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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04051944
Recruitment Status : Completed
First Posted : August 9, 2019
Results First Posted : November 3, 2022
Last Update Posted : November 3, 2022
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Study Description
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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).

Condition or disease Intervention/treatment Phase
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Drug: Rozanolixizumab Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Actual Study Start Date : August 21, 2019
Actual Primary Completion Date : November 10, 2021
Actual Study Completion Date : November 10, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Rozanolixizumab
Subjects in this arm will receive predefined subcutaneous doses of rozanolixizumab at a specified frequency.
 Drug: Rozanolixizumab
Subjects will receive rozanolixizumab in a specified sequence during the treatment period.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Treatment-emergent Adverse Event (TEAEs) [ Time Frame: From Baseline until Follow-Up Visit (up to Week 84) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051944


Locations
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United States, Arizona
Cidp04 50082
Scottsdale, Arizona, United States, 85251
United States, Georgia
Cidp04 50075
Augusta, Georgia, United States, 30912
United States, North Carolina
Cidp04 50117
Charlotte, North Carolina, United States, 28210
Cidp04 50080
Durham, North Carolina, United States, 27710
Belgium
Cidp04 40169
Gent, Belgium
Cidp04 40002
Leuven, Belgium
Cidp04 40120
Liège, Belgium
Denmark
Cidp04 40126
Copenhagen, Denmark
France
Cidp04 40170
Strasbourg, France
Germany
Cidp04 40134
Essen, Germany
Cidp04 40140
Göttingen, Germany
Netherlands
Cidp04 40034
Amsterdam, Netherlands
Spain
Cidp04 40160
Barcelona, Spain
United Kingdom
Cidp04 40167
Sheffield, United Kingdom
Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
  Study Documents (Full-Text)

Documents provided by UCB Pharma ( UCB Biopharma SRL ):
Study Protocol  [PDF] March 16, 2020
Statistical Analysis Plan  [PDF] June 8, 2021

More Information
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT04051944    
Other Study ID Numbers: CIDP04
2018-004392-12 ( EudraCT Number )
First Posted: August 9, 2019    Key Record Dates
Results First Posted: November 3, 2022
Last Update Posted: November 3, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
Chronic inflammatory demyelinating polyradiculoneuropathy
CIDP
UCB7665
rozanolixizumab
Additional relevant MeSH terms:
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Polyradiculoneuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
 Immune System Diseases
Chronic Disease
Disease Attributes
Pathologic Processes
Rozanolixizumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs