Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 21.1 Level: PT Classification code 10057645 Term: Chronic inflammatory demyelinating polyradiculoneuropathy System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
UCB Biopharma SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject is = 18 years of age at Visit 1 (Screening) - Subject has a documented definite or probable diagnosis of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) according to the European Federation of Neurological Societies (EFNS)/ Peripheral Nerve Society (PNS) criteria 2010 - Subject has an immunoglobulin-dependency confirmed by clinical examination during therapy or upon interruption or reduction of therapy within 18 months prior to Screening and documented in medical history - Subject is on a stable dosage (not more than ±20% deviation) for subcutaneous immunoglobulin (SCIg) or intravenous immunoglobulin (IVIg) and a fixed interval for at least 4 months of either treatment - 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 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 26 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: - Previously received treatment in this study or subject has previously been exposed to rozanolixizumab - Current diagnosis or has a history of Type 1 or Type 2 diabetes mellitus and/or hemoglobin A1c level >6.0% - Known immunoglobulin M (IgM)-mediated neuropathy - Clinical or known evidence of associated systemic diseases that might cause neuropathy or treatment with agents that might lead to neuropathy - History of clinically relevant ongoing chronic infections - Family history of primary immunodeficiency - Received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of IMP - Received any experimental biological agent within or outside of a clinical study in the past 3 months or within 5 half-lives prior to Baseline - Prior treatment with rituximab, ofatumumab, or ocrelizumab in the 6 months prior to the Baseline Visit or subject has had prior treatment with rituximab, ofatumumab, or ocrelizumab in the 12 months prior to Baseline and B cells are not within the normal range - Female subject who is pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical efficacy of rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) ;Secondary Objective: - To evaluate the safety and tolerability of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) - To assess the pharmacodynamic (PD) effect of rozanolixizumab as measured by the total immunoglobulin G (IgG) concentrations in serum;Primary end point(s): Change from Baseline to Week 13 (Day 85) in inflammatory Rasch-built Overall Disability Scale (iRODS) score ;Timepoint(s) of evaluation of this end point: From Baseline up to Week 13 (Day 85) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No secondary end points are defined.;Timepoint(s) of evaluation of this end point: No secondary end points are defined. | — |
Countries
Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed