Atopic Dermatitis
Conditions
Brief summary
Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving TCS, who were not adequately controlled with topical treatments.
Detailed description
The aim of the study is to assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving topical corticosteroids, who were not adequately controlled with topical treatments.
Interventions
DRUGNemolizumab
Injection every 4 weeks during 24 weeks (last injection at week 20)
DRUGPlacebo
Injection every 4 weeks during 24 weeks (last injection at week 20)
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects ≥ 18 years (or legal age when higher) * Chronic AD, that has been present for at least 2 years before the visit * Eczema Area and Severity Index (EASI) score ≥12 * Investigator Global Assessment (IGA) score ≥ 3 * AD involvement ≥ 10% of Body Surface Area (BSA) * Severe pruritus on at least 3 of the last 7 days before the visit * Documented recent history (within 6 months before the visit) of inadequate response to topical medications * Female subjects must fulfill one of the criteria below: * Female subjects of non-childbearing potential * Female subjects of childbearing potential who agree to a true abstinence or to use an effective or highly effective method of contraception throughout the clinical trial and for 120 days after the last study drug administration
Exclusion criteria
* Body weight \< 45 kg * subjects with a medical history of asthma requiring hospitalization in the last 12 months before screening visit and/or whose asthma has not been well-controlled during the last 3 months before the screening visit and/or Peak Expiratory Flow (PEF) \<80% of the predicted value * Cutaneous bacterial or viral infection within 1 week before the screening visit or during the run-in period * Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit or during the run-in period * History of intolerance to low or mid potency TCS or for whom TCS is not advisable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24 | From Baseline to Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24 | From Week 1 to Week 24 | 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. |
| Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24 | Baseline, Week 24 | 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. |
| Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24 | Baseline, Week 24 | 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. |
| Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24 | Baseline, Week 24 | 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. |
| Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24 | Baseline, Week 24 | 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. |
| 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 | From Week 1 to Week 24 | 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. |
| 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 | From Week 1 to Week 24 | 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. |
| 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 | From Week 1 to Week 24 | 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. |
| Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24 | Week 24 | 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. |
| 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 to Week 24 | 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. |
| Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | From Baseline to Week 24 | 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. |
| Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | At baseline and Week 24 | 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. |
| Number of Participants With Adverse Events | From screening to Follow-up visit (Week 32)/Early termination visit | To evaluate the safety of nemolizumab in participants with moderate-to-severe AD |
| Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Baseline to Week 24 | 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. |
| Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Baseline to Week 24 | 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. |
| Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Baseline to Week 24 | 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. |
| 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 | From Week 1 to Week 24 | 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. |
Countries
Australia, Canada, France, Germany, Poland, United States
Participant flow
Recruitment details
This study was conducted at 57 investigational sites in Australia, Canada, Germany, France, Poland and the United States.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 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. | 57 |
| Nemolizumab (10 mg) 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. | 55 |
| 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 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. | 57 |
| 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) 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. | 57 |
| Total | 226 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 | 2 | 3 |
| Overall Study | Lack of Efficacy | 2 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 10 | 7 | 4 | 8 |
Baseline characteristics
| Characteristic | Placebo | Nemolizumab (10 mg) | Nemolizumab (30 mg) | Nemolizumab (90 mg) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 6 Participants | 6 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants | 53 Participants | 51 Participants | 51 Participants | 209 Participants |
| Age, Continuous | 40.9 years STANDARD_DEVIATION 15.01 | 35.3 years STANDARD_DEVIATION 14.83 | 40.2 years STANDARD_DEVIATION 16.64 | 40.9 years STANDARD_DEVIATION 14.95 | 39.3 years STANDARD_DEVIATION 15.45 |
| Body mass index | 27.79 kilogram per square metre STANDARD_DEVIATION 5.638 | 25.54 kilogram per square metre STANDARD_DEVIATION 4.429 | 26.18 kilogram per square metre STANDARD_DEVIATION 6.37 | 27.51 kilogram per square metre STANDARD_DEVIATION 6.694 | 26.77 kilogram per square metre STANDARD_DEVIATION 5.894 |
| Height | 170.0 centimetre STANDARD_DEVIATION 10.28 | 169.7 centimetre STANDARD_DEVIATION 8.98 | 171.5 centimetre STANDARD_DEVIATION 8.55 | 170.6 centimetre STANDARD_DEVIATION 9.94 | 170.5 centimetre STANDARD_DEVIATION 9.43 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 11 Participants | 6 Participants | 4 Participants | 25 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 3 Participants | 10 Participants | 8 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 45 Participants | 38 Participants | 40 Participants | 44 Participants | 167 Participants |
| Sex: Female, Male Female | 26 Participants | 26 Participants | 28 Participants | 31 Participants | 111 Participants |
| Sex: Female, Male Male | 31 Participants | 29 Participants | 29 Participants | 26 Participants | 115 Participants |
| Weight | 80.58 kilogram STANDARD_DEVIATION 18.835 | 73.72 kilogram STANDARD_DEVIATION 14.629 | 76.90 kilogram STANDARD_DEVIATION 18.613 | 80.49 kilogram STANDARD_DEVIATION 22.77 | 77.96 kilogram STANDARD_DEVIATION 19.052 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 1 / 55 | 0 / 57 | 0 / 57 |
| other Total, other adverse events | 43 / 56 | 47 / 55 | 47 / 57 | 47 / 57 |
| serious Total, serious adverse events | 1 / 56 | 3 / 55 | 2 / 57 | 2 / 57 |
Outcome results
Primary
Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24
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.
Time frame: From Baseline to Week 24
Population: All participants in intent-to-treat (ITT) population who received at least one dose of study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24 | -58.4 percentage change | Standard Deviation 31.99 |
| Nemolizumab (10 mg) | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24 | -72.2 percentage change | Standard Deviation 25.96 |
| Nemolizumab (30 mg) | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24 | -73.4 percentage change | Standard Deviation 29.67 |
| Nemolizumab (90 mg) | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24 | -69.2 percentage change | Standard Deviation 31.06 |
p-value: 0.05195% CI: [-27.3, 0]Kenward-Rogers
p-value: 0.01695% CI: [-30.2, -3.2]Kenward Roger
p-value: 0.32295% CI: [-20.5, 6.8]Kenward Roger
Secondary
Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24
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.
