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Safety and Efficacy of Nemolizumab in PN

Primary Purpose

Prurigo Nodularis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

CD14152 Dose A

CD14152 placebo

About this trial

This is an interventional treatment trial for Prurigo Nodularis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female of at least 18 years at screening
Clinical diagnosis of PN for at least 6 months with:
- Prurigo lesions on upper limbs with or without lesions on the trunk or lower limbs
- At least 20 nodules on the entire body with a bilateral distribution
Severe pruritus defined as follows on a Numerical Rating Scale (NRS)
- At the Screening visit 1: Mean of the worst daily intensity of the NRS score is ≥ 7 over the previous 3 days
- At the Baseline visit: Mean of the worst daily intensity of the NRS score is ≥ 7 over the previous week; NOTE: NRS score should be measured on at least 5 days during the week preceding the baseline visit.
Female subjects must fulfill one of the criteria below:
- Female subjects of non-childbearing potential (postmenopausal [absence of menstrual bleeding for 1 year prior to screening, without any other medical reason], hysterectomy or bilateral oophorectomy);
- Female subjects of childbearing potential who agree to a true abstinence (when in line with the preferred and usual lifestyle of the subject), or to use an effective method of contraception throughout the clinical trial and for 120 days after the last study drug administration:

Exclusion Criteria:

Chronic pruritus resulting from another condition than PN such as scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease
Unilateral lesions of prurigo (e.g only one arm affected)
Cutaneous bacterial or viral infection within 1 week before the baseline visit.
Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit, or during the screening period, unless completely resolved at the screening/ baseline visits respectively,
Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results and/or put the subject at Chronic pruritus resulting from another condition than PN such as scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease

Sites / Locations

LKH-Univ. Klinikum Graz
Centre-Hospitalier Universitaire (CHU) - Hopital Morvan - Br
CHU de Nice - Hôpital Archet 2
Hopital Saint-Louis - Dermatology
Centre Hospitalier Universitaire De Toulouse
Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie
Universitätsklinikum Bonn AöR
Klinikum der Johann-Wolfgang Goethe-Universität
Unikl. Schleswig-Holstein - Lübeck
Universitätsmedizin Mainz
Klinikum Der Universität München - Campus Innenstadt - Dermatologie und Allergologie
Universitätsklinikum Münster
Eberhard-Karls Universitaet Tuebingen - Universitaets Hautkl
Kliniczny Szpital Wojew. nr 1 im. F.Chopina w Rzeszowie
Centrum Medyczne DERMED
Dermoklinika Centrum Medyczne s.c. M.Kierstan, J.Narbutt, A.Lesiak

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Nemolizumab 0.5 mg/kg

Arm Description

Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) every 4 weeks (Q4W) up to Week 8.

Participants received 3 subcutaneous injections of nemolizumab 0.5 milligram per kilogram (mg/kg) Q4W up to Week 8.

Outcomes

Primary Outcome Measures

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.

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.

Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Observed Data

Secondary Outcome Measures

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

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

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.

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

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

VRS consists of a list of adjectives describing different levels of symptom intensity used by participants to report intensity of their pruritus (itch) over last 24 hours. Participants marked on a 5-point VRS (0=no itch, 1=mild itch, 2=moderate itch, 3=severe itch, 4=very severe itch), a response that best described their pruritus intensity in last 24 hours. Participants were asked following questions in their local language: 1) For average itch intensity: "on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your itch overall during previous 24 hours?"; 2) For maximum itch intensity: "on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your worst itch during previous 24 hours?". Where, higher score indicated very severe itch. Missing values including those who took rescue medication were replaced by LOCF approach.

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

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

Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach

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.

Prurigo Activity Score (PAS) Item 5: Overall Number of Prurigo Lesions at 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%.

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.

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

Full Information

NCT ID

NCT03181503

First Posted

June 7, 2017

Last Updated

February 7, 2020

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT03181503

Brief Title

Safety and Efficacy of Nemolizumab in PN

Official Title

A Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis (PN)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

October 2, 2017 (Actual)

Primary Completion Date

September 26, 2018 (Actual)

Study Completion Date

September 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galderma R&D

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

This is a randomized, placebo-controlled, double-blinded, parallel group, multicenter study to evaluate the safety and efficacy of nemolizumab over a 12-week treatment period in patients suffering from prurigo nodularis compared to its placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prurigo Nodularis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) every 4 weeks (Q4W) up to Week 8.

Arm Title

Nemolizumab 0.5 mg/kg

Arm Type

Experimental

Arm Description

Participants received 3 subcutaneous injections of nemolizumab 0.5 milligram per kilogram (mg/kg) Q4W up to Week 8.

