A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT04204616) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
United States500 participantsStarted 2021-01-11
Plain-language summary
The primary purpose of this study is to assess the long-term safety of nemolizumab (CD14152) in participants with prurigo nodularis (PN).
Who can participate
Age range18 Years
SexALL
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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 participat…