A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (MyCIDPchoice)

UCB

Status and phase: Completed; Phase 2

Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Treatments: Drug: Rozanolixizumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03861481

CIDP01

2016-002411-17 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to evaluate clinical efficacy of rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups, including a placebo group

Rozanolixizumab

Experimental group

Description:

Subjects will be randomized to receive predefined subcutaneous doses of rozanolixizumab at a specified frequency

Treatment:

Drug: Rozanolixizumab

Placebo

Placebo Comparator group

Description:

Subjects will be randomized to receive predefined subcutaneous doses of placebo at a specified frequency

Treatment:

Other: Placebo