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

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

In brief

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

Key facts

Study ID: NCT03861481
Run by: UCB Biopharma S.P.R.L.
People needed: 34
Starts: 2019-03-26
Expected to finish: 2021-03-31
Last updated by the study team: 2023-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Cidp01 902 — Phoenix, Arizona, United States
Cidp01 905 — Los Angeles, California, United States
Cidp01 901 — Tampa, Florida, United States
Cidp01 907 — Augusta, Georgia, United States
Cidp01 911 — Lexington, Kentucky, United States
Cidp01 903 — Charlotte, North Carolina, United States
Cidp01 912 — Durham, North Carolina, United States
Cidp01 101 — Ghent, Belgium
Cidp01 102 — Leuven, Belgium
Cidp01 103 — Liège, Belgium
Cidp01 302 — Copenhagen, Denmark
Cidp01 402 — Bordeaux, France
Cidp01 404 — Nice, France
Cidp01 401 — Strasbourg, France
Cidp01 501 — Berlin, Germany
Cidp01 503 — Essen, Germany
Cidp01 505 — Göttingen, Germany
Cidp01 502 — Würzburg, Germany
Cidp01 601 — Amsterdam, Netherlands
Cidp01 701 — Barcelona, Spain
Cidp01 702 — Barcelona, Spain
Cidp01 802 — Sheffield, United Kingdom

Full record on ClinicalTrials.gov

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