MedDataX Logo

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

NCT ID: NCT04204616

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-11

Study Completion Date

2026-10-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prurigo Nodularis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nemolizumab

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.

Group Type EXPERIMENTAL

Nemolizumab

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nemolizumab

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CD14152

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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) OR (c). Participants who completed through Week 24 of the phase 3b durability study (NCT05052983) or who exit the study due to relapse may be eligible to re-enter in the LTE study within 28 days of exiting the durability study (selected countries/ selected sites)
* 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 or re-entry Week R0 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 or re-entry Week R0 visit
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Galderma Investigational Site

Birmingham, Alabama, United States

Site Status

Galderma Investigational Site

Birmingham, Alabama, United States

Site Status

Galderma Investigational Site

Fountain Valley, California, United States

Site Status

Galderma Investigational Site

Los Angeles, California, United States

Site Status

Galderma Investigational Site

San Diego, California, United States

Site Status

Galderma Investigational Site

San Diego, California, United States

Site Status

Galderma Investigational Site

Santa Monica, California, United States

Site Status

Galderma Investigational Site

Washington D.C., District of Columbia, United States

Site Status

Galderma Investigational Site

Aventura, Florida, United States

Site Status

Galderma Investigational Site

Delray Beach, Florida, United States

Site Status

Galderma Investigational Site

Hollywood, Florida, United States

Site Status

Galderma Investigational Site

Largo, Florida, United States

Site Status

Galderma Investigational Site

Miami, Florida, United States

Site Status

Galderma Investigational Site

Miami, Florida, United States

Site Status

Galderma Investigational Site

North Miami Beach, Florida, United States

Site Status

Galderma Investigational Site

Ormond Beach, Florida, United States

Site Status

Galderma Investigational Site

Pembroke Pines, Florida, United States

Site Status

Galderma Investigational Site

Tampa, Florida, United States

Site Status

Galderma Investigational Galderma Investigational Site

Columbus, Georgia, United States

Site Status

Galderma Investigational Site

Macon, Georgia, United States

Site Status

Galderma Investigational Site

Newnan, Georgia, United States

Site Status

Galderma Investigational Site

Chicago, Illinois, United States

Site Status

Galderma Investigational Galderma Investigational Site

Chicago, Illinois, United States

Site Status

Galderma I Galderma Investigational Site

Lake Bluff, Illinois, United States

Site Status

Galderma Investigational Site

Indianapolis, Indiana, United States

Site Status

Galderma Investigational Site

Topeka, Kansas, United States

Site Status

Galderma Investigational Site

Louisville, Kentucky, United States

Site Status

Galderma Investigational Site

Baltimore, Maryland, United States

Site Status

Galderma Investigational Site

Boston, Massachusetts, United States

Site Status

Galderma Investigational Site

Ann Arbor, Michigan, United States

Site Status

Galderma Investigational Site

Saint Joseph, Michigan, United States

Site Status

Galderma Investigational Site

Saint Joseph, Missouri, United States

Site Status

Galderma Investigational Site

St Louis, Missouri, United States

Site Status

Galderma Investigational Site

Henderson, Nevada, United States

Site Status

Galderma Investigational Site

New York, New York, United States

Site Status

Galderma Investigational Galderma Investigational Site

New York, New York, United States

Site Status

Galderma Investigational Site

High Point, North Carolina, United States

Site Status

Galderma Investigational Site

Raleigh, North Carolina, United States

Site Status

Galderma Investigational Site

Winston-Salem, North Carolina, United States

Site Status

Galderma Investigational Site

Cincinnati, Ohio, United States

Site Status

Galderma Investigational Site

Cleveland, Ohio, United States

Site Status

Galderma Investigational Site

Dublin, Ohio, United States

Site Status

Galderma Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Galderma Investigational Site

