Prurigo Nodularis
Conditions
Brief summary
The aim of this study is to assess the safety and efficacy of nemolizumab in subjects with prurigo nodularis.
Detailed description
This is a randomized, placebo-controlled, double-blinded, parallel group, multicenter study to evaluate the safety and efficacy of nemolizumab over a 12-week treatment period in patients suffering from prurigo nodularis compared to its placebo.
Interventions
DRUGCD14152 Dose A
3 subcutaneous injections (every 4 weeks during the 12-week treatment period)
DRUGCD14152 placebo
3 subcutaneous injections (every 4 weeks during the 12-week treatment period)
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
1. Male or female of at least 18 years at screening 2. Clinical diagnosis of PN for at least 6 months with: * Prurigo lesions on upper limbs with or without lesions on the trunk or lower limbs * At least 20 nodules on the entire body with a bilateral distribution 3. Severe pruritus defined as follows on a Numerical Rating Scale (NRS) * At the Screening visit 1: Mean of the worst daily intensity of the NRS score is ≥ 7 over the previous 3 days * At the Baseline visit: Mean of the worst daily intensity of the NRS score is ≥ 7 over the previous week; NOTE: NRS score should be measured on at least 5 days during the week preceding the baseline visit. 4. Female subjects must fulfill one of the criteria below: * Female subjects of non-childbearing potential (postmenopausal \[absence of menstrual bleeding for 1 year prior to screening, without any other medical reason\], hysterectomy or bilateral oophorectomy); * Female subjects of childbearing potential who agree to a true abstinence (when in line with the preferred and usual lifestyle of the subject), or to use an effective method of contraception throughout the clinical trial and for 120 days after the last study drug administration:
Exclusion criteria
1. Chronic pruritus resulting from another condition than PN such as scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease 2. Unilateral lesions of prurigo (e.g only one arm affected) 3. Cutaneous bacterial or viral infection within 1 week before the baseline visit. 4. Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit, or during the screening period, unless completely resolved at the screening/ baseline visits respectively, 5. Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results and/or put the subject at Chronic pruritus resulting from another condition than PN such as scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) Score at Week 4 Using Last Observation Carried Forward (LOCF) Approach | Baseline, Week 4 | Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach. |
| Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Multiple Imputation (MI) Method | Baseline, Week 4 | Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch. Multiple imputation generated twenty-five sets of data with missing values imputed from observed data using linear regression. |
| Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Observed Data | Baseline, Week 4 | Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 | Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach. |
| Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach | Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 | VRS consists of a list of adjectives describing different levels of symptom intensity used by participants to report intensity of their pruritus (itch) over last 24 hours. Participants marked on a 5-point VRS (0=no itch, 1=mild itch, 2=moderate itch, 3=severe itch, 4=very severe itch), a response that best described their pruritus intensity in last 24 hours. Participants were asked following questions in their local language: 1) For average itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your itch overall during previous 24 hours?; 2) For maximum itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your worst itch during previous 24 hours?. Where, higher score indicated very severe itch. Missing values including those who took rescue medication were replaced by LOCF approach. |
| Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Baseline, Weeks 1, 2, 4, 8, 12,16 and 18 | VRS consists of a list of adjectives describing different levels of symptom intensity used by participants to report intensity of their pruritus (itch) over last 24 hours. Participants marked on a 5-point VRS (0=no itch, 1=mild itch, 2=moderate itch, 3=severe itch, 4=very severe itch), a response that best described their pruritus intensity in last 24 hours. Participants were asked following questions in their local language: 1) For average itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your itch overall during previous 24 hours?; 2) For maximum itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your worst itch during previous 24 hours?. Where, higher score indicated very severe itch. Missing values including those who took rescue medication were replaced by LOCF approach. |
| Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 | VRS consists of a list of adjectives describing different levels of symptom intensity used by participants to report intensity of their pruritus (itch) over last 24 hours. Participants marked on a 5-point VRS (0=no itch, 1=mild itch, 2=moderate itch, 3=severe itch, 4=very severe itch), a response that best described their pruritus intensity in last 24 hours. Participants were asked following questions in their local language: 1) For average itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your itch overall during previous 24 hours?; 2) For maximum itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your worst itch during previous 24 hours?. Where, higher score indicated very severe itch. Missing values including those who took rescue medication were replaced by LOCF approach. |
| Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach | Baseline, Weeks 1, 2, 4, 8, 12,16 and 18 | VRS consists of a list of adjectives describing different levels of symptom intensity used by participants to report intensity of their pruritus (itch) over last 24 hours. Participants marked on a 5-point VRS (0=no itch, 1=mild itch, 2=moderate itch, 3=severe itch, 4=very severe itch), a response that best described their pruritus intensity in last 24 hours. Participants were asked following questions in their local language: 1) For average itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your itch overall during previous 24 hours?; 2) For maximum itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your worst itch during previous 24 hours?. Where, higher score indicated very severe itch. Missing values including those who took rescue medication were replaced by LOCF approach. |
| Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 | Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach. |
| Prurigo Activity Score (PAS) Item 5: Overall Number of Prurigo Lesions at Week 12 | Baseline, Week 12 | PAS includes 7-descriptive items; 1) lesions type (papules nodules/plaques/umbilicated ulcers/ulcers/hypo-/hyperpigmented maculae); 2) number (prurigo lesions on whole body); 3) distribution (disseminated/localized \[only 1/2 areas affected\]/neither of them); 4) affected areas (forearm/upper arm/lower and upper leg/trunk/head); 5) number of prurigo lesions in selected area; 6) activity (prurigo lesions with excoriations/crusts and healed prurigo lesions compared to all prurigo lesions) and 7) front and back, areas of marked monitor lesions to recognize on next visit. |
| Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Day 1 (Baseline), Weeks 4, 8, 12 and 18 | PAS includes 7-descriptive items; 1) lesions type (papules nodules/plaques/umbilicated ulcers/ulcers/hypo-/hyperpigmented maculae); 2) number (prurigo lesions on whole body); 3) distribution (disseminated/localized \[only 1/2 areas affected\]/neither of them); 4) affected areas (forearm/upper arm/lower and upper leg/trunk/head); 5) number of prurigo lesions in selected area; 6) activity (prurigo lesions with excoriations/crusts and healed prurigo lesions compared to all prurigo lesions) and 7) front and back, areas of marked monitor lesions to recognize on next visit. Item 6 has 5 stages (0-4) where each stage represents percentage of prurigo lesions with excoriations/crusts and healed prurigo lesions compared to all prurigo lesions: excoriations/crusts lesions; stage 0=0%, 1=1-25%, 2=26-50%, 3=51-75%, 4=76-100%; for healed lesions; stage 0=100%, 1=75-99%, 2=50-74%, 3=25-49%, 4=0-24%. |
| Investigator Global Assessment (IGA) Score at Each Visit | Day 1 (Baseline), Weeks 4, 8, 12 and 18 | IGA is a 5-point scale used by the investigator or trained designee to evaluate the severity of the disease ranging from 0 to 4 where, 0 = clear, 1= almost clear, 2 = mild, 3 = moderate and 4 severe. IGA corresponds to the overall assessment of the severity of prurigo including presence of crust and nodules or skin bleeding. Higher score indicated greater severity of disease. |
| Percentage of Participants Achieving Investigator Global Assessment Success (Defined as IGA= 0 [Clear] or IGA = 1 [Almost Clear] With Two-point Improvement From Baseline) at Week 12 | Week 12 | IGA is a 5-point scale used by the investigator or trained designee to evaluate the severity of the disease ranging from 0 to 4 where, 0 = clear, 1= almost clear, 2 = mild, 3 = moderate and 4 severe. IGA corresponds to the overall assessment of the severity of prurigo including presence of crust and nodules or skin bleeding. Higher score indicated greater severity of disease. |
| Dynamic Pruritus Score (DPS) at 24, 48, and 72 Hours After First Injection and Before Second Injection (Week 4) | After 24, 48, 72 hours of first Injection and before second injection (Week 4) | The 9-point DPS is a dynamic scale used by participants to evaluate the change of their pruritus compared with an earlier time point. The scale ranges from 0 (strongly worsened pruritus) to 8 (\[almost\] no pruritus anymore), including intermediate marks for slightly improved/worsened, moderately improved/worsened, and rather improved/worsened. Participants recorded their DPS score in their local language, and completed the assessment 24, 48 and 72 hours after the first injection at baseline and at week 4 before the second injection. |
| Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 | Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach. |
| Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 | Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach. |
Countries
Austria, France, Germany, Poland
Participant flow
Recruitment details
The study was conducted at 16 sites in 4 countries.
