A Phase 2 interventional study of CD14152 Dose A and CD14152 placebo in Prurigo Nodularis, sponsored by Galderma R&D. Completed at 16 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-19.
Sponsored by Galderma R&D · Phase 2, Interventional, and Treatment
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.
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:
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) every 4 weeks (Q4W) up to Week 8.
Drug: CD14152 placebo
Participants received 3 subcutaneous injections of nemolizumab 0.5 milligram per kilogram (mg/kg) Q4W up to Week 8.
Drug: CD14152 Dose A
3 subcutaneous injections (every 4 weeks during the 12-week treatment period)
Also known as: Nemolizumab
3 subcutaneous injections (every 4 weeks during the 12-week treatment period)
Also known as: 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
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
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
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
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
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
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
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
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
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
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
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
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)
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
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
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
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
The study was conducted at 16 sites in 4 countries.
| Milestone | Placebo | Nemolizumab 0.5 mg/kg |
|---|---|---|
| Started | 36 | 34 |
| Treated | 36 | 34 |
| Completed | 29 | 31 |
| Not completed | 7 | 3 |
| Withdrew: Adverse event | 2 | 2 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Withdrawal by subject | 3 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 |
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 | Placebo | 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 | -13.8 ± 16.10 | -52.6 ± 33.96 |
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 | Placebo | 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 | -18.3 ± 22.39 | -52.0 ± 33.94 |
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 | Placebo | Nemolizumab 0.5 mg/kg |
|---|---|---|
| Week 1 | -6.1 ± 11.45 | -26.0 ± 21.93 |
| Week 2 | -7.4 ± 14.85 | -41.7 ± 30.31 |
| Week 4 | -13.8 ± 16.10 | -52.6 ± 33.96 |
| Week 8 | -19.7 ± 20.03 | -56.5 ± 34.73 |
| Week 12 | -18.7 ± 22.80 | -61.8 ± 34.95 |
| Week 16 | -20.8 ± 22.29 | -61.1 ± 35.35 |
| Week 18 | -21.7 ± 22.95 | -59.6 ± 35.89 |
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.
| Units on a scale | Placebo | Nemolizumab 0.5 mg/kg |
|---|---|---|
| Week 1 | -0.5 ± 0.87 | -2.1 ± 1.66 |
| Week 2 | -0.6 ± 1.21 | -3.4 ± 2.38 |
| Week 4 | -1.2 ± 1.33 | -4.3 ± 2.77 |
| Week 8 | -1.6 ± 1.62 | -4.7 ± 2.90 |
| Week 12 | -1.5 ± 1.84 | -5.1 ± 2.95 |
| Week 16 | -1.7 ± 1.81 | -5.1 ± 3.00 |
| Week 18 | -1.8 ± 1.87 | -4.9 ± 3.07 |
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.
| Percent change | Placebo | Nemolizumab 0.5 mg/kg |
|---|---|---|
| Week 1 | -7.5 ± 12.82 | -26.6 ± 21.25 |
| Week 2 | -9.6 ± 15.28 | -44.0 ± 29.54 |
| Week 4 | -16.5 ± 18.25 | -53.4 ± 33.23 |
| Week 8 | -24.6 ± 23.38 | -57.3 ± 34.78 |
| Week 12 | -23.0 ± 26.31 | -62.6 ± 34.98 |
| Week 16 | -25.9 ± 24.89 | -62.4 ± 35.93 |
| Week 18 | -26.2 ± 25.39 | -60.4 ± 36.15 |
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.
