ROZANOLIXIZUMAB in subjects with CIDP
Research type
Research Study
Full title
A multicentre, randomized, subject blind, investigator blind, placebo controlled, parallel group study evaluating the efficacy, safety, and tolerability of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
IRAS ID
259113
Contact name
Fakhria Amiri
Contact email
Sponsor organisation
UCB BIOPHARMA SPRL
Eudract number
2016-002411-17
Clinicaltrials.gov Identifier
134848, IND number
Duration of Study in the UK
1 years, 1 months, 30 days
Research summary
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a rare immune mediated disorder (condition caused by immune-system abnormality) 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 see if rozanolixizumab is effective in controlling the CIDP symptoms; how safe and tolerable rozanolixizumab is; how rozanolixizumab acts in the body; how the body reacts to rozanolixizumab; and to measure the amount of rozanolixizumab in the body.
To ensure study results are not biased, rozanolixizumab will be compared to a placebo (dummy drug).
Participants will be randomly assigned to 1 of 2 treatments. Half of the participants will receive a total of 12 subcutaneous (under the skin) infusions of rozanolixizumab while the other half will receive a total of 12 subcutaneous infusions of placebo during the Treatment period. Neither the participant nor the study doctor will know whether they are given rozanolixizumab or placebo.
The study will last for approximately 28 weeks, including a Screening Period of 2-5 weeks before the first dose of study drug, Treatment Period of 11 weeks, and Observation Period of 12 weeks. Duration of each period may vary depending on the events occurring during the study. At most, the duration of the study may be extended up to 40 weeks.
Sponsor is UCB Biopharma SPRL. Approximately 50 participants will be enrolled in about 24 sites across Europe, the USA, and Canada. Additional countries/sites may be added. Only those participants who meet certain eligibility criteria will receive the study drug.REC name
London - Westminster Research Ethics Committee
REC reference
19/LO/0421
Date of REC Opinion
23 Jul 2019
REC opinion
Further Information Favourable Opinion