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

Galderma

Status and phase: Active, not recruiting; Phase 3

Conditions: Prurigo Nodularis

Treatments: Drug: Nemolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04204616

2019-004294-13 (EudraCT Number)

RD.06.SPR.202699

Details and patient eligibility

About

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

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Nemolizumab

Experimental group

Description:

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.

Treatment:

Drug: Nemolizumab