Back to resultsA Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (MyCIDPchoice)
Primary Purpose
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Rozanolixizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) focused on measuring Chronic inflammatory demyelinating polyradiculoneuropathy, CIDP, UCB7665, rozanolixizumab
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
Sites / Locations
- Cidp01 902
- Cidp01 905
- Cidp01 901
- Cidp01 907
- Cidp01 911
- Cidp01 903
- Cidp01 912
- Cidp01 101
- Cidp01 102
- Cidp01 103
- Cidp01 302
- Cidp01 402
- Cidp01 404
- Cidp01 401
- Cidp01 501
- Cidp01 503
- Cidp01 505
- Cidp01 502
- Cidp01 601
- Cidp01 701
- Cidp01 702
- Cidp01 802
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rozanolixizumab
Placebo
Arm Description
Subjects will be randomized to receive predefined subcutaneous doses of rozanolixizumab at a specified frequency
Subjects will be randomized to receive predefined subcutaneous doses of placebo at a specified frequency
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03861481
Brief Title
A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 26, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma S.P.R.L.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Keywords
Chronic inflammatory demyelinating polyradiculoneuropathy, CIDP, UCB7665, rozanolixizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rozanolixizumab
Arm Type
Experimental
Arm Description
Subjects will be randomized to receive predefined subcutaneous doses of rozanolixizumab at a specified frequency
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be randomized to receive predefined subcutaneous doses of placebo at a specified frequency
Intervention Type
Drug
Intervention Name(s)
Rozanolixizumab
Intervention Description
Subjects will receive rozanolixizumab in a specified sequence during the treatment period.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive placebo in a specified sequence during the treatment period.
Primary Outcome Measure Information:
Title
Change From Baseline to Week 13 (Day 85) in Inflammatory Rasch-built Overall Disability Scale (iRODS) Score
Description
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.
Time Frame
From Baseline up to Week 13 (Day 85)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
+1 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Cidp01 902
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Cidp01 905
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cidp01 901
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Cidp01 907
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Cidp01 911
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Cidp01 903
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Cidp01 912
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cidp01 101
City
Gent
Country
Belgium
Facility Name
Cidp01 102
City
Leuven
Country
Belgium
Facility Name
Cidp01 103
City
Liège
Country
Belgium
Facility Name
Cidp01 302
City
Copenhagen
Country
Denmark
Facility Name
Cidp01 402
City
Bordeaux
Country
France
Facility Name
Cidp01 404
City
Nice
Country
France
Facility Name
Cidp01 401
City
Strasbourg
Country
France
Facility Name
Cidp01 501
City
Berlin
Country
Germany
Facility Name
Cidp01 503
City
Essen
Country
Germany
Facility Name
Cidp01 505
City
Göttingen
Country
Germany
Facility Name
Cidp01 502
City
Würzburg
Country
Germany
Facility Name
Cidp01 601
City
Amsterdam
Country
Netherlands
Facility Name
Cidp01 701
City
Barcelona
Country
Spain
Facility Name
Cidp01 702
City
Barcelona
Country
Spain
Facility Name
Cidp01 802
City
Sheffield
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD Sharing Time Frame
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD Sharing Access Criteria
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
IPD Sharing URL
https://vivli.org/
Learn more about this trial
A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
We'll reach out to this number within 24 hrs