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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis

    Summary
    EudraCT number
    		 2019-004778-25
    Trial protocol
    		 DE   FR   NL   IT   PT  
    Global end of trial date
    26 Apr 2024

    Results information
    Results version number
    		 v2(current)
    This version publication date
    03 May 2025
    First version publication date
    23 Mar 2025
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Alignment with final posting on ClinicalTrials.gov after NIH review.

    Trial information

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    Trial identification
    Sponsor protocol code
    AIE001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04875975
    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
    29 May 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Mar 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Apr 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Assess the efficacy of rozanolixizumab as measured by seizure freedom
    Protection of trial subjects
    During the conduct of the study all participants were closely monitored.
    Background therapy
    		 Corticosteroids was initiated prior to the start of the Screening Period, however, the study participant randomized within 42 days of corticosteroids initiation. As individual disease entities, IgG autoantibody-mediated conditions are relatively rare. Treatment of these disorders remains a difficult clinical problem, requiring in many of these conditions the long-term use of corticosteroids alone or combined with other immunomodulatory therapy.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    27 Sep 2021
    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
    Belgium: 1
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    United Kingdom: 2
    Worldwide total number of subjects
    12
    EEA total number of subjects
    10
    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)
    4
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study started to enroll participants in September 2021 and concluded in April 2024.

    Pre-assignment
    Screening details
    		 The Participant Flow refers to the Randomized Set (RS).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo as a subcutaneous (sc) infusion once a week (Q1W) for 25 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo at pre-specified timepoints.

    Arm title
    		 Rozanolixizumab (RLZ)
    Arm description
    		 Participants received rozanolixizumab as a sc infusion Q1W for 25 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rozanolixizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received rozanolixizumab at pre-specified timepoints.

    Number of subjects in period 1
    		Placebo Rozanolixizumab (RLZ)
    Started
    6
    6
    Completed
    2
    0
    Not completed
    4
    6
         Permanently left due to new seizure recurrence
    -
    1
         Adverse event, non-fatal
    1
    2
         Relapse With Insults
    -
    1
         Permanently left due to seizure recurrence
    1
    -
         Lack of efficacy
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo as a subcutaneous (sc) infusion once a week (Q1W) for 25 weeks.

    Reporting group title
    Rozanolixizumab (RLZ)
    Reporting group description
    		 Participants received rozanolixizumab as a sc infusion Q1W for 25 weeks.

    Reporting group values
    		 Placebo Rozanolixizumab (RLZ) Total
    Number of subjects
    		 6 6 12
    Age Categorical
    Units: participants
        18 - <65 years
    		 3 1 4
        65 - <85 years
    		 3 5 8
        >=85 years
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 60.7 ( 12.4 ) 70.7 ( 11.4 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 2 2 4
        Male
    		 4 4 8

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo as a subcutaneous (sc) infusion once a week (Q1W) for 25 weeks.

    Reporting group title
    Rozanolixizumab (RLZ)
    Reporting group description
    		 Participants received rozanolixizumab as a sc infusion Q1W for 25 weeks.

    Primary: Number of seizure free study participants at the end of the Treatment

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    End point title
    		 Number of seizure free study participants at the end of the Treatment [1]
    End point description
    Seizure freedom was defined as a minimum of 28 consecutive days of no seizures of any type during the treatment and maintained until the end of the treatment (Week 25). The Randomized Set (RS) consisted of all enrolled study participants who were randomized to treatment arms.
    End point type
    Primary
    End point timeframe
    From Baseline until the end of the Treatment (Week 25)
    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: Formal statistical hypothesis testing was planned for primary endpoint in this study. However, analysis was not feasible due to insufficient number of participants. Results were summarized as descriptive statistics only.
    End point values
    		 Placebo Rozanolixizumab (RLZ)
    Number of subjects analysed
    6
    6
    Units: participants
    1
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total scale index score at the end of the Treatment

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    End point title
    		 Change from Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total scale index score at the end of the Treatment
    End point description
    RBANS consists of 12 subtests that contribute to 5 age-based domain index scores (immediate memory, visuospatial/constructional, language, attention, delayed memory) that were aggregated for total scale index score. All index scores have age-based mean of 100, with standard deviation (SD) of 15. Total scale score was calculated by taking mean of sum of five index scores. Total possible scale index scores range from 40-135. Higher scores reflect better neurocognitive performance. Total scale index score is score typically used to reflect global neurocognitive status. Baseline (BL) of RBANS is defined as screening (Visit 1, Week -1) value. 99999: As pre-specified in the SAP, mean and SD will only be calculated if number of participants are equal to 3 or greater than 3. Here, Mean and SD were not calculated due to less than 3 participants. Randomized Set (RS). Number of participants analyzed = participants evaluable for this endpoint. n = participants evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 5, 13, 21 and 25
    End point values
    		 Placebo Rozanolixizumab (RLZ)
    Number of subjects analysed
    4
    6
    Units: score on a scale
    arithmetic mean (standard deviation)
        Week 5 (n= 4, 6)
    4.5 ( 2.6 )
    2.2 ( 11.3 )
        Week 13 (n= 4, 4)
    7.0 ( 2.9 )
    12.3 ( 7.9 )
        Week 21 (n= 4, 2)
    7.0 ( 7.3 )
    99999 ( 99999 )
        Week 25 (n= 2, 1)
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Percentage of participants with a favorable outcome in the Modified Rankin Scale (mRS) during the Treatment

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    End point title
    		 Percentage of participants with a favorable outcome in the Modified Rankin Scale (mRS) during the Treatment
    End point description
    Percentage of participants with favorable outcome in mRS, defined as no worsening for participants BL mRS score of ≤1 or improvement of ≥1 point BL mRS score of ≥2. mRS:scale for measuring degree of disability or dependence in daily activities of people suffered stroke or causes of neurological disability. Scale ranges from 0(perfect health) to 6(death). 0-No symptoms 1-No significant disability; carry usual activities; 2-Slight disability;able to handle own affairs without help 3-Moderate disability; able to walk without help 4-Moderately severe disability unable to walk and attend to own bodily needs without help 5-Severe disability requiring nursing care 6-Dead. Number of subjects analyzed:subject evaluable for this endpoint. 99999:Data to calculate descriptive statistics is only possible if number of participants are 3 or more. At Week 25, less than 3 participants were evaluated due to early study termination and early discontinuation of most patients hence no data to report. RS.
    End point type
    Secondary
    End point timeframe
    From Baseline until the end of the Treatment (Week 25)
    End point values
    		 Placebo Rozanolixizumab (RLZ)
    Number of subjects analysed
    2
    1
    Units: percentage of participants
        number (not applicable)
    99999
    99999
    No statistical analyses for this end point

    Secondary: Number of participants who required rescue medication due to an absence or loss of clinical benefit during the Treatment

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    End point title
    		 Number of participants who required rescue medication due to an absence or loss of clinical benefit during the Treatment
    End point description
    Study participants who required rescue medication due to an absence or loss of clinical benefit were discontinued blinded treatment and completed the assessments for the early discontinuation visit. The Randomized Set (RS) consisted of all enrolled study participants who were randomized to treatment arms.
    End point type
    Secondary
    End point timeframe
    From Baseline until the end of the Treatment (Week 25)
    End point values
    		 Placebo Rozanolixizumab (RLZ)
    Number of subjects analysed
    6
    6
    Units: participants
    3
    2
    No statistical analyses for this end point

    Secondary: Time to first occurrence of seizure freedom during the Treatment

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    End point title
    		 Time to first occurrence of seizure freedom during the Treatment
    End point description
    The time to first occurrence of seizure freedom was defined by the number of days after randomization to the first day of the first 28 consecutive days without seizures during the treatment. Time to first occurrence of 28 consecutive days of seizure freedom (days) during the treatment was calculated as date of first day of occurrence of 28 consecutive days of seizure freedom – Date of Randomization + 1. The Randomized Set (RS) consisted of all enrolled study participants who were randomized to treatment arms.
    End point type
    Secondary
    End point timeframe
    From Baseline until the end of the Treatment (Week 25)
    End point values
    		 Placebo Rozanolixizumab (RLZ)
    Number of subjects analysed
    6
    6
    Units: Weeks
        median (full range (min-max))
    0.1 (0.1 to 8.4)
    0.1 (0.1 to 8.3)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    		 Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)
    End point description
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP, whether or not related to the IMP. A TEAE was defined as an AE starting on or after the time of first administration of IMP or any unresolved event already present before the first administration of IMP that worsens in intensity following exposure to treatment up to the end of the Treatment (EOT) and including the 8-week (56 days) Safety-Follow Up (SFU). The Safety Set (SS) consisted of all randomized study participants who received at least one dose of IMP.
    End point type
    Secondary
    End point timeframe
    From Baseline until the End of Study (Week 32)
    End point values
    		 Placebo Rozanolixizumab (RLZ)
    Number of subjects analysed
    6
    6
    Units: percentage of participants
        number (not applicable)
    100
    100
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline until the End of Study (up to Week 32)
    Adverse event reporting additional description
    TEAE: AE starting on or after time of first administration of IMP or any unresolved event already present before first administration of IMP that worsens in intensity following exposure to treatment up to EOT and including 8-week (56 days) SFU. The Safety Set consisted of all randomized study participants who received at least one dose of IMP.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo as a subcutaneous (sc) infusion once a week (Q1W) for 25 weeks.

