Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Study to Evaluate the Efficacy, Safety and PK/PD of the human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE)

    Summary
    EudraCT number
    		 2020-002985-15
    Trial protocol
    		 GB   DE   GR  
    Global end of trial date
    14 Dec 2023

    Results information
    Results version number
    		 v1
    This version publication date
    26 Dec 2024
    First version publication date
    26 Dec 2024
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MOR202C205
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04733040
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    HI-Bio, A Biogen Company
    Sponsor organisation address
    6000 Shoreline Ct. Suite 304, South San Francisco, United States, 94080
    Public contact
    Global Program Medical Director, HI-Bio, A Biogen Company, +1 1-408-548-7261, clinicaltrialdisclosure@hibio.com
    Scientific contact
    Global Program Medical Director, HI-Bio, A Biogen Company, +1 1-408-548-7261, clinicaltrialdisclosure@hibio.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
    14 Dec 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Dec 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess the effectiveness of 2 different dosing regimens of MOR202 in adults with anti phospholipase A2 receptor antibodies (anti-PLA2R) antibody positive membranous nephropathy (aMN).
    Protection of trial subjects
    This trial was designed and implemented, executed and reported in accordance with the ICH Harmonized Tripartite Guidelines for Good Clinical Practice (ICH-GCP), with applicable local regulations and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jan 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Korea, Republic of: 4
    Country: Number of subjects enrolled
    Russian Federation: 3
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Georgia: 7
    Country: Number of subjects enrolled
    Greece: 6
    Country: Number of subjects enrolled
    Germany: 3
    Worldwide total number of subjects
    24
    EEA total number of subjects
    9
    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)
    20
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were screened for a period of 6 weeks before study start.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MOR202 - 5 Doses
    Arm description
    		 Participants received 5 doses of MOR202 on Days 1, 8, 15, 29, and 57.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MOR202
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received MOR202 via an intravenous (IV) infusion based on their body weight.

    Arm title
    		 MOR202 - 2 Doses
    Arm description
    		 Participants received 2 doses of MOR202 on Days 1 and 15.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MOR202
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received MOR202 via an IV infusion based on their body weight

    Number of subjects in period 1
    		MOR202 - 5 Doses MOR202 - 2 Doses
    Started
    11
    13
    Received At Least 1 Dose of Study Drug
    11
    13
    Completed
    9
    11
    Not completed
    2
    2
         Consent withdrawn by subject
    2
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    MOR202 - 5 Doses
    Reporting group description
    		 Participants received 5 doses of MOR202 on Days 1, 8, 15, 29, and 57.

    Reporting group title
    MOR202 - 2 Doses
    Reporting group description
    		 Participants received 2 doses of MOR202 on Days 1 and 15.

    Reporting group values
    		 MOR202 - 5 Doses MOR202 - 2 Doses Total
    Number of subjects
    		 11 13 24
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.8 ( 12.94 ) 53.5 ( 9.01 ) -
    Gender categorical
    Units: Subjects
        Female
    		 1 3 4
        Male
    		 10 10 20
    Race
    Units: Subjects
        White
    		 8 12 20
        Asian
    		 3 1 4
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 0 1
        Not Hispanic or Latino
    		 10 13 23

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    MOR202 - 5 Doses
    Reporting group description
    		 Participants received 5 doses of MOR202 on Days 1, 8, 15, 29, and 57.

    Reporting group title
    MOR202 - 2 Doses
    Reporting group description
    		 Participants received 2 doses of MOR202 on Days 1 and 15.

    Primary: Percent Change From Baseline in Anti-PLA2R Antibody Levels

    		 Close Top of page
    End point title
    		 Percent Change From Baseline in Anti-PLA2R Antibody Levels [1]
    End point description
    Per-Protocol Set (PPS) included all randomized participants who did not have any protocol deviation which could impact the efficacy outcome.
    End point type
    Primary
    End point timeframe
    Baseline, Month 3
    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 statistical analyses were planned for this end point
    End point values
    		 MOR202 - 5 Doses MOR202 - 2 Doses
    Number of subjects analysed
    2
    6
    Units: percent change
        arithmetic mean (standard deviation)
    -53.21 ( 54.466 )
    9.28 ( 56.041 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Immunological Complete Response (ICR)

    		 Close Top of page
    End point title