Pre-assignment details
A total of 100 participants were screened, out of which 70 participants were randomized and treated (36 participants in Placebo and 34 participants in Nemolizumab group). Total 60 participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks. | 36 |
| Nemolizumab 0.5 mg/kg Participants received 3 subcutaneous injections of 0.5 mg/kg nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks. | 34 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Placebo | Nemolizumab 0.5 mg/kg | Total |
|---|---|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 17.47 | 59.7 years STANDARD_DEVIATION 13.16 | 56.0 years STANDARD_DEVIATION 15.85 |
| Presence or absence of background of atopy Absence | 30 Participants | 29 Participants | 59 Participants |
| Presence or absence of background of atopy Presence | 6 Participants | 5 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 33 Participants | 68 Participants |
| Sex: Female, Male Female | 22 Participants | 19 Participants | 41 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 34 |
| other Total, other adverse events | 22 / 36 | 26 / 34 |
| serious Total, serious adverse events | 3 / 36 | 4 / 34 |
Outcome results
Primary
Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) Score at Week 4 Using Last Observation Carried Forward (LOCF) Approach
Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach.
Time frame: Baseline, Week 4
Population: Intent-to-treat (ITT) population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) Score at Week 4 Using Last Observation Carried Forward (LOCF) Approach | -13.8 Percent change | Standard Deviation 16.1 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) Score at Week 4 Using Last Observation Carried Forward (LOCF) Approach | -52.6 Percent change | Standard Deviation 33.96 |
Primary
Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Multiple Imputation (MI) Method
Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch. Multiple imputation generated twenty-five sets of data with missing values imputed from observed data using linear regression.
Time frame: Baseline, Week 4
Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Multiple Imputation (MI) Method | -18.3 Percent change | Standard Deviation 22.39 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Multiple Imputation (MI) Method | -52.0 Percent change | Standard Deviation 33.94 |
Primary
Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Observed Data
Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch.
Time frame: Baseline, Week 4
Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Observed Data | -15.2 Percent change | Standard Deviation 17.42 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Observed Data | -54.9 Percent change | Standard Deviation 33.8 |
Secondary
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach.
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18
Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 4 | -1.3 Units on a scale | Standard Deviation 1.41 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 12 | -1.8 Units on a scale | Standard Deviation 2.05 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 2 | -0.8 Units on a scale | Standard Deviation 1.14 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 16 | -2.0 Units on a scale | Standard Deviation 1.97 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 8 | -1.9 Units on a scale | Standard Deviation 1.8 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 18 | -2.1 Units on a scale | Standard Deviation 2.02 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 1 | -0.5 Units on a scale | Standard Deviation 0.82 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 18 | -4.5 Units on a scale | Standard Deviation 2.94 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 1 | -1.9 Units on a scale | Standard Deviation 1.47 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 2 | -3.2 Units on a scale | Standard Deviation 2.03 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 4 | -3.9 Units on a scale | Standard Deviation 2.44 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 8 | -4.2 Units on a scale | Standard Deviation 2.6 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 12 | -4.6 Units on a scale | Standard Deviation 2.71 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 16 | -4.6 Units on a scale | Standard Deviation 2.86 |
Secondary
Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach
VRS consists of a list of adjectives describing different levels of symptom intensity used by participants to report intensity of their pruritus (itch) over last 24 hours. Participants marked on a 5-point VRS (0=no itch, 1=mild itch, 2=moderate itch, 3=severe itch, 4=very severe itch), a response that best described their pruritus intensity in last 24 hours. Participants were asked following questions in their local language: 1) For average itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your itch overall during previous 24 hours?; 2) For maximum itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your worst itch during previous 24 hours?. Where, higher score indicated very severe itch. Missing values including those who took rescue medication were replaced by LOCF approach.
