The purpose of the study is to assess long-term safety and tolerability of weekly doses of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Subjects will receive rozanolixizumab in a specified sequence during the treatment period.
Cidp04 50082
Scottsdale, Arizona, United States
Cidp04 50075
Augusta, Georgia, United States
Cidp04 50117
Charlotte, North Carolina, United States
Number of Participants With Treatment-emergent Adverse Event (TEAEs)
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product, which does not necessarily had a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE was defined as any event that was not present prior the first administration of investigational medicinal product (IMP) in CIDP04 study or any unresolved event already present before the first administration of IMP in CIDP04 study that worsened in intensity following exposure to treatment until 8 weeks following the last administration of IMP in CIDP04 study.
Time frame: From Baseline until Follow-Up Visit (up to Week 84)
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Cidp04 50080
Durham, North Carolina, United States
Cidp04 40169
Ghent, Belgium
Cidp04 40002
Leuven, Belgium
Cidp04 40120
Liège, Belgium
Cidp04 40126
Copenhagen, Denmark
Cidp04 40170
Strasbourg, France
Cidp04 40134
Essen, Germany
...and 4 more locations