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A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

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

NCT04204616•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).

Eligibility

Age

18 - No limit years

Sex

ALL

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) 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

Key Dates

Start Date

January 11, 2021

Primary Completion Date

October 26, 2026

Completion Date

October 26, 2026

Last Updated

November 12, 2025

Enrollment

500

ESTIMATED participants

Conditions

Prurigo Nodularis

Interventions

Nemolizumab

DRUG

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

NCT06342713

Healthy ParticipantsHealthy Subjects+5 more

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RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1)

Phase III Clinical Study of MG-K10 Humanized Mab Injection in Subjects With Prurigo Nodularis

Effect of EMD Protocol for Urge on Dermatology-specific Quality of Life

A Study to Evaluate the Safety and Tolerability of Maximal Use Ruxolitinib Cream

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