Time frame: Baseline, Weeks 1, 2, 4, 8, 12,16 and 18
Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 4 | -0.6 Units on a scale | Standard Deviation 0.73 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 12 | -0.7 Units on a scale | Standard Deviation 0.82 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 2 | -0.4 Units on a scale | Standard Deviation 0.61 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 16 | -0.8 Units on a scale | Standard Deviation 0.78 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 8 | -0.7 Units on a scale | Standard Deviation 0.72 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 18 | -0.8 Units on a scale | Standard Deviation 0.79 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 1 | -0.4 Units on a scale | Standard Deviation 0.5 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 18 | -1.8 Units on a scale | Standard Deviation 1.16 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 1 | -0.9 Units on a scale | Standard Deviation 0.49 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 2 | -1.3 Units on a scale | Standard Deviation 0.68 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 4 | -1.6 Units on a scale | Standard Deviation 0.84 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 8 | -1.7 Units on a scale | Standard Deviation 0.96 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 12 | -1.9 Units on a scale | Standard Deviation 0.94 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 16 | -1.9 Units on a scale | Standard Deviation 1.06 |
Secondary
Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach
VRS consists of a list of adjectives describing different levels of symptom intensity used by participants to report intensity of their pruritus (itch) over last 24 hours. Participants marked on a 5-point VRS (0=no itch, 1=mild itch, 2=moderate itch, 3=severe itch, 4=very severe itch), a response that best described their pruritus intensity in last 24 hours. Participants were asked following questions in their local language: 1) For average itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your itch overall during previous 24 hours?; 2) For maximum itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your worst itch during previous 24 hours?. Where, higher score indicated very severe itch. Missing values including those who took rescue medication were replaced by LOCF approach.
Time frame: Baseline, Weeks 1, 2, 4, 8, 12,16 and 18
Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 4 | -0.6 Units on a scale | Standard Deviation 0.74 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 12 | -0.7 Units on a scale | Standard Deviation 0.83 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 2 | -0.4 Units on a scale | Standard Deviation 0.61 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 16 | -0.7 Units on a scale | Standard Deviation 0.78 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 8 | -0.7 Units on a scale | Standard Deviation 0.74 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 18 | -0.8 Units on a scale | Standard Deviation 0.77 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 1 | -0.3 Units on a scale | Standard Deviation 0.47 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 18 | -1.7 Units on a scale | Standard Deviation 1.26 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 1 | -0.9 Units on a scale | Standard Deviation 0.57 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 2 | -1.3 Units on a scale | Standard Deviation 0.83 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 4 | -1.6 Units on a scale | Standard Deviation 1 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 8 | -1.8 Units on a scale | Standard Deviation 1.06 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 12 | -1.8 Units on a scale | Standard Deviation 1.09 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 16 | -1.8 Units on a scale | Standard Deviation 1.16 |
Secondary
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach.
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18
Population: ITT population included all randomized participants analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 4 | -1.2 Units on a scale | Standard Deviation 1.33 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 12 | -1.5 Units on a scale | Standard Deviation 1.84 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 2 | -0.6 Units on a scale | Standard Deviation 1.21 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 16 | -1.7 Units on a scale | Standard Deviation 1.81 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 8 | -1.6 Units on a scale | Standard Deviation 1.62 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 18 | -1.8 Units on a scale | Standard Deviation 1.87 |
| Placebo | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 1 | -0.5 Units on a scale | Standard Deviation 0.87 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 18 | -4.9 Units on a scale | Standard Deviation 3.07 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 1 | -2.1 Units on a scale | Standard Deviation 1.66 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 2 | -3.4 Units on a scale | Standard Deviation 2.38 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 4 | -4.3 Units on a scale | Standard Deviation 2.77 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 8 | -4.7 Units on a scale | Standard Deviation 2.9 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 12 | -5.1 Units on a scale | Standard Deviation 2.95 |
| Nemolizumab 0.5 mg/kg | Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 16 | -5.1 Units on a scale | Standard Deviation 3 |
Secondary
Dynamic Pruritus Score (DPS) at 24, 48, and 72 Hours After First Injection and Before Second Injection (Week 4)
The 9-point DPS is a dynamic scale used by participants to evaluate the change of their pruritus compared with an earlier time point. The scale ranges from 0 (strongly worsened pruritus) to 8 (\[almost\] no pruritus anymore), including intermediate marks for slightly improved/worsened, moderately improved/worsened, and rather improved/worsened. Participants recorded their DPS score in their local language, and completed the assessment 24, 48 and 72 hours after the first injection at baseline and at week 4 before the second injection.