Anderson, South Carolina, United States

Site Status

Galderma Investigational Site

Knoxville, Tennessee, United States

Site Status

Galderma Investigational Site

Murfreesboro, Tennessee, United States

Site Status

Galderma Investigational Galderma Investigational Site

Austin, Texas, United States

Site Status

Galderma Investigational Site

Dallas, Texas, United States

Site Status

Galderma Investigational Site

Dripping Springs, Texas, United States

Site Status

Galderma Investigational Site

Houston, Texas, United States

Site Status

Galderma Investigational Site

Pflugerville, Texas, United States

Site Status

Galderma Investigational Site

Webster, Texas, United States

Site Status

Galderma Investigational Site

Salt Lake City, Utah, United States

Site Status

Galderma Investigational Galderma Investigational Site

Springville, Utah, United States

Site Status

Galderma Investigational Site

Fairfax, Virginia, United States

Site Status

Galderma Investigational Site

Lynchburg, Virginia, United States

Site Status

Galderma Investigational Site

Morgantown, West Virginia, United States

Site Status

Galderma Investigational Site

Graz, , Austria

Site Status

Galderma Investigational Site

Linz, , Austria

Site Status

Galderma Investigational Site

Vienna, , Austria

Site Status

Galderma Investigational Site

Brussels, , Belgium

Site Status

Galderma Investigational Site

Ghent, , Belgium

Site Status

Galderma Investigational Site

Jette, , Belgium

Site Status

Galderma Investigational Site

Leuven, , Belgium

Site Status

Galderma Investigational Site

Liège, , Belgium

Site Status

Galderma Investigational Site

Calgary, AL, Canada

Site Status

Galderma Investigational Site

London, Ontario, Canada

Site Status

Galderma Investigational Site

North York, Ontario, Canada

Site Status

Galderma Investigational Site

Saskatoon, Saskatchewan, Canada

Site Status

Galderma Investigational Site

Calgary, , Canada

Site Status

Galderma Investigational Site

London, , Canada

Site Status

Galderma Investigational Site

Markham, , Canada

Site Status

Galderma Investigational Site

Toronto, , Canada

Site Status

Galderma Investigational Site

Aarhus, , Denmark

Site Status

Galderma Investigational Site

Hellerup, , Denmark

Site Status

Galderma Investigational Site

Bordeaux, , France

Site Status

Galderma Investigational Site

Brest, , France

Site Status

Galderma Investigational Site

Nantes, , France

Site Status

Galderma Investigational Site

Nice, , France

Site Status

Galderma Investigational Site

Paris, , France

Site Status

Galderma Investigational Site

Paris, , France

Site Status

Galderma Investigational Site

Pierre-Bénite, , France

Site Status

Galderma Investigational Site

Rouen, , France

Site Status

Galderma Investigational Site

Saint-Etienne, , France

Site Status

Galderma Investigational Site

Toulouse, , France

Site Status

Galderma Investigational Site

Valence, , France

Site Status

Galderma Investigational Site

Aachen, , Germany

Site Status

Galderma Investigational Site

Augsburg, , Germany

Site Status

Galderma Investigational Site

Bad Bentheim, , Germany

Site Status

Galderme Investigational Site

Berlin, , Germany

Site Status

Galderma Investigational Site

Bonn, , Germany

Site Status

Galderma Investigational Site

Darmstadt, , Germany

Site Status

Galderma Investigational Site

Dresden, , Germany

Site Status

Galderma Investigational Site

Düsseldorf, , Germany

Site Status

Galderma Investigational Site

Eppendorf, , Germany

Site Status

Galderma Investigational Site

Göttingen, , Germany

Site Status

Galderma Investigational Site

Halle, , Germany

Site Status

Galderma Investigational Site

Hamburg, , Germany

Site Status

Galderma Investigational Site

Heidelberg, , Germany

Site Status

Galderma Investigational Site

Kiel, , Germany

Site Status

Galderma Investigational Site

Lübeck, , Germany

Site Status

Galderma Investigational Site

Mainz, , Germany

Site Status

Galderma Investigational Site

Münich, , Germany

Site Status

Galderma Investigational Site

Münich, , Germany

Site Status

Galderma Investigational Site