Intervention Type

Drug

Intervention Name(s)

CD14152 Dose A

Other Intervention Name(s)

Nemolizumab

Intervention Description

3 subcutaneous injections (every 4 weeks during the 12-week treatment period)

Intervention Type

Drug

Intervention Name(s)

CD14152 placebo

Other Intervention Name(s)

Placebo

Intervention Description

3 subcutaneous injections (every 4 weeks during the 12-week treatment period)

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, Week 4

Title

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

Description

Time Frame

Baseline, Week 4

Title

Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Observed Data

Description

Time Frame

Baseline, Week 4

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18

Title

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

Description

Time Frame

Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18

Title

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

Description

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

Title

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

Description

Time Frame

Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18

Title

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

Description

Time Frame

Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18

Title

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

Description

Time Frame

Baseline, Weeks 1, 2, 4, 8, 12,16 and 18

Title

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

Description

Time Frame

Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18

Title

Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach

Description

Time Frame

Baseline, Weeks 1, 2, 4, 8, 12,16 and 18

Title

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

Description

Time Frame

After 24, 48, 72 hours of first Injection and before second injection (Week 4)

Title

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

Description

Time Frame

Baseline, Week 12

Title

Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit

Description

Time Frame

Day 1 (Baseline), Weeks 4, 8, 12 and 18

Title

Investigator Global Assessment (IGA) Score at Each Visit

Description

Time Frame

Day 1 (Baseline), Weeks 4, 8, 12 and 18

Title

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

Description

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female of at least 18 years at screening Clinical diagnosis of PN for at least 6 months with: Prurigo lesions on upper limbs with or without lesions on the trunk or lower limbs At least 20 nodules on the entire body with a bilateral distribution Severe pruritus defined as follows on a Numerical Rating Scale (NRS) At the Screening visit 1: Mean of the worst daily intensity of the NRS score is ≥ 7 over the previous 3 days At the Baseline visit: Mean of the worst daily intensity of the NRS score is ≥ 7 over the previous week; NOTE: NRS score should be measured on at least 5 days during the week preceding the baseline visit. Female subjects must fulfill one of the criteria below: Female subjects of non-childbearing potential (postmenopausal [absence of menstrual bleeding for 1 year prior to screening, without any other medical reason], hysterectomy or bilateral oophorectomy); Female subjects of childbearing potential who agree to a true abstinence (when in line with the preferred and usual lifestyle of the subject), or to use an effective method of contraception throughout the clinical trial and for 120 days after the last study drug administration: Exclusion Criteria: Chronic pruritus resulting from another condition than PN such as scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease Unilateral lesions of prurigo (e.g only one arm affected) Cutaneous bacterial or viral infection within 1 week before the baseline visit. Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit, or during the screening period, unless completely resolved at the screening/ baseline visits respectively, Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results and/or put the subject at Chronic pruritus resulting from another condition than PN such as scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease

Facility Information:

Facility Name

LKH-Univ. Klinikum Graz

City

Graz

Country

Austria

Facility Name

Centre-Hospitalier Universitaire (CHU) - Hopital Morvan - Br

City

Brest

Country

France

Facility Name

CHU de Nice - Hôpital Archet 2

City

Nice

Country

France

Facility Name

Hopital Saint-Louis - Dermatology

City

Paris

Country

France

Facility Name

Centre Hospitalier Universitaire De Toulouse

City

Toulouse

Country

France

Facility Name

Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie

City

Berlin

Country

Germany

Facility Name

Universitätsklinikum Bonn AöR

City

Bonn

Country

Germany

Facility Name

Klinikum der Johann-Wolfgang Goethe-Universität

City

Frankfurt

Country

Germany

Facility Name

Unikl. Schleswig-Holstein - Lübeck

City

Lubeck

Country

Germany

Facility Name

Universitätsmedizin Mainz

City

Mainz

Country

Germany

Facility Name

Klinikum Der Universität München - Campus Innenstadt - Dermatologie und Allergologie

City

München

Country

Germany

Facility Name

Universitätsklinikum Münster

City

Münster

Country

Germany

Facility Name

Eberhard-Karls Universitaet Tuebingen - Universitaets Hautkl

City

Tuebingen

Country

Germany

Facility Name

Kliniczny Szpital Wojew. nr 1 im. F.Chopina w Rzeszowie

City

Rzeszów

Country

Poland

Facility Name

Centrum Medyczne DERMED

City

Łódź

Country

Poland

Facility Name

Dermoklinika Centrum Medyczne s.c. M.Kierstan, J.Narbutt, A.Lesiak

City

Łódź

Country

Poland

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32074418

Citation

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.

Results Reference

derived

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Safety and Efficacy of Nemolizumab in PN

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