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

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Clinical Trial

Official title:

An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04051944
• Other study ID #: CIDP04
• Secondary ID: 2018-004392-12
• Status: Completed
• Phase: Phase 2
• Start date: August 21, 2019
• Est. completion date: November 10, 2021

Study information

• Verified date: October 2022
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 10, 2021
• Est. primary completion date: November 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
• Polyradiculoneuropathy
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

Drug:
• Rozanolixizumab
Subjects will receive rozanolixizumab in a specified sequence during the treatment period.

Locations

Country	Name	City	State
Belgium	Cidp04 40169	Gent
Belgium	Cidp04 40002	Leuven
Belgium	Cidp04 40120	Liège
Denmark	Cidp04 40126	Copenhagen
France	Cidp04 40170	Strasbourg
Germany	Cidp04 40134	Essen
Germany	Cidp04 40140	Göttingen
Netherlands	Cidp04 40034	Amsterdam
Spain	Cidp04 40160	Barcelona
United Kingdom	Cidp04 40167	Sheffield
United States	Cidp04 50075	Augusta	Georgia
United States	Cidp04 50117	Charlotte	North Carolina
United States	Cidp04 50080	Durham	North Carolina
United States	Cidp04 50082	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  France,  Germany,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From Baseline until Follow-Up Visit (up to Week 84)