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

Sponsor

UCB Biopharma SRL (Industry)

Overall Status

Completed

CT.gov ID

NCT04051944

Collaborator

(none)

Enrollment

Locations

Arm

26.7

Actual Duration (Months)

1.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)	Drug: Rozanolixizumab	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Aug 21, 2019

Actual Primary Completion Date :

Nov 10, 2021

Actual Study Completion Date :

Nov 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rozanolixizumab Subjects in this arm will receive predefined subcutaneous doses of rozanolixizumab at a specified frequency.	Drug: Rozanolixizumab Subjects will receive rozanolixizumab in a specified sequence during the treatment period.

Arm

Intervention/Treatment

Experimental: Rozanolixizumab

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

Drug: Rozanolixizumab

Subjects will receive rozanolixizumab in a specified sequence during the treatment period.

Outcome Measures

Primary Outcome Measures

Incidence of 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 patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cidp04 50082	Scottsdale	Arizona	United States	85251
2	Cidp04 50075	Augusta	Georgia	United States	30912
3	Cidp04 50117	Charlotte	North Carolina	United States	28210
4	Cidp04 50080	Durham	North Carolina	United States	27710
5	Cidp04 40169	Gent		Belgium
6	Cidp04 40002	Leuven		Belgium
7	Cidp04 40120	Liège		Belgium
8	Cidp04 40126	Copenhagen		Denmark
9	Cidp04 40170	Strasbourg		France
10	Cidp04 40134	Essen		Germany
11	Cidp04 40140	Göttingen		Germany
12	Cidp04 40034	Amsterdam		Netherlands
13	Cidp04 40160	Barcelona		Spain
14	Cidp04 40167	Sheffield		United Kingdom