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

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Clinical Trial

— MyCIDPchoice  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03861481
• Other study ID #: CIDP01
• Secondary ID: 2016-002411-17
• Status: Completed
• Phase: Phase 2
• Start date: March 26, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: July 2023
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
• Polyradiculoneuropathy
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

Drug:
• Rozanolixizumab
Subjects will receive rozanolixizumab in a specified sequence during the treatment period.

Other:
• Placebo
Subjects will receive placebo in a specified sequence during the treatment period.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma S.P.R.L.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 13 (Day 85) in Inflammatory Rasch-built Overall Disability Scale (iRODS) Score	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.	From Baseline up to Week 13 (Day 85)