Time frame: Baseline, Week 24
Population: ITT population: All randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24 | -27.9 units on a scale | Standard Deviation 19.61 |
| Nemolizumab (10 mg) | Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24 | -40.1 units on a scale | Standard Deviation 19.19 |
| Nemolizumab (30 mg) | Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24 | -40.6 units on a scale | Standard Deviation 17.22 |
| Nemolizumab (90 mg) | Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24 | -36.1 units on a scale | Standard Deviation 16.56 |
p-value: 0.01695% CI: [-17.5, -1.8]Kenward Roger
p-value: 0.00195% CI: [-20.6, -5.1]Kenward Roger
p-value: 0.05895% CI: [-15.4, 0.3]Kenward Roger
Secondary
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
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.
Time frame: Baseline to Week 24
Population: ITT population: All randomized participants. Number of participants in this analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Nemolizumab (10 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 8 | -4.1 units on a scale | Standard Deviation 2.42 |
| Nemolizumab (10 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 16 | -5.3 units on a scale | Standard Deviation 2.18 |
| Nemolizumab (10 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 1 | -2.0 units on a scale | Standard Deviation 1.94 |
| Nemolizumab (10 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 12 | -4.9 units on a scale | Standard Deviation 2.48 |
| Nemolizumab (10 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 2 | -3.1 units on a scale | Standard Deviation 2.32 |
| Nemolizumab (10 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 24 | -5.5 units on a scale | Standard Deviation 2.53 |
| Nemolizumab (10 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 20 | -5.3 units on a scale | Standard Deviation 2.47 |
| Nemolizumab (10 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 4 | -3.5 units on a scale | Standard Deviation 2.47 |
| Nemolizumab (30 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 8 | -4.9 units on a scale | Standard Deviation 2.13 |
| Nemolizumab (30 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 12 | -5.5 units on a scale | Standard Deviation 2.29 |
| Nemolizumab (30 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 1 | -2.3 units on a scale | Standard Deviation 1.86 |
| Nemolizumab (30 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 2 | -3.3 units on a scale | Standard Deviation 1.89 |
| Nemolizumab (30 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 4 | -4.1 units on a scale | Standard Deviation 2.16 |
| Nemolizumab (30 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 16 | -5.7 units on a scale | Standard Deviation 2.19 |
| Nemolizumab (30 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 20 | -5.8 units on a scale | Standard Deviation 2.18 |
| Nemolizumab (30 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 24 | -5.6 units on a scale | Standard Deviation 2.49 |
| Nemolizumab (90 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 8 | -4.7 units on a scale | Standard Deviation 2.39 |
| Nemolizumab (90 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 2 | -3.3 units on a scale | Standard Deviation 2.5 |
| Nemolizumab (90 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 24 | -5.2 units on a scale | Standard Deviation 2.19 |
| Nemolizumab (90 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 20 | -5.3 units on a scale | Standard Deviation 2.5 |
| Nemolizumab (90 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 1 | -1.8 units on a scale | Standard Deviation 1.64 |
| Nemolizumab (90 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 12 | -4.6 units on a scale | Standard Deviation 2.5 |
| Nemolizumab (90 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 4 | -3.8 units on a scale | Standard Deviation 2.63 |
| Nemolizumab (90 mg) | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 16 | -5.1 units on a scale | Standard Deviation 2.59 |
Comparison: Week 24p-value: <0.00195% CI: [-3, -0.9]Kenward Roger
Comparison: Week 24p-value: <0.00195% CI: [-3.6, -1.6]Kenward Roger
Comparison: Week 24p-value: <0.00195% CI: [-3.1, -1.1]Kenward Roger
Secondary
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
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.
Time frame: Baseline to Week 24
Population: ITT population: All randomized participants. Number of participants in this analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Nemolizumab (10 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 8 | -4.1 units on a scale | Standard Deviation 2.58 |
| Nemolizumab (10 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 16 | -5.2 units on a scale | Standard Deviation 2.34 |
| Nemolizumab (10 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 12 | -4.9 units on a scale | Standard Deviation 2.45 |
| Nemolizumab (10 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 2 | -3.1 units on a scale | Standard Deviation 2.34 |
| Nemolizumab (10 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 20 | -5.4 units on a scale | Standard Deviation 2.61 |
| Nemolizumab (10 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 4 | -3.4 units on a scale | Standard Deviation 2.62 |
| Nemolizumab (10 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 1 | -2.0 units on a scale | Standard Deviation 1.96 |
| Nemolizumab (10 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 24 | -5.6 units on a scale | Standard Deviation 2.55 |
| Nemolizumab (30 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 16 | -5.8 units on a scale | Standard Deviation 2.25 |
| Nemolizumab (30 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 1 | -2.3 units on a scale | Standard Deviation 1.89 |
| Nemolizumab (30 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 2 | -3.4 units on a scale | Standard Deviation 1.96 |
| Nemolizumab (30 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 4 | -4.2 units on a scale | Standard Deviation 2.21 |
| Nemolizumab (30 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 8 | -5.0 units on a scale | Standard Deviation 2.14 |
| Nemolizumab (30 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 12 | -5.6 units on a scale | Standard Deviation 2.29 |
| Nemolizumab (30 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 20 | -5.9 units on a scale | Standard Deviation 2.22 |
| Nemolizumab (30 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 24 | -5.8 units on a scale | Standard Deviation 2.54 |
| Nemolizumab (90 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 4 | -3.8 units on a scale | Standard Deviation 2.73 |
| Nemolizumab (90 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 2 | -3.3 units on a scale | Standard Deviation 2.56 |
| Nemolizumab (90 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 24 | -5.5 units on a scale | Standard Deviation 2.33 |
| Nemolizumab (90 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 20 | -5.4 units on a scale | Standard Deviation 2.66 |
| Nemolizumab (90 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 1 | -1.7 units on a scale | Standard Deviation 1.66 |
| Nemolizumab (90 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 16 | -5.1 units on a scale | Standard Deviation 2.77 |
| Nemolizumab (90 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 12 | -4.7 units on a scale | Standard Deviation 2.66 |
| Nemolizumab (90 mg) | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 8 | -4.7 units on a scale | Standard Deviation 2.54 |
Comparison: Week 24p-value: <0.00195% CI: [-3, -1]Kenward Roger
Comparison: Week 24p-value: <0.00195% CI: [-3.8, -1.8]Kenward Roger
Comparison: Week 24p-value: <0.00195% CI: [-3.3, -1.3]Kenward Roger
Secondary
Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24
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.