Münster, , Germany

Site Status

Galderma Investigational Site

Tübingen, , Germany

Site Status

Galderma Investigational Site

Kecskemét, , Hungary

Site Status

Galderma Investigational Site

Szeged, , Hungary

Site Status

Galderma Investigational Site

Szolnok, , Hungary

Site Status

Galderma Investigational Site

Catania, , Italy

Site Status

Galderma Investigational Site

Chieti, , Italy

Site Status

Galderma Investigational Site

Genova, , Italy

Site Status

Galderma Investigational Site

L’Aquila, , Italy

Site Status

Galderma Investigational Site

Modena, , Italy

Site Status

Galderma Investigational Site

Napoli, , Italy

Site Status

Galderma Investigational Site

Parma, , Italy

Site Status

Galderma Investigational Site

Perugia, , Italy

Site Status

Galderma Investigational Site

Roma, , Italy

Site Status

Galderma Investigational Site

Roma, , Italy

Site Status

Galderma Investigational Site

Vicenza, , Italy

Site Status

Galderma Investigational Site

Groningen, , Netherlands

Site Status

Galderma Investigational Site

Utrecht, , Netherlands

Site Status

Galderma Investigational Site

Bydgoszcz, , Poland

Site Status

Galderma Investigational Site

Chorzów, , Poland

Site Status

Galderma Investigational Site

Częstochowa, , Poland

Site Status

Galderma Investigational Site

Gdansk, , Poland

Site Status

Galderma Investigational Site

Gdynia, , Poland

Site Status

Galderma Investigational Site

Katowice, , Poland

Site Status

Galderma Investigational Site

Krakow, , Poland

Site Status

Galderma Investigational Site

Lodz, , Poland

Site Status

Galderma Investigational Site

Lodz, , Poland

Site Status

Galderma Investigational Site

Lodz, , Poland

Site Status

Galderma Investigational Site

Lublin, , Poland

Site Status

Galderma Investigational Site

Olsztyn, , Poland

Site Status

Galderma Investigational Site

Ostrowiec Świętokrzyski, , Poland

Site Status

Galderma Investigational Site

Poznan, , Poland

Site Status

Galderma Investigational Site

Rzeszów, , Poland

Site Status

Galderma Investigational Site

Szczecin, , Poland

Site Status

Galderma Investigational Site

Warsaw, , Poland

Site Status

Galderma Investigational Site

Warsaw, , Poland

Site Status

Galderma Investigational Site

Warsaw, , Poland

Site Status

Galderma Investigational Site

Warsaw, , Poland

Site Status

Galderma Investigational Site

Warsaw, , Poland

Site Status

Galderma Investigational Site

Wroclaw, , Poland

Site Status

Galderma Investigational Site

Wroclaw, , Poland

Site Status

Galderma Investigational Site

Wroclaw, , Poland

Site Status

Galderma Investigational Site

Gyeonggi-do, , South Korea

Site Status

Galderma Investigational Site

Seoul, , South Korea

Site Status

Galderma Investigational Site

Seoul, , South Korea

Site Status

Galderma Investigational Site

Seoul, , South Korea

Site Status

Galderma Investigational Site

Seoul, , South Korea

Site Status

Galderma Investigational Site

Barcelona, , Spain

Site Status

Galderma Investigational Site

Las Palmas de Gran Canaria, , Spain

Site Status

Galderma Investigational Site

Solna, , Sweden

Site Status

Galderma Investigational Site

Bern, , Switzerland

Site Status

Galderma Investigational Site

Buochs, , Switzerland

Site Status

Galderma Investigational Site

Lausanne, , Switzerland

Site Status

Galderma Investigational Site

Obbürgen, , Switzerland

Site Status

Galderma Investigational Site

Sankt Gallen, , Switzerland

Site Status

Galderma Investigational Site

Weinfelden, , Switzerland

Site Status

Galderma Investigational Site

Dudley, , United Kingdom

Site Status

Galderma Investigational Site

Glasgow, , United Kingdom

Site Status

Galderma Investigational Site

London, , United Kingdom

Site Status

Galderma Investigational Site

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Austria Belgium Canada Denmark France Germany Hungary Italy Netherlands Poland South Korea Spain Sweden Switzerland United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-004294-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RD.06.SPR.202699

Identifier Type: -

Identifier Source: org_study_id