Trial Outcomes & Findings for Dose-ranging Study of Nemolizumab in Atopic Dermatitis (NCT NCT03100344)

NCT ID: NCT03100344

Last Updated: 2019-10-22

Results Overview

EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 226 participants
• Primary outcome timeframe: From Baseline to Week 24
• Results posted on: 2019-10-22

Participant Flow

This study was conducted at 57 investigational sites in Australia, Canada, Germany, France, Poland and the United States.

In this study, 226 participants with moderate-to-severe atopic dermatitis (AD) were randomized across the 4 treatment groups after a 2 to 4-week run-in period. All participants underwent inclusion and exclusion criteria assessment and all eligible participants signed the informed consent before undergoing any study related procedures.

Participant milestones

Measure	Placebo Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20). As background therapy a medium potency topical corticosteroids (TCS) (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (10 mg) Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20) with a loading dose of 20mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20) with a loading dose of 60mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Overall Study STARTED	57	55	57	57
Overall Study COMPLETED	43	44	50	45
Overall Study NOT COMPLETED	14	11	7	12

Reasons for withdrawal

Measure	Placebo Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20). As background therapy a medium potency topical corticosteroids (TCS) (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (10 mg) Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20) with a loading dose of 20mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20) with a loading dose of 60mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at Week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Overall Study Adverse Event	0	3	2	3
Overall Study Lack of Efficacy	2	0	0	0
Overall Study Protocol Violation	1	0	0	0
Overall Study Withdrawal by Subject	10	7	4	8
Overall Study Lost to Follow-up	1	1	1	1

Baseline Characteristics

Dose-ranging Study of Nemolizumab in Atopic Dermatitis

Baseline characteristics by cohort

Measure	Placebo n=57 Participants Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) for areas where medium potency TCS are considered unsafe.	Nemolizumab (10 mg) n=55 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 weeks treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) for areas where medium potency TCS are considered unsafe.	Total n=226 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=5 Participants	53 Participants n=7 Participants	51 Participants n=5 Participants	51 Participants n=4 Participants	209 Participants n=21 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	17 Participants n=21 Participants
Age, Continuous	40.9 years STANDARD_DEVIATION 15.01 • n=5 Participants	35.3 years STANDARD_DEVIATION 14.83 • n=7 Participants	40.2 years STANDARD_DEVIATION 16.64 • n=5 Participants	40.9 years STANDARD_DEVIATION 14.95 • n=4 Participants	39.3 years STANDARD_DEVIATION 15.45 • n=21 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	26 Participants n=7 Participants	28 Participants n=5 Participants	31 Participants n=4 Participants	111 Participants n=21 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	29 Participants n=7 Participants	29 Participants n=5 Participants	26 Participants n=4 Participants	115 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	11 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	25 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants	8 Participants n=4 Participants	29 Participants n=21 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants	38 Participants n=7 Participants	40 Participants n=5 Participants	44 Participants n=4 Participants	167 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Height	170.0 centimetre STANDARD_DEVIATION 10.28 • n=5 Participants	169.7 centimetre STANDARD_DEVIATION 8.98 • n=7 Participants	171.5 centimetre STANDARD_DEVIATION 8.55 • n=5 Participants	170.6 centimetre STANDARD_DEVIATION 9.94 • n=4 Participants	170.5 centimetre STANDARD_DEVIATION 9.43 • n=21 Participants
Weight	80.58 kilogram STANDARD_DEVIATION 18.835 • n=5 Participants	73.72 kilogram STANDARD_DEVIATION 14.629 • n=7 Participants	76.90 kilogram STANDARD_DEVIATION 18.613 • n=5 Participants	80.49 kilogram STANDARD_DEVIATION 22.770 • n=4 Participants	77.96 kilogram STANDARD_DEVIATION 19.052 • n=21 Participants
Body mass index	27.79 kilogram per square metre STANDARD_DEVIATION 5.638 • n=5 Participants	25.54 kilogram per square metre STANDARD_DEVIATION 4.429 • n=7 Participants	26.18 kilogram per square metre STANDARD_DEVIATION 6.370 • n=5 Participants	27.51 kilogram per square metre STANDARD_DEVIATION 6.694 • n=4 Participants	26.77 kilogram per square metre STANDARD_DEVIATION 5.894 • n=21 Participants

PRIMARY outcome

Timeframe: From Baseline to Week 24

Population: All participants in intent-to-treat (ITT) population who received at least one dose of study drug.

EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.

Outcome measures

Measure	Placebo n=57 Participants Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy , a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe	Nemolizumab (10 mg) n=55 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24	-58.4 percentage change Standard Deviation 31.99	-72.2 percentage change Standard Deviation 25.96	-73.4 percentage change Standard Deviation 29.67	-69.2 percentage change Standard Deviation 31.06

SECONDARY outcome

Timeframe: Week 24

Population: ITT population: All randomized participants.

The 4-point pruritus categorical scale was provided in their local language for the participants to report the intensity of their pruritus. Overall itching was scored as 0 for absence of pruritus and 3 for severe pruritus (bothersome itching/scratching that disturbs sleep). Higher scores indicate worse outcome.

Outcome measures

Measure	Placebo n=57 Participants Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy , a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe	Nemolizumab (10 mg) n=55 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24	13 Participants	23 Participants	31 Participants	20 Participants

SECONDARY outcome

Timeframe: From Week 1 to Week 24

Population: ITT population: All randomized participants.

Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.

Outcome measures

Measure	Placebo n=57 Participants Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy , a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe	Nemolizumab (10 mg) n=55 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24 Week 1	3 Participants	9 Participants	10 Participants	6 Participants
Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24 Week 2	6 Participants	19 Participants	21 Participants	17 Participants
Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24 Week 4	4 Participants	19 Participants	27 Participants	22 Participants
Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24 Week 8	11 Participants	22 Participants	36 Participants	26 Participants
Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24 Week 12	13 Participants	26 Participants	38 Participants	24 Participants
Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24 Week 16	12 Participants	30 Participants	39 Participants	25 Participants
Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24 Week 20	13 Participants	27 Participants	34 Participants	27 Participants
Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24 Week 24	14 Participants	25 Participants	28 Participants	24 Participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population: All randomized participants.

SCORAD ranges from 0 to 103 and has three components: extent (body surface area [BSA]), signs, and symptoms of AD. The severity of the 6 signs of AD (erythema/darkening, edema/papulation, oozing/crusting, excoriation, lichenification/prurigo and dryness), was assessed, each on a scale ranging from 0 (none) to 3 (severe).The component of extent corresponded to the extent of BSA affected by atopic dermatitis.The BSA involvement of AD was assessed for each part of the body (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]), and was reported as a percentage of all major body sections combined. Participants were also asked to evaluate their symptoms of pruritus and sleep loss (average for the last 3 days/nights), each evaluated on a Visual analog scale (VAS) from 0 to 10. Higher scores indicate worse outcome.

Outcome measures

Measure	Placebo n=57 Participants Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy , a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe	Nemolizumab (10 mg) n=55 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24	-42.6 Percentage change Standard Deviation 28.25	-60.8 Percentage change Standard Deviation 25.04	-62.5 Percentage change Standard Deviation 25.37	-55.9 Percentage change Standard Deviation 25.85

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population: All randomized participants.

SCORAD ranges from 0 to 103 and has three components: extent (body surface area [BSA]), signs, and symptoms of AD. The severity of the 6 signs of AD (erythema/darkening, edema/papulation, oozing/crusting, excoriation, lichenification/prurigo and dryness), was assessed, each on a scale ranging from 0 (none) to 3 (severe).The component of extent corresponded to the extent of BSA affected by atopic dermatitis.The BSA involvement of AD was assessed for each part of the body (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]), and was reported as a percentage of all major body sections combined. Participants were also asked to evaluate their symptoms of pruritus and sleep loss (average for the last 3 days/nights), each evaluated on a Visual analog scale (VAS) from 0 to 10. Higher scores indicate worse outcome.

Outcome measures

Measure	Placebo n=57 Participants Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy , a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe	Nemolizumab (10 mg) n=55 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24	-27.9 units on a scale Standard Deviation 19.61	-40.1 units on a scale Standard Deviation 19.19	-40.6 units on a scale Standard Deviation 17.22	-36.1 units on a scale Standard Deviation 16.56

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population: All randomized participants.

