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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004392-12 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rozanolixizumab | Experimental | Subjects in this arm will receive predefined subcutaneous doses of rozanolixizumab at a specified frequency. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rozanolixizumab | Drug | Subjects will receive rozanolixizumab in a specified sequence during the treatment period. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cidp04 50082 | Scottsdale | Arizona | 85251 | United States | ||
| Cidp04 50075 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38729747 | Derived | 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. |
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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.
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.
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.
Participant Flow refers to the Enrolled Set. Participants from parent study CIDP01 (NCT03861481) who had completed the Treatment Period without a relapse of chronic inflammatory demyelinating polyradiculoneuropathy were directly enrolled into this study. Newly treated participants are participants treated with placebo in parent study CIDP01 (NCT03861481). Previously treated participants are participants treated with rozanolixizumab in parent study CIDP01 (NCT03861481).
The study started to enroll study participants in Aug 2019 and concluded in Nov 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rozanolixizumab (Newly Treated) | Participants received rozanolixizumab Dose A as a subcutaneous infusion once weekly up to Week 76. |
| FG001 | Rozanolixizumab (Previously Treated) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 16, 2020 | Oct 6, 2022 |
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| 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 |
Participants received rozanolixizumab Dose A as a subcutaneous infusion once weekly up to Week 76.
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| NOT COMPLETED |
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Baseline Characteristics refers to the Safety Set (SS) which consisted of all enrolled study participants who were administered at least one dose of rozanolixizumab in CIDP04.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rozanolixizumab (Newly Treated) | Participants received rozanolixizumab Dose A as a subcutaneous infusion once weekly up to Week 76. |
| BG001 | Rozanolixizumab (Previously Treated) | Participants received rozanolixizumab Dose A as a subcutaneous infusion once weekly up to Week 76. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Primary | 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. | The Safety Set (SS) consisted of all enrolled study participants who were administered at least one dose of rozanolixizumab in CIDP04. | Posted | Count of Participants | Participants | From Baseline until Follow-Up Visit (up to Week 84) |
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From Baseline until Follow-Up Visit (up to Week 84)
A TEAE was defined as any event that was not present prior the first administration of 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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rozanolixizumab (Newly Treated) | Participants received rozanolixizumab Dose A as a subcutaneous infusion once weekly up to Week 76. | 0 | 11 | 2 | 11 | 10 | 11 |
| EG001 | Rozanolixizumab (Previously Treated) | Participants received rozanolixizumab Dose A as a subcutaneous infusion once weekly up to Week 76. | 0 | 10 | 2 | 10 | 9 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Non-systematic Assessment |
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| Chronic inflammatory demyelinating polyradiculoneuropathy | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Sensory loss | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 24.0 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Non-systematic Assessment |
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| Blood immunoglobulin G decreased | Investigations | MedDRA 24.0 | Non-systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Sensory loss | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 8, 2021 | Oct 6, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000627812 | rozanolixizumab |
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| >=65 years |
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| Male |
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| White |
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| Other/Mixed |
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| Missing |
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| Missing |
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