Time frame: After 24, 48, 72 hours of first Injection and before second injection (Week 4)
Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Dynamic Pruritus Score (DPS) at 24, 48, and 72 Hours After First Injection and Before Second Injection (Week 4) | First injection, after 24 hours | 4.3 Units on a scale | Standard Deviation 0.96 |
| Placebo | Dynamic Pruritus Score (DPS) at 24, 48, and 72 Hours After First Injection and Before Second Injection (Week 4) | First injection, after 48 hours | 4.0 Units on a scale | Standard Deviation 1.69 |
| Placebo | Dynamic Pruritus Score (DPS) at 24, 48, and 72 Hours After First Injection and Before Second Injection (Week 4) | First injection, after 72 hours | 4.0 Units on a scale | Standard Deviation 1.37 |
| Placebo | Dynamic Pruritus Score (DPS) at 24, 48, and 72 Hours After First Injection and Before Second Injection (Week 4) | Before Second Injection (Week 4) | 4.4 Units on a scale | Standard Deviation 1.07 |
| Nemolizumab 0.5 mg/kg | Dynamic Pruritus Score (DPS) at 24, 48, and 72 Hours After First Injection and Before Second Injection (Week 4) | Before Second Injection (Week 4) | 6.3 Units on a scale | Standard Deviation 1.89 |
| Nemolizumab 0.5 mg/kg | Dynamic Pruritus Score (DPS) at 24, 48, and 72 Hours After First Injection and Before Second Injection (Week 4) | First injection, after 24 hours | 5.0 Units on a scale | Standard Deviation 1.2 |
| Nemolizumab 0.5 mg/kg | Dynamic Pruritus Score (DPS) at 24, 48, and 72 Hours After First Injection and Before Second Injection (Week 4) | First injection, after 72 hours | 5.7 Units on a scale | Standard Deviation 1.34 |
| Nemolizumab 0.5 mg/kg | Dynamic Pruritus Score (DPS) at 24, 48, and 72 Hours After First Injection and Before Second Injection (Week 4) | First injection, after 48 hours | 5.3 Units on a scale | Standard Deviation 1.4 |
Secondary
Investigator Global Assessment (IGA) Score at Each Visit
IGA is a 5-point scale used by the investigator or trained designee to evaluate the severity of the disease ranging from 0 to 4 where, 0 = clear, 1= almost clear, 2 = mild, 3 = moderate and 4 severe. IGA corresponds to the overall assessment of the severity of prurigo including presence of crust and nodules or skin bleeding. Higher score indicated greater severity of disease.
Time frame: Day 1 (Baseline), Weeks 4, 8, 12 and 18
Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here, 'n' (number analyzed) signifies number of participants evaluable for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Investigator Global Assessment (IGA) Score at Each Visit | Week 4 | 3.3 Units on a scale | Standard Deviation 0.61 |
| Placebo | Investigator Global Assessment (IGA) Score at Each Visit | Week 12 | 2.8 Units on a scale | Standard Deviation 0.82 |
| Placebo | Investigator Global Assessment (IGA) Score at Each Visit | Week 8 | 3.1 Units on a scale | Standard Deviation 0.67 |
| Placebo | Investigator Global Assessment (IGA) Score at Each Visit | Week 18 | 3.0 Units on a scale | Standard Deviation 0.93 |
| Placebo | Investigator Global Assessment (IGA) Score at Each Visit | Day 1 (Baseline) | 3.4 Units on a scale | Standard Deviation 0.49 |
| Nemolizumab 0.5 mg/kg | Investigator Global Assessment (IGA) Score at Each Visit | Week 18 | 2.0 Units on a scale | Standard Deviation 1.11 |
| Nemolizumab 0.5 mg/kg | Investigator Global Assessment (IGA) Score at Each Visit | Day 1 (Baseline) | 3.5 Units on a scale | Standard Deviation 0.51 |
| Nemolizumab 0.5 mg/kg | Investigator Global Assessment (IGA) Score at Each Visit | Week 4 | 2.8 Units on a scale | Standard Deviation 0.81 |
| Nemolizumab 0.5 mg/kg | Investigator Global Assessment (IGA) Score at Each Visit | Week 8 | 2.4 Units on a scale | Standard Deviation 0.8 |
| Nemolizumab 0.5 mg/kg | Investigator Global Assessment (IGA) Score at Each Visit | Week 12 | 2.0 Units on a scale | Standard Deviation 0.8 |
Secondary
Percentage of Participants Achieving Investigator Global Assessment Success (Defined as IGA= 0 [Clear] or IGA = 1 [Almost Clear] With Two-point Improvement From Baseline) at Week 12
IGA is a 5-point scale used by the investigator or trained designee to evaluate the severity of the disease ranging from 0 to 4 where, 0 = clear, 1= almost clear, 2 = mild, 3 = moderate and 4 severe. IGA corresponds to the overall assessment of the severity of prurigo including presence of crust and nodules or skin bleeding. Higher score indicated greater severity of disease.