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	Placebo n=57 Participants Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy , a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe	Nemolizumab (10 mg) n=55 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24	-50.7 Percentage change Standard Deviation 33.52	-75.4 Percentage change Standard Deviation 27.64	-76.2 Percentage change Standard Deviation 23.60	-74.9 Percentage change Standard Deviation 29.39

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: ITT population: All randomized participants.

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	Placebo n=57 Participants Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy , a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe	Nemolizumab (10 mg) n=55 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24	-3.9 units on a scale Standard Deviation 2.74	-6.2 units on a scale Standard Deviation 2.34	-5.7 units on a scale Standard Deviation 2.51	-5.8 units on a scale Standard Deviation 2.62

SECONDARY outcome

Timeframe: From Week 1 to Week 24

Population: ITT population: All randomized participants.

IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used to evaluate the global severity of AD. Higher scores indicate worse outcome.

Outcome measures

Measure	Placebo n=57 Participants Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy , a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe	Nemolizumab (10 mg) n=55 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Number of Participants Achieving Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24 Week 16	7 Participants	9 Participants	19 Participants	15 Participants
Number of Participants Achieving Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24 Week 1	1 Participants	1 Participants	2 Participants	0 Participants
Number of Participants Achieving Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24 Week 2	2 Participants	1 Participants	4 Participants	1 Participants
Number of Participants Achieving Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24 Week 4	2 Participants	1 Participants	9 Participants	7 Participants
Number of Participants Achieving Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24 Week 8	2 Participants	3 Participants	10 Participants	11 Participants
Number of Participants Achieving Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24 Week 12	6 Participants	6 Participants	15 Participants	15 Participants
Number of Participants Achieving Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24 Week 20	9 Participants	11 Participants	19 Participants	14 Participants
Number of Participants Achieving Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24 Week 24	12 Participants	14 Participants	21 Participants	13 Participants

SECONDARY outcome

Timeframe: From Week 1 to Week 24

Population: ITT Population:All randomized participants.

EASI is a composite score ranging from 0 to 72. The severity of erythema, induration/papulation, excoriation, and lichenification were assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.

Outcome measures

Measure	Placebo n=57 Participants Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy , a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe	Nemolizumab (10 mg) n=55 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Number of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 1	4 Participants	6 Participants	12 Participants	11 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 2	8 Participants	18 Participants	18 Participants	21 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 4	14 Participants	22 Participants	29 Participants	24 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 8	15 Participants	26 Participants	31 Participants	31 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 12	20 Participants	30 Participants	36 Participants	30 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 16	21 Participants	30 Participants	34 Participants	32 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 20	23 Participants	32 Participants	38 Participants	33 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 24	25 Participants	33 Participants	38 Participants	31 Participants

SECONDARY outcome

Timeframe: From Week 1 to Week 24

Population: ITT Population: All randomized participants.

EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification were assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.

Outcome measures

Measure	Placebo n=57 Participants Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy , a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe	Nemolizumab (10 mg) n=55 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Number of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 1	2 Participants	2 Participants	3 Participants	3 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 2	4 Participants	5 Participants	6 Participants	12 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 4	3 Participants	7 Participants	12 Participants	15 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 8	7 Participants	10 Participants	21 Participants	15 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 12	10 Participants	15 Participants	25 Participants	21 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 16	11 Participants	18 Participants	28 Participants	21 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 20	16 Participants	21 Participants	25 Participants	21 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 24	15 Participants	20 Participants	26 Participants	25 Participants

SECONDARY outcome

Timeframe: From Week 1 to Week 24

Population: ITT Population: All randomized participants.

EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification were assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.

Outcome measures

Measure	Placebo n=57 Participants Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy , a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe	Nemolizumab (10 mg) n=55 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Number of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 1	1 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 2	2 Participants	0 Participants	2 Participants	2 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 4	2 Participants	1 Participants	4 Participants	3 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 8	1 Participants	3 Participants	11 Participants	6 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 12	4 Participants	7 Participants	13 Participants	14 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 16	5 Participants	10 Participants	19 Participants	12 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 20	6 Participants	13 Participants	18 Participants	14 Participants
Number of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 Week 24	6 Participants	13 Participants	17 Participants	13 Participants

SECONDARY outcome

Timeframe: Week 1 to Week 24

Population: All participants in ITT population who received at least one dose of study drug.

IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used to evaluate the global severity of AD. Higher scores indicate worse outcome.

