NCT03181503

Safety and Efficacy of Nemolizumab in PN

Completed Phase 2 Results posted Last updated 19 February 2020

What this trial tests

Phase 2 trial testing CD14152 Dose A in Prurigo Nodularis in 70 participants. Completed in 26 September 2018.

Timeline

2 October 2017

Primary endpoint
26 September 2018

26 September 2018

Quick facts

Lead sponsor	Galderma R&D
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	70
Start date	2 October 2017
Primary completion	26 September 2018
Estimated completion	26 September 2018
Sites	16 locations across Austria, France, Germany, Poland

Drugs / interventions tested

• CD14152 Dose A — full drug profile →
• CD14152 placebo — full drug profile →

Conditions studied

• Prurigo Nodularis — all drugs for Prurigo Nodularis →

Sponsor

Galderma R&D — full company profile →

Who can join

18 and older, any sex, with Prurigo Nodularis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 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

Group	Value	95% CI
Placebo	-13.8	± 16.10
Nemolizumab 0.5 mg/kg	-52.6	± 33.96

Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Multiple Imputation (MI) Method Primary · 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

Group	Value	95% CI
Placebo	-18.3	± 22.39
Nemolizumab 0.5 mg/kg	-52.0	± 33.94

Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach Secondary · 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

Week 1

Group	Value	95% CI
Placebo	-6.1	± 11.45
Nemolizumab 0.5 mg/kg	-26.0	± 21.93

Week 2

Group	Value	95% CI
Placebo	-7.4	± 14.85
Nemolizumab 0.5 mg/kg	-41.7	± 30.31

Week 4

Group	Value	95% CI
Placebo	-13.8	± 16.10
Nemolizumab 0.5 mg/kg	-52.6	± 33.96

Week 8

Group	Value	95% CI
Placebo	-19.7	± 20.03
Nemolizumab 0.5 mg/kg	-56.5	± 34.73

Week 12

Group	Value	95% CI
Placebo	-18.7	± 22.80
Nemolizumab 0.5 mg/kg	-61.8	± 34.95

Week 16

Group	Value	95% CI
Placebo	-20.8	± 22.29
Nemolizumab 0.5 mg/kg	-61.1	± 35.35

Week 18

Group	Value	95% CI
Placebo	-21.7	± 22.95
Nemolizumab 0.5 mg/kg	-59.6	± 35.89

Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach Secondary · 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

Week 1

Group	Value	95% CI
Placebo	-0.5	± 0.87
Nemolizumab 0.5 mg/kg	-2.1	± 1.66

Week 2

Group	Value	95% CI
Placebo	-0.6	± 1.21
Nemolizumab 0.5 mg/kg	-3.4	± 2.38

Week 4

Group	Value	95% CI
Placebo	-1.2	± 1.33
Nemolizumab 0.5 mg/kg	-4.3	± 2.77

Week 8

Group	Value	95% CI
Placebo	-1.6	± 1.62
Nemolizumab 0.5 mg/kg	-4.7	± 2.90

Week 12

Group	Value	95% CI
Placebo	-1.5	± 1.84
Nemolizumab 0.5 mg/kg	-5.1	± 2.95

Week 16

Group	Value	95% CI
Placebo	-1.7	± 1.81
Nemolizumab 0.5 mg/kg	-5.1	± 3.00

Week 18

Group	Value	95% CI
Placebo	-1.8	± 1.87
Nemolizumab 0.5 mg/kg	-4.9	± 3.07

Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach Secondary · 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

Week 1

Group	Value	95% CI
Placebo	-7.5	± 12.82
Nemolizumab 0.5 mg/kg	-26.6	± 21.25

Week 2

Group	Value	95% CI
Placebo	-9.6	± 15.28
Nemolizumab 0.5 mg/kg	-44.0	± 29.54

Week 4

Group	Value	95% CI
Placebo	-16.5	± 18.25
Nemolizumab 0.5 mg/kg	-53.4	± 33.23

Week 8

Group	Value	95% CI
Placebo	-24.6	± 23.38
Nemolizumab 0.5 mg/kg	-57.3	± 34.78

Week 12

Group	Value	95% CI
Placebo	-23.0	± 26.31
Nemolizumab 0.5 mg/kg	-62.6	± 34.98

Week 16

Group	Value	95% CI
Placebo	-25.9	± 24.89
Nemolizumab 0.5 mg/kg	-62.4	± 35.93

Week 18

Group	Value	95% CI
Placebo	-26.2	± 25.39
Nemolizumab 0.5 mg/kg	-60.4	± 36.15

Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach Secondary · 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

Week 1

Group	Value	95% CI
Placebo	-0.5	± 0.82
Nemolizumab 0.5 mg/kg	-1.9	± 1.47

Week 2

Group	Value	95% CI
Placebo	-0.8	± 1.14
Nemolizumab 0.5 mg/kg	-3.2	± 2.03

Week 4

Group	Value	95% CI
Placebo	-1.3	± 1.41
Nemolizumab 0.5 mg/kg	-3.9	± 2.44

Week 8

Group	Value	95% CI
Placebo	-1.9	± 1.80
Nemolizumab 0.5 mg/kg	-4.2	± 2.60

Week 12

Group	Value	95% CI
Placebo	-1.8	± 2.05
Nemolizumab 0.5 mg/kg	-4.6	± 2.71

Week 16

Group	Value	95% CI
Placebo	-2.0	± 1.97
Nemolizumab 0.5 mg/kg	-4.6	± 2.86

Week 18

Group	Value	95% CI
Placebo	-2.1	± 2.02
Nemolizumab 0.5 mg/kg	-4.5	± 2.94

Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach Secondary · 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?";

Week 1

Group	Value	95% CI
Placebo	-9.8	± 14.24
Nemolizumab 0.5 mg/kg	-27.6	± 17.21

Week 2

Group	Value	95% CI
Placebo	-12.3	± 17.64
Nemolizumab 0.5 mg/kg	-39.1	± 25.38

Week 4

Group	Value	95% CI
Placebo	-15.6	± 20.95
Nemolizumab 0.5 mg/kg	-50.7	± 29.37

Week 8

Group	Value	95% CI
Placebo	-20.7	± 21.22
Nemolizumab 0.5 mg/kg	-54.3	± 30.61

Week 12

Group	Value	95% CI
Placebo	-19.4	± 23.60
Nemolizumab 0.5 mg/kg	-56.9	± 32.64

Week 16

Group	Value	95% CI
Placebo	-21.2	± 22.24
Nemolizumab 0.5 mg/kg	-55.6	± 34.48

Week 18

Group	Value	95% CI
Placebo	-23.0	± 21.97
Nemolizumab 0.5 mg/kg	-53.4	± 36.56

Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach Secondary · 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?";

Week 1

Group	Value	95% CI
Placebo	-0.3	± 0.47
Nemolizumab 0.5 mg/kg	-0.9	± 0.57

Week 2

Group	Value	95% CI
Placebo	-0.4	± 0.61
Nemolizumab 0.5 mg/kg	-1.3	± 0.83

Week 4

Group	Value	95% CI
Placebo	-0.6	± 0.74
Nemolizumab 0.5 mg/kg	-1.6	± 1.00

Week 8

Group	Value	95% CI
Placebo	-0.7	± 0.74
Nemolizumab 0.5 mg/kg	-1.8	± 1.06

Week 12

Group	Value	95% CI
Placebo	-0.7	± 0.83
Nemolizumab 0.5 mg/kg	-1.8	± 1.09

Week 16

Group	Value	95% CI
Placebo	-0.7	± 0.78
Nemolizumab 0.5 mg/kg	-1.8	± 1.16

Week 18

Group	Value	95% CI
Placebo	-0.8	± 0.77
Nemolizumab 0.5 mg/kg	-1.7	± 1.26

Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach Secondary · 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?";

Week 1

Group	Value	95% CI
Placebo	-10.5	± 19.72
Nemolizumab 0.5 mg/kg	-29.6	± 16.90

Week 2

Group	Value	95% CI
Placebo	-13.0	± 19.20
Nemolizumab 0.5 mg/kg	-42.9	± 24.22

Week 4

Group	Value	95% CI
Placebo	-16.4	± 24.10
Nemolizumab 0.5 mg/kg	-52.1	± 27.63

Week 8

Group	Value	95% CI
Placebo	-23.5	± 22.89
Nemolizumab 0.5 mg/kg	-55.4	± 30.63

Week 12

Group	Value	95% CI
Placebo	-21.9	± 25.90
Nemolizumab 0.5 mg/kg	-62.1	± 29.98

Week 16

Group	Value	95% CI
Placebo	-25.1	± 24.15
Nemolizumab 0.5 mg/kg	-62.0	± 32.48

Week 18

Group	Value	95% CI
Placebo	-26.2	± 24.40
Nemolizumab 0.5 mg/kg	-58.7	± 34.81

Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach Secondary · 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?";

Week 1

Group	Value	95% CI
Placebo	-0.4	± 0.50
Nemolizumab 0.5 mg/kg	-0.9	± 0.49

Week 2

Group	Value	95% CI
Placebo	-0.4	± 0.61
Nemolizumab 0.5 mg/kg	-1.3	± 0.68

Week 4

Group	Value	95% CI
Placebo	-0.6	± 0.73
Nemolizumab 0.5 mg/kg	-1.6	± 0.84

Week 8

Group	Value	95% CI
Placebo	-0.7	± 0.72
Nemolizumab 0.5 mg/kg	-1.7	± 0.96

Week 12

Group	Value	95% CI
Placebo	-0.7	± 0.82
Nemolizumab 0.5 mg/kg	-1.9	± 0.94

Week 16

Group	Value	95% CI
Placebo	-0.8	± 0.78
Nemolizumab 0.5 mg/kg	-1.9	± 1.06

Week 18

Group	Value	95% CI
Placebo	-0.8	± 0.79
Nemolizumab 0.5 mg/kg	-1.8	± 1.16

Dynamic Pruritus Score (DPS) at 24, 48, and 72 Hours After First Injection and Before Second Injection (Week 4) Secondary · 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.

First injection, after 24 hours

Group	Value	95% CI
Placebo	4.3	± 0.96
Nemolizumab 0.5 mg/kg	5.0	± 1.20

First injection, after 48 hours

Group	Value	95% CI
Placebo	4.0	± 1.69
Nemolizumab 0.5 mg/kg	5.3	± 1.40

First injection, after 72 hours

Group	Value	95% CI
Placebo	4.0	± 1.37
Nemolizumab 0.5 mg/kg	5.7	± 1.34

Before Second Injection (Week 4)

Group	Value	95% CI
Placebo	4.4	± 1.07
Nemolizumab 0.5 mg/kg	6.3	± 1.89

Prurigo Activity Score (PAS) Item 5: Overall Number of Prurigo Lesions at Week 12 Secondary · 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.

Baseline

Group	Value	95% CI
Placebo	87.1	± 5.42
Nemolizumab 0.5 mg/kg	84.9	± 5.50

Week 12

Group	Value	95% CI
Placebo	74.2	± 6.83
Nemolizumab 0.5 mg/kg	54.8	± 6.42

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 18 Weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 3/36 (8%)

Deaths: 0/36

Nemolizumab 0.5 mg/kg

Serious: 4/34 (12%)

Deaths: 0/34

Serious adverse events (8 terms)

Reaction	System	Placebo	Nemolizumab 0.5 mg/kg
Neurodermatitis	Skin and subcutaneous tissue disorders	—	—
Dermatitis Psoriasiform	Skin and subcutaneous tissue disorders	—	—
Eczema Nummular	Skin and subcutaneous tissue disorders	—	—
Clavicle Fracture	Injury, poisoning and procedural complications	—	—
Spinal Fracture	Injury, poisoning and procedural complications	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—
Fibromyalgia	Musculoskeletal and connective tissue disorders	—	—
Calculus Bladder	Renal and urinary disorders	—	—

Other adverse events (16 terms — click to expand)

Reaction	System	Placebo	Nemolizumab 0.5 mg/kg
Nasopharyngitis	Infections and infestations	—	—
Neurodermatitis	Skin and subcutaneous tissue disorders	—	—
Conjunctivitis	Infections and infestations	—	—
Dermatitis Atopic	Skin and subcutaneous tissue disorders	—	—
Bronchitis	Infections and infestations	—	—
Cystitis	Infections and infestations	—	—
Postoperative Wound Infection	Infections and infestations	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—
Dermatitis Contact	Skin and subcutaneous tissue disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Abdominal Pain	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—
Increased Appetite	Metabolism and nutrition disorders	—	—

Most-reported serious reactions: Neurodermatitis, Dermatitis Psoriasiform, Eczema Nummular, Clavicle Fracture, Spinal Fracture, Back Pain, Fibromyalgia, Calculus Bladder.

Data from ClinicalTrials.gov NCT03181503 adverse events section.

Sponsor's own description

The aim of this study is to assess the safety and efficacy of nemolizumab in subjects with prurigo nodularis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.