Time frame: Week 12
Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Investigator Global Assessment Success (Defined as IGA= 0 [Clear] or IGA = 1 [Almost Clear] With Two-point Improvement From Baseline) at Week 12 | 2.8 percentage of participants |
| Nemolizumab 0.5 mg/kg | Percentage of Participants Achieving Investigator Global Assessment Success (Defined as IGA= 0 [Clear] or IGA = 1 [Almost Clear] With Two-point Improvement From Baseline) at Week 12 | 20.6 percentage of participants |
Secondary
Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach.
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18
Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 4 | -16.5 Percent change | Standard Deviation 18.25 |
| Placebo | Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 12 | -23.0 Percent change | Standard Deviation 26.31 |
| Placebo | Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 2 | -9.6 Percent change | Standard Deviation 15.28 |
| Placebo | Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 16 | -25.9 Percent change | Standard Deviation 24.89 |
| Placebo | Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 8 | -24.6 Percent change | Standard Deviation 23.38 |
| Placebo | Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 18 | -26.2 Percent change | Standard Deviation 25.39 |
| Placebo | Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 1 | -7.5 Percent change | Standard Deviation 12.82 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 18 | -60.4 Percent change | Standard Deviation 36.15 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 1 | -26.6 Percent change | Standard Deviation 21.25 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 2 | -44.0 Percent change | Standard Deviation 29.54 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 4 | -53.4 Percent change | Standard Deviation 33.23 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 8 | -57.3 Percent change | Standard Deviation 34.78 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 12 | -62.6 Percent change | Standard Deviation 34.98 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 16 | -62.4 Percent change | Standard Deviation 35.93 |
Secondary
Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach
VRS consists of a list of adjectives describing different levels of symptom intensity used by participants to report intensity of their pruritus (itch) over last 24 hours. Participants marked on a 5-point VRS (0=no itch, 1=mild itch, 2=moderate itch, 3=severe itch, 4=very severe itch), a response that best described their pruritus intensity in last 24 hours. Participants were asked following questions in their local language: 1) For average itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your itch overall during previous 24 hours?; 2) For maximum itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your worst itch during previous 24 hours?. Where, higher score indicated very severe itch. Missing values including those who took rescue medication were replaced by LOCF approach.
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18
Population: ITT population that included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 1 | -10.5 percent change | Standard Deviation 19.72 |
| Placebo | Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 4 | -16.4 percent change | Standard Deviation 24.1 |
| Placebo | Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 18 | -26.2 percent change | Standard Deviation 24.4 |
| Placebo | Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 8 | -23.5 percent change | Standard Deviation 22.89 |
| Placebo | Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 2 | -13.0 percent change | Standard Deviation 19.2 |
| Placebo | Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 12 | -21.9 percent change | Standard Deviation 25.9 |
| Placebo | Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 16 | -25.1 percent change | Standard Deviation 24.15 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 12 | -62.1 percent change | Standard Deviation 29.98 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 16 | -62.0 percent change | Standard Deviation 32.48 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 18 | -58.7 percent change | Standard Deviation 34.81 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 1 | -29.6 percent change | Standard Deviation 16.9 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 2 | -42.9 percent change | Standard Deviation 24.22 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 4 | -52.1 percent change | Standard Deviation 27.63 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach | Week 8 | -55.4 percent change | Standard Deviation 30.63 |
Secondary
Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach
VRS consists of a list of adjectives describing different levels of symptom intensity used by participants to report intensity of their pruritus (itch) over last 24 hours. Participants marked on a 5-point VRS (0=no itch, 1=mild itch, 2=moderate itch, 3=severe itch, 4=very severe itch), a response that best described their pruritus intensity in last 24 hours. Participants were asked following questions in their local language: 1) For average itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your itch overall during previous 24 hours?; 2) For maximum itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your worst itch during previous 24 hours?. Where, higher score indicated very severe itch. Missing values including those who took rescue medication were replaced by LOCF approach.
