A Multicenter, 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)
- Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)10012303
- Registration Number
- NL-OMON48909
- Lead Sponsor
- CB Biopharma SPR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
- 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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy variable is the change from Baseline to Week 13 (Day 85)<br /><br>in iRODS score.<br /><br><br /><br>Further variables include values and change from Baseline in maximum grip<br /><br>strength score recorded by site personnel at each scheduled assessment during<br /><br>the Treatment and Observation Periods; values and change from Baseline in daily<br /><br>maximum grip strength score recorded by the subject each day during the<br /><br>Treatment and Observation Periods; additional patient-reported outcomes (PROs);<br /><br>values and change from Baseline in Rasch-built, modified interval Medical<br /><br>Research Council scale (RT-MRC) sum score at each scheduled assessment during<br /><br>the Treatment and Observation Periods; and subjects receiving rescue medication<br /><br>and time to rescue medication administration.</p><br>
- Secondary Outcome Measures
Name Time Method