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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-003870-21 | EudraCT Number |
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The purpose of this study is to evaluate the ability of study participants with generalized Myasthenia Gravis (gMG) to successfully self-administer rozanolixizumab after training in the self-administration technique using the syringe driver and manual push methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rozanolixizumab Sequence 1: Syringe Driver - Manual Push | Experimental | Study participants will receive predefined weekly doses of rozanolixizumab for 18 weeks. |
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| Rozanolixizumab Sequence 2: Manual Push - Syringe Driver | Experimental | Study participants will receive predefined weekly doses of rozanolixizumab for 18 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rozanolixizumab | Drug | Rozanolixizumab self-administration via Syringe Driver or Manual Push. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Successful Self-administration of Rozanolixizumab (With Correct Use of Syringe Driver and Manual Push, Respectively) During the Self-administration Period at Visit 13 (Week 12) | Successful self-administration was defined by the participant (i) choosing the correct infusion site, (ii) administering SC, and (iii) delivering the intended dose. | Week 12 (last dose of Self-administration Period 1) |
| Percentage of Participants With Successful Self-administration of Rozanolixizumab (With Correct Use of Syringe Driver and Manual Push, Respectively) During the Self-administration Period at Visit 19 (Week 18) | Successful Self-administration was defined by the participant (i) choosing the correct infusion site, (ii) administering SC, and (iii) delivering the intended dose. | Week 18 (last dose of Self-administration Period 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) After Syringe Driver or Manual Push Self-administration From Visit 2 (Week 1) up to the End of Study Visit (Visit 21 [Week 26]) | An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which did not necessarily have 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 an AE starting on or after the date of first administration of rozanolixizumab in the study, up to and including 8 weeks (56 days) after the final dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mg0020 50092 | Orange | California | 92868 | United States | ||
| Mg0020 50099 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41074934 | Result | Bril V, Antozzi C, Berkowicz T, Druzdz A, Gandhi Mehta RK, Mahuwala ZK, Zschuntzsch J, Boehnlein M, Kerbusch V, Lavrov A, Morris M, Singh P, Leite MI. Self-administration of rozanolixizumab via manual push and infusion pump methods in patients with generalised myasthenia gravis: a randomised, phase 3, open-label, crossover study. J Neurol. 2025 Oct 11;272(10):686. doi: 10.1007/s00415-025-13420-6. |
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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 study 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 Safety Set (SS) for Training Period and Randomized Safety Set (RSS) for Self-administration Periods 1 and 2.
The study started to enroll participants in April 2023 and concluded in April 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants: Training Period | All participants received weekly doses of subcutaneous rozanolixizumab (RLZ) as per their body weight. During the Training Period, the study participants were trained by healthcare professionals on the subcutaneous self-administration of RLZ using both the Syringe Driver (SRD) and Manual Push (MP) methods for 6 weeks before randomization. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Training Period (6-weeks) |
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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 | Nov 30, 2023 | Apr 21, 2025 |
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| From Week 1 up to the End of Study Visit (Week 26) |
| Percentage of Participants With Local Site Reactions up to 24 Hours After Each Administration During the Training Period and Self-administration Periods | The local site reactions up to 24 hours after each administration were defined as AEs reported as local site reactions as per case report form within one day after RLZ administration. | Up to 24 hours after each administration during the Training Period (Baseline to Week 6) and Self-administration Periods (Week 7 to Week 18) |
| Percentage of Participants With Medication Errors Associated With Adverse Reactions During the 2 Self-administration Periods of the Study | Medication errors were defined as an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the study participant. Medication Errors associated with adverse reactions during the 2 Self-administration Periods were measured. | During the Self-administration Periods (Week 7 to Week 18) |
| San Francisco |
| California |
| 94143 |
| United States |
| Mg0020 50561 | Lexington | Kentucky | 40536-0284 | United States |
| Mg0020 50090 | Winston-Salem | North Carolina | 27157 | United States |
| Mg0020 50560 | Edmonton | Canada |
| Mg0020 50069 | Toronto | Canada |
| Mg0020 20161 | Tbilisi | Georgia |
| Mg0020 20165 | Tbilisi | Georgia |
| Mg0020 20305 | Tbilisi | Georgia |
| Mg0020 40140 | Göttingen | Germany |
| Mg0020 40177 | Münster | Germany |
| Mg0020 40144 | Milan | Italy |
| Mg0020 40146 | Pavia | Italy |
| Mg0020 40150 | Roma | Italy |
| Mg0020 20068 | Chiba | Japan |
| Mg0020 20078 | Hanamaki-shi | Japan |
| Mg0020 20077 | Sendai | Japan |
| Mg0020 20076 | Shinjuku-ku | Japan |
| Mg0020 40155 | Gdansk | Poland |
| Mg0020 40727 | Lodz | Poland |
| Mg0020 40153 | Poznan | Poland |
| Mg0020 40729 | Niš | Serbia |
| Mg0020 40160 | Barcelona | Spain |
| Mg0020 40267 | Barcelona | Spain |
| Mg0020 40308 | San Sebastián de los Reyes | Spain |
| Mg0020 40168 | Nottingham | United Kingdom |
| Mg0020 40163 | Oxford | United Kingdom |
| FG001 | Sequence 1: RLZ Syringe Driver (SRD) - RLZ Manual Push (MP) | Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with SRD once every week from Week 7 to 12 during Self-administration Period 1 followed by RLZ administered subcutaneously with MP once every week from Week 13 to 18 during Self-administration Period 2. Study has no wash-out period. |
| FG002 | Sequence 2: RLZ MP - RLZ SRD | Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with MP once every week from Week 7 to 12 during Self-administration Period 1 followed by RLZ administered subcutaneously with SRD once every week from Week 13 to 18 during Self-administration Period 2. Study had no wash-out period. |
| COMPLETED |
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| NOT COMPLETED |
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| Self-administration Period 1 (6 Weeks) |
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| Self-administration Period 2 (6 Weeks) |
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Baseline characteristics refers to the Safety set which included all study participants who received at least 1 dose of investigational medicinal product (IMP) (partial or full).
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants: Training Period | All participants received weekly doses of subcutaneous rozanolixizumab (RLZ) as per their body weight. During the Training Period, the study participants were trained by healthcare professionals on the subcutaneous self-administration of RLZ using both the Syringe Driver (SRD) and Manual Push (MP) methods for 6 weeks before randomization. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Successful Self-administration of Rozanolixizumab (With Correct Use of Syringe Driver and Manual Push, Respectively) During the Self-administration Period at Visit 13 (Week 12) | Successful self-administration was defined by the participant (i) choosing the correct infusion site, (ii) administering SC, and (iii) delivering the intended dose. | The Full Analysis Set (FAS) consisted of all participants who were included in SS, were randomized, and completed both self-administration periods in accordance with the randomization scheme. | Posted | Number | percentage of participants | Week 12 (last dose of Self-administration Period 1) |
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| Primary | Percentage of Participants With Successful Self-administration of Rozanolixizumab (With Correct Use of Syringe Driver and Manual Push, Respectively) During the Self-administration Period at Visit 19 (Week 18) | Successful Self-administration was defined by the participant (i) choosing the correct infusion site, (ii) administering SC, and (iii) delivering the intended dose. | FAS consisted of all participants who were included in SS, were randomized, and completed both self-administration periods in accordance with the randomization scheme. | Posted | Number | percentage of participants | Week 18 (last dose of Self-administration Period 2) |
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| Secondary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) After Syringe Driver or Manual Push Self-administration From Visit 2 (Week 1) up to the End of Study Visit (Visit 21 [Week 26]) | An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which did not necessarily have 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 an AE starting on or after the date of first administration of rozanolixizumab in the study, up to and including 8 weeks (56 days) after the final dose. | SS included all study participants who received at least 1 dose of investigational medicinal product (partial or full). The Randomized Safety Set (RSS) consisted of all participants who were included in SS and were randomized. Here, number of participants analyzed included those participants who were evaluable for the outcome measure. | Posted | Number | percentage of participants | From Week 1 up to the End of Study Visit (Week 26) |
