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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 August 2023
• Main ID: NCT03861481
• Date of registration: 01/03/2019
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma S.P.R.L.
• Public title: A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy MyCIDPchoice
• Scientific title: 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)
• Date of first enrolment: March 26, 2019
• Target sample size: 34
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03861481
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Belgium, Canada, Denmark, France, Germany, Netherlands, Spain, United Kingdom, United States

Contacts

• Name: UCB Cares
• Affiliation: [phone] (UCB)

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Intervention(s)

Other: Placebo

Drug: Rozanolixizumab

Primary Outcome(s)

Change From Baseline to Week 13 (Day 85) in Inflammatory Rasch-built Overall Disability Scale (iRODS) Score [Time Frame: From Baseline up to Week 13 (Day 85)]

Secondary ID(s)

2016-002411-17

CIDP01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/04/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03861481