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

Primary Purpose

Prurigo Nodularis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Nemolizumab

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:

Clinical diagnosis of PN for at least 6 months with: Pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs, at least 20 nodules on the entire body with a bilateral distribution and 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:
1. At the screening visit (Visit 1): PP NRS score is >= 7.0 for the 24-hour period immediately preceding the screening visit.
2. 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 adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection

Exclusion Criteria:

Body weight less than (<) 30 kg
Chronic pruritus resulting from another active condition other than PN, such as but not limited to scabies, lichen simplex chronicus, psoriasis, atopic dermatitis, contact dermatitis, acne, folliculitis, lichen planus, habitual picking/excoriation disorder, sporotrichosis, bullous autoimmune disease, end-stage renal disease, or cholestatic liver disease (example [eg] primary biliary cirrhosis) or diabetes mellitus or thyroid disease that is not adequately treated, as per standard of care
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
Neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis
Requiring rescue therapy for PN during the screening period or expected to require rescue therapy within 4 weeks following the baseline visit
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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nemolizumab

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). Participants weighing greater than or equal to (>=) 90 kg will receive two SC injections of 60 mg nemolizumab at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks.

Participants weighing < 90 kg will receive two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing >= 90 kg will receive two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks.

Outcomes

Primary Outcome Measures

Proportion of Participants with an Improvement of Greater than or Equal to (>=) 4 from Baseline in Peak Pruritus Numeric Rating Scale (PP 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 Less than (<) 2 PP NRS at Week 16

Proportion of Participants with an Improvement of >= 4 from Baseline in Sleep Disturbance (SD) Numeric Rating Scale (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 < 2 PP NRS at Week 4

IGA Success Rate at Each Visit Through Week 16

Percentage of Pruriginous Lesions with Excoriations/Crusts (Prurigo Activity Score [PAS] item 5a) at Each Visit Through Week 16

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 16

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 16

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 16

Proportion of Participants with PP NRS < 2 from Baseline Through Week 16

Proportion of Participants with PP NRS < 3 from Baseline Through Week 16

Absolute Change from Baseline in PP NRS Through Week 16

Percent Change from Baseline in PP NRS Through Week 16

Proportion of Participants with an Improvement of >= 4 from Baseline in Average Pruritus (AP) Numeric Rating Scale (NRS) Through Week 16

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 16

Absolute Change from Baseline in AP NRS Through Week 16

Percent Change from Baseline in AP NRS Through Week 16

Proportion of Participants with an Improvement of >= 4 from Baseline in Sleep Disturbance (SD) Numeric Rating Scale (NRS) Through 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".

Absolute Change from Baseline in SD NRS Through Week 16

Percent Change from Baseline in SD NRS Through Week 16

Change from Baseline in Sleep Onset Latency Through Week 16

Change from baseline in sleep onset latency based on recordings from participant's sleep diary.

Change from Baseline in Wakefulness After Sleep Onset (WASO) Through Week 16

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 Time and Sleep Time Through Week 16

Change from Baseline in Sleep Efficiency Through Week 16

The Sleep Efficiency Index 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 16

Change from Baseline in Number of WASO related to PN Through Week 16

Change from Baseline in PN-associated Pain Frequency Through Week 16

The pain frequency will be assessed on a 6 point scale of 0 to 5 where 0 = never, 1 = less than once a week, 2 = 1-2 days a week, 3 = 3-4 days a week, and 4 = 5-6 days a week, 5 = every day.

Change from Baseline in PN-associated Pain Intensity Through Week 16

The pain intensity will be assessed on a scale of 0 to 10, with 0 being "no pain" and 10 being "the worst unbearable pain".

Proportion of Participants Reporting low Disease Activity (Clear, Almost clear, or Mild) Based on Patient Global Assessment of Disease (PGAD) at Week 16

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 16

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 Dermatology Life Quality Index (DLQI) Through Week 16

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). A higher total score indicates a poorer quality of life (QoL).

Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 16

Change from Baseline in Hospital Anxiety and Depression Scale (HADS) for each Subscale (Depression and Anxiety) at Week 16

Hospital Anxiety and Depression Scale (HADS) is a 14-question validated questionnaire completed by the participant for each subscale (i.e. depression and anxiety). Each 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 16

The EQ-5D instrument is a validated questionnaire, completed by the participant that consists of 2 parts. The first part consists of 5 multiple choice QoL questions and the second is a 100 point visual analogue scale (VAS) with 0 being "Worst imaginable health state" and 100 being "Best imaginable health state".

Observed Ctrough of Nemolizumab in Serum

Number of Participants with Positive Anti-drug antibody (ADA) for Nemolizumab

Proportion of subjects with PP NRS improvement ≥ 4 from baseline and IGA success

Nemolizumab (CD14152) serum concentrations

Full Information

NCT ID

NCT04501679

First Posted

July 30, 2020

Last Updated

June 27, 2023

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT04501679

Brief Title

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

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

November 2021

Overall Recruitment Status

Completed

Study Start Date

August 11, 2020 (Actual)

Primary Completion Date

March 30, 2022 (Actual)

Study Completion Date

March 31, 2022 (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

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

274 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nemolizumab

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Nemolizumab

Other Intervention Name(s)

CD14152

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 Numeric Rating Scale (PP 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

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

Time Frame

Up to Week 24

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 Less than (<) 2 PP NRS at Week 16

Time Frame

Week 16

Title

Proportion of Participants with an Improvement of >= 4 from Baseline in Sleep Disturbance (SD) Numeric Rating Scale (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 < 2 PP NRS at Week 4

Time Frame

Week 4

Title

IGA Success Rate at Each Visit Through Week 16

Time Frame

At each visit through Week 16

Title

Percentage of Pruriginous Lesions with Excoriations/Crusts (Prurigo Activity Score [PAS] item 5a) at Each Visit Through Week 16

Description

Time Frame

At each visit through Week 16

Title

Percentage of Healed Prurigo Lesions (PAS Item 5b) at Each Visit Through Week 16

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 16

Title

Change from Baseline in Number of Lesions in Representative Area (PAS Item 4) at Each Visit Through Week 16

Description

PAS Item 4 is measure of number of lesions in representative area.

Time Frame

Baseline, at each visit through Week 16

Title

Proportion of Participants with an Improvement of >=4 from Baseline in PP NRS Through Week 16

Time Frame

Through Week 16

Title

Proportion of Participants with PP NRS < 2 from Baseline Through Week 16

Time Frame

Through Week 16

Title

Proportion of Participants with PP NRS < 3 from Baseline Through Week 16

Time Frame

Through Week 16

Title

Absolute Change from Baseline in PP NRS Through Week 16

Time Frame

Baseline, through Week 16

Title

Percent Change from Baseline in PP NRS Through Week 16

Time Frame

Baseline, through Week 16

Title

Proportion of Participants with an Improvement of >= 4 from Baseline in Average Pruritus (AP) Numeric Rating Scale (NRS) Through Week 16

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 16

Title

Proportion of Participants with AP NRS < 2 from Baseline Through Week 16

Time Frame

Through Week 16

Title

Absolute Change from Baseline in AP NRS Through Week 16

Time Frame

Baseline, through Week 16

Title

Percent Change from Baseline in AP NRS Through Week 16

Time Frame

Baseline, through Week 16

Title

Proportion of Participants with an Improvement of >= 4 from Baseline in Sleep Disturbance (SD) Numeric Rating Scale (NRS) Through 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

Through Week 16

Title

Absolute Change from Baseline in SD NRS Through Week 16

Time Frame

Baseline, through Week 16

Title

Percent Change from Baseline in SD NRS Through Week 16

Time Frame

Baseline, through Week 16

Title

Change from Baseline in Sleep Onset Latency Through Week 16

Description

Change from baseline in sleep onset latency based on recordings from participant's sleep diary.

Time Frame

Baseline, through Week 16

Title

Change from Baseline in Wakefulness After Sleep Onset (WASO) Through Week 16

Description

Time Frame

Baseline, through Week 16

Title

Change from Baseline in Total Awake Time and Sleep Time Through Week 16

Time Frame

Baseline, through Week 16

Title

Change from Baseline in Sleep Efficiency Through Week 16

Description

Time Frame

Baseline, through Week 16

Title

Change from Baseline in WASO related to PN Through Week 16

Time Frame

Baseline, through Week 16

Title

Change from Baseline in Number of WASO related to PN Through Week 16

Time Frame

Baseline, through Week 16

Title

Change from Baseline in PN-associated Pain Frequency Through Week 16

Description

The pain frequency will be assessed on a 6 point scale of 0 to 5 where 0 = never, 1 = less than once a week, 2 = 1-2 days a week, 3 = 3-4 days a week, and 4 = 5-6 days a week, 5 = every day.

Time Frame

Baseline, through Week 16

Title

Change from Baseline in PN-associated Pain Intensity Through Week 16

Description

The pain intensity will be assessed on a scale of 0 to 10, with 0 being "no pain" and 10 being "the worst unbearable pain".

Time Frame

Baseline, through Week 16

Title

Proportion of Participants Reporting low Disease Activity (Clear, Almost clear, or Mild) Based on Patient Global Assessment of Disease (PGAD) at Week 16

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 16

Title

Proportion of Participants Satisfied with Study Treatment (Good, Very good, or Excellent) Based on Patient Global Assessment of Treatment (PGAT) at Week 16

Description

Time Frame

Week 16

Title

Proportion of Participants with an Improvement of >= 4 in Dermatology Life Quality Index (DLQI) Through Week 16

Description

Time Frame

Through Week 16

Title

Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 16

Time Frame

Baseline, through Week 16

Title

Change from Baseline in Hospital Anxiety and Depression Scale (HADS) for each Subscale (Depression and Anxiety) at Week 16

Description

Time Frame

Baseline, Week 16

Title

Change from Baseline in EuroQoL 5-Dimension (EQ-5D) at Week 16

Description

Time Frame

Baseline, Week 16

Title

Observed Ctrough of Nemolizumab in Serum

Time Frame

Pre-infusion, Post infusion on Day 8, 29, 57, 85, 113, 169

Title

Number of Participants with Positive Anti-drug antibody (ADA) for Nemolizumab

Time Frame

Baseline, Day 57, Day 113/ Early Termination (ET)

Title

Proportion of subjects with PP NRS improvement ≥ 4 from baseline and IGA success

Time Frame

Week 16

Title

Nemolizumab (CD14152) serum concentrations

Time Frame

Week 4, 8, 12, 16, 24, ET

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of PN for at least 6 months with: Pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs, at least 20 nodules on the entire body with a bilateral distribution and 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: At the screening visit (Visit 1): PP NRS score is >= 7.0 for the 24-hour period immediately preceding the screening visit. 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 adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection Exclusion Criteria: Body weight less than (<) 30 kg Chronic pruritus resulting from another active condition other than PN, such as but not limited to scabies, lichen simplex chronicus, psoriasis, atopic dermatitis, contact dermatitis, acne, folliculitis, lichen planus, habitual picking/excoriation disorder, sporotrichosis, bullous autoimmune disease, end-stage renal disease, or cholestatic liver disease (example [eg] primary biliary cirrhosis) or diabetes mellitus or thyroid disease that is not adequately treated, as per standard of care 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 Neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis Requiring rescue therapy for PN during the screening period or expected to require rescue therapy within 4 weeks following the baseline visit 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

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Galderma Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Galderma Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

Galderma Investigational Site

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Galderma Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Galderma Investigational Site

City

North Miami Beach

State/Province

Florida

ZIP/Postal Code

33162-4708

Country

United States

Facility Name

Galderma Investigational Site

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Galderma Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60602

Country

United States

Facility Name

Galderma Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46250

Country

United States

Facility Name

Galderma Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40241

Country

United States

Facility Name

Galderma Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Galderma Investigational Site

City

Saint Joseph

State/Province

Michigan

ZIP/Postal Code

49085

Country

United States

Facility Name

Galderma Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Galderma Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45627

Country

United States

Facility Name

Galderma Investigational Site

City

Dublin

State/Province

Ohio

ZIP/Postal Code

43016

Country

United States

Facility Name

Galderma Investigational Site

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

Galderma Investigational Site

City

Murfreesboro

State/Province

Tennessee

ZIP/Postal Code

37130

Country

United States

Facility Name

Galderma Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Galderma Investigational Site

City

Dripping Springs

State/Province

Texas

ZIP/Postal Code

78620

Country

United States

Facility Name

Galderma Investigational Site

City

Pflugerville

State/Province

Texas

ZIP/Postal Code

78660

Country

United States

Facility Name

Galderma Investigational Site

City

Webster

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

Galderma Investigational Site

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26505

Country

United States

Facility Name

Galderma Investigational Site

City

Brussel

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Galderma Investigational Site

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Galderma Investigational Site

City

Jette

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Galderma Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Galderma Investigational Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Galderma Investigational Site

