Clinical trial NCT03861481: A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Keywords: Chronic inflammatory demyelinating polyradiculoneuropathy
CIDP
UCB7665
rozanolixizumab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2019-03-04
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change From Baseline to Week 13 (Day 85) in Inflammatory Rasch-built Overall Disability Scale (iRODS) Score
timeFrame: From Baseline up to Week 13 (Day 85)
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Cidp01 902
state: Arizona
city: Los Angeles
country: United States
facility: Cidp01 905
state: California
city: Tampa
country: United States
facility: Cidp01 901
state: Florida
city: Augusta
country: United States
facility: Cidp01 907
state: Georgia
city: Lexington
country: United States
facility: Cidp01 911
state: Kentucky
city: Charlotte
country: United States
facility: Cidp01 903
state: North Carolina
city: Durham
country: United States
facility: Cidp01 912
state: North Carolina
city: Gent
country: Belgium
facility: Cidp01 101
city: Leuven
country: Belgium
facility: Cidp01 102
city: Liège
country: Belgium
facility: Cidp01 103
city: Copenhagen
country: Denmark
facility: Cidp01 302
city: Bordeaux
country: France
facility: Cidp01 402
city: Nice
country: France
facility: Cidp01 404
city: Strasbourg
country: France
facility: Cidp01 401
city: Berlin
country: Germany
facility: Cidp01 501
city: Essen
country: Germany
facility: Cidp01 503
city: Göttingen
country: Germany
facility: Cidp01 505
city: Würzburg
country: Germany
facility: Cidp01 502
city: Amsterdam
country: Netherlands
facility: Cidp01 601
city: Barcelona
country: Spain
facility: Cidp01 701
city: Barcelona
country: Spain
facility: Cidp01 702
city: Sheffield
country: United Kingdom
facility: Cidp01 802
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: