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)
Incidence of Adverse Events (AEs) by Severity — Up to 192 weeks 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.
Trial sites (164)
Facility
City
Region
Status
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.
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.
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