Time frame: Baseline, Week 24
Population: ITT population: All randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| Nemolizumab (10 mg) | Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24 | -6.2 units on a scale | Standard Deviation 2.34 |
| Nemolizumab (30 mg) | Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24 | -5.7 units on a scale | Standard Deviation 2.51 |
| Nemolizumab (90 mg) | Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24 | -5.8 units on a scale | Standard Deviation 2.62 |
p-value: <0.00195% CI: [-3.1, -1]Kenward Roger
p-value: <0.00195% CI: [-3.4, -1.3]Kenward Roger
p-value: <0.00195% CI: [-3, -0.9]Kenward Roger
Secondary
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
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.
Time frame: Week 1 to Week 24
Population: All participants in ITT population who received at least one dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Nemolizumab (10 mg) | 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 | 9 Participants |
| Nemolizumab (10 mg) | 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 |
| Nemolizumab (10 mg) | 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 | 1 Participants |
| Nemolizumab (10 mg) | 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 | 14 Participants |
| Nemolizumab (10 mg) | 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 | 11 Participants |
| Nemolizumab (10 mg) | 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 | 3 Participants |
| Nemolizumab (10 mg) | 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 | 1 Participants |
| Nemolizumab (10 mg) | 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 |
| Nemolizumab (30 mg) | 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 | 19 Participants |
| Nemolizumab (30 mg) | 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 | 9 Participants |
| Nemolizumab (30 mg) | 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 | 10 Participants |
| Nemolizumab (30 mg) | 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 | 15 Participants |
| Nemolizumab (30 mg) | 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 | 19 Participants |
| Nemolizumab (30 mg) | 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 | 21 Participants |
| Nemolizumab (30 mg) | 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 | 2 Participants |
| Nemolizumab (30 mg) | 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 | 4 Participants |
| Nemolizumab (90 mg) | 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 | 7 Participants |
| Nemolizumab (90 mg) | 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 | 11 Participants |
| Nemolizumab (90 mg) | 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 | 1 Participants |
| Nemolizumab (90 mg) | 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 | 0 Participants |
| Nemolizumab (90 mg) | 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 | 15 Participants |
| Nemolizumab (90 mg) | 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 | 13 Participants |
| Nemolizumab (90 mg) | 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 | 14 Participants |
| Nemolizumab (90 mg) | 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 | 15 Participants |
Comparison: Week 1p-value: 0.9795% CI: [-4.9, 5.1]Cochran-Mantel-Haenszel
Comparison: Week 1p-value: 0.57495% CI: [-4.1, 7.5]Cochran-Mantel-Haenszel
Comparison: Week 1p-value: 0.31195% CI: [-5.2, 1.7]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.55895% CI: [-7.7, 4.1]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.41395% CI: [-4.7, 11.6]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.54395% CI: [-7.7, 4]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.58395% CI: [-7.6, 4.2]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.02895% CI: [1.8, 22.5]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.08795% CI: [-0.9, 18.3]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.63295% CI: [-5.6, 9.4]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.01695% CI: [3.1, 24.8]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.00995% CI: [4.5, 27]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.97495% CI: [-11.2, 11.6]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.03195% CI: [1.8, 29.3]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.03295% CI: [1.8, 29.5]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.55395% CI: [-9, 16.9]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.00895% CI: [6.1, 35.8]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.06195% CI: [-0.3, 28.2]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.58595% CI: [-10.1, 18]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.03295% CI: [2, 32.8]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.25495% CI: [-5.9, 23.1]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.59895% CI: [-11.3, 19.8]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.06695% CI: [-0.4, 31.4]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.82695% CI: [-13.5, 16.9]Cochran-Mantel-Haenszel
Secondary
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
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.
Time frame: From Week 1 to Week 24
Population: ITT population: All randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Nemolizumab (10 mg) | 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 | 9 Participants |
| Nemolizumab (10 mg) | 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 |
| Nemolizumab (10 mg) | 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 | 1 Participants |
| Nemolizumab (10 mg) | 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 | 14 Participants |
| Nemolizumab (10 mg) | 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 | 11 Participants |
| Nemolizumab (10 mg) | 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 | 3 Participants |
| Nemolizumab (10 mg) | 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 | 1 Participants |
| Nemolizumab (10 mg) | 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 |
| Nemolizumab (30 mg) | 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 | 19 Participants |
| Nemolizumab (30 mg) | 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 | 9 Participants |
| Nemolizumab (30 mg) | 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 | 10 Participants |
| Nemolizumab (30 mg) | 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 | 15 Participants |
| Nemolizumab (30 mg) | 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 | 19 Participants |
| Nemolizumab (30 mg) | 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 | 21 Participants |
| Nemolizumab (30 mg) | 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 | 2 Participants |
| Nemolizumab (30 mg) | 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 | 4 Participants |
| Nemolizumab (90 mg) | 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 | 7 Participants |
| Nemolizumab (90 mg) | 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 | 11 Participants |
| Nemolizumab (90 mg) | 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 | 1 Participants |
| Nemolizumab (90 mg) | 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 | 0 Participants |
| Nemolizumab (90 mg) | 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 | 15 Participants |
| Nemolizumab (90 mg) | 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 | 13 Participants |
| Nemolizumab (90 mg) | 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 | 14 Participants |
| Nemolizumab (90 mg) | 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 | 15 Participants |
Comparison: At week 1p-value: 0.9795% CI: [-4.9, 5.1]Cochran-Mantel-Haenszel
Comparison: At week 1p-value: 0.57495% CI: [-4.1, 7.5]Cochran-Mantel-Haenszel
Comparison: At week 1p-value: 0.31195% CI: [-5.2, 1.7]Cochran-Mantel-Haenszel
Comparison: At week 24p-value: 0.59895% CI: [-11.3, 19.8]Cochran-Mantel-Haenszel
Comparison: At week 24p-value: 0.06695% CI: [-0.4, 31.4]Cochran-Mantel-Haenszel
Comparison: At week 24p-value: 0.82695% CI: [-13.5, 16.9]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.55895% CI: [-7.7, 4.1]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.41395% CI: [-4.7, 11.6]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.54395% CI: [-7.7, 4]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.58395% CI: [-7.6, 4.2]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.02895% CI: [1.8, 22.5]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.08795% CI: [-0.9, 18.3]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.63295% CI: [-5.6, 9.4]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.01695% CI: [3.1, 24.8]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.00995% CI: [4.5, 27]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.97495% CI: [-11.2, 11.6]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.03195% CI: [1.8, 29.3]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.03295% CI: [-0.3, 28.2]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.55395% CI: [-9, 16.9]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.00895% CI: [6.1, 35.8]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.06195% CI: [-0.3, 28.2]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.58595% CI: [-10.1, 18]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.03295% CI: [2, 32.8]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.25495% CI: [-5.9, 23.1]Cochran-Mantel-Haenszel
Secondary
Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24
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.