Outcome measures

Measure	Placebo n=57 Participants Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy , a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe	Nemolizumab (10 mg) n=55 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Number of Participants Achieving Investigator Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) and a Reduction of ≥2 Points at Each Visit up to Week 24 Week 1	1 Participants	1 Participants	2 Participants	0 Participants
Number of Participants Achieving Investigator Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) and a Reduction of ≥2 Points at Each Visit up to Week 24 Week 2	2 Participants	1 Participants	4 Participants	1 Participants
Number of Participants Achieving Investigator Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) and a Reduction of ≥2 Points at Each Visit up to Week 24 Week 4	2 Participants	1 Participants	9 Participants	7 Participants
Number of Participants Achieving Investigator Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) and a Reduction of ≥2 Points at Each Visit up to Week 24 Week 8	2 Participants	3 Participants	10 Participants	11 Participants
Number of Participants Achieving Investigator Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) and a Reduction of ≥2 Points at Each Visit up to Week 24 Week 12	6 Participants	6 Participants	15 Participants	15 Participants
Number of Participants Achieving Investigator Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) and a Reduction of ≥2 Points at Each Visit up to Week 24 Week 16	7 Participants	9 Participants	19 Participants	15 Participants
Number of Participants Achieving Investigator Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) and a Reduction of ≥2 Points at Each Visit up to Week 24 Week 20	9 Participants	11 Participants	19 Participants	14 Participants
Number of Participants Achieving Investigator Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) and a Reduction of ≥2 Points at Each Visit up to Week 24 Week 24	12 Participants	14 Participants	21 Participants	13 Participants

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: ITT population: All randomized participants.

EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.

Outcome measures

Measure	Placebo n=57 Participants Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy , a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe	Nemolizumab (10 mg) n=55 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 Week 1	-12.4 Percentage of change Standard Deviation 24.32	-22.7 Percentage of change Standard Deviation 23.54	-29.3 Percentage of change Standard Deviation 31.44	-28.6 Percentage of change Standard Deviation 25.52
Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 Week 2	-24.8 Percentage of change Standard Deviation 29.16	-34.9 Percentage of change Standard Deviation 27.70	-40.1 Percentage of change Standard Deviation 26.96	-40.1 Percentage of change Standard Deviation 32.83
Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 Week 4	-26.5 Percentage of change Standard Deviation 33.45	-40.3 Percentage of change Standard Deviation 28.36	-46.7 Percentage of change Standard Deviation 38.49	-41.8 Percentage of change Standard Deviation 41.57
Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 Week 8	-28.6 Percentage of change Standard Deviation 36.85	-42.0 Percentage of change Standard Deviation 38.15	-51.7 Percentage of change Standard Deviation 47.73	-49.9 Percentage of change Standard Deviation 37.21
Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 Week 12	-43.3 Percentage of change Standard Deviation 35.22	-58.5 Percentage of change Standard Deviation 28.16	-64.1 Percentage of change Standard Deviation 33.92	-56.7 Percentage of change Standard Deviation 37.25
Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 Week 16	-47.6 Percentage of change Standard Deviation 32.09	-59.1 Percentage of change Standard Deviation 33.09	-72.2 Percentage of change Standard Deviation 27.59	-61.8 Percentage of change Standard Deviation 41.62
Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 Week 20	-57.3 Percentage of change Standard Deviation 31.66	-67.2 Percentage of change Standard Deviation 35.18	-71.6 Percentage of change Standard Deviation 29.39	-70.9 Percentage of change Standard Deviation 27.07
Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 Week 24	-58.4 Percentage of change Standard Deviation 31.99	-72.2 Percentage of change Standard Deviation 25.96	-73.4 Percentage of change Standard Deviation 29.67	-69.2 Percentage of change Standard Deviation 31.06

SECONDARY outcome

Timeframe: At baseline and Week 24

Population: ITT population: All randomized participants.

Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.

