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The aim of this study is to assess the safety and efficacy of nemolizumab in subjects with prurigo nodularis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) every 4 weeks (Q4W) up to Week 8. |
|
| Nemolizumab 0.5 mg/kg | Experimental | Participants received 3 subcutaneous injections of nemolizumab 0.5 milligram per kilogram (mg/kg) Q4W up to Week 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD14152 Dose A | Drug | 3 subcutaneous injections (every 4 weeks during the 12-week treatment period) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 4 |
| 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. | Baseline, Week 4 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Male or female of at least 18 years at screening
Clinical diagnosis of PN for at least 6 months with:
Severe pruritus defined as follows on a Numerical Rating Scale (NRS)
Female subjects must fulfill one of the criteria below:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH-Univ. Klinikum Graz | Graz | Austria | ||||
| Centre-Hospitalier Universitaire (CHU) - Hopital Morvan - Br |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37615836 | Derived | Kwatra SG, Rodriguez D, Dias-Barbosa C, Budhiarso I, Fofana F, Vernon M, Gabriel S, Piketty C, Puelles J. Validation of the Peak Pruritus Numerical Rating Scale as a Patient-Reported Outcome Measure in Prurigo Nodularis. Dermatol Ther (Heidelb). 2023 Oct;13(10):2403-2416. doi: 10.1007/s13555-023-00999-9. Epub 2023 Aug 24. | |
| 32074418 |
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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.
The study was conducted at 16 sites in 4 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) every 4 weeks (Q4W) (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks. |
| FG001 | Nemolizumab 0.5 mg/kg | Participants received 3 subcutaneous injections of 0.5 milligram per kilogram (mg/kg) of nemolizumab Q4W (at baseline, week 4 and week 8). Participants were further followed up for 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Analysis was performed on all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Nemolizumab 0.5 mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 4 |
Up to 18 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) Q4W for 12 weeks (Baseline, Week 4 and Week 8). Participants were further followed up for 6 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | (0) 4 93 95 70 70 | +33 | Clinical.Studies@galderma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 30, 2017 | Sep 30, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 21, 2019 | Sep 30, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000612881 | nemolizumab |
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| CD14152 placebo | Drug | 3 subcutaneous injections (every 4 weeks during the 12-week treatment period) |
|
|
| Baseline, Week 4 |
| Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 |
| 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. | Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 |
| 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. | Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 |
| 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. | Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 |
| 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. | Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 |
| 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. | Baseline, Weeks 1, 2, 4, 8, 12,16 and 18 |
| 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. | Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 |
| 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. | Baseline, Weeks 1, 2, 4, 8, 12,16 and 18 |
| 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. | After 24, 48, 72 hours of first Injection and before second injection (Week 4) |
| 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. | Baseline, Week 12 |
| 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%. | Day 1 (Baseline), Weeks 4, 8, 12 and 18 |
| 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. | Day 1 (Baseline), Weeks 4, 8, 12 and 18 |
| 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. | Week 12 |
| Brest |
| France |
| CHU de Nice - Hôpital Archet 2 | Nice | France |
| Hopital Saint-Louis - Dermatology | Paris | France |
| Centre Hospitalier Universitaire De Toulouse | Toulouse | France |
| Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie | Berlin | Germany |
| Universitätsklinikum Bonn AöR | Bonn | Germany |
| Klinikum der Johann-Wolfgang Goethe-Universität | Frankfurt | Germany |
| Unikl. Schleswig-Holstein - Lübeck | Lübeck | Germany |
| Universitätsmedizin Mainz | Mainz | Germany |
| Klinikum Der Universität München - Campus Innenstadt - Dermatologie und Allergologie | München | Germany |
| Universitätsklinikum Münster | Münster | Germany |
| Eberhard-Karls Universitaet Tuebingen - Universitaets Hautkl | Tübingen | Germany |
| Centrum Medyczne DERMED | Lodz | Poland |
| Dermoklinika Centrum Medyczne s.c. M.Kierstan, J.Narbutt, A.Lesiak | Lodz | Poland |
| Kliniczny Szpital Wojew. nr 1 im. F.Chopina w Rzeszowie | Rzeszów | Poland |
| Stander S, Yosipovitch G, Legat FJ, Lacour JP, Paul C, Narbutt J, Bieber T, Misery L, Wollenberg A, Reich A, Ahmad F, Piketty C. Trial of Nemolizumab in Moderate-to-Severe Prurigo Nodularis. N Engl J Med. 2020 Feb 20;382(8):706-716. doi: 10.1056/NEJMoa1908316. |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
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.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Presence or absence of background of atopy | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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. |
| OG001 | 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. |
|
|
| 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. | ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 4 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Percent change | Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Percent change | Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Weeks 1, 2, 4, 8, 12,16 and 18 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Weeks 1, 2, 4, 8, 12,16 and 18 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | After 24, 48, 72 hours of first Injection and before second injection (Week 4) |
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| 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. | ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. | Posted | Mean | Standard Error | Prurigo Lesions | Baseline, Week 12 |
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| 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%. | 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. | Posted | Count of Participants | Participants | Day 1 (Baseline), Weeks 4, 8, 12 and 18 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Day 1 (Baseline), Weeks 4, 8, 12 and 18 |
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| 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. | ITT population included all randomized participants and were analyzed 'as randomized' regardless of the treatment they received. | Posted | Number | percentage of participants | Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 4 |
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| 0 |
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| 3 |
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| 22 |
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| EG001 | Nemolizumab 0.5 mg/kg | Participants received 3 subcutaneous injections of nemolizumab 0.5 mg/kg Q4W for 12 weeks (Baseline, Week 4 and Week 8). Participants were further followed up for 6 weeks. | 0 | 34 | 4 | 34 | 26 | 34 |
| Dermatitis Psoriasiform | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Eczema Nummular | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Clavicle Fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Calculus Bladder | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Postoperative Wound Infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Dermatitis Atopic | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
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| Increased Appetite | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
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| Excoriation/Crusts: Week 18: Stage 0 |
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| Healed Lesions: Day 1: Stage 0 |
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| Healed Lesions: Week 8: Stage 0 |
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| Healed Lesions: Week 18: Stage 0 |
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