Time frame: Week 24
Population: ITT population: All randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | 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 |
| Nemolizumab (10 mg) | Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24 | 23 Participants |
| Nemolizumab (30 mg) | Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24 | 31 Participants |
| Nemolizumab (90 mg) | Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24 | 20 Participants |
p-value: 0.03495% CI: [2, 35.8]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [14.7, 48.2]Cochran-Mantel-Haenszel
p-value: 0.15495% CI: [-4.2, 28.6]Cochran-Mantel-Haenszel
Secondary
Number of Participants With Adverse Events
To evaluate the safety of nemolizumab in participants with moderate-to-severe AD
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events | Subjects with TEAE leading to temporary study drug | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Subjects with TEAE leading to study withdrawal | 0 Participants |
| Placebo | Number of Participants With Adverse Events | Subjects with TEAE leading to permanent study drug | 4 Participants |
| Placebo | Number of Participants With Adverse Events | Subjects with treatment-emergent SAEs | 1 Participants |
| Placebo | Number of Participants With Adverse Events | Subjects with at least 1 TEAE | 43 Participants |
| Placebo | Number of Participants With Adverse Events | Subjects with severe TEAEs | 6 Participants |
| Placebo | Number of Participants With Adverse Events | Treatment-emergent AEs (TEAE) with fatal outcome | 0 Participants |
| Nemolizumab (10 mg) | Number of Participants With Adverse Events | Subjects with at least 1 TEAE | 47 Participants |
| Nemolizumab (10 mg) | Number of Participants With Adverse Events | Subjects with severe TEAEs | 3 Participants |
| Nemolizumab (10 mg) | Number of Participants With Adverse Events | Subjects with TEAE leading to study withdrawal | 3 Participants |
| Nemolizumab (10 mg) | Number of Participants With Adverse Events | Subjects with TEAE leading to temporary study drug | 1 Participants |
| Nemolizumab (10 mg) | Number of Participants With Adverse Events | Subjects with TEAE leading to permanent study drug | 4 Participants |
| Nemolizumab (10 mg) | Number of Participants With Adverse Events | Treatment-emergent AEs (TEAE) with fatal outcome | 1 Participants |
| Nemolizumab (10 mg) | Number of Participants With Adverse Events | Subjects with treatment-emergent SAEs | 3 Participants |
| Nemolizumab (30 mg) | Number of Participants With Adverse Events | Subjects with TEAE leading to study withdrawal | 2 Participants |
| Nemolizumab (30 mg) | Number of Participants With Adverse Events | Subjects with at least 1 TEAE | 47 Participants |
| Nemolizumab (30 mg) | Number of Participants With Adverse Events | Subjects with treatment-emergent SAEs | 2 Participants |
| Nemolizumab (30 mg) | Number of Participants With Adverse Events | Treatment-emergent AEs (TEAE) with fatal outcome | 0 Participants |
| Nemolizumab (30 mg) | Number of Participants With Adverse Events | Subjects with TEAE leading to temporary study drug | 2 Participants |
| Nemolizumab (30 mg) | Number of Participants With Adverse Events | Subjects with TEAE leading to permanent study drug | 2 Participants |
| Nemolizumab (30 mg) | Number of Participants With Adverse Events | Subjects with severe TEAEs | 5 Participants |
| Nemolizumab (90 mg) | Number of Participants With Adverse Events | Subjects with TEAE leading to temporary study drug | 1 Participants |
| Nemolizumab (90 mg) | Number of Participants With Adverse Events | Treatment-emergent AEs (TEAE) with fatal outcome | 0 Participants |
| Nemolizumab (90 mg) | Number of Participants With Adverse Events | Subjects with at least 1 TEAE | 48 Participants |
| Nemolizumab (90 mg) | Number of Participants With Adverse Events | Subjects with treatment-emergent SAEs | 2 Participants |
| Nemolizumab (90 mg) | Number of Participants With Adverse Events | Subjects with TEAE leading to study withdrawal | 3 Participants |
| Nemolizumab (90 mg) | Number of Participants With Adverse Events | Subjects with severe TEAEs | 2 Participants |
| Nemolizumab (90 mg) | Number of Participants With Adverse Events | Subjects with TEAE leading to permanent study drug | 7 Participants |
Secondary
Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24
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.