Outcome measures

Measure	Placebo n=57 Participants Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy , a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe	Nemolizumab (10 mg) n=55 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 1	-9.8 percentage of change Standard Deviation 18.47	-22.6 percentage of change Standard Deviation 21.76	-25.5 percentage of change Standard Deviation 30.15	-19.8 percentage of change Standard Deviation 21.16
Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 2	-12.9 percentage of change Standard Deviation 23.97	-36.9 percentage of change Standard Deviation 27.34	-42.1 percentage of change Standard Deviation 23.91	-37.6 percentage of change Standard Deviation 32.29
Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 4	-16.3 percentage of change Standard Deviation 23.77	-38.7 percentage of change Standard Deviation 30.25	-51.8 percentage of change Standard Deviation 26.87	-45.7 percentage of change Standard Deviation 32.64
Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 8	-23.0 percentage of change Standard Deviation 23.88	-48.2 percentage of change Standard Deviation 28.82	-61.5 percentage of change Standard Deviation 24.16	-58.0 percentage of change Standard Deviation 28.63
Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 12	-28.2 percentage of change Standard Deviation 28.83	-58.0 percentage of change Standard Deviation 28.99	-68.7 percentage of change Standard Deviation 25.04	-56.4 percentage of change Standard Deviation 29.81
Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 16	-36.2 percentage of change Standard Deviation 30.25	-61.4 percentage of change Standard Deviation 28.62	-71.7 percentage of change Standard Deviation 22.53	-63.7 percentage of change Standard Deviation 33.07
Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 20	-38.0 percentage of change Standard Deviation 30.11	-64.6 percentage of change Standard Deviation 28.62	-69.9 percentage of change Standard Deviation 26.30	-69.7 percentage of change Standard Deviation 28.47
Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 24	-42.2 percentage of change Standard Deviation 31.66	-65.8 percentage of change Standard Deviation 29.94	-66.9 percentage of change Standard Deviation 38.60	-68.2 percentage of change Standard Deviation 26.88

SECONDARY outcome

Timeframe: From screening to Follow-up visit (Week 32)/Early termination visit

Population: Safety population: The safety population comprised all subjects in ITT population who received at least one dose of study drug.

To evaluate the safety of nemolizumab in participants with moderate-to-severe AD

Outcome measures

Measure	Placebo n=56 Participants Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy , a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe	Nemolizumab (10 mg) n=55 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Number of Participants With Adverse Events Subjects with TEAE leading to study withdrawal	0 Participants	3 Participants	2 Participants	3 Participants
Number of Participants With Adverse Events Subjects with treatment-emergent SAEs	1 Participants	3 Participants	2 Participants	2 Participants
Number of Participants With Adverse Events Treatment-emergent AEs (TEAE) with fatal outcome	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events Subjects with TEAE leading to temporary study drug	0 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Adverse Events Subjects with TEAE leading to permanent study drug	4 Participants	4 Participants	2 Participants	7 Participants
Number of Participants With Adverse Events Subjects with at least 1 TEAE	43 Participants	47 Participants	47 Participants	48 Participants
Number of Participants With Adverse Events Subjects with severe TEAEs	6 Participants	3 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: ITT population: All randomized participants. Number of participants in this analysis

Pruritus NRS is a scale to be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.

Outcome measures

Measure	Placebo n=57 Participants Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy , a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe	Nemolizumab (10 mg) n=55 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 1	-0.9 units on a scale Standard Deviation 1.38	-2.0 units on a scale Standard Deviation 1.96	-2.3 units on a scale Standard Deviation 1.89	-1.7 units on a scale Standard Deviation 1.66
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 2	-1.2 units on a scale Standard Deviation 1.82	-3.1 units on a scale Standard Deviation 2.34	-3.4 units on a scale Standard Deviation 1.96	-3.3 units on a scale Standard Deviation 2.56
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 4	-1.4 units on a scale Standard Deviation 1.84	-3.4 units on a scale Standard Deviation 2.62	-4.2 units on a scale Standard Deviation 2.21	-3.8 units on a scale Standard Deviation 2.73
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 8	-1.9 units on a scale Standard Deviation 1.94	-4.1 units on a scale Standard Deviation 2.58	-5.0 units on a scale Standard Deviation 2.14	-4.7 units on a scale Standard Deviation 2.54
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 12	-2.3 units on a scale Standard Deviation 2.44	-4.9 units on a scale Standard Deviation 2.45	-5.6 units on a scale Standard Deviation 2.29	-4.7 units on a scale Standard Deviation 2.66
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 16	-2.9 units on a scale Standard Deviation 2.55	-5.2 units on a scale Standard Deviation 2.34	-5.8 units on a scale Standard Deviation 2.25	-5.1 units on a scale Standard Deviation 2.77
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 20	-3.1 units on a scale Standard Deviation 2.52	-5.4 units on a scale Standard Deviation 2.61	-5.9 units on a scale Standard Deviation 2.22	-5.4 units on a scale Standard Deviation 2.66
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 24	-3.5 units on a scale Standard Deviation 2.65	-5.6 units on a scale Standard Deviation 2.55	-5.8 units on a scale Standard Deviation 2.54	-5.5 units on a scale Standard Deviation 2.33

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: ITT population: All randomized participants. Number of participants in this analysis

Pruritus NRS is a scale to be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For average itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.

