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

Phase 2

Completed

• Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
• Interventions: Other: Placebo; Drug: Rozanolixizumab

• Registration Number: NCT03861481
• Lead Sponsor: UCB Biopharma S.P.R.L.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-01
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-04
• Study Start: 2019-03-26
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Results First Submitted: 2022-03-09
• Results First Submitted QC: 2022-03-09
• Results First Posted: 2022-04-04
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-28
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects will be randomized to receive predefined subcutaneous doses of placebo at a specified frequency
Rozanolixizumab	Rozanolixizumab	Subjects will be randomized to receive predefined subcutaneous doses of rozanolixizumab at a specified frequency

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 13 (Day 85) in Inflammatory Rasch-built Overall Disability Scale (iRODS) Score	From Baseline up to Week 13 (Day 85)	iRODS is a linearly weighted patient-reported outcome measure (questionnaire) that captures activity and social participation limitations in participants with chronic inflammatory demyelinating polyradiculoneuropathy. Questionnaire consisted of 24 items (including eating, taking a shower, walking a flight of stairs, standing for hours, etc.) and assesses a participant's ability to perform daily and social activities. Participants had 3 response options: 0=impossible to perform; 1=performed with difficulty; 2=easily performed, performed without difficulty. Raw sum scores of iRODS (range 0 to 48, where 0=worse and 48=best) were translated to log odds units (logits) scale, placing participant' estimates on same logit scale, which had a score range of -6.95 (most severe activity and social participation restrictions) to 8.11 (no activity and social participation limitations). A positive change is associated with a better outcome of less disease activity and more social activity.

Trial Locations

Locations (22)

Cidp01 601; 🇳🇱 Amsterdam, Netherlands

Cidp01 701; 🇪🇸 Barcelona, Spain

Cidp01 702; 🇪🇸 Barcelona, Spain

Cidp01 907; 🇺🇸 Augusta, Georgia, United States

Cidp01 103; 🇧🇪 Liège, Belgium

Cidp01 402; 🇫🇷 Bordeaux, France

Cidp01 903; 🇺🇸 Charlotte, North Carolina, United States

Cidp01 101; 🇧🇪 Gent, Belgium

Cidp01 404; 🇫🇷 Nice, France

Cidp01 502; 🇩🇪 Würzburg, Germany

Cidp01 302; 🇩🇰 Copenhagen, Denmark

Cidp01 802; 🇬🇧 Sheffield, United Kingdom

Cidp01 401; 🇫🇷 Strasbourg, France

Cidp01 905; 🇺🇸 Los Angeles, California, United States

Cidp01 505; 🇩🇪 Göttingen, Germany

Cidp01 912; 🇺🇸 Durham, North Carolina, United States

Cidp01 501; 🇩🇪 Berlin, Germany

Cidp01 102; 🇧🇪 Leuven, Belgium

Cidp01 503; 🇩🇪 Essen, Germany

Cidp01 902; 🇺🇸 Phoenix, Arizona, United States

Cidp01 901; 🇺🇸 Tampa, Florida, United States

Cidp01 911; 🇺🇸 Lexington, Kentucky, United States