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    Clinical Trial Results:
    An open-label, crossover study to evaluate rozanolixizumab self-administration by study participants with generalized Myasthenia Gravis

    Summary
    EudraCT number
    		 2022-003870-21
    Trial protocol
    		 IT   ES  
    Global end of trial date
    23 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 May 2025
    First version publication date
    07 May 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MG0020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05681715
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UCB Biopharma SRL
    Sponsor organisation address
    Allée de la Recherche 60, Brussels, Belgium, 1070
    Public contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Scientific contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 May 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Apr 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    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.
    Protection of trial subjects
    During the conduct of the study all participants were closely monitored.
    Background therapy
    		 Background therapy as permitted in the protocol
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    17 Apr 2023
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Georgia: 6
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Japan: 4
    Country: Number of subjects enrolled
    Poland: 15
    Country: Number of subjects enrolled
    Serbia: 2
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    United States: 10
    Worldwide total number of subjects
    62
    EEA total number of subjects
    32
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    45
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study started to enroll participants in April 2023 and concluded in April 2024.

    Pre-assignment
    Screening details
    		 Participant Flow refers to Safety Set (SS) for Training Period and Randomized Safety Set (RSS) for Self-administration Periods 1 and 2.

    Period 1
    Period 1 title
    Training Period (6-weeks)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All Participants: Training Period
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rozanolixizumab
    Investigational medicinal product code
    UCB7665
    Other name
    RLZ
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received RLZ with syringe driver or manual push at pre-specified time-points.

    Number of subjects in period 1
    		All Participants: Training Period
    Started
    62
    Completed
    55
    Not completed
    7
         Consent withdrawn by participant (not due to AE)
    1
         Adverse event, non-fatal
    3
         Not Eligible for SA but continued in study
    3
    Period 2
    Period 2 title
    Self-administration Period 1 (6 Weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence 1: RLZ Syringe driver (SRD) – RLZ Manual Push (MP)
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rozanolixizumab
    Investigational medicinal product code
    UCB7665
    Other name
    RLZ
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received RLZ with syringe driver or manual push at pre-specified time-points.

    Arm title
    		 Sequence 2: RLZ MP – RLZ SRD
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rozanolixizumab
    Investigational medicinal product code
    UCB7665
    Other name
    RLZ
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received RLZ with syringe driver or manual push at pre-specified time-points.

    Number of subjects in period 2
    		Sequence 1: RLZ Syringe driver (SRD) – RLZ Manual Push (MP) Sequence 2: RLZ MP – RLZ SRD
    Started
    28
    27
    Completed
    23
    26
    Not completed
    5
    1
         Participant became ineligible for SA
    1
    -
         Consent withdrawn by participant (not due to AE)
    -
    1
         Adverse event, non-fatal
    1
    -
         Diagnosis change to amyotrophic lateral sclerosis
    1
    -
         Missed infusion at Visit 13, SA Period1 incomplete
    2
    -
    Period 3
    Period 3 title
    Self-administration Period 2 (6 Weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence 1: RLZ SRD – RLZ MP
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rozanolixizumab
    Investigational medicinal product code
    UCB7665
    Other name
    RLZ
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received RLZ with syringe driver or manual push at pre-specified time-points.

    Arm title
    		 Sequence 2: RLZ MP – RLZ SRD
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rozanolixizumab
    Investigational medicinal product code
    UCB7665
    Other name
    RLZ
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received RLZ with syringe driver or manual push at pre-specified time-points.

    Number of subjects in period 3
    		Sequence 1: RLZ SRD – RLZ MP Sequence 2: RLZ MP – RLZ SRD
    Started
    23
    26
    Missed V13 at P1, continued P2
    2 [1]
    0 [2]
    Completed
    23
    26
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Two participants missed Visit 13 (Week 12) during Period 1, so were not counted as having completed Period 1. Both participants continued into Period 2.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Two participants missed Visit 13 (Week 12) during Period 1, so were not counted as having completed Period 1. Both participants continued into Period 2.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    All Participants: Training Period
    Reporting group description
    		 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.