| Units on a scale | Placebo | Nemolizumab 0.5 mg/kg |
|---|---|---|
| Week 1 | -0.5 ± 0.82 | -1.9 ± 1.47 |
| Week 2 | -0.8 ± 1.14 | -3.2 ± 2.03 |
| Week 4 | -1.3 ± 1.41 | -3.9 ± 2.44 |
| Week 8 | -1.9 ± 1.80 | -4.2 ± 2.60 |
| Week 12 | -1.8 ± 2.05 | -4.6 ± 2.71 |
| Week 16 | -2.0 ± 1.97 | -4.6 ± 2.86 |
| Week 18 | -2.1 ± 2.02 | -4.5 ± 2.94 |
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 | Placebo | Nemolizumab 0.5 mg/kg |
|---|---|---|
| Week 1 | -9.8 ± 14.24 | -27.6 ± 17.21 |
| Week 2 | -12.3 ± 17.64 | -39.1 ± 25.38 |
| Week 4 | -15.6 ± 20.95 | -50.7 ± 29.37 |
| Week 8 | -20.7 ± 21.22 | -54.3 ± 30.61 |
| Week 12 | -19.4 ± 23.60 | -56.9 ± 32.64 |
| Week 16 | -21.2 ± 22.24 | -55.6 ± 34.48 |
| Week 18 | -23.0 ± 21.97 | -53.4 ± 36.56 |
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.
| Units on a scale | Placebo | Nemolizumab 0.5 mg/kg |
|---|---|---|
| Week 1 | -0.3 ± 0.47 | -0.9 ± 0.57 |
| Week 2 | -0.4 ± 0.61 | -1.3 ± 0.83 |
| Week 4 | -0.6 ± 0.74 | -1.6 ± 1.00 |
| Week 8 | -0.7 ± 0.74 | -1.8 ± 1.06 |
| Week 12 | -0.7 ± 0.83 | -1.8 ± 1.09 |
| Week 16 | -0.7 ± 0.78 | -1.8 ± 1.16 |
| Week 18 | -0.8 ± 0.77 | -1.7 ± 1.26 |
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 | Placebo | Nemolizumab 0.5 mg/kg |
|---|---|---|
| Week 1 | -10.5 ± 19.72 | -29.6 ± 16.90 |
| Week 2 | -13.0 ± 19.20 | -42.9 ± 24.22 |
| Week 4 | -16.4 ± 24.10 | -52.1 ± 27.63 |
| Week 8 | -23.5 ± 22.89 | -55.4 ± 30.63 |
| Week 12 | -21.9 ± 25.90 | -62.1 ± 29.98 |
| Week 16 | -25.1 ± 24.15 | -62.0 ± 32.48 |
| Week 18 | -26.2 ± 24.40 | -58.7 ± 34.81 |
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.
| Units on a scale | Placebo | Nemolizumab 0.5 mg/kg |
|---|---|---|
| Week 1 | -0.4 ± 0.50 | -0.9 ± 0.49 |
| Week 2 | -0.4 ± 0.61 | -1.3 ± 0.68 |
| Week 4 | -0.6 ± 0.73 | -1.6 ± 0.84 |
| Week 8 | -0.7 ± 0.72 | -1.7 ± 0.96 |
| Week 12 | -0.7 ± 0.82 | -1.9 ± 0.94 |
| Week 16 | -0.8 ± 0.78 | -1.9 ± 1.06 |
| Week 18 | -0.8 ± 0.79 | -1.8 ± 1.16 |
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.
| Units on a scale | Placebo | Nemolizumab 0.5 mg/kg |
|---|---|---|
| First injection, after 24 hours | 4.3 ± 0.96 | 5.0 ± 1.20 |
| First injection, after 48 hours | 4.0 ± 1.69 | 5.3 ± 1.40 |
| First injection, after 72 hours | 4.0 ± 1.37 | 5.7 ± 1.34 |
| Before Second Injection (Week 4) | 4.4 ± 1.07 | 6.3 ± 1.89 |
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 Lesions | Placebo | Nemolizumab 0.5 mg/kg |
|---|---|---|
| Baseline | 87.1 ± 5.42 | 84.9 ± 5.50 |
| Week 12 | 74.2 ± 6.83 | 54.8 ± 6.42 |
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%.
| Participants | Placebo | Nemolizumab 0.5 mg/kg |
|---|---|---|
| Excoriation/Crusts: Day 1: Stage 0 | 0 | 0 |
| Excoriation/Crusts: Day 1: Stage 1 | 2 | 4 |
| Excoriation/Crusts: Day 1: Stage 2 | 7 | 5 |
| Excoriation/Crusts: Day 1: Stage 3 | 14 | 12 |
| Excoriation/Crusts: Day 1: Stage 4 | 13 | 13 |
| Excoriation/Crusts: Week 4: Stage 0 | 2 | 2 |
| Excoriation/Crusts: Week 4: Stage 1 | 6 | 10 |
| Excoriation/Crusts: Week 4: Stage 2 | 7 | 9 |
| Excoriation/Crusts: Week 4: Stage 3 | 10 | 9 |
| Excoriation/Crusts: Week 4: Stage 4 | 9 | 3 |
| Excoriation/Crusts: Week 8: Stage 0 | 2 | 4 |
| Excoriation/Crusts: Week 8: Stage 1 | 5 | 13 |
| Excoriation/Crusts: Week 8: Stage 2 | 7 | 6 |
| Excoriation/Crusts: Week 8: Stage 3 | 11 | 9 |
| Excoriation/Crusts: Week 8: Stage 4 | 7 | 0 |
| Excoriation/CrustsWeek 12: Stage 0 | 1 | 3 |
| Excoriation/Crusts: Week 12: Stage 1 | 7 | 17 |
| Excoriation/Crusts: Week 12: Stage 2 | 5 | 9 |
| Excoriation/Crusts: Week 12: Stage 3 | 12 | 3 |
| Excoriation/Crusts: Week 12: Stage 4 | 5 | 0 |
| Excoriation/Crusts: Week 18: Stage 0 | 1 | 6 |
| Excoriation/Crusts: Week 18: Stage 1 | 4 | 12 |
| Excoriation/Crusts: Week 18: Stage 2 | 8 | 4 |
| Excoriation/Crusts: Week 18: Stage 3 | 11 | 5 |
| Excoriation/Crusts: Week 18: Stage 4 | 6 | 4 |
| Healed Lesions: Day 1: Stage 0 | 1 | 0 |
| Healed Lesions: Day 1: Stage 1 | 0 | 1 |
| Healed Lesions: Day 1: Stage 2 | 3 | 5 |
| Healed Lesions: Day 1: Stage 3 | 13 | 9 |
| Healed Lesions: Day 1: Stage 4 | 19 | 19 |
| Healed Lesions: Week 4: Stage 0 | 2 | 3 |
| Healed Lesions: Week 4: Stage 1 | 2 | 5 |
| Healed Lesions: Week 4: Stage 2 | 6 | 5 |
| Healed Lesions: Week 4: Stage 3 | 11 | 14 |
| Healed Lesions: Week 4: Stage 4 | 13 | 6 |
| Healed Lesions: Week 8: Stage 0 | 2 | 3 |
| Healed Lesions: Week 8: Stage 1 | 3 | 8 |
| Healed Lesions: Week 8: Stage 2 | 7 | 8 |
| Healed Lesions: Week 8: Stage 3 | 9 | 12 |
| Healed Lesions: Week 8: Stage 4 | 11 | 1 |
| Healed Lesions: Week 12: Stage 0 | 1 | 2 |
| Healed Lesions: Week 12: Stage 1 | 2 | 9 |
| Healed Lesions: Week 12: Stage 2 | 7 | 16 |
| Healed Lesions: Week 12: Stage 3 | 8 | 5 |
| Healed Lesions: Week 12: Stage 4 | 12 | 0 |
| Healed Lesions: Week 18: Stage 0 | 1 | 3 |
| Healed Lesions: Week 18: Stage 1 | 2 | 12 |
| Healed Lesions: Week 18: Stage 2 | 7 | 7 |
| Healed Lesions: Week 18: Stage 3 | 8 | 5 |
| Healed Lesions: Week 18: Stage 4 | 12 | 4 |
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.
| Units on a scale | Placebo | Nemolizumab 0.5 mg/kg |
|---|---|---|
| Day 1 (Baseline) | 3.4 ± 0.49 | 3.5 ± 0.51 |
| Week 4 | 3.3 ± 0.61 | 2.8 ± 0.81 |
| Week 8 | 3.1 ± 0.67 | 2.4 ± 0.80 |
| Week 12 | 2.8 ± 0.82 | 2.0 ± 0.80 |
| Week 18 | 3.0 ± 0.93 | 2.0 ± 1.11 |
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 | Placebo | 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 | 2.8 | 20.6 |
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.
| Percent change | Placebo | 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 | -15.2 ± 17.42 | -54.9 ± 33.80 |
Collected over Up to 18 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/36 (0%) | 3/36 (8.3%) | 22/36 (61.1%) |
| Nemolizumab 0.5 mg/kg | 0/34 (0%) | 4/34 (11.8%) | 26/34 (76.5%) |
| Event | Placebo | Nemolizumab 0.5 mg/kg |
|---|---|---|
| NeurodermatitisSkin and subcutaneous tissue disorders | 3/36 | 0/34 |
| Dermatitis PsoriasiformSkin and subcutaneous tissue disorders | 0/36 | 1/34 |
| Eczema NummularSkin and subcutaneous tissue disorders | 0/36 | 1/34 |
| Clavicle FractureInjury, poisoning and procedural complications | 0/36 | 1/34 |
| FibromyalgiaMusculoskeletal and connective tissue disorders | 0/36 | 1/34 |
| Calculus BladderRenal and urinary disorders | 0/36 | 1/34 |
| Spinal FractureInjury, poisoning and procedural complications | 1/36 | 0/34 |
| Back PainMusculoskeletal and connective tissue disorders | 1/36 | 0/34 |
| Event | Placebo | Nemolizumab 0.5 mg/kg |
|---|---|---|
| NasopharyngitisInfections and infestations | 4/36 | 5/34 |
| NeurodermatitisSkin and subcutaneous tissue disorders | 5/36 | 2/34 |
| ConjunctivitisInfections and infestations | 2/36 | 3/34 |
| Dermatitis AtopicSkin and subcutaneous tissue disorders | 0/36 | 3/34 |
| BronchitisInfections and infestations | 0/36 | 2/34 |
| Dermatitis ContactSkin and subcutaneous tissue disorders | 0/36 | 2/34 |
| Abdominal PainGastrointestinal disorders | 0/36 | 2/34 |
| DiarrhoeaGastrointestinal disorders | 0/36 | 2/34 |
| LymphadenopathyBlood and lymphatic system disorders | 0/36 | 2/34 |
| Increased AppetiteMetabolism and nutrition disorders | 0/36 | 2/34 |
Analysis was performed on all randomized participants.
| Age, Continuous(years) | Placebo | Nemolizumab 0.5 mg/kg | Total |
|---|---|---|---|
| Mean | 52.4 ± 17.47 | 59.7 ± 13.16 | 56.0 ± 15.85 |
| Sex: Female, Male(Participants) | Placebo | Nemolizumab 0.5 mg/kg | Total |
|---|---|---|---|
| Female | 22 | 19 | 41 |
| Male | 14 | 15 | 29 |
| Race (NIH/OMB)(Participants) | Placebo | Nemolizumab 0.5 mg/kg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 35 | 33 | 68 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Presence or absence of background of atopy(Participants) | Placebo | Nemolizumab 0.5 mg/kg | Total |
|---|---|---|---|
| Presence | 6 | 5 | 11 |
| Absence | 30 | 29 | 59 |
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Galderma R&D