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Clinical Trials in Germany / NCT04204616
Active, not recruiting Phase 3

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

NCT04204616 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2021-01-11
Last updated
2025-11-12

Condition(s) studied

Prurigo Nodularis

Investigational drug(s) / intervention(s)

Nemolizumab →

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (164)

FacilityCityRegionStatus
Galderma Investigational Site Birmingham Alabama
Galderma Investigational Site Birmingham Alabama
Galderma Investigational Site Fountain Valley California
Galderma Investigational Site Los Angeles California
Galderma Investigational Site San Diego California
Galderma Investigational Site San Diego California
Galderma Investigational Site Santa Monica California
Galderma Investigational Site Washington D.C. District of Columbia
Galderma Investigational Site Aventura Florida
Galderma Investigational Site Delray Beach Florida
Galderma Investigational Site Hollywood Florida
Galderma Investigational Site Largo Florida
Galderma Investigational Site Miami Florida
Galderma Investigational Site Miami Florida
Galderma Investigational Site North Miami Beach Florida
Galderma Investigational Site Ormond Beach Florida
Galderma Investigational Site Pembroke Pines Florida
Galderma Investigational Site Tampa Florida
Galderma Investigational Galderma Investigational Site Columbus Georgia
Galderma Investigational Site Macon Georgia
Galderma Investigational Site Newnan Georgia
Galderma Investigational Site Chicago Illinois
Galderma Investigational Galderma Investigational Site Chicago Illinois
Galderma I Galderma Investigational Site Lake Bluff Illinois
Galderma Investigational Site Indianapolis Indiana
Galderma Investigational Site Topeka Kansas
Galderma Investigational Site Louisville Kentucky
Galderma Investigational Site Baltimore Maryland
Galderma Investigational Site Boston Massachusetts
Galderma Investigational Site Ann Arbor Michigan
Galderma Investigational Site Saint Joseph Michigan
Galderma Investigational Site Saint Joseph Missouri
Galderma Investigational Site St Louis Missouri
Galderma Investigational Site Henderson Nevada
Galderma Investigational Site New York New York
Galderma Investigational Galderma Investigational Site New York New York
Galderma Investigational Site High Point North Carolina
Galderma Investigational Site Raleigh North Carolina
Galderma Investigational Site Winston-Salem North Carolina
Galderma Investigational Site Cincinnati Ohio

+ 124 more sites — see the full list on the official registry below.

More Galderma R&D trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04204616 on ClinicalTrials.gov ↗ ← All trials in Germany