    Reporting group title
    Rozanolixizumab (RLZ)
    Reporting group description
    		 Participants received rozanolixizumab as a sc infusion Q1W for 25 weeks.

    Serious adverse events
    		 Placebo Rozanolixizumab (RLZ)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 6 (50.00%)
    3 / 6 (50.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis autoimmune
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Mania
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoas abscess
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Rozanolixizumab (RLZ)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    6 / 6 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign ear neoplasm
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Paraproteinaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Asthenia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    Oedema peripheral
         subjects affected / exposed
    0 / 6 (0.00%)
    4 / 6 (66.67%)
         occurrences all number
    0
    4
    Infusion site erythema
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Swelling face
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Influenza like illness
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Lung opacity
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Cough
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Dyspnoea
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Affect lability
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    3
    Anxiety
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    Insomnia
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 6 (33.33%)
         occurrences all number
    1
    3
    Emotional disorder
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Impulse-control disorder
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Mania
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    Sleep disorder
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Blood immunoglobulin M increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Skin injury
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Spinal compression fracture
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Balance disorder
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Depressed level of consciousness
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Encephalitis autoimmune
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
         occurrences all number
    4
    1
    Parkinsonism
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Seizure
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Ageusia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Dysgeusia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
         occurrences all number
    2
    1
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Gingival pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 6 (16.67%)
    3 / 6 (50.00%)
         occurrences all number
    3
    7
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Rash maculo-papular
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Pruritus
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Bursitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Periarthritis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Infections and infestations
    Tooth infection
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Suspected COVID-19
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    COVID-19
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Cellulitis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Otitis externa
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Anal abscess
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Dec 2020
    Protocol Amendment 1 was dated 04 Dec 2020: Changes to the protocol were made to change the dose of rozanolixizumab from weight-tiered doses to fixed dose. Other corrections to ensure consistency across the rozanolixizumab clinical development program were also made. Minor grammatical, editorial, and formatting changes were also made for clarification purposes only.
    07 Sep 2021
    Protocol Amendment 2 was dated 07 Sep 2021: Changes to the protocol were made to amend the inclusion critera to ensure greater specificity for the target population, the addition of regular monitoring of lipid parameters, and to provide clarity on how the treatment blind maintained. This amendment also introduced blood sampling for antibody response to COVID-19 vaccination, and provided clarity on the management of study participants undergoing COVID-19 vaccination. Requests from regulatory authorities or ethics committees were incorporated, and country-specific revisions added. Minor grammatical, editorial, and formatting changes were also made for clarification purposes only.
    14 Jan 2022
    Protocol Amendment 3 was dated 14 Jan 2022: The overall rationale for the amendment was to address comments and queries from Food and Drug Administration (FDA) raised during the Investigational New Drug (IND) review. Minor grammatical, editorial, and formatting changes were also made for clarification purposes only.
    19 Oct 2022
    Protocol Amendment 4 was dated 19 Oct 2022: Changes to the protocol were made to update safety information in line with the revised IB dated 06 September 2022. Additional changes were also made to reduce the study burden for patients. Minor grammatical, editorial, and formatting changes were also made for clarification purposes only.
    09 Feb 2023
    Protocol Amendment 5 was dated 09 Feb 2023: In the past 3 years (since the initial protocol), there was an emerging understanding about the experiences of patients with Leucine-rich glioma inactivated 1 AIE (LGI1 AIE), changed in medical management of such patients, and more widespread use of the clinical outcome assessments supporting efficacy endpoints selected for this study. Therefore, changes to the protocol were made to update the secondary endpoints and associated statistical methods and better align the protocol with the current treatment practices and understanding of the disease. Minor grammatical, editorial, and formatting changes were also made for clarification purposes only.
    18 Jul 2023
    Protocol Amendment 6 was dated 18 Jul 2023: The overall rationale for the amendment was to address a request from FDA to re-introduce certain safety assessments to support the safety profile of rozanolixizumab in a new population. Since Amendment 5, there was no change in the benefit/risk profile of rozanolixizumab. Minor grammatical, editorial, and formatting changes were also made for clarification purposes only.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    29 Nov 2023
    UCB had determined that it is no longer feasible to complete the study within the targeted timelines and as a result made the decision to prematurely terminate the AIE001 study. This decision does not relate to any concern about the safety, tolerability, or efficacy of rozanolixizumab and the established benefit-risk profile remains unchanged.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to the early termination of the recruitment and insufficient participants, it was not feasible to carry out the statistical analyses as originally planned.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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