A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Condition: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MeSH terms: Polyradiculoneuropathy; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Intervention: Rozanolixizumab; Placebo
Intervention description: Subjects will receive rozanolixizumab in a specified sequence during the treatment period.; Subjects will receive placebo in a specified sequence during the treatment period.
Intervention MeSH terms: Rozanolixizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic inflammatory demyelinating polyradiculoneuropathy; CIDP; UCB7665; rozanolixizumab

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 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