A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Phase 2

Completed

Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Brief Summary: 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).

Recruitment & Eligibility

Inclusion Criteria

Subject who 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 3 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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Rozanolixizumab	Rozanolixizumab	Subjects in this arm will receive predefined subcutaneous doses of rozanolixizumab at a specified frequency.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-emergent Adverse Event (TEAEs)	From Baseline until Follow-Up Visit (up to Week 84)	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.

Secondary Outcome Measures

Name	Time	Method

Locations (14): Cidp04 50080
🇺🇸
Durham, North Carolina, United States
Cidp04 50075
🇺🇸
Augusta, Georgia, United States
Cidp04 40167
🇬🇧
Sheffield, United Kingdom
Cidp04 40169
🇧🇪
Gent, Belgium
Cidp04 50082
🇺🇸
Scottsdale, Arizona, United States
Cidp04 50117
🇺🇸
Charlotte, North Carolina, United States
Cidp04 40120
🇧🇪
Liège, Belgium
Cidp04 40140
🇩🇪
Göttingen, Germany
Cidp04 40134
🇩🇪
Essen, Germany
Cidp04 40002
🇧🇪
Leuven, Belgium
Cidp04 40126
🇩🇰
Copenhagen, Denmark
Cidp04 40170
🇫🇷
Strasbourg, France
Cidp04 40034
🇳🇱
Amsterdam, Netherlands
Cidp04 40160
🇪🇸
Barcelona, Spain