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| Secondary | Percentage of Participants With Local Site Reactions up to 24 Hours After Each Administration During the Training Period and Self-administration Periods | The local site reactions up to 24 hours after each administration were defined as AEs reported as local site reactions as per case report form within one day after RLZ administration. | SS included all study participants who received at least 1 dose of investigational medicinal product (partial or full). Here, number of participants analyzed included those participants who were evaluable for the outcome measure. | Posted | Number | percentage of participants | Up to 24 hours after each administration during the Training Period (Baseline to Week 6) and Self-administration Periods (Week 7 to Week 18) |
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| Secondary | Percentage of Participants With Medication Errors Associated With Adverse Reactions During the 2 Self-administration Periods of the Study | Medication errors were defined as an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the study participant. Medication Errors associated with adverse reactions during the 2 Self-administration Periods were measured. | RSS consisted of all participants who were included in SS and were randomized. Here, number of participants analyzed included those participants who were evaluable for the outcome measure. | Posted | Number | percentage of participants | During the Self-administration Periods (Week 7 to Week 18) |
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From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the 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 | All Participants: Training Period | All participants received weekly doses of subcutaneous rozanolixizumab (RLZ) as per their body weight. During the Training Period, the study participants were trained by healthcare professionals on the subcutaneous self-administration of RLZ using both the Syringe Driver (SRD) and Manual Push (MP) methods for 6 weeks before randomization. | 0 | 62 | 1 | 62 | 19 | 62 |
| EG001 | Self-Administration Period 1 and 2: RLZ SRD | Participants in Sequence 1 (from Week 7 to Week 12) and in Sequence 2 (from Week 13 to Week 18) received weekly doses of RLZ subcutaneously using the SRD administration method. | 0 | 54 | 3 | 54 | 6 | 54 |
| EG002 | Self-Administration Period 1 and 2: RLZ MP | Participants in Sequence 2 (from Week 7 to Week 12) and in Sequence 1 (from Week 13 to Week 18) received weekly doses of RLZ subcutaneously using the MP administration method. | 0 | 53 | 1 | 53 | 6 | 53 |
| EG003 | RLZ Total | All study participants who received at least 1 dose of RLZ subcutaneously once every week with SRD or MP in Training Period, SA Period 1 and SA Period 2 for 18 weeks. | 0 | 62 | 7 | 62 | 24 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myasthenia gravis | Nervous system disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.0 | Non-systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 24.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 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 | May 3, 2024 | Apr 21, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000627812 | rozanolixizumab |
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| Adverse Event |
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| Participant became ineligible for SA |
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| Missed infusion at Visit 13, SA Period1 incomplete |
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| >=85 years |
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| White |
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| Other/Mixed |
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Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with MP once every week from Week 7 to 12 during Self-administration Period 1
| OG002 | Period 2: RLZ SRD | Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with SRD once every week from Week 13 to 18 during Self-administration Period 2. |
| OG003 | Period 2: RLZ MP | Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with MP once every week from Week 13 to 18 during Self-administration Period 2. |
| OG004 | RLZ Total | All study participants who received at least 1 dose of RLZ subcutaneously once every week with SRD or MP in Training Period, SA Period 1 and SA Period 2 for 18 weeks. |
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| OG002 |
| Period 1: RLZ MP |
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with MP once every week from Week 7 to 12 during Self-administration Period 1 |
| OG003 | Period 2: RLZ SRD | Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with SRD once every week from Week 13 to 18 during Self-administration Period 2. |
| OG004 | Period 2: RLZ MP | Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with MP once every week from Week 13 to 18 during Self-administration Period 2. |
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| OG003 | Period 2: RLZ MP | Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with MP once every week from Week 13 to 18 during Self-administration Period 2. |
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