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A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

Primary Purpose

Prurigo Nodularis

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Nemolizumab

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:

Participants who may benefit from study participation in the opinion of the investigator and participated in a prior nemolizumab study for PN including: (a). Participants who completed the treatment period in a phase 3 pivotal study (NCT04501666 or NCT04501679) and enroll within 56 days OR (b).Participants who were previously randomized in the nemolizumab phase 2a PN study (NCT03181503)
Female participants of childbearing potential (that is, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection
Participant willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including periodic weekly recordings by the participant using an electronic handheld device provided for this study
Understand and sign an informed consent form (ICF) before any investigational procedure(s) are performed

Exclusion Criteria:

Participants who, during their participation in a prior nemolizumab study, experienced an adverse event (AE) which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the participant
Body weight < 30 kg
Pregnant women (positive pregnancy test result at screening or baseline visit), breastfeeding women, or women planning a pregnancy during the clinical study
Any medical or psychological condition that may put the participant at significant risk according to the investigator's judgment, if he/she participates in the clinical study, or may interfere with study assessments (example, poor venous access or needle-phobia)
Planning or expected to have a major surgical procedure during the clinical study
Participants unwilling to refrain from using prohibited medications during the clinical study
History of alcohol or substance abuse within 6 months prior to the screening visit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nemolizumab

Arm Description

Participants weighing less than (<) 90kilogram (kg) will receive 30 milligram (mg) nemolizumab every 4 weeks (Q4W) and participants weighing greater than or equal to (>=) 90 kg will receive 60 mg nemolizumab (two 30-mg injections) Q4W.

Outcomes

Primary Outcome Measures

Incidence of Adverse Events (AEs) by Severity

Incidence of AEs including AEs of Special Interest (AESIs), Treatment Emergent AEs (TEAEs) and Serious AEs (SAEs) by severity as mild, moderate or severe will be reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with relevant investigational product. SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. TEAE is an AE that occurs on or after the first date of study drug(s) administration until the date of last study visit. An AESI is a noteworthy treatment-emergent event for the study drug that should be monitored closely and reported promptly.

Secondary Outcome Measures

Percentage of Participants with an Investigator Global Assessment (IGA) Success up to Week 184

Percentage of participants with an IGA success (defined as IGA of 0 [Clear] or 1 [Almost clear]) up to Week 184 will be reported.

Percentage of Participants with an Improvement of >=4 from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) up to Week 184

Percentage of participants with an improvement of >= 4 from baseline in PP NRS up to Week 184 will be reported. The PP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

Percentage of Participants with Low Disease Activity State up to Week 184

Percentage of participants with low disease activity state (that is, IGA <=2) up to Week 184 will be reported.

Percentage of Pruriginous Lesions with Excoriations/Crusts up (PAS item 5a) up to Week 184

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 pruriginous lesions with excoriations/crusts (PAS item 5a) up to Week 184 will be reported.

Percentage of Healed Prurigo Lesions (PAS item 5b) up to Week 184

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. Percentage of healed prurigo lesions (PAS item 5b) up to Week 184 will be reported.

Change from Baseline in Number of Lesions in Representative Area (PAS item 4) up to Week 184

Change from baseline in number of lesions in representative area (PAS item 4) up to Week 184 will be reported.

Percentage of Participants with PP NRS <2 up to Week 184

Percentage of participants with PP NRS <2 up to Week 184 will be reported. PP NRS is a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

Percent Change from Baseline in PP NRS up to Week 184

Percent change from baseline in PP NRS up to Week 184 will be reported. PP NRS is a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

Absolute Change from Baseline in PP NRS up to Week 184

Absolute change from baseline in PP NRS up to Week 184 will be reported. PP NRS is a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

Percentage of Participants with Average Pruritus (AP) NRS <2 up to Week 52

Percentage of participants with AP NRS less than (<) 2 up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

Percentage of Participants with an Improvement of >=4 from Baseline in AP NRS up to Week 52

Percentage of participants with an improvement of >=4 from baseline in AP NRS up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

Percent Change from Baseline in AP NRS up to Week 52

Percent change from baseline in AP NRS up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

Absolute Change from Baseline in AP NRS up to Week 52

Absolute change from baseline in AP NRS up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

Percentage of Participants with an Improvement of >=4 from Baseline in Sleep Disturbance (SD) NRS up to Week 184

Percentage of participants with an improvement of >=4 from baseline in Sleep Disturbance (SD) NRS up to Week 184 will be reported. SD NRS has a scale of 0 to 10, with 0 being "no sleep loss related to the symptoms of my skin disease (prurigo nodularis)" and 10 being "I did not sleep at all due to the symptoms of my skin disease (prurigo nodularis)".

Percent Change from Baseline in SD NRS up to Week 184

Percent change from baseline in SD NRS up to Week 184 will be reported. SD NRS has a scale of 0 to 10, with 0 being "no sleep loss related to the symptoms of my skin disease (prurigo nodularis)" and 10 being "I did not sleep at all due to the symptoms of my skin disease (prurigo nodularis)".

Absolute Change from Baseline in SD NRS up to Week 184

Absolute change from baseline in SD NRS up to Week 184 will be reported. SD NRS has a scale of 0 to 10, with 0 being "no sleep loss related to the symptoms of my skin disease (prurigo nodularis)" and 10 being "I did not sleep at all due to the symptoms of my skin disease (prurigo nodularis)".

Change from Baseline in Prurigo Nodularis (PN)-associated Pain Frequency up to Week 184

Change from baseline in PN-associated pain frequency up to Week 184 will be reported. The pain frequency will be assessed on a 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.

Change from Baseline in PN-associated Pain Intensity up to Week 184

Change from baseline in PN-associated pain intensity up to Week 184 will be reported. 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".

Percentage of Participants Reporting low Disease Activity Based on Patient Global Assessment of Disease (PGAD) up to Week 52

Percentage of participants reporting low disease activity (clear, almost clear, or mild) based on Patient Global Assessment of Disease (PGAD) up to Week 52 to be reported.

Percentage of Participants Satisfied with Study Treatment Based on Patient Global Assessment of Treatment (PGAT) up to Week 52

Percentage of participants satisfied with study treatment (good, very good, or excellent) based on Patient Global Assessment of Treatment (PGAT) up to Week 52 will be reported.

Percentage of Participants with a Change of >=4 from Baseline in Dermatology Life Quality Index (DLQI) up to Week 184

Percentage of participants with a change of >=4 from baseline in Dermatology Life Quality Index (DLQI) up to Week 184 will be reported. 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 EuroQoL 5-Dimension (EQ-5D) up to Week 184

Change from baseline in EuroQoL 5-Dimension (EQ-5D) up to Week 184 will be reported. 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 Analog Scale (VAS) with 0 being "Worst imaginable health state" and 100 being "Best imaginable health state".

Time to Permanent Study Drug Discontinuation

Time to Rescue Therapy

Percentage of Participants Receiving Any Rescue Treatment by Rescue Treatment

Full Information

NCT ID

NCT04204616

First Posted

December 17, 2019

Last Updated

October 10, 2023

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT04204616

Brief Title

A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

Official Title

A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 11, 2021 (Actual)

Primary Completion Date

October 26, 2026 (Anticipated)

Study Completion Date

October 26, 2026 (Anticipated)

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 purpose of this study is to assess the long-term safety of nemolizumab (CD14152) in participants with prurigo nodularis (PN).

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

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nemolizumab

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Nemolizumab

Other Intervention Name(s)

CD14152

Intervention Description

Nemolizumab 30 mg will be administered as subcutaneous (SC) injection.

Primary Outcome Measure Information:

Title

Incidence of Adverse Events (AEs) by Severity

Description

Time Frame

Up to 192 weeks

Secondary Outcome Measure Information:

Title

Percentage of Participants with an Investigator Global Assessment (IGA) Success up to Week 184

Description

Percentage of participants with an IGA success (defined as IGA of 0 [Clear] or 1 [Almost clear]) up to Week 184 will be reported.

Time Frame

Up to Week 184

Title

Percentage of Participants with an Improvement of >=4 from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) up to Week 184

Description

Time Frame

Baseline up to Week 184

Title

Percentage of Participants with Low Disease Activity State up to Week 184

Description

Percentage of participants with low disease activity state (that is, IGA <=2) up to Week 184 will be reported.

Time Frame

Up to Week 184

Title

Percentage of Pruriginous Lesions with Excoriations/Crusts up (PAS item 5a) up to Week 184

Description

Time Frame

Up to Week 184

Title

Percentage of Healed Prurigo Lesions (PAS item 5b) up to Week 184

Description

Time Frame

Up to Week 184

Title

Change from Baseline in Number of Lesions in Representative Area (PAS item 4) up to Week 184

Description

Change from baseline in number of lesions in representative area (PAS item 4) up to Week 184 will be reported.

Time Frame

Baseline up to Week 184

Title

Percentage of Participants with PP NRS <2 up to Week 184

Description

Percentage of participants with PP NRS <2 up to Week 184 will be reported. PP NRS is a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

Time Frame

Up to Week 184

Title

Percent Change from Baseline in PP NRS up to Week 184

Description

Percent change from baseline in PP NRS up to Week 184 will be reported. PP NRS is a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

Time Frame

Baseline up to Week 184

Title

Absolute Change from Baseline in PP NRS up to Week 184

Description

Absolute change from baseline in PP NRS up to Week 184 will be reported. PP NRS is a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

Time Frame

Baseline up to Week 184

Title

Percentage of Participants with Average Pruritus (AP) NRS <2 up to Week 52

Description

Percentage of participants with AP NRS less than (<) 2 up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

Time Frame

Up to Week 52

Title

Percentage of Participants with an Improvement of >=4 from Baseline in AP NRS up to Week 52

Description

Time Frame

Up to Week 52

Title

Percent Change from Baseline in AP NRS up to Week 52

Description

Percent change from baseline in AP NRS up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

Time Frame

Up to Week 52

Title

Absolute Change from Baseline in AP NRS up to Week 52

Description

Absolute change from baseline in AP NRS up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