Outcome measures

Measure	Placebo n=57 Participants Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy , a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe	Nemolizumab (10 mg) n=55 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 1	-0.9 units on a scale Standard Deviation 1.24	-2.0 units on a scale Standard Deviation 1.94	-2.3 units on a scale Standard Deviation 1.86	-1.8 units on a scale Standard Deviation 1.64
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 2	-1.2 units on a scale Standard Deviation 1.73	-3.1 units on a scale Standard Deviation 2.32	-3.3 units on a scale Standard Deviation 1.89	-3.3 units on a scale Standard Deviation 2.50
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 4	-1.5 units on a scale Standard Deviation 1.73	-3.5 units on a scale Standard Deviation 2.47	-4.1 units on a scale Standard Deviation 2.16	-3.8 units on a scale Standard Deviation 2.63
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 8	-2.1 units on a scale Standard Deviation 1.95	-4.1 units on a scale Standard Deviation 2.42	-4.9 units on a scale Standard Deviation 2.13	-4.7 units on a scale Standard Deviation 2.39
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 12	-2.4 units on a scale Standard Deviation 2.43	-4.9 units on a scale Standard Deviation 2.48	-5.5 units on a scale Standard Deviation 2.29	-4.6 units on a scale Standard Deviation 2.50
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 16	-3.0 units on a scale Standard Deviation 2.47	-5.3 units on a scale Standard Deviation 2.18	-5.7 units on a scale Standard Deviation 2.19	-5.1 units on a scale Standard Deviation 2.59
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 20	-3.3 units on a scale Standard Deviation 2.55	-5.3 units on a scale Standard Deviation 2.47	-5.8 units on a scale Standard Deviation 2.18	-5.3 units on a scale Standard Deviation 2.50
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 24	-3.7 units on a scale Standard Deviation 2.59	-5.5 units on a scale Standard Deviation 2.53	-5.6 units on a scale Standard Deviation 2.49	-5.2 units on a scale Standard Deviation 2.19

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: ITT population: All randomized participants. Number of participants in this analysis

Pruritus NRS is a scale to be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For average itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.

Outcome measures

Measure	Placebo n=57 Participants Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy , a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe	Nemolizumab (10 mg) n=55 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 Participants Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 1	-11.0 Percentage of change Standard Deviation 16.33	-24.6 Percentage of change Standard Deviation 23.39	-29.4 Percentage of change Standard Deviation 28.24	-23.2 Percentage of change Standard Deviation 22.63
Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 2	-14.6 Percentage of change Standard Deviation 23.01	-39.9 Percentage of change Standard Deviation 29.89	-45.2 Percentage of change Standard Deviation 25.06	-40.4 Percentage of change Standard Deviation 33.77
Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 4	-19.7 Percentage of change Standard Deviation 22.48	-43.5 Percentage of change Standard Deviation 31.66	-55.8 Percentage of change Standard Deviation 27.60	-48.2 Percentage of change Standard Deviation 33.16
Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 8	-26.9 Percentage of change Standard Deviation 25.34	-52.0 Percentage of change Standard Deviation 29.50	-65.1 Percentage of change Standard Deviation 24.67	-61.5 Percentage of change Standard Deviation 28.03
Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 12	-30.9 Percentage of change Standard Deviation 31.63	-61.7 Percentage of change Standard Deviation 30.02	-72.2 Percentage of change Standard Deviation 25.36	-60.1 Percentage of change Standard Deviation 29.77
Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 16	-40.2 Percentage of change Standard Deviation 31.73	-66.8 Percentage of change Standard Deviation 27.02	-73.9 Percentage of change Standard Deviation 22.83	-67.1 Percentage of change Standard Deviation 31.64
Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 20	-42.7 Percentage of change Standard Deviation 32.43	-67.5 Percentage of change Standard Deviation 30.03	-74.5 Percentage of change Standard Deviation 24.85	-70.6 Percentage of change Standard Deviation 29.39
Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 Week 24	-47.7 Percentage of change Standard Deviation 32.60	-68.7 Percentage of change Standard Deviation 30.60	-69.9 Percentage of change Standard Deviation 35.76	-70.5 Percentage of change Standard Deviation 26.41

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 43 other events

Deaths: 0 deaths

Nemolizumab (10 mg)

Serious events: 3 serious events

Other events: 47 other events

Deaths: 1 deaths

Nemolizumab (30 mg)

Serious events: 2 serious events

Other events: 47 other events

Deaths: 0 deaths

Nemolizumab (90 mg)

Serious events: 2 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=56 participants at risk Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (10 mg) n=55 participants at risk Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 participants at risk Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 participants at risk Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Infections and infestations Cellulitis	0.00% 0/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Infections and infestations Septic shock	0.00% 0/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Infections and infestations Staphylococcal sepsis	0.00% 0/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Infections and infestations Urinary tract infection	0.00% 0/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
General disorders Asthenia	0.00% 0/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Psychiatric disorders Post-traumatic amnestic disorder	0.00% 0/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Vascular disorders Hypertension	1.8% 1/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.

Other adverse events

Measure	Placebo n=56 participants at risk Randomized participants received Nemolizumab placebo subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (10 mg) n=55 participants at risk Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (30 mg) n=57 participants at risk Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 60 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.	Nemolizumab (90 mg) n=57 participants at risk Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe.
Infections and infestations Nasopharyngitis	21.4% 12/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	32.7% 18/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	24.6% 14/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	22.8% 13/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Infections and infestations Upper respiratory tract infection	1.8% 1/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	7.3% 4/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	10.5% 6/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	7.0% 4/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Infections and infestations Sinusitis	0.00% 0/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	7.3% 4/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	5.3% 3/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Infections and infestations Gastroenteritis	1.8% 1/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	5.3% 3/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	7.0% 4/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Infections and infestations Oral herpes	1.8% 1/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	3.6% 2/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	5.3% 3/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Infections and infestations Urinary tract infection	5.4% 3/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	5.5% 3/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Infections and infestations Rhinitis	5.4% 3/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	5.3% 3/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Infections and infestations Folliculitis	3.6% 2/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	5.3% 3/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Skin and subcutaneous tissue disorders Dermatitis atopic	32.1% 18/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	20.0% 11/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	22.8% 13/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	28.1% 16/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	5.3% 3/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Respiratory, thoracic and mediastinal disorders Asthma	1.8% 1/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	3.6% 2/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	12.3% 7/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	17.5% 10/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Respiratory, thoracic and mediastinal disorders Cough	3.6% 2/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	5.3% 3/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	3.5% 2/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Investigations Blood creatine phosphokinase increased	7.1% 4/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	3.6% 2/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
General disorders Pyrexia	0.00% 0/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	5.3% 3/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Musculoskeletal and connective tissue disorders Back pain	3.6% 2/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	5.3% 3/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	3.5% 2/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Musculoskeletal and connective tissue disorders Arthralgia	1.8% 1/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	5.3% 3/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Gastrointestinal disorders Diarrhoea	5.4% 3/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	5.5% 3/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	5.3% 3/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Gastrointestinal disorders Nausea	5.4% 3/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	7.3% 4/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Gastrointestinal disorders Abdominal pain	1.8% 1/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	1.8% 1/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	5.3% 3/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	0.00% 0/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.
Nervous system disorders Headache	12.5% 7/56 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	12.7% 7/55 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	7.0% 4/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.	8.8% 5/57 • From screening to Follow-up visit (Week 32)/Early termination visit Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of the causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product. Note: All participants in ITT population who received at least one dose of study drug were included.

Additional Information

Kenny Frazier

Galderma

Phone: 817-961-5120

Email: Kenny.frazier@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee All the information provided to the investigator and his/her staff and all data obtained through this clinical trial are confidential. The Sponsor reserves all proprietary rights. No information may be disclosed to any third party without prior written consent from the Sponsor.
• Publication restrictions are in place

Restriction type: OTHER