City

North York

State/Province

Ontario

ZIP/Postal Code

M2M 4J5

Country

Canada

Facility Name

Galderma Investigational Site

City

Bathurst

ZIP/Postal Code

M3H 5Y8

Country

Canada

Facility Name

Galderma Investigational Site

City

Calgary

ZIP/Postal Code

T2G 1B1

Country

Canada

Facility Name

Galderma Investigational Site

City

London

ZIP/Postal Code

N6H 5L5

Country

Canada

Facility Name

Galderma Investigational Site

City

Markham

ZIP/Postal Code

L3P 1X2

Country

Canada

Facility Name

Galderma Investigational Site

City

Bordeaux

ZIP/Postal Code

33000

Country

France

Facility Name

Galderma Investigational Site

City

Brest

ZIP/Postal Code

29200

Country

France

Facility Name

Galderma Investigational Site

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Galderma Investigational Site

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Galderma Investigational Site

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

Galderma Investigational Site

City

Paris

ZIP/Postal Code

75020

Country

France

Facility Name

Galderma Investigational Site

City

Paris

ZIP/Postal Code

75475

Country

France

Facility Name

Galderma Investigational Site

City

Pierre-Bénite

ZIP/Postal Code

69495

Country

France

Facility Name

Galderma Investigational Site

City

Rouen

ZIP/Postal Code

76000

Country

France

Facility Name

Galderma Investigational Site

City

Saint-Étienne

ZIP/Postal Code

42055

Country

France

Facility Name

Galderma Investigational Site

City

Toulouse

ZIP/Postal Code

31000

Country

France

Facility Name

Galderma Investigational Site

City

Valence

ZIP/Postal Code

26953

Country

France

Facility Name

Galderma Investigational Site

City

Gyeonggi-do

ZIP/Postal Code

15355

Country

Korea, Republic of

Facility Name

Galderma Investigational Site

City

Seoul

ZIP/Postal Code

02841

Country

Korea, Republic of

Facility Name

Galderma Investigational Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Galderma Investigational Site

City

Seoul

ZIP/Postal Code

04763

Country

Korea, Republic of

Facility Name

Galderma Investigational Site

City

Seoul

ZIP/Postal Code

07441

Country

Korea, Republic of

Facility Name

Galderma Investigational Site

City

Groningen

ZIP/Postal Code

9713

Country

Netherlands

Facility Name

Galderma Investigational Site

City

Utrecht

ZIP/Postal Code

3508

Country

Netherlands

Facility Name

Galderma Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-065

Country

Poland

Facility Name

Galderma Investigational Site

City

Chorzów

ZIP/Postal Code

41-500

Country

Poland

Facility Name

Galderma Investigational Site

City

Kraków

ZIP/Postal Code

31-559

Country

Poland

Facility Name

Galderma Investigational Site

City

Lublin

ZIP/Postal Code

20-081

Country

Poland

Facility Name

Galderma Investigational Site

City

Olsztyn

ZIP/Postal Code

10-229

Country

Poland

Facility Name

Galderma Investigational Site

City

Ostrowiec Świętokrzyski

ZIP/Postal Code

27-400

Country

Poland

Facility Name

Galderma Investigational Site

City

Rzeszów

ZIP/Postal Code

35-055

Country

Poland

Facility Name

Galderma Investigational Site

City

Szczecin

ZIP/Postal Code

71-434

Country

Poland

Facility Name

Galderma Investigational Site

City

Warsaw

ZIP/Postal Code

01-518

Country

Poland

Facility Name

Galderma Investigational Site

City

Warsaw

ZIP/Postal Code

01-817

Country

Poland

Facility Name

Galderma Investigational Site

City

Warsaw

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Galderma Investigational Site

City

Warsaw

ZIP/Postal Code

02-758

Country

Poland

Facility Name

Galderma Investigational Site

City

Wrocław

ZIP/Postal Code

50-566

Country

Poland

Facility Name

Galderma Investigational Site

City

Wrocław

ZIP/Postal Code

51-318

Country

Poland

Facility Name

Galderma Investigational Site

City

Łódź

ZIP/Postal Code

90-265

Country

Poland

Facility Name

Galderma Investigational Site

City

Łódź

ZIP/Postal Code

90-436

Country

Poland

Facility Name

Galderma Investigational Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Galderma Investigational Site

City

Las Palmas De Gran Canaria

ZIP/Postal Code

35019

Country

Spain

Facility Name

Galderma Investigational Site

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Galderma Investigational Site

City

Buochs

ZIP/Postal Code

6374

Country

Switzerland

Facility Name

Galderma Investigational Site

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Galderma Investigational Site

City

Saint Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Galderma Investigational Site

City

Weinfelden

ZIP/Postal Code

8570

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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

Prurigo Nodularis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial