Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The primary purpose of this study is to assess the long-term safety of nemolizumab (CD14152)
in participants with prurigo nodularis (PN).
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
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)
- 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),
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