Open-Label Extension of ROZANOLIXIZUMAB in subjects with CIDP
Research type
Research Study
Full 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)
IRAS ID
262121
Contact name
Michael Lunn
Contact email
Sponsor organisation
UCB BIOPHARMA SPRL
Eudract number
2018-004392-12
Clinicaltrials.gov Identifier
134848, IND Number
Duration of Study in the UK
1 years, 1 months, 0 days
Research summary
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a rare immune mediated disorder where some types of cells, IgG or antibodies (body proteins) that normally fight infections, go wrong, and attack patient’s own nerves. For example, patients may have some numbness or weakness of upper and lower limbs.
IgG treatment - currently on the market - reduces the concentration of abnormal antibodies in the blood. Rozanolixizumab is also an antibody; it aims at lowering the levels of IgG including the disease causing IgG.
In this study, we want to assess how safe, tolerable, and effective rozanolixizumab is in controlling CIDP symptoms when it is taken long-term (24 weeks); how rozanolixizumab acts in the body and how the body reacts to rozanolixizumab.
Sponsor is UCB Biopharma SPRL. This study will enrol participants coming from the parent study (CIDP01) and meeting the conditions to be eligible for this study. This would represent at most approximately 34 participants, in about 24 study sites across Europe, the USA, Canada, and possibly other countries as required in CIDP04 study.
The study will last for approximately 32 weeks including Treatment Period of 24 weeks and Observation Period of 8 weeks. If the participant enters the study after a gap period between parent study and this study, the participant will have to undergo a screening period of 2 to 5 weeks, increasing the study duration for patient from 32 to 34 or 37 weeks. Overall, 29 scheduled visits are foreseen. Additional visits may be performed as needed.
Participants will receive a total of 24 subcutaneous (under the skin) infusions of rozanolixizumab during Treatment Period .
Thereafter, Observation Period will continue monitoring participants’ safety and disease activity for up-to 8 weeks after rozanolixizumab was stopped.REC name
London - Westminster Research Ethics Committee
REC reference
19/LO/0841
Date of REC Opinion
20 Nov 2019
REC opinion
Further Information Favourable Opinion