    Reporting group values
    		 All Participants: Training Period Total
    Number of subjects
    		 62 62
    Age Categorical
    Units: participants
        18 - <65 years
    		 45 45
        65 - <85 years
    		 17 17
        >=85 years
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53.3 ( 15.7 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 35 35
        Male
    		 27 27

    End points

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    End points reporting groups
    Reporting group title
    All Participants: Training Period
    Reporting group description
    		 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.
    Reporting group title
    Sequence 1: RLZ Syringe driver (SRD) – RLZ Manual Push (MP)
    Reporting group description
    		 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.

    Reporting group title
    Sequence 2: RLZ MP – RLZ SRD
    Reporting group description
    		 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.
    Reporting group title
    Sequence 1: RLZ SRD – RLZ MP
    Reporting group description
    		 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.

    Reporting group title
    Sequence 2: RLZ MP – RLZ SRD
    Reporting group description
    		 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.

    Subject analysis set title
    All Participants: Training Period
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All participants received weekly doses of rozanolixizumab (RLZ) as per their body weight administered subcutaneously with Manual push (MP) and/or Syringe driver (SRD) with the guidance of healthcare professional or Self-administered to practice both methods of administration during this Training Period for 6 weeks before randomization.

    Subject analysis set title
    Period 1: RLZ SRD
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    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.

    Subject analysis set title
    Period 1: RLZ MP
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    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.

    Subject analysis set title
    Period 2: RLZ SRD
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    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.

    Subject analysis set title
    Period 2: RLZ MP
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    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.

    Subject analysis set title
    Period 1: RLZ SRD
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    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.

    Subject analysis set title
    Period 1: RLZ MP
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    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.

    Subject analysis set title
    Period 2: RLZ SRD
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    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.

    Subject analysis set title
    Period 2: RLZ MP
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    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.

    Subject analysis set title
    RLZ Total‌
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    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.

    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)

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    End point title
    		 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) [1]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Week 12 (last dose of Self-administration Period 1)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.
    End point values
    		 Period 1: RLZ SRD Period 1: RLZ MP
    Number of subjects analysed
    18
    23
    Units: percentage of participants
        number (not applicable)
    100
    100
    No statistical analyses for this end point

    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)

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    End point title
    		 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) [2]
    End point description
    Successful Self-administration was defined by the participant (i) choosing the correct infusion site, (ii) administering SC, and (iii) delivering the intended dose. The FAS consisted of all participants who were included in SS, were randomized, and completed both Self-administration periods, in accordance with the randomization scheme.
    End point type
    Primary
    End point timeframe
    Week 18 (last dose of Self-administration Period 2)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.
    End point values
    		 Period 2: RLZ SRD Period 2: RLZ MP
    Number of subjects analysed
    23
    18
    Units: percentage of participants
        number (not applicable)
    100
    100
    No statistical analyses for this end point

    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])

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    End point title
    		 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])
    End point description
    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). Randomized safety set (RSS) consisted of all participants who are included in SS and were randomized. Here, 'Number of Participants Analyzed' included those participants who were evaluable for the outcome measure.
    End point type
    Secondary
    End point timeframe
    From Week 1 up to the End of Study Visit (Week 26)
    End point values
    		 Period 1: RLZ SRD Period 1: RLZ MP Period 2: RLZ SRD Period 2: RLZ MP RLZ Total‌
    Number of subjects analysed
    28
    27
    26
    26
    62
    Units: percentage of participants
        number (not applicable)
    35.7
    29.6
    26.9
    38.5
    75.8
    No statistical analyses for this end point

    Secondary: Percentage of participants with local site reactions up to 24 hours after each administration during the Training Period and Self-administration Periods

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    End point title
    		 Percentage of participants with local site reactions up to 24 hours after each administration during the Training Period and Self-administration Periods
    End point description
    The local site reactions up to 24 hours after each administration are 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 IMP (partial or full). Here, 'Number of Participants Analyzed' included those participants who were evaluable for the outcome measure.
    End point type
    Secondary
    End point timeframe
    Up to 24 hours after each administration during the Training Period (Baseline to Week 6) and Self-administration Periods (Week 7 to Week 18)
    End point values
    		 All Participants: Training Period Period 1: RLZ SRD Period 1: RLZ MP Period 2: RLZ SRD Period 2: RLZ MP
    Number of subjects analysed
    62
    28
    27
    26
    26
    Units: percentage of participants
        number (not applicable)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants with medication errors associated with adverse reactions during the 2 Self-administration Periods of the study

