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ACTIVE NOT RECRUITING

NCT04204616

PHASE3

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

Sponsor: Galderma R&D

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to assess the long-term safety 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2021-01-11

Completion Date

2026-10-26

Last Updated

2025-11-12

Healthy Volunteers

Conditions

Prurigo Nodularis

Interventions

DRUG

Nemolizumab

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

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

Locations (164)

Galderma Investigational Site

Birmingham, Alabama, United States

Galderma Investigational Site

Birmingham, Alabama, United States

Galderma Investigational Site

Fountain Valley, California, United States

Galderma Investigational Site

Los Angeles, California, United States

Galderma Investigational Site

San Diego, California, United States

Galderma Investigational Site

San Diego, California, United States

Galderma Investigational Site

Santa Monica, California, United States

Galderma Investigational Site

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

Galderma Investigational Site

Aventura, Florida, United States

Galderma Investigational Site

Delray Beach, Florida, United States

Galderma Investigational Site

Hollywood, Florida, United States

Galderma Investigational Site

Largo, Florida, United States

Galderma Investigational Site

Miami, Florida, United States

Galderma Investigational Site

Miami, Florida, United States

Galderma Investigational Site

North Miami Beach, Florida, United States

Galderma Investigational Site

Ormond Beach, Florida, United States

Galderma Investigational Site

Pembroke Pines, Florida, United States

Galderma Investigational Site

Tampa, Florida, United States

Galderma Investigational Galderma Investigational Site

Columbus, Georgia, United States

Galderma Investigational Site

Macon, Georgia, United States

Galderma Investigational Site

Newnan, Georgia, United States

Galderma Investigational Site

Chicago, Illinois, United States

Galderma Investigational Galderma Investigational Site

Chicago, Illinois, United States

Galderma I Galderma Investigational Site

Lake Bluff, Illinois, United States

Galderma Investigational Site

Indianapolis, Indiana, United States

Galderma Investigational Site

Topeka, Kansas, United States

Galderma Investigational Site

Louisville, Kentucky, United States

Galderma Investigational Site

Baltimore, Maryland, United States

Galderma Investigational Site

Boston, Massachusetts, United States

Galderma Investigational Site

Ann Arbor, Michigan, United States

Galderma Investigational Site

Saint Joseph, Michigan, United States

Galderma Investigational Site

Saint Joseph, Missouri, United States

Galderma Investigational Site

St Louis, Missouri, United States

Galderma Investigational Site

Henderson, Nevada, United States

Galderma Investigational Site

New York, New York, United States

Galderma Investigational Galderma Investigational Site

New York, New York, United States

Galderma Investigational Site

High Point, North Carolina, United States

Galderma Investigational Site

Raleigh, North Carolina, United States

Galderma Investigational Site

Winston-Salem, North Carolina, United States

Galderma Investigational Site

Cincinnati, Ohio, United States

Galderma Investigational Site

Cleveland, Ohio, United States

Galderma Investigational Site

Dublin, Ohio, United States

Galderma Investigational Site

Philadelphia, Pennsylvania, United States

Galderma Investigational Site

Anderson, South Carolina, United States

Galderma Investigational Site

Knoxville, Tennessee, United States

Galderma Investigational Site

Murfreesboro, Tennessee, United States

Galderma Investigational Galderma Investigational Site

Austin, Texas, United States

Galderma Investigational Site

Dallas, Texas, United States

Galderma Investigational Site

Dripping Springs, Texas, United States

Galderma Investigational Site

Houston, Texas, United States

Galderma Investigational Site

Pflugerville, Texas, United States

Galderma Investigational Site

Webster, Texas, United States

Galderma Investigational Site

Salt Lake City, Utah, United States

Galderma Investigational Galderma Investigational Site

Springville, Utah, United States

Galderma Investigational Site

Fairfax, Virginia, United States

Galderma Investigational Site

Lynchburg, Virginia, United States

Galderma Investigational Site

Morgantown, West Virginia, United States

Galderma Investigational Site

Graz, Austria

Galderma Investigational Site

Linz, Austria

Galderma Investigational Site

Vienna, Austria

Galderma Investigational Site

Brussels, Belgium

Galderma Investigational Site

Ghent, Belgium

Galderma Investigational Site

Jette, Belgium

Galderma Investigational Site

Leuven, Belgium

Galderma Investigational Site

Liège, Belgium

Galderma Investigational Site

Calgary, AL, Canada

Galderma Investigational Site

London, Ontario, Canada

Galderma Investigational Site

North York, Ontario, Canada

Galderma Investigational Site

Saskatoon, Saskatchewan, Canada

Galderma Investigational Site

Calgary, Canada

Galderma Investigational Site

London, Canada

Galderma Investigational Site

Markham, Canada

Galderma Investigational Site

Toronto, Canada

Galderma Investigational Site

Aarhus, Denmark

Galderma Investigational Site

Hellerup, Denmark

Galderma Investigational Site

Bordeaux, France

Galderma Investigational Site

Brest, France

Galderma Investigational Site

Nantes, France

Galderma Investigational Site

Nice, France

Galderma Investigational Site

Paris, France

Galderma Investigational Site

Paris, France

Galderma Investigational Site

Pierre-Bénite, France

Galderma Investigational Site

Rouen, France

Galderma Investigational Site

Saint-Etienne, France

Galderma Investigational Site

Toulouse, France

Galderma Investigational Site

Valence, France

Galderma Investigational Site

Aachen, Germany

Galderma Investigational Site

Augsburg, Germany

Galderma Investigational Site

Bad Bentheim, Germany

Galderme Investigational Site

Berlin, Germany

Galderma Investigational Site

Bonn, Germany

Galderma Investigational Site

Darmstadt, Germany

Galderma Investigational Site

Dresden, Germany

Galderma Investigational Site

Düsseldorf, Germany

Galderma Investigational Site

Eppendorf, Germany

Galderma Investigational Site

Göttingen, Germany

Galderma Investigational Site

Halle, Germany

Galderma Investigational Site

Hamburg, Germany

Galderma Investigational Site

Heidelberg, Germany

Galderma Investigational Site

Kiel, Germany

And 64 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (164)