An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
- Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)10012303
- Registration Number
- NL-OMON49386
- Lead Sponsor
- CB Biopharma SPR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
- Subject has completed one of the previous rozanolixizumab study(ies) that
allow access to the present study (e.g. study CIDP01)
- Female subjects of childbearing potential must agree to use a highly
effective method of birth control, during the study and for a period of 2
months after their final dose of investigational medicinal product (IMP)
- Male subjects with a partner of childbearing potential must be willing to use
a condom when sexually active during the study and for 3 months after the final
administration of IMP
- Subject has any medical (acute or chronic illness) or psychiatric condition
that, in the opinion of the investigator, could harm the subject or would
compromise the subject*s ability to participate in this study
- Subject has a clinically relevant active infection (eg, sepsis, pneumonia,
abscess)
- Subject has a known hypersensitivity to any components of rozanolixizumab
- Subject intends to have a live vaccination during the course of the study or
within 7 weeks following the final dose of rozanolixizumab
- Subject has an ongoing serious adverse event (SAE) or a medical condition in
the parent study that the investigator considers to put the subject at a
significantly increased risk of participating in CIDP04
- Subject has any planned elective surgery due to occur during the study dosing
period which in the opinion of the investigator could interfere with study
procedures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of the study is to assess long-term safety and<br /><br>tolerability of weekly doses of rozanolixizumab in subjects with CIDP.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective of the study is to assess long-term clinical efficacy<br /><br>of weekly doses of rozanolixizumab.<br /><br><br /><br>The exploratory objectives of the study are to assess the PD, PK, and<br /><br>immunological variables in the treatment course with rozanolixizumab and to<br /><br>assess whether long-term dosing of rozanolixizumab improves PROs. </p><br>