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An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis

Primary Purpose

Prurigo Nodularis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nemolizumab 30 mg
Placebo
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  • Clinical diagnosis of PN for at least 6 months with: (a) Pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs; (b) At least 20 nodules on the entire body with a bilateral distribution; (c) Investigator Global Assessment (IGA) score >= 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits
  • Severe pruritus defined as follows on the PP NRS: (a) at the screening visit (Visit 1): PP NRS score is >= 7.0 for the 24-hour period immediately preceding the screening visit; (b) at the baseline visit (Visit 2): Mean of the daily intensity of the PP NRS score is >= 7.0 over the previous week
  • Female participants of childbearing potential (that is [i.e,], fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree to use at least 1 effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection
  • Participant is willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including daily diary recordings by the participant using an electronic handheld device provided for this study

Exclusion Criteria:

  • Body weight < 30 kilogram (kg)
  • Unilateral lesions of prurigo (eg, only one arm affected)
  • History of or current confounding skin condition (eg, Netherton syndrome, cutaneous T-cell lymphoma [mycosis fungoides or Sezary syndrome], chronic actinic dermatitis, dermatitis herpetiformis)
  • Participants with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis
  • Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb], hepatitis C (HCV) antibody with positive confirmatory test for HCV (eg, polymerase chain reaction [PCR]), or human immunodeficiency virus antibody) at the screening visit

Sites / Locations

  • Galderma Investigational Site
  • Galderma Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nemolizumab 30 milligram (mg)

Placebo

Arm Description

Participants weighing less than (<) 90 kilogram (kg) will receive two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W) and participants >= 90 kg will receive two SC injections of 60 mg nemolizumab at baseline (no loading dose) and two SC injections Q4W up to 24 weeks.

Participants weighing < 90 kg will receive matching placebo of two SC injections at baseline, then one SC injection Q4W and participants weighing >= 90 kg will receive matching placebo of two SC injections at baseline, then two SC injections Q4W up to 24 weeks.

Outcomes

Primary Outcome Measures

Proportion of Participants with an Improvement of Greater than or Equal to (>=) 4 from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) at Week 16
PP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".
Proportion of Participants with an Investigator Global Assessment (IGA) Success (Defined as an IGA of 0 [Clear] or 1 [Almost clear] and a >= 2-Point Improvement from Baseline) at Week 16
IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of PN. The Investigator will review the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe).

Secondary Outcome Measures

Number of Participants with Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)
An AE is defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not it is related to the medicinal (investigational) product.
Proportion of Participants with an Improvement of >= 4 from Baseline in PP NRS at Week 4
Proportion of Participants with PP NRS < 2 at Week 16
Proportion of Participants with an Improvement of >= 4 from Baseline in Sleep Disturbance (SD) NRS at Week 16
SD NRS is an 11-point scale (0 to10) where 0 is "no sleep loss" and 10 is "I did not sleep at all".
Proportion of Participants with an Improvement of >= 4 from Baseline in SD NRS at Week 4
Proportion of Participants with PP NRS < 2 at Week 4
IGA Success Rate at Each Visit Through Week 24
Percentage of Pruriginous Lesions with Excoriations/Crusts ((Prurigo Activity Score [PAS] item 5a) at Each Visit Through Week 24
PAS will include a count of the number of lesions in a representative area and a calculated staging (stage 0 to stage 4) based on the percentage of lesions with excoriations/crusts and healed lesions compared to all lesions. PAS item 5a reflects the current itch/scratch activity. It is used to estimate what percentage of the pruriginous legions show excoriations/crusts. 100 percent (%) = All pruriginous lesions have excoriations/crusts.
Percentage of Healed Prurigo Lesions (PAS item 5b) at Each Visit Through Week 24
PAS item 5b item reflects the stage of the prurigo. It is used to estimate what percentage of the pruriginous lesions have healed.100% = all pruriginous lesions have healed.
Change from Baseline in Number of Lesions in Representative Area (PAS item 4) at Each Visit Through Week 24
PAS Item 4 is measure of number of lesions in representative area.
Proportion of Participants with an Improvement of >= 4 from Baseline in PP NRS Through Week 24
Proportion of Participants with PP NRS < 2 Through Week 24
Proportion of Participants with PP NRS < 3 Through Week 24
Percent Change from Baseline in PP NRS Through Week 24
Absolute Change from Baseline in PP NRS Through Week 24
Proportion of Participants with an Improvement of >= 4 from Baseline in Average Pruritus (AP) NRS Through Week 24
AP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".
Proportion of Participants with AP NRS < 2 from Baseline Through Week 24
Absolute Change from Baseline in AP NRS Through Week 24
Percent Change from Baseline in AP NRS Through Week 24
Proportion of Participants with an Improvement of >= 4 from Baseline in SD NRS Through Week 24
Absolute Change from Baseline in SD NRS Through Week 24
Percent Change from Baseline in SD NRS Through Week 24
Change from Baseline in Sleep Onset Latency Through Week 24
Change from Baseline in Wakefulness After Sleep Onset (WASO) Through Week 24
Change from baseline in WASO, defined as the duration of wakefulness from the onset of persistent sleep. WASO is assessed with 3 questions: 1) How many times did you wake up due to the symptoms of prurigo nodularis (for example itching, burning), not counting the final time you woke up for the day? 2) In total, how long did the awakenings related to the symptoms of prurigo nodularis (for example itching, burning) last and 3) In total, how long did these awakenings related to other things last (for example to drink water, to go to the bathroom).
Change from Baseline in Total Awake and Sleep Time Through Week 24
Change from Baseline in Sleep Efficiency Through Week 24
The Sleep Efficiency is the ratio of total sleep time to time in bed. This shall be assessed by responses from the following questions from participant's sleep diary: 1) What time did you get into bed? 2) What time did you try to go to sleep? 3) How long did it take you to fall asleep? 4) What time did you wake up for the day? 5) What time did you get out of bed for the day?
Change from Baseline in WASO Related to PN Through Week 24
Change from Baseline in Number of WASO Related to PN Through Week 24
Change from Baseline in PN-associated Pain Frequency Through Week 24
Change from Baseline in PN-associated Pain Intensity Through Week 24
Proportion of Participants Reporting low Disease Activity (Clear, Almost clear, or Mild) Based on Patient Global Assessment of Disease (PGAD) at Week 24
For the PGAD, participants will be asked to rate their overall impression of their skin disease (prurigo nodularis) severity using a 5-point scale from "0=clear" to "5=severe".
Proportion of Participants Satisfied with Study Treatment (Good, Very Good, or Excellent) Based on Patient Global Assessment of Treatment (PGAT) at Week 24
The PGAT utilizes a 5-point scale with ratings: poor, fair, good, very good, or excellent, for participants to rate the way they feel their skin disease (prurigo nodularis) is responding to the study treatment.
Proportion of Participants with an Improvement of >= 4 in DLQI Through Week 24
The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant will rate each question ranging from 0 (not at all) to 3 (very much) and score ranges from 0 to 30. A higher total score indicates a poorer quality of life (QoL).
Change from Baseline in DLQI Through Week 24
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 24
HADS is a 14-question validated questionnaire completed by the participant for each subscale (i.e. depression and anxiety). Question has a multiple choice answer which is scored between 0 and 3. Questions are identified as relating to anxiety (A) or depression (D) and a summation for each area is performed leading to a total score of 0 to 21 for each area. Scores of 0 to 7 are considered normal, 8 to 10 are borderline, and >= 11 indicates clinical effects.
Change from Baseline in EuroQoL 5-Dimension (EQ-5D) at Week 24
The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Area Under Curve (AUC) of Nemolizumab in the Serum
Trough Level (Ctrough) of Nemolizumab in the Serum
Maximum Serum Concentration (Cmax) of Nemolizumab in Serum
Half-Life (t1/2) of Nemolizumab in Serum
Observed Ctrough of Nemolizumab in Serum
Number of Participants with Positive Anti-drug antibody (ADA) for Nemolizumab