Time Frame

Up to Week 52

Title

Percentage of Participants with an Improvement of >=4 from Baseline in Sleep Disturbance (SD) NRS up to Week 184

Description

Time Frame

Up to Week 184

Title

Percent Change from Baseline in SD NRS up to Week 184

Description

Time Frame

Up to Week 184

Title

Absolute Change from Baseline in SD NRS up to Week 184

Description

Time Frame

Up to Week 184

Title

Change from Baseline in Prurigo Nodularis (PN)-associated Pain Frequency up to Week 184

Description

Time Frame

Baseline up to Week 184

Title

Change from Baseline in PN-associated Pain Intensity up to Week 184

Description

Time Frame

Baseline up to Week 184

Title

Percentage of Participants Reporting low Disease Activity Based on Patient Global Assessment of Disease (PGAD) up to Week 52

Description

Percentage of participants reporting low disease activity (clear, almost clear, or mild) based on Patient Global Assessment of Disease (PGAD) up to Week 52 to be reported.

Time Frame

Up to Week 52

Title

Percentage of Participants Satisfied with Study Treatment Based on Patient Global Assessment of Treatment (PGAT) up to Week 52

Description

Percentage of participants satisfied with study treatment (good, very good, or excellent) based on Patient Global Assessment of Treatment (PGAT) up to Week 52 will be reported.

Time Frame

Up to Week 52

Title

Percentage of Participants with a Change of >=4 from Baseline in Dermatology Life Quality Index (DLQI) up to Week 184

Description

Time Frame

Baseline up to Week 184

Title

Change from Baseline in EuroQoL 5-Dimension (EQ-5D) up to Week 184

Description

Time Frame

Baseline up to Week 184

Title

Time to Permanent Study Drug Discontinuation

Time Frame

Baseline to 184 weeks

Title

Time to Rescue Therapy

Time Frame

Baseline to 184 weeks

Title

Percentage of Participants Receiving Any Rescue Treatment by Rescue Treatment

Time Frame

Baseline up to 184 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants who may benefit from study participation in the opinion of the investigator and participated in a prior nemolizumab study for PN including: (a). Participants who completed the treatment period in a phase 3 pivotal study (NCT04501666 or NCT04501679) and enroll within 56 days OR (b).Participants who were previously randomized in the nemolizumab phase 2a PN study (NCT03181503) Female participants of childbearing potential (that is, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection Participant willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including periodic weekly recordings by the participant using an electronic handheld device provided for this study Understand and sign an informed consent form (ICF) before any investigational procedure(s) are performed Exclusion Criteria: Participants who, during their participation in a prior nemolizumab study, experienced an adverse event (AE) which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the participant Body weight < 30 kg Pregnant women (positive pregnancy test result at screening or baseline visit), breastfeeding women, or women planning a pregnancy during the clinical study Any medical or psychological condition that may put the participant at significant risk according to the investigator's judgment, if he/she participates in the clinical study, or may interfere with study assessments (example, poor venous access or needle-phobia) Planning or expected to have a major surgical procedure during the clinical study Participants unwilling to refrain from using prohibited medications during the clinical study History of alcohol or substance abuse within 6 months prior to 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

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

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

San Diego

State/Province

California

ZIP/Postal Code

92123

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

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

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

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

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

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 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

Newnan

State/Province

Georgia

ZIP/Postal Code

30263

Country

United States

Facility Name

Galderma Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60602

Country

United States

Facility Name

Galderma Investigational Galderma Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60613

Country

United States

Facility Name

Galderma I Galderma Investigational Site

City

Lake Bluff

State/Province

Illinois

ZIP/Postal Code

60044

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

Topeka

State/Province

Kansas

ZIP/Postal Code

66614

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

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

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

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

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

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

Henderson

State/Province

Nevada

ZIP/Postal Code

89052

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 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

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27104

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

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

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

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19103

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

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37909

Country

United States

Facility Name

Galderma Investigational Site

City

Murfreesboro

State/Province

Tennessee

ZIP/Postal Code

37130

Country

United States

Facility Name

Galderma Investigational Galderma Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78738

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

Houston

State/Province

Texas

ZIP/Postal Code

77401

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

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84117

Country

United States

Facility Name

Galderma Investigational 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

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24501

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

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

Brussels

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

Calgary

State/Province

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

North York

State/Province

Ontario

ZIP/Postal Code

M2M 4J5

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

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

Toronto

ZIP/Postal Code

M3H 5Y8

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

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

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

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

Galderme 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

64297

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

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

20251

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

Tübingen

ZIP/Postal Code

72076

Country

Germany

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

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

36100

Country

Italy

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

9700

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

Częstochowa

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

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

10-900

Country

Poland

Facility Name

Galderma Investigational Site

City

Ostrowiec Świętokrzyski

ZIP/Postal Code

27-400

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

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

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

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

90-127

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

Solna

ZIP/Postal Code

17176

Country

Sweden

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

Obbürgen

ZIP/Postal Code

6363

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

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

A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

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A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

Prurigo Nodularis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

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