A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
2 other identifiers
interventional
21
8 countries
14
Brief Summary
The purpose of the study is to assess long-term safety and tolerability of weekly doses of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2019
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2019
CompletedFirst Posted
Study publicly available on registry
August 9, 2019
CompletedStudy Start
First participant enrolled
August 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2021
CompletedResults Posted
Study results publicly available
November 3, 2022
CompletedNovember 3, 2022
October 1, 2022
2.2 years
August 8, 2019
October 6, 2022
October 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-emergent Adverse Event (TEAEs)
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product, which does not necessarily had a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE was defined as any event that was not present prior the first administration of investigational medicinal product (IMP) in CIDP04 study or any unresolved event already present before the first administration of IMP in CIDP04 study that worsened in intensity following exposure to treatment until 8 weeks following the last administration of IMP in CIDP04 study.
From Baseline until Follow-Up Visit (up to Week 84)
Study Arms (1)
Rozanolixizumab
EXPERIMENTALSubjects in this arm will receive predefined subcutaneous doses of rozanolixizumab at a specified frequency.
Interventions
Subjects will receive rozanolixizumab in a specified sequence during the treatment period.
Eligibility Criteria
You may qualify if:
- Subject who has completed one of the previous rozanolixizumab study(ies) that allow access to the present study (e.g. study CIDP01)
- 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
You may not qualify if:
- Subject has any medical (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could harm the subject or would compromise the subject's ability to participate in this study
- Subject has a clinically relevant active infection (eg, sepsis, pneumonia, abscess)
- Subject has a known hypersensitivity to any components of rozanolixizumab
- Subject intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of rozanolixizumab
- Subject has an ongoing serious adverse event (SAE) or a medical condition in the parent study that the investigator considers to put the subject at a significantly increased risk of participating in CIDP04
- Subject has any planned elective surgery due to occur during the study dosing period which in the opinion of the investigator could interfere with study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Cidp04 50082
Scottsdale, Arizona, 85251, United States
Cidp04 50075
Augusta, Georgia, 30912, United States
Cidp04 50117
Charlotte, North Carolina, 28210, United States
Cidp04 50080
Durham, North Carolina, 27710, United States
Cidp04 40169
Ghent, Belgium
Cidp04 40002
Leuven, Belgium
Cidp04 40120
Liège, Belgium
Cidp04 40126
Copenhagen, Denmark
Cidp04 40170
Strasbourg, France
Cidp04 40134
Essen, Germany
Cidp04 40140
Göttingen, Germany
Cidp04 40034
Amsterdam, Netherlands
Cidp04 40160
Barcelona, Spain
Cidp04 40167
Sheffield, United Kingdom
Related Publications (1)
Querol L, De Seze J, Dysgaard T, Levine T, Rao TH, Rivner M, Hartung HP, Kiessling P, Shimizu S, Marmol D, Bozorg A, Colson AO, Massow U, Eftimov F; CIDP01 Study Investigators. Efficacy, safety and tolerability of rozanolixizumab in patients with chronic inflammatory demyelinating polyradiculoneuropathy: a randomised, subject-blind, investigator-blind, placebo-controlled, phase 2a trial and open-label extension study. J Neurol Neurosurg Psychiatry. 2024 Aug 16;95(9):845-854. doi: 10.1136/jnnp-2023-333112.
PMID: 38729747DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
August 8, 2019
First Posted
August 9, 2019
Study Start
August 21, 2019
Primary Completion
November 10, 2021
Study Completion
November 10, 2021
Last Updated
November 3, 2022
Results First Posted
November 3, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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.