Full Information

First Posted
July 30, 2020
Last Updated
June 27, 2023
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT04501666
Brief Title
An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 11, 2020 (Actual)
Primary Completion Date
November 11, 2022 (Actual)
Study Completion Date
February 21, 2023 (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
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective is to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (>=) 18 years of age with prurigo nodularis (PN) after a 16 week treatment period.

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
286 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nemolizumab 30 milligram (mg)
Arm Type
Experimental
Arm Description
Participants weighing less than (<) 90 kilogram (kg) will receive two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W) and participants >= 90 kg will receive two SC injections of 60 mg nemolizumab at baseline (no loading dose) and two SC injections Q4W up to 24 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants weighing < 90 kg will receive matching placebo of two SC injections at baseline, then one SC injection Q4W and participants weighing >= 90 kg will receive matching placebo of two SC injections at baseline, then two SC injections Q4W up to 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Nemolizumab 30 mg
Intervention Description
Participants will receive either 30 mg or 60 mg dose of nemolizumab as SC injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive matching placebo as SC injection.
Primary Outcome Measure Information:
Title
Proportion of Participants with an Improvement of Greater than or Equal to (>=) 4 from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) at Week 16
Description
PP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".
Time Frame
Week 16
Title
Proportion of Participants with an Investigator Global Assessment (IGA) Success (Defined as an IGA of 0 [Clear] or 1 [Almost clear] and a >= 2-Point Improvement from Baseline) at Week 16
Description
IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of PN. The Investigator will review the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe).
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)
Description
An AE is defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not it is related to the medicinal (investigational) product.
Time Frame
Up to 36 weeks
Title
Proportion of Participants with an Improvement of >= 4 from Baseline in PP NRS at Week 4
Time Frame
Week 4
Title
Proportion of Participants with PP NRS < 2 at Week 16
Time Frame
Week 16
Title
Proportion of Participants with an Improvement of >= 4 from Baseline in Sleep Disturbance (SD) NRS at Week 16
Description
SD NRS is an 11-point scale (0 to10) where 0 is "no sleep loss" and 10 is "I did not sleep at all".
Time Frame
Week 16
Title
Proportion of Participants with an Improvement of >= 4 from Baseline in SD NRS at Week 4
Time Frame
Week 4
Title
Proportion of Participants with PP NRS < 2 at Week 4
Time Frame
Week 4
Title
IGA Success Rate at Each Visit Through Week 24
Time Frame
At Each Visit Through Week 24
Title
Percentage of Pruriginous Lesions with Excoriations/Crusts ((Prurigo Activity Score [PAS] item 5a) at Each Visit Through Week 24
Description
PAS will include a count of the number of lesions in a representative area and a calculated staging (stage 0 to stage 4) based on the percentage of lesions with excoriations/crusts and healed lesions compared to all lesions. PAS item 5a reflects the current itch/scratch activity. It is used to estimate what percentage of the pruriginous legions show excoriations/crusts. 100 percent (%) = All pruriginous lesions have excoriations/crusts.
Time Frame
At Each Visit Through Week 24
Title
Percentage of Healed Prurigo Lesions (PAS item 5b) at Each Visit Through Week 24
Description
PAS item 5b item reflects the stage of the prurigo. It is used to estimate what percentage of the pruriginous lesions have healed.100% = all pruriginous lesions have healed.
Time Frame
At Each Visit Through Week 24
Title
Change from Baseline in Number of Lesions in Representative Area (PAS item 4) at Each Visit Through Week 24
Description
PAS Item 4 is measure of number of lesions in representative area.
Time Frame
Baseline, at each visit through Week 24
Title
Proportion of Participants with an Improvement of >= 4 from Baseline in PP NRS Through Week 24
Time Frame
Through Week 24
Title
Proportion of Participants with PP NRS < 2 Through Week 24
Time Frame
Through Week 24
Title
Proportion of Participants with PP NRS < 3 Through Week 24
Time Frame
Through Week 24
Title
Percent Change from Baseline in PP NRS Through Week 24
Time Frame
Baseline, through Week 24
Title
Absolute Change from Baseline in PP NRS Through Week 24
Time Frame
Baseline, through Week 24
Title
Proportion of Participants with an Improvement of >= 4 from Baseline in Average Pruritus (AP) NRS Through Week 24
Description
AP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".
Time Frame