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    End point title
    		 Percentage of participants with medication errors associated with adverse reactions during the 2 Self-administration Periods of the study
    End point description
    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 are included in SS and were randomized. Here, 'Number of Participants Analyzed' included those participants who were evaluable for the outcome measure.
    End point type
    Secondary
    End point timeframe
    During the Self-administration Periods (Week 7 to Week 18)
    End point values
    		 Period 1: RLZ SRD Period 1: RLZ MP Period 2: RLZ SRD Period 2: RLZ MP
    Number of subjects analysed
    28
    27
    26
    26
    Units: percentage of participants
        number (not applicable)
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Week 1 up to the End of Study Visit (Week 26)
    Adverse event reporting additional description
    TEAEs were reported for SS and RSS. The RLZ Total arm included 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.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    All Participants: Training Period
    Reporting group description
    		 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.

    Reporting group title
    RLZ Total
    Reporting group description
    		 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.

    Reporting group title
    Self-Administration Period 1 and 2: RLZ MP
    Reporting group description
    		 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.

    Reporting group title
    Self-Administration Period 1 and 2: RLZ SRD
    Reporting group description
    		 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.

    Serious adverse events
    		 All Participants: Training Period RLZ Total Self-Administration Period 1 and 2: RLZ MP Self-Administration Period 1 and 2: RLZ SRD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 62 (1.61%)
    7 / 62 (11.29%)
    1 / 53 (1.89%)
    3 / 54 (5.56%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung cancer metastatic
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 62 (1.61%)
    0 / 53 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 62 (1.61%)
    1 / 53 (1.89%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Myasthenia gravis
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 62 (3.23%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 62 (1.61%)
    0 / 53 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 62 (1.61%)
    0 / 53 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 62 (1.61%)
    0 / 53 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All Participants: Training Period RLZ Total Self-Administration Period 1 and 2: RLZ MP Self-Administration Period 1 and 2: RLZ SRD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 62 (30.65%)
    24 / 62 (38.71%)
    6 / 53 (11.32%)
    6 / 54 (11.11%)
    Nervous system disorders
    Headaches
         subjects affected / exposed
    12 / 62 (19.35%)
    13 / 62 (20.97%)
    1 / 53 (1.89%)
    4 / 54 (7.41%)
         occurrences all number
    21
    29
    1
    7
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 62 (6.45%)
    6 / 62 (9.68%)
    3 / 53 (5.66%)
    1 / 54 (1.85%)
         occurrences all number
    4
    10
    5
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 62 (6.45%)
    5 / 62 (8.06%)
    1 / 53 (1.89%)
    0 / 54 (0.00%)
         occurrences all number
    4
    5
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 62 (0.00%)
    5 / 62 (8.06%)
    2 / 53 (3.77%)
    3 / 54 (5.56%)
         occurrences all number
    0
    6
    2
    3
    COVID-19
         subjects affected / exposed
    4 / 62 (6.45%)
    7 / 62 (11.29%)
    1 / 53 (1.89%)
    0 / 54 (0.00%)
         occurrences all number
    4
    7
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Nov 2022
    Protocol Amendment 2 (dated 04 Nov 2022) was implemented to provide an update on the safety information in line with the updated Investigator’s Brochure (dated Sep 2022), updates on the adverse events of special monitoring (AESM), and an update on the planned fixed dose of rozanolixizumab based on study participants’ body weight. The secondary endpoint related to the occurrence of medication errors, the Schedule of Activities, and the criteria for IMP discontinuation and participant discontinuation from the study were also updated. Additional updates to provide further clarity on the protocol were also incorporated. This amendment was considered to be substantial based on the criteria set forth in Article 10(a) of Directive 2001/20/EC of the European Parliament and the Council of the European Union.
    07 Sep 2023
    Protocol Amendment 4 (dated 07 Sep 2023) was implemented to align with the approved label in the USA and with the proposed dosing regimen under review in Europe. This amendment was considered to be substantial based on the criteria set forth in Article 10(a) of Directive 2001/20/EC of the European Parliament and the Council of the European Union.
    30 Nov 2023
    Protocol Amendment 5 (dated 30 Nov 2023) was implemented to update the text and reflect the total number of participants screened, and to update the End of Study definition. This amendment was considered to be substantial based on the criteria set forth in Article 10(a) of Directive 2001/20/EC of the European Parliament and the Council of the European Union.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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