Status:
COMPLETED
A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Lead Sponsor:
UCB Biopharma S.P.R.L.
Conditions:
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate clinical efficacy of rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
Eligibility Criteria
Inclusion
- Subject is ≥ 18 years of age with a minimum body weight of ≥42 kg 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 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
- 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
Key Trial Info
Start Date :
March 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03861481
Start Date
March 26 2019
End Date
March 31 2021
Last Update
August 1 2023
Active Locations (22)
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1
Cidp01 902
Phoenix, Arizona, United States, 85018
2
Cidp01 905
Los Angeles, California, United States, 90033
3
Cidp01 901
Tampa, Florida, United States, 33612
4
Cidp01 907
Augusta, Georgia, United States, 30912