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18
Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach | Week 4 | -15.6 Percent change | Standard Deviation 20.95 |
| Placebo | Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach | Week 12 | -19.4 Percent change | Standard Deviation 23.6 |
| Placebo | Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach | Week 2 | -12.3 Percent change | Standard Deviation 17.64 |
| Placebo | Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach | Week 16 | -21.2 Percent change | Standard Deviation 22.24 |
| Placebo | Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach | Week 8 | -20.7 Percent change | Standard Deviation 21.22 |
| Placebo | Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach | Week 18 | -23.0 Percent change | Standard Deviation 21.97 |
| Placebo | Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach | Week 1 | -9.8 Percent change | Standard Deviation 14.24 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach | Week 18 | -53.4 Percent change | Standard Deviation 36.56 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach | Week 1 | -27.6 Percent change | Standard Deviation 17.21 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach | Week 2 | -39.1 Percent change | Standard Deviation 25.38 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach | Week 4 | -50.7 Percent change | Standard Deviation 29.37 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach | Week 8 | -54.3 Percent change | Standard Deviation 30.61 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach | Week 12 | -56.9 Percent change | Standard Deviation 32.64 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach | Week 16 | -55.6 Percent change | Standard Deviation 34.48 |
Secondary
Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach.
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18
Population: ITT population included all randomized participants analyzed 'as randomized' regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 4 | -13.8 percent change | Standard Deviation 16.1 |
| Placebo | Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 12 | -18.7 percent change | Standard Deviation 22.8 |
| Placebo | Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 2 | -7.4 percent change | Standard Deviation 14.85 |
| Placebo | Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 16 | -20.8 percent change | Standard Deviation 22.29 |
| Placebo | Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 8 | -19.7 percent change | Standard Deviation 20.03 |
| Placebo | Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 18 | -21.7 percent change | Standard Deviation 22.95 |
| Placebo | Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 1 | -6.1 percent change | Standard Deviation 11.45 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 18 | -59.6 percent change | Standard Deviation 35.89 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 1 | -26.0 percent change | Standard Deviation 21.93 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 2 | -41.7 percent change | Standard Deviation 30.31 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 4 | -52.6 percent change | Standard Deviation 33.96 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 8 | -56.5 percent change | Standard Deviation 34.73 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 12 | -61.8 percent change | Standard Deviation 34.95 |
| Nemolizumab 0.5 mg/kg | Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach | Week 16 | -61.1 percent change | Standard Deviation 35.35 |
Secondary
Prurigo Activity Score (PAS) Item 5: Overall Number of Prurigo Lesions at Week 12
PAS includes 7-descriptive items; 1) lesions type (papules nodules/plaques/umbilicated ulcers/ulcers/hypo-/hyperpigmented maculae); 2) number (prurigo lesions on whole body); 3) distribution (disseminated/localized \[only 1/2 areas affected\]/neither of them); 4) affected areas (forearm/upper arm/lower and upper leg/trunk/head); 5) number of prurigo lesions in selected area; 6) activity (prurigo lesions with excoriations/crusts and healed prurigo lesions compared to all prurigo lesions) and 7) front and back, areas of marked monitor lesions to recognize on next visit.
Time frame: Baseline, Week 12
Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Prurigo Activity Score (PAS) Item 5: Overall Number of Prurigo Lesions at Week 12 | Baseline | 87.1 Prurigo Lesions | Standard Error 5.42 |
| Placebo | Prurigo Activity Score (PAS) Item 5: Overall Number of Prurigo Lesions at Week 12 | Week 12 | 74.2 Prurigo Lesions | Standard Error 6.83 |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 5: Overall Number of Prurigo Lesions at Week 12 | Baseline | 84.9 Prurigo Lesions | Standard Error 5.5 |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 5: Overall Number of Prurigo Lesions at Week 12 | Week 12 | 54.8 Prurigo Lesions | Standard Error 6.42 |
Secondary
Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
PAS includes 7-descriptive items; 1) lesions type (papules nodules/plaques/umbilicated ulcers/ulcers/hypo-/hyperpigmented maculae); 2) number (prurigo lesions on whole body); 3) distribution (disseminated/localized \[only 1/2 areas affected\]/neither of them); 4) affected areas (forearm/upper arm/lower and upper leg/trunk/head); 5) number of prurigo lesions in selected area; 6) activity (prurigo lesions with excoriations/crusts and healed prurigo lesions compared to all prurigo lesions) and 7) front and back, areas of marked monitor lesions to recognize on next visit. Item 6 has 5 stages (0-4) where each stage represents percentage of prurigo lesions with excoriations/crusts and healed prurigo lesions compared to all prurigo lesions: excoriations/crusts lesions; stage 0=0%, 1=1-25%, 2=26-50%, 3=51-75%, 4=76-100%; for healed lesions; stage 0=100%, 1=75-99%, 2=50-74%, 3=25-49%, 4=0-24%.
