Eine prospektive, multizentrische Langzeitstudie zur Beurteilung der Sicherheit und Wirksamkeit von Nemolizumab (CD14152) bei Patienten mit Prurigo Nodularis

Drug: Nemolizumab

Gender: All
Maximum age: N/A
Minimum age: 18 Years
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