Through Week 24
Title
Proportion of Participants with AP NRS < 2 from Baseline Through Week 24
Time Frame
Through Week 24
Title
Absolute Change from Baseline in AP NRS Through Week 24
Time Frame
Baseline, Through Week 24
Title
Percent Change from Baseline in AP NRS Through Week 24
Time Frame
Baseline, Through Week 24
Title
Proportion of Participants with an Improvement of >= 4 from Baseline in SD NRS Through Week 24
Time Frame
Through Week 24
Title
Absolute Change from Baseline in SD NRS Through Week 24
Time Frame
Baseline, through Week 24
Title
Percent Change from Baseline in SD NRS Through Week 24
Time Frame
Baseline, through Week 24
Title
Change from Baseline in Sleep Onset Latency Through Week 24
Time Frame
Baseline, through Week 24
Title
Change from Baseline in Wakefulness After Sleep Onset (WASO) Through Week 24
Description
Change from baseline in WASO, defined as the duration of wakefulness from the onset of persistent sleep. WASO is assessed with 3 questions: 1) How many times did you wake up due to the symptoms of prurigo nodularis (for example itching, burning), not counting the final time you woke up for the day? 2) In total, how long did the awakenings related to the symptoms of prurigo nodularis (for example itching, burning) last and 3) In total, how long did these awakenings related to other things last (for example to drink water, to go to the bathroom).
Time Frame
Baseline, through Week 24
Title
Change from Baseline in Total Awake and Sleep Time Through Week 24
Time Frame
Baseline, through Week 24
Title
Change from Baseline in Sleep Efficiency Through Week 24
Description
The Sleep Efficiency is the ratio of total sleep time to time in bed. This shall be assessed by responses from the following questions from participant's sleep diary: 1) What time did you get into bed? 2) What time did you try to go to sleep? 3) How long did it take you to fall asleep? 4) What time did you wake up for the day? 5) What time did you get out of bed for the day?
Time Frame
Baseline, through Week 24
Title
Change from Baseline in WASO Related to PN Through Week 24
Time Frame
Baseline, through Week 24
Title
Change from Baseline in Number of WASO Related to PN Through Week 24
Time Frame
Baseline, through Week 24
Title
Change from Baseline in PN-associated Pain Frequency Through Week 24
Time Frame
Baseline, through Week 24
Title
Change from Baseline in PN-associated Pain Intensity Through Week 24
Time Frame
Baseline, through Week 24
Title
Proportion of Participants Reporting low Disease Activity (Clear, Almost clear, or Mild) Based on Patient Global Assessment of Disease (PGAD) at Week 24
Description
For the PGAD, participants will be asked to rate their overall impression of their skin disease (prurigo nodularis) severity using a 5-point scale from "0=clear" to "5=severe".
Time Frame
Week 24
Title
Proportion of Participants Satisfied with Study Treatment (Good, Very Good, or Excellent) Based on Patient Global Assessment of Treatment (PGAT) at Week 24
Description
The PGAT utilizes a 5-point scale with ratings: poor, fair, good, very good, or excellent, for participants to rate the way they feel their skin disease (prurigo nodularis) is responding to the study treatment.
Time Frame
Week 24
Title
Proportion of Participants with an Improvement of >= 4 in DLQI Through Week 24
Description
The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant will rate each question ranging from 0 (not at all) to 3 (very much) and score ranges from 0 to 30. A higher total score indicates a poorer quality of life (QoL).
Time Frame
Through Week 24
Title
Change from Baseline in DLQI Through Week 24
Time Frame
Baseline, through Week 24
Title
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 24
Description
HADS is a 14-question validated questionnaire completed by the participant for each subscale (i.e. depression and anxiety). Question has a multiple choice answer which is scored between 0 and 3. Questions are identified as relating to anxiety (A) or depression (D) and a summation for each area is performed leading to a total score of 0 to 21 for each area. Scores of 0 to 7 are considered normal, 8 to 10 are borderline, and >= 11 indicates clinical effects.
Time Frame
Baseline, Week 24
Title
Change from Baseline in EuroQoL 5-Dimension (EQ-5D) at Week 24
Description
The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame
Baseline, Week 24
Title
Area Under Curve (AUC) of Nemolizumab in the Serum
Time Frame
Pre-infusion, Post infusion on Day 29, 57, 85, 113, 169, 225
Title
Trough Level (Ctrough) of Nemolizumab in the Serum
Time Frame
Pre-infusion, Post infusion on Day 29, 57, 85, 113, 169, 225
Title
Maximum Serum Concentration (Cmax) of Nemolizumab in Serum
Time Frame
Pre-infusion, Post infusion on Day 29, 57, 85, 113, 169, 225
Title
Half-Life (t1/2) of Nemolizumab in Serum
Time Frame
Pre-infusion, Post infusion on Day 29, 57, 85, 113, 169, 225
Title
Observed Ctrough of Nemolizumab in Serum
Time Frame
Pre-infusion, Post infusion on Day 29, 57, 85, 113, 169, 225
Title