Time frame: Day 1 (Baseline), Weeks 4, 8, 12 and 18
Population: ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. Here 'n' (number analyzed) signifies number of participants evaluable at each time point for specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 8: Stage 2 | 7 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Day 1: Stage 1 | 2 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Day 1: Stage 2 | 7 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Day 1: Stage 3 | 14 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Day 1: Stage 4 | 13 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 4: Stage 0 | 2 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 4: Stage 1 | 6 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 4: Stage 2 | 7 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 4: Stage 3 | 10 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 4: Stage 4 | 9 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 8: Stage 0 | 2 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 8: Stage 1 | 5 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Day 1: Stage 0 | 0 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 8: Stage 3 | 11 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 8: Stage 4 | 7 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/CrustsWeek 12: Stage 0 | 1 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 12: Stage 1 | 7 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 12: Stage 2 | 5 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 12: Stage 3 | 12 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 12: Stage 4 | 5 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 18: Stage 0 | 1 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 18: Stage 1 | 4 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 18: Stage 2 | 8 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 18: Stage 3 | 11 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 18: Stage 4 | 6 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Day 1: Stage 0 | 1 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Day 1: Stage 1 | 0 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Day 1: Stage 2 | 3 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Day 1: Stage 3 | 13 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Day 1: Stage 4 | 19 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 4: Stage 0 | 2 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 4: Stage 1 | 2 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 4: Stage 2 | 6 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 4: Stage 3 | 11 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 4: Stage 4 | 13 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 8: Stage 0 | 2 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 8: Stage 1 | 3 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 8: Stage 2 | 7 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 8: Stage 3 | 9 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 8: Stage 4 | 11 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 12: Stage 0 | 1 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 12: Stage 1 | 2 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 12: Stage 2 | 7 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 12: Stage 3 | 8 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 12: Stage 4 | 12 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 18: Stage 0 | 1 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 18: Stage 1 | 2 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 18: Stage 2 | 7 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 18: Stage 3 | 8 Participants |
| Placebo | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 18: Stage 4 | 12 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 8: Stage 2 | 8 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Day 1: Stage 0 | 0 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Day 1: Stage 0 | 0 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Day 1: Stage 1 | 4 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 18: Stage 3 | 5 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Day 1: Stage 2 | 5 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Day 1: Stage 1 | 1 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Day 1: Stage 3 | 12 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 8: Stage 3 | 12 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Day 1: Stage 4 | 13 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Day 1: Stage 2 | 5 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 4: Stage 0 | 2 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 12: Stage 4 | 0 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 4: Stage 1 | 10 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Day 1: Stage 3 | 9 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 4: Stage 2 | 9 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 8: Stage 4 | 1 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 4: Stage 3 | 9 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Day 1: Stage 4 | 19 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 4: Stage 4 | 3 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 18: Stage 2 | 7 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 8: Stage 0 | 4 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 4: Stage 0 | 3 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 8: Stage 1 | 13 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 12: Stage 0 | 2 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 8: Stage 2 | 6 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 4: Stage 1 | 5 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 8: Stage 3 | 9 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 18: Stage 0 | 3 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 8: Stage 4 | 0 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 4: Stage 2 | 5 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/CrustsWeek 12: Stage 0 | 3 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 12: Stage 1 | 9 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 12: Stage 1 | 17 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 4: Stage 3 | 14 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 12: Stage 2 | 9 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 18: Stage 4 | 4 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 12: Stage 3 | 3 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 4: Stage 4 | 6 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 12: Stage 4 | 0 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 12: Stage 2 | 16 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 18: Stage 0 | 6 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 8: Stage 0 | 3 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 18: Stage 1 | 12 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 18: Stage 1 | 12 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 18: Stage 2 | 4 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 8: Stage 1 | 8 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 18: Stage 3 | 5 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Healed Lesions: Week 12: Stage 3 | 5 Participants |
| Nemolizumab 0.5 mg/kg | Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit | Excoriation/Crusts: Week 18: Stage 4 | 4 Participants |