Time frame: From Week 1 to Week 24
Population: ITT population: All randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Nemolizumab (10 mg) | 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 | 9 Participants |
| Nemolizumab (10 mg) | 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 | 22 Participants |
| Nemolizumab (10 mg) | 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 | 26 Participants |
| Nemolizumab (10 mg) | 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 | 25 Participants |
| Nemolizumab (10 mg) | 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 | 19 Participants |
| Nemolizumab (10 mg) | 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 | 27 Participants |
| Nemolizumab (10 mg) | 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 | 30 Participants |
| Nemolizumab (10 mg) | 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 | 19 Participants |
| Nemolizumab (30 mg) | 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 | 39 Participants |
| Nemolizumab (30 mg) | 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 | 34 Participants |
| Nemolizumab (30 mg) | 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 | 21 Participants |
| Nemolizumab (30 mg) | 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 | 28 Participants |
| Nemolizumab (30 mg) | 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 | 27 Participants |
| Nemolizumab (30 mg) | 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 | 10 Participants |
| Nemolizumab (30 mg) | 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 | 36 Participants |
| Nemolizumab (30 mg) | 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 | 38 Participants |
| Nemolizumab (90 mg) | 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 | 24 Participants |
| Nemolizumab (90 mg) | 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 | 6 Participants |
| Nemolizumab (90 mg) | 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 | 17 Participants |
| Nemolizumab (90 mg) | 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 | 22 Participants |
| Nemolizumab (90 mg) | 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 | 26 Participants |
| Nemolizumab (90 mg) | 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 | 24 Participants |
| Nemolizumab (90 mg) | 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 | 25 Participants |
| Nemolizumab (90 mg) | 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 | 27 Participants |
Comparison: Week 1p-value: 0.06295% CI: [-0.4, 22.2]Cochran-Mantel-Haenszel
Comparison: Week 1p-value: 0.04295% CI: [0.8, 23.6]Cochran-Mantel-Haenszel
Comparison: Week 1p-value: 0.30795% CI: [-4.7, 15]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.00395% CI: [9.3, 38.7]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.00195% CI: [11.4, 40.9]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.01195% CI: [4.9, 33.1]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: <0.00195% CI: [13.5, 41.7]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: <0.00195% CI: [25.7, 54.8]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: <0.00195% CI: [17.4, 45.8]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.01895% CI: [4.2, 37.1]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: <195% CI: [27.6, 59.9]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.00395% CI: [9.7, 42.6]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.00795% CI: [7.3, 41.4]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: <0.00195% CI: [27.4, 59.9]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.0395% CI: [2.4, 35.9]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: <0.00195% CI: [16.4, 50.2]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: <0.00195% CI: [31.2, 63.2]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.0195% CI: [6.1, 39.4]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.00495% CI: [9.2, 43.5]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: <0.00195% CI: [20.1, 53.3]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.00795% CI: [7.6, 41.4]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.02295% CI: [3.6, 38.1]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.00795% CI: [7.4, 41.3]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.0595% CI: [0.4, 34.4]Cochran-Mantel-Haenszel
Secondary
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
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.
Time frame: From Week 1 to Week 24
Population: ITT Population:All randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Nemolizumab (10 mg) | 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 | 26 Participants |
| Nemolizumab (10 mg) | 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 | 30 Participants |
| Nemolizumab (10 mg) | 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 | 30 Participants |
| Nemolizumab (10 mg) | 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 | 18 Participants |
| Nemolizumab (10 mg) | 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 | 32 Participants |
| Nemolizumab (10 mg) | 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 | 22 Participants |
| Nemolizumab (10 mg) | 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 | 6 Participants |
| Nemolizumab (10 mg) | 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 | 33 Participants |
| Nemolizumab (30 mg) | 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 | 34 Participants |
| Nemolizumab (30 mg) | 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 | 12 Participants |
| Nemolizumab (30 mg) | 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 | 18 Participants |
| Nemolizumab (30 mg) | 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 | 29 Participants |
| Nemolizumab (30 mg) | 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 | 31 Participants |
| Nemolizumab (30 mg) | 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 | 36 Participants |
| Nemolizumab (30 mg) | 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 | 38 Participants |
| Nemolizumab (30 mg) | 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 | 38 Participants |
| Nemolizumab (90 mg) | 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 | 24 Participants |
| Nemolizumab (90 mg) | 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 | 21 Participants |
| Nemolizumab (90 mg) | 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 | 31 Participants |
| Nemolizumab (90 mg) | 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 | 33 Participants |
| Nemolizumab (90 mg) | 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 | 11 Participants |
| Nemolizumab (90 mg) | 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 | 32 Participants |
| Nemolizumab (90 mg) | 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 | 30 Participants |
| Nemolizumab (90 mg) | 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 | 31 Participants |
Comparison: Week 1p-value: 0.48795% CI: [-6.8, 14.3]Cochran-Mantel-Haenszel
Comparison: Week 1p-value: 0.03395% CI: [1.6, 26.5]Cochran-Mantel-Haenszel
Comparison: Week 1p-value: 0.05395% CI: [0.2, 23.8]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.02195% CI: [3.2, 33.8]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.02795% CI: [2.4, 32.3]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.00695% CI: [7.3, 38.1]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.08695% CI: [-1.7, 32.2]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.00495% CI: [9.3, 43.1]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.0595% CI: [0.5, 34.2]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.02395% CI: [3.3, 38.1]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.00295% CI: [10.7, 45]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.00295% CI: [10.7, 45]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.04195% CI: [1.3, 37.3]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.00395% CI: [10.4, 45.4]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.06395% CI: [-0.5, 35.2]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.06495% CI: [-0.4, 35.6]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.01695% CI: [4.9, 40.3]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.04195% CI: [1.3, 36.9]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.06495% CI: [-0.4, 35.6]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.00595% CI: [8.6, 43.4]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.06495% CI: [-0.6, 35]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.09495% CI: [-2, 33.8]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.01495% CI: [5.1, 39.6]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.27395% CI: [-7.7, 28]Cochran-Mantel-Haenszel
Secondary
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
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.
Time frame: From Week 1 to Week 24
Population: ITT Population: All randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Nemolizumab (10 mg) | 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 | 18 Participants |
| Nemolizumab (10 mg) | 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 | 15 Participants |
| Nemolizumab (10 mg) | 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 | 5 Participants |
| Nemolizumab (10 mg) | 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 | 20 Participants |
| Nemolizumab (10 mg) | 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 | 21 Participants |
| Nemolizumab (10 mg) | 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 | 10 Participants |
| Nemolizumab (10 mg) | 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 | 7 Participants |
| Nemolizumab (10 mg) | 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 |
| Nemolizumab (30 mg) | 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 | 25 Participants |
| Nemolizumab (30 mg) | 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 | 12 Participants |
| Nemolizumab (30 mg) | 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 | 21 Participants |
| Nemolizumab (30 mg) | 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 | 25 Participants |
| Nemolizumab (30 mg) | 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 | 28 Participants |
| Nemolizumab (30 mg) | 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 | 26 Participants |
| Nemolizumab (30 mg) | 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 | 3 Participants |
| Nemolizumab (30 mg) | 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 | 6 Participants |
| Nemolizumab (90 mg) | 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 | 15 Participants |
| Nemolizumab (90 mg) | 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 | 15 Participants |
| Nemolizumab (90 mg) | 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 | 12 Participants |
| Nemolizumab (90 mg) | 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 | 3 Participants |
| Nemolizumab (90 mg) | 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 | 21 Participants |
| Nemolizumab (90 mg) | 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 | 25 Participants |
| Nemolizumab (90 mg) | 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 | 21 Participants |
| Nemolizumab (90 mg) | 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 | 21 Participants |
Comparison: Week 1p-value: 0.97995% CI: [-6.8, 7]Cochran-Mantel-Haenszel
Comparison: Week 1p-value: 0.66895% CI: [-5.8, 9]Cochran-Mantel-Haenszel
Comparison: Week 1p-value: 0.65895% CI: [-5.8, 9.2]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.6995% CI: [-8, 12.2]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.52195% CI: [-6.9, 13.7]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.03395% CI: [1.5, 26.5]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.17295% CI: [-3.1, 18]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.01495% CI: [3.7, 27.7]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.00295% CI: [8.2, 33.9]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.40495% CI: [-7.5, 18.8]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.00395% CI: [9.4, 39.6]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.05995% CI: [-0.1, 28.2]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.22295% CI: [-5.6, 25]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.00395% CI: [10, 42.3]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.2295% CI: [3.3, 35]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.11195% CI: [-2.8, 29.3]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: <0.00195% CI: [13.2, 46]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.0495% CI: [1.3, 33.6]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.26295% CI: [-7.3, 27.4]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.32795% CI: [-8.4, 25.7]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.08395% CI: [-1.7, 33.1]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.25595% CI: [-7, 27.2]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.03495% CI: [2.2, 35.9]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.05395% CI: [0.3, 34.6]Cochran-Mantel-Haenszel
Secondary
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
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.
Time frame: From Week 1 to Week 24
Population: ITT Population: All randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Nemolizumab (10 mg) | 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 | 10 Participants |
| Nemolizumab (10 mg) | 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 | 7 Participants |
| Nemolizumab (10 mg) | 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 | 0 Participants |
| Nemolizumab (10 mg) | 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 | 13 Participants |
| Nemolizumab (10 mg) | 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 | 13 Participants |
| Nemolizumab (10 mg) | 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 | 3 Participants |
| Nemolizumab (10 mg) | 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 | 1 Participants |
| Nemolizumab (10 mg) | 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 |
| Nemolizumab (30 mg) | 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 | 18 Participants |
| Nemolizumab (30 mg) | 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 | 4 Participants |
| Nemolizumab (30 mg) | 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 | 11 Participants |
| Nemolizumab (30 mg) | 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 | 13 Participants |
| Nemolizumab (30 mg) | 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 | 19 Participants |
| Nemolizumab (30 mg) | 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 | 17 Participants |
| Nemolizumab (30 mg) | 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 | 2 Participants |
| Nemolizumab (30 mg) | 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 |
| Nemolizumab (90 mg) | 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 | 3 Participants |
| Nemolizumab (90 mg) | 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 | 6 Participants |
| Nemolizumab (90 mg) | 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 |
| Nemolizumab (90 mg) | 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 |
| Nemolizumab (90 mg) | 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 | 14 Participants |
| Nemolizumab (90 mg) | 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 | 13 Participants |
| Nemolizumab (90 mg) | 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 | 14 Participants |
| Nemolizumab (90 mg) | 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 | 12 Participants |
Comparison: Week 1p-value: 0.9795% CI: [-4.9, 5.1]Cochran-Mantel-Haenszel
Comparison: Week 1p-value: 0.57495% CI: [-4.1, 7.5]Cochran-Mantel-Haenszel
Comparison: Week 1p-value: 0.98595% CI: [-4.8, 4.8]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.15495% CI: [-8.4, 1.2]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.97895% CI: [-6.8, 6.6]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.97895% CI: [-6.8, 6.6]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.60295% CI: [-7.5, 4.3]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.41395% CI: [-4.5, 11.4]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.65895% CI: [-5.7, 9.1]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.30795% CI: [-3.2, 10.3]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.00295% CI: [6.9, 27.8]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.05495% CI: [0.1, 17.4]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.32595% CI: [-5.4, 16.5]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.01995% CI: [3.1, 28.1]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.01195% CI: [4.5, 30.5]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.15395% CI: [-3.2, 21.7]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.00195% CI: [10.3, 38.4]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.06995% CI: [-0.7, 25.1]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.0795% CI: [-0.8, 26.6]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.00695% CI: [6.5, 35.3]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.05295% CI: [0.3, 27.7]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.06995% CI: [-0.7, 26.3]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.01195% CI: [4.9, 33.3]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.08395% CI: [-1.3, 25.7]Cochran-Mantel-Haenszel
Secondary
Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24
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.
Time frame: From Baseline to Week 24
Population: ITT population: All randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 2 | -34.9 Percentage of change | Standard Deviation 27.7 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 1 | -22.7 Percentage of change | Standard Deviation 23.54 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 16 | -59.1 Percentage of change | Standard Deviation 33.09 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 12 | -58.5 Percentage of change | Standard Deviation 28.16 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 24 | -72.2 Percentage of change | Standard Deviation 25.96 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 8 | -42.0 Percentage of change | Standard Deviation 38.15 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 20 | -67.2 Percentage of change | Standard Deviation 35.18 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 4 | -40.3 Percentage of change | Standard Deviation 28.36 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 24 | -73.4 Percentage of change | Standard Deviation 29.67 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 1 | -29.3 Percentage of change | Standard Deviation 31.44 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 2 | -40.1 Percentage of change | Standard Deviation 26.96 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 4 | -46.7 Percentage of change | Standard Deviation 38.49 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 8 | -51.7 Percentage of change | Standard Deviation 47.73 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 12 | -64.1 Percentage of change | Standard Deviation 33.92 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 16 | -72.2 Percentage of change | Standard Deviation 27.59 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 20 | -71.6 Percentage of change | Standard Deviation 29.39 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 16 | -61.8 Percentage of change | Standard Deviation 41.62 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 4 | -41.8 Percentage of change | Standard Deviation 41.57 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 2 | -40.1 Percentage of change | Standard Deviation 32.83 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 12 | -56.7 Percentage of change | Standard Deviation 37.25 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 20 | -70.9 Percentage of change | Standard Deviation 27.07 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 1 | -28.6 Percentage of change | Standard Deviation 25.52 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 8 | -49.9 Percentage of change | Standard Deviation 37.21 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 | Week 24 | -69.2 Percentage of change | Standard Deviation 31.06 |
Comparison: Week 8p-value: 0.00395% CI: [-38.9, -7.9]Kenward Roger
Comparison: Week 1p-value: 0.04995% CI: [-20, 0]Kenward-Rogers
Comparison: Week 8p-value: 0.00995% CI: [-36, -5.2]Kenward Roger
Comparison: Week 12p-value: 0.02295% CI: [-29.4, -2.3]Kenward Roger
Comparison: Week 12p-value: <0.00195% CI: [-37.1, -10.2]Kenward Roger
Comparison: Week 1p-value: <0.00195% CI: [-26.7, -7]Kenward Roger
Comparison: Week 1p-value: 0.00295% CI: [-25.6, -5.8]Kenward Roger
Comparison: Week 2p-value: 0.08495% CI: [-20.9, 1.3]Kenward Roger
Comparison: Week 2p-value: 0.00495% CI: [-27.2, -5.2]Kenward Roger
Comparison: Week 2p-value: 0.00895% CI: [-25.8, -3.8]Kenward Roger
Comparison: Week 4p-value: 0.04495% CI: [-27.5, -0.4]Kenward Roger
Comparison: Week 4p-value: 0.00295% CI: [-34.7, -7.6]Kenward Roger
Comparison: Week 4p-value: 0.02695% CI: [-28.8, -1.8]Kenward Roger
Comparison: Week 8p-value: 0.06295% CI: [-30.2, 0.7]Kenward Roger
Comparison: Week 12p-value: 0.03295% CI: [-28.1, -1.3]Kenward Roger
Comparison: Week 16p-value: 0.0795% CI: [-28.6, 1.1]Kenward Roger
Comparison: Week 16p-value: 0.00295% CI: [-38.5, -8.9]Kenward Roger
Comparison: Week 16p-value: 0.15495% CI: [-25.6, 4.1]Kenward Roger
Comparison: Week 20p-value: 0.0995% CI: [-26, 1.9]Kenward Roger
Comparison: Week 20p-value: 0.02495% CI: [-29.7, -2.1]Kenward Roger
Comparison: Week 20p-value: 0.1895% CI: [-23.4, 4.4]Kenward Roger
Comparison: Week 24p-value: 0.05195% CI: [-27.3, 0]Kenward Roger
Comparison: Week 24p-value: 0.01695% CI: [-30.2, -3.2]Kenward Roger
Comparison: Week 24p-value: 0.32295% CI: [-20.5, 6.8]Kenward Roger
Secondary
Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
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.
Time frame: Baseline to Week 24
Population: ITT population: All randomized participants. Number of participants in this analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 32.6 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 24 | -68.7 Percentage of change | Standard Deviation 30.6 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 12 | -61.7 Percentage of change | Standard Deviation 30.02 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 16 | -66.8 Percentage of change | Standard Deviation 27.02 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 2 | -39.9 Percentage of change | Standard Deviation 29.89 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 1 | -24.6 Percentage of change | Standard Deviation 23.39 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 4 | -43.5 Percentage of change | Standard Deviation 31.66 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 20 | -67.5 Percentage of change | Standard Deviation 30.03 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 8 | -52.0 Percentage of change | Standard Deviation 29.5 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 16 | -73.9 Percentage of change | Standard Deviation 22.83 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 20 | -74.5 Percentage of change | Standard Deviation 24.85 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 2 | -45.2 Percentage of change | Standard Deviation 25.06 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 24 | -69.9 Percentage of change | Standard Deviation 35.76 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 4 | -55.8 Percentage of change | Standard Deviation 27.6 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 1 | -29.4 Percentage of change | Standard Deviation 28.24 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 8 | -65.1 Percentage of change | Standard Deviation 24.67 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 12 | -72.2 Percentage of change | Standard Deviation 25.36 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 24 | -70.5 Percentage of change | Standard Deviation 26.41 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 1 | -23.2 Percentage of change | Standard Deviation 22.63 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 2 | -40.4 Percentage of change | Standard Deviation 33.77 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 4 | -48.2 Percentage of change | Standard Deviation 33.16 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 8 | -61.5 Percentage of change | Standard Deviation 28.03 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 12 | -60.1 Percentage of change | Standard Deviation 29.77 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 16 | -67.1 Percentage of change | Standard Deviation 31.64 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 20 | -70.6 Percentage of change | Standard Deviation 29.39 |
Comparison: Week 24p-value: <0.00195% CI: [-37.7, -9.9]Kenward Roger
Comparison: Week 24p-value: <0.00195% CI: [-45, -17.7]Kenward Roger
Comparison: Week 24p-value: <0.00195% CI: [-43.2, -15.2]Kenward Roger
Secondary
Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
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.
Time frame: At baseline and Week 24
Population: ITT population: All randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 16 | -61.4 percentage of change | Standard Deviation 28.62 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 20 | -64.6 percentage of change | Standard Deviation 28.62 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 1 | -22.6 percentage of change | Standard Deviation 21.76 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 2 | -36.9 percentage of change | Standard Deviation 27.34 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 4 | -38.7 percentage of change | Standard Deviation 30.25 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 8 | -48.2 percentage of change | Standard Deviation 28.82 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 12 | -58.0 percentage of change | Standard Deviation 28.99 |
| Nemolizumab (10 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 24 | -65.8 percentage of change | Standard Deviation 29.94 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 1 | -25.5 percentage of change | Standard Deviation 30.15 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 2 | -42.1 percentage of change | Standard Deviation 23.91 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 12 | -68.7 percentage of change | Standard Deviation 25.04 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 24 | -66.9 percentage of change | Standard Deviation 38.6 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 16 | -71.7 percentage of change | Standard Deviation 22.53 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 8 | -61.5 percentage of change | Standard Deviation 24.16 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 20 | -69.9 percentage of change | Standard Deviation 26.3 |
| Nemolizumab (30 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 4 | -51.8 percentage of change | Standard Deviation 26.87 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 24 | -68.2 percentage of change | Standard Deviation 26.88 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 8 | -58.0 percentage of change | Standard Deviation 28.63 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 1 | -19.8 percentage of change | Standard Deviation 21.16 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 2 | -37.6 percentage of change | Standard Deviation 32.29 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 4 | -45.7 percentage of change | Standard Deviation 32.64 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 12 | -56.4 percentage of change | Standard Deviation 29.81 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 16 | -63.7 percentage of change | Standard Deviation 33.07 |
| Nemolizumab (90 mg) | Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 | Week 20 | -69.7 percentage of change | Standard Deviation 28.47 |
Comparison: Week 1p-value: 0.01295% CI: [-19.4, -2.4]Kenward Roger
Comparison: Week 1p-value: <0.00195% CI: [-23.8, -7.1]Kenward Roger
Comparison: Week 1p-value: 0.02995% CI: [-17.8, -0.9]Kenward Roger
Comparison: Week 2p-value: <0.00195% CI: [-32, -11.6]Kenward Roger
Comparison: Week 2p-value: <0.00195% CI: [-39.1, -19.1]Kenward Roger
Comparison: Week 2p-value: <0.00195% CI: [-34, -13.6]Kenward Roger
Comparison: Week 4p-value: <0.00195% CI: [-32.1, -10.5]Kenward Roger
Comparison: Week 4p-value: <0.00195% CI: [-45.5, -24.2]Kenward Roger
Comparison: Week 4p-value: <0.00195% CI: [-41.6, -19.9]Kenward Roger
Comparison: Week 8p-value: <0.00195% CI: [-33.2, -12.6]Kenward Roger
Comparison: Week 8p-value: <0.00195% CI: [-47.4, -27.2]Kenward Roger
Comparison: Week 8p-value: <0.00195% CI: [-44.4, -23.8]Kenward Roger
Comparison: Week 12p-value: <0.00195% CI: [-35.6, -12.5]Kenward Roger
Comparison: Week 12p-value: <0.00195% CI: [-49.7, -27.2]Kenward Roger
Comparison: Week 12p-value: <0.00195% CI: [-41.7, -18.7]Kenward Roger
Comparison: Week 16p-value: <0.00195% CI: [-32.8, -8.9]Kenward Roger
Comparison: Week 16p-value: <0.00195% CI: [-46, -22.6]Kenward Roger
Comparison: Week 16p-value: <0.00195% CI: [-40.7, -16.8]Kenward Roger
Comparison: Week 20p-value: 0.00195% CI: [-33.7, -8.4]Kenward Roger
Comparison: Week 20p-value: <0.00195% CI: [-42.1, -17.3]Kenward Roger
Comparison: Week 20p-value: <0.00195% CI: [-40.6, -15.2]Kenward Roger
Comparison: Week 24p-value: 0.00295% CI: [-36.1, -8.6]Kenward Roger
Comparison: Week 24p-value: <0.00195% CI: [-44.9, -18]Kenward Roger
Comparison: Week 24p-value: <0.00195% CI: [-43.8, -16.2]Kenward Roger
Secondary
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24
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.
Time frame: Baseline, Week 24
Population: ITT population: All randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24 | -42.6 Percentage change | Standard Deviation 28.25 |
| Nemolizumab (10 mg) | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24 | -60.8 Percentage change | Standard Deviation 25.04 |
| Nemolizumab (30 mg) | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24 | -62.5 Percentage change | Standard Deviation 25.37 |
| Nemolizumab (90 mg) | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24 | -55.9 Percentage change | Standard Deviation 25.85 |
p-value: 0.01795% CI: [-26.2, -2.7]Kenward Roger
p-value: 0.05895% CI: [-23.1, 0.4]Kenward Roger
p-value: <0.00195% CI: [-31.6, -8.3]Kenward Roger
Secondary
Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24
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.
Time frame: Baseline, Week 24
Population: ITT population: All randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24 | -50.7 Percentage change | Standard Deviation 33.52 |
| Nemolizumab (10 mg) | Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24 | -75.4 Percentage change | Standard Deviation 27.64 |
| Nemolizumab (30 mg) | Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24 | -76.2 Percentage change | Standard Deviation 23.6 |
| Nemolizumab (90 mg) | Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24 | -74.9 Percentage change | Standard Deviation 29.39 |
p-value: <0.00195% CI: [-37.8, -11.2]Kenward Roger
p-value: <0.00195% CI: [-44.9, -18.6]Kenward Roger
p-value: <0.00195% CI: [-38.4, -11.8]Kenward Roger