Number of Participants with Positive Anti-drug antibody (ADA) for Nemolizumab
Time Frame
Baseline, Day 57, Day 113, Day 169/Early Termination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of PN for at least 6 months with: (a) Pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs; (b) At least 20 nodules on the entire body with a bilateral distribution; (c) Investigator Global Assessment (IGA) score >= 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits Severe pruritus defined as follows on the PP NRS: (a) at the screening visit (Visit 1): PP NRS score is >= 7.0 for the 24-hour period immediately preceding the screening visit; (b) at the baseline visit (Visit 2): Mean of the daily intensity of the PP NRS score is >= 7.0 over the previous week Female participants of childbearing potential (that is [i.e,], fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree to use at least 1 effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection Participant is willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including daily diary recordings by the participant using an electronic handheld device provided for this study Exclusion Criteria: Body weight < 30 kilogram (kg) Unilateral lesions of prurigo (eg, only one arm affected) History of or current confounding skin condition (eg, Netherton syndrome, cutaneous T-cell lymphoma [mycosis fungoides or Sezary syndrome], chronic actinic dermatitis, dermatitis herpetiformis) Participants with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb], hepatitis C (HCV) antibody with positive confirmatory test for HCV (eg, polymerase chain reaction [PCR]), or human immunodeficiency virus antibody) at the screening visit
Facility Information:
Facility Name
Galderma Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Galderma Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Galderma Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Galderma Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Galderma Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Galderma Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States
Facility Name
Galderma Investigational Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
94404
Country
United States
Facility Name
Galderma Investigational Site
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Galderma Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Galderma Investigational Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Galderma Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Galderma Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Galderma Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Galderma Investigational Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Galderma Investigational Site
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Galderma Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60613
Country
United States
Facility Name
Galderma Investigational Site
City
Lake Bluff
State/Province
Illinois
ZIP/Postal Code
60044
Country
United States
Facility Name
Galderma Investigational Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66614
Country
United States
Facility Name
Galderma Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Galderma Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Galderma Investigational Site
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Galderma Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Galderma Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Galderma Investigational Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Galderma Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27617
Country
United States
Facility Name
Galderma Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Galderma Investigational Site
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Galderma Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Galderma Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Galderma Investigational Site
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Galderma Investigational Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Galderma Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Galderma Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78738
Country
United States
Facility Name
Galderma Investigational Site
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Galderma Investigational Site
City
Laredo
State/Province
Texas
ZIP/Postal Code
78401
Country
United States
Facility Name
Galderma Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Galderma Investigational Site
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States
Facility Name
Galderma Investigational Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Galderma Investigational Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Galderma Investigational Site
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Galderma Investigational Site
City
Wien
ZIP/Postal Code
1220
Country
Austria
Facility Name
Galderma Investigational Site
City
Calgary
State/Province
AL
ZIP/Postal Code
T3E OB2
Country
Canada
Facility Name
Galderma Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3H7
Country
Canada
Facility Name
Galderma Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K OH6
Country
Canada
Facility Name
Galderma Investigational Site
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Galderma Investigational Site
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Galderma Investigational Site
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Galderma Investigational Site
City
Augsburg
ZIP/Postal Code
86179
Country
Germany
Facility Name
Galderma Investigational Site
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Facility Name
Galderma Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Galderma Investigational Site
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Galderma Investigational Site
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Galderma Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Galderma Investigational Site
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Galderma Investigational Site
City
Eppendorf
ZIP/Postal Code
20246
Country
Germany
Facility Name
Galderma Investigational Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Galderma Investigational Site
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Galderma Investigational Site
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Galderma Investigational Site
City
Hamburg
ZIP/Postal Code
20537
Country
Germany
Facility Name
Galderma Investigational Site
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Galderma Investigational Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Galderma Investigational Site
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Galderma Investigational Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Galderma Investigational Site
City
Münich
ZIP/Postal Code
80337
Country
Germany
Facility Name
Galderma Investigational Site
City
Münich
ZIP/Postal Code
80802
Country
Germany
Facility Name
Galderma Investigational Site
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Galderma Investigational Site
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Galderma Investigational Site
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Galderma Investigational Site
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Galderma Investigational Site
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Galderma Investigational Site
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Galderma Investigational Site
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Galderma Investigational Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Galderma Investigational Site
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Galderma Investigational Site
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Galderma Investigational Site
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Galderma Investigational Site
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Galderma Investigational Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Galderma Investigational Site
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
Facility Name
Galderma Investigational Site
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Galderma Investigational Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Galderma Investigational Site
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
Galderma Investigational Site
City
Perugia
ZIP/Postal Code
06129
Country
Italy
Facility Name
Galderma Investigational Site
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Galderma Investigational Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Galderma Investigational Site
City
Vicenza
ZIP/Postal Code
24128
Country
Italy
Facility Name
Galderma Investigational Site
City
Czestochowa
ZIP/Postal Code
42-202
Country
Poland
Facility Name
Galderma Investigational Site
City
Gdańsk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
Galderma Investigational Site
City
Gdynia
ZIP/Postal Code
81-537
Country
Poland
Facility Name
Galderma Investigational Site
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Galderma Investigational Site
City
Poznań
ZIP/Postal Code
60-702
Country
Poland
Facility Name
Galderma Investigational Site
City
Rzeszów
ZIP/Postal Code
30-055
Country
Poland
Facility Name
Galderma Investigational Site
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Galderma Investigational Site
City
Wrocław
ZIP/Postal Code
50-381
Country
Poland
Facility Name
Galderma Investigational Site
City
Łódź
ZIP/Postal Code
90-127
Country
Poland
Facility Name
Galderma Investigational Site
City
Solna
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Galderma Investigational Site
City
Dudley
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Galderma Investigational Site
City
Glasgow
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
Facility Name
Galderma Investigational Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Galderma Investigational Site
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis

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