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

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Brief Title

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

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)

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).
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Incidence of treatment-emergent adverse event (TEAEs)


Condition

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Intervention

Rozanolixizumab

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

21

Start Date

August 21, 2019

Completion Date

November 10, 2021

Primary Completion Date

November 10, 2021

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

UCB Cares, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT04051944

Organization ID

CIDP04

Secondary IDs

2018-004392-12

Responsible Party

Sponsor

Study Sponsor

UCB Biopharma SRL


Study Sponsor

UCB Cares, Study Director, 001 844 599 2273 (UCB)


Verification Date

March 2022