signed informed consent form. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]), higher scores indicated greater severity.
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Percent Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Week 16
|
-40.85 Percent change
Standard Deviation 37.293
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: ITT population included all enrolled participants who signed informed consent form. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicate worse outcome.
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) Score at Week 16
|
-3.050 score on a scale
Standard Deviation 3.2367
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: ITT population included all enrolled participants who signed informed consent form. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicate worse outcome.
Outcome measures
| Measure |
Nemolizumab
n=18 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) Score at Week 16
|
-53.51 Percent change
Standard Deviation 47.782
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: ITT population included all enrolled participants who signed informed consent form. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Scoring Atopic Dermatitis (SCORAD) is a validated measure commonly used to assess the severity and the extent of AD signs and symptoms. SCORAD is a clinical tool for assessing the severity and the extent of AD signs and symptoms. Extent and intensity of six types of basic lesions (erythema/darkening, edema/papule, oozing/crusting, excoriation, lichenification/prurigo and dryness) and symptoms (itching and loss of sleep) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
Outcome measures
| Measure |
Nemolizumab
n=20 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 16
|
-50.08 Percent change
Standard Deviation 26.925
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: ITT population included all enrolled participants who signed informed consent form. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at the specified time point.
Number of topical AD medication-free days through Week 16 was calculated as the number of days that a participant used neither topical corticosteroid (TCS)/ topical calcineurin inhibitors (TCI) nor system rescue therapy divided by the study days.
Outcome measures
| Measure |
Nemolizumab
n=20 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Number of Topical Atopic Dermatitis Medication-Free Days Through Week 24
Baseline to Week 1-2
|
3.5 Days
Standard Deviation 2.25
|
|
Number of Topical Atopic Dermatitis Medication-Free Days Through Week 24
Week 1-2 to Week 4
|
7.5 Days
Standard Deviation 4.87
|
|
Number of Topical Atopic Dermatitis Medication-Free Days Through Week 24
Week 4 to Week 8
|
12.1 Days
Standard Deviation 7.20
|
|
Number of Topical Atopic Dermatitis Medication-Free Days Through Week 24
Week 8 to Week 12
|
9.7 Days
Standard Deviation 5.96
|
|
Number of Topical Atopic Dermatitis Medication-Free Days Through Week 24
Week 12 to Week 16
|
10.7 Days
Standard Deviation 5.82
|
|
Number of Topical Atopic Dermatitis Medication-Free Days Through Week 24
Week 16 to Week 24
|
23.4 Days
Standard Deviation 11.88
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: ITT population included all enrolled participants who signed informed consent form. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at the specified time point.
The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participants were rate each question ranging from 0 (not at all) to 3 (very much) and overall score ranges from 0 to 30. A higher total score indicates a poorer quality of life (QoL).
Outcome measures
| Measure |
Nemolizumab
n=5 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Dermatology Life Quality Index (DLQI) For Participants > 16 Years of Age at Baseline and Week 16
Baseline
|
11.8 score on a scale
Standard Deviation 3.11
|
|
Dermatology Life Quality Index (DLQI) For Participants > 16 Years of Age at Baseline and Week 16
Week 16
|
3.0 score on a scale
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: ITT population included all enrolled participants who signed informed consent form. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at the specified time point.
The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participants were rate each question ranging from 0 (not at all) to 3 (very much) and overall score ranges from 0 to 30. A higher total score indicates a poorer quality of life (QoL).
Outcome measures
| Measure |
Nemolizumab
n=13 Participants
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
Children's Dermatology Life Quality Index (cDLQI) For Participants 12-16 Years of Age at Baseline and Week 16
Baseline
|
10.6 score on a scale
Standard Deviation 5.42
|
|
Children's Dermatology Life Quality Index (cDLQI) For Participants 12-16 Years of Age at Baseline and Week 16
Week 16
|
6.2 score on a scale
Standard Deviation 5.29
|
Adverse Events
Nemolizumab
Serious adverse events
| Measure |
Nemolizumab
n=18 participants at risk
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
General disorders
Oedema peripheral
|
5.6%
1/18 • Number of events 1 • Baseline through Week 24
Safety population included all participants in the ITT set who were administered at least 1 dose of study medication.
|
|
Infections and infestations
Eczema infected
|
5.6%
1/18 • Number of events 1 • Baseline through Week 24
Safety population included all participants in the ITT set who were administered at least 1 dose of study medication.
|
|
Infections and infestations
Staphylococcus skin infection
|
5.6%
1/18 • Number of events 1 • Baseline through Week 24
Safety population included all participants in the ITT set who were administered at least 1 dose of study medication.
|
Other adverse events
| Measure |
Nemolizumab
n=18 participants at risk
Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
|
|---|---|
|
General disorders
Oedema peripheral
|
5.6%
1/18 • Baseline through Week 24
Safety population included all participants in the ITT set who were administered at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
5.6%
1/18 • Baseline through Week 24
Safety population included all participants in the ITT set who were administered at least 1 dose of study medication.
|
|
Infections and infestations
Bronchitis
|
5.6%
1/18 • Baseline through Week 24
Safety population included all participants in the ITT set who were administered at least 1 dose of study medication.
|
|
Infections and infestations
Rash pustular
|
5.6%
1/18 • Baseline through Week 24
Safety population included all participants in the ITT set who were administered at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
1/18 • Baseline through Week 24
Safety population included all participants in the ITT set who were administered at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
5.6%
1/18 • Baseline through Week 24
Safety population included all participants in the ITT set who were administered at least 1 dose of study medication.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.6%
1/18 • Baseline through Week 24
Safety population included all participants in the ITT set who were administered at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
1/18 • Baseline through Week 24
Safety population included all participants in the ITT set who were administered at least 1 dose of study medication.
|
|
Psychiatric disorders
Depression
|
5.6%
1/18 • Baseline through Week 24
Safety population included all participants in the ITT set who were administered at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
5.6%
1/18 • Baseline through Week 24
Safety population included all participants in the ITT set who were administered at least 1 dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place