A Long-term Study of Nemolizumab (CD14152) in Participant... | NCT04204616

ID	Type	Description	Link
2019-004294-13	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nemolizumab	Experimental	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.	Drug: Nemolizumab

Name	Type	Description	Arm Group Labels	Other Names
Nemolizumab	Drug	Nemolizumab 30 mg will be administered as subcutaneous (SC) injection.	Nemolizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Adverse Events (AEs) by Severity	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.	Up to 192 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants with an Investigator Global Assessment (IGA) Success up to Week 184	Percentage of participants with an IGA success (defined as IGA of 0 [Clear] or 1 [Almost clear]) up to Week 184 will be reported.	Up to Week 184
Percentage of Participants with an Improvement of >=4 from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) up to Week 184

Eligibility Module

Eligibility Criteria

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

Facility	Status	City	State	ZIP	Country	Contacts
Galderma Investigational Site		Birmingham	Alabama	35233	United States
Galderma Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41405008	Derived	Legat FJ, Kwatra SG, Reich A, Boulinguez S, Tsianakas A, Sauder M, Barbarot S, Szepietowski JC, Conrad C, Pink AE, Weisshaar E, Misery L, Metz M, Laquer VT, Sivamani RK, Yosipovitch G, Thaci D, Skov L, Chen X, Noda A, Jabbar-Lopez ZK, Piketty C, Stander S. Nemolizumab in prurigo nodularis up to 100 weeks: OLYMPIA LTE interim analysis. J Eur Acad Dermatol Venereol. 2026 Jul;40(7):1195-1207. doi: 10.1111/jdv.70266. Epub 2025 Dec 17.