| 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. | All participants in intent-to-treat (ITT) population who received at least one dose of study drug. | Posted | | Mean | Standard Deviation | percentage change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe | | OG001 | Nemolizumab (10 mg) | Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. | | OG002 | 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) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. | | OG003 | Nemolizumab (90 mg) | Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20). As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. |
| | Units | Counts |
|---|
| Participants | - OG00057
- OG00155
- OG00257
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-58.4± 31.99
- OG001-72.2± 25.96
- OG002-73.4± 29.67
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Kenward-Rogers | | 0.051 | | mean difference of percentage changes | -13.6 | | | 2-Sided | 95 | -27.3 | 0.0 | | | | | Other | mixed-effect model for repeated measures (MMRM) | | | | Kenward Roger | |
|
| 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. | ITT population: All randomized participants. | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. | | OG001 | Nemolizumab (10 mg) | Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. |
|
| 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. | ITT population: All randomized participants. | Posted | | Count of Participants | | Participants | | From Week 1 to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. | | OG001 | Nemolizumab (10 mg) | Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. |
|
| 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. | ITT population: All randomized participants. | Posted | | Mean | Standard Deviation | Percentage change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. | | OG001 |
|
| 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. | ITT population: All randomized participants. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. | | OG001 |
|
| 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. | ITT population: All randomized participants. | Posted | | Mean | Standard Deviation | Percentage change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. | | OG001 | Nemolizumab (10 mg) | Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. |
|
| 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. | ITT population: All randomized participants. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. | | OG001 | Nemolizumab (10 mg) | Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. |
|
| 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. | ITT population: All randomized participants. | Posted | | Count of Participants | | Participants | | From Week 1 to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. | | OG001 | Nemolizumab (10 mg) | Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. | |
|
| 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. | ITT Population:All randomized participants. | Posted | | Count of Participants | | Participants | | From Week 1 to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. | | OG001 | Nemolizumab (10 mg) | Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. |
|
| 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. | ITT Population: All randomized participants. | Posted | | Count of Participants | | Participants | | From Week 1 to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. | | OG001 | Nemolizumab (10 mg) | Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. |
|
| 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. | ITT Population: All randomized participants. | Posted | | Count of Participants | | Participants | | From Week 1 to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. | | OG001 | Nemolizumab (10 mg) | Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. |
|
| 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. | All participants in ITT population who received at least one dose of study drug. | Posted | | Count of Participants | | Participants | | Week 1 to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe | | OG001 | Nemolizumab (10 mg) | Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. |
|
| 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. | ITT population: All randomized participants. | Posted | | Mean | Standard Deviation | Percentage of change | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe | | OG001 | Nemolizumab (10 mg) | Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. |
|
| 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. | ITT population: All randomized participants. | Posted | | Mean | Standard Deviation | percentage of change | | At baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe | | OG001 | Nemolizumab (10 mg) | Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. |
|
| Secondary | Number of Participants With Adverse Events | To evaluate the safety of nemolizumab in participants with moderate-to-severe AD | Safety population: The safety population comprised all subjects in ITT population who received at least one dose of study drug. | Posted | | Count of Participants | | Participants | | From screening to Follow-up visit (Week 32)/Early termination visit | | | | ID | Title | Description |
|---|
| OG000 | 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) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. | | OG001 | Nemolizumab (10 mg) | Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. | | OG002 |
|
| 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. | ITT population: All randomized participants. Number of participants in this analysis | Posted | | Mean | Standard Deviation | units on a scale | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. | | OG001 | Nemolizumab (10 mg) | Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. |
|
| 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. | ITT population: All randomized participants. Number of participants in this analysis | Posted | | Mean | Standard Deviation | units on a scale | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. | | OG001 | Nemolizumab (10 mg) | Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. |
|
| 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. | ITT population: All randomized participants. Number of participants in this analysis | Posted | | Mean | Standard Deviation | Percentage of change | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. | | OG001 | Nemolizumab (10 mg) | Randomized participants received Nemolizumab subcutaneous injection every 4 weeks during 24 week treatment period (last injection at week 20) with a loading dose of 20 mg. As background therapy a medium potency TCS (mometasone furoate 0.1% cream or hydrocortisone butyrate 0.1% cream) was used for the body and a low potency TCS (hydrocortisone acetate 0.05-1% cream or desonide 0.05% cream) was used for areas where medium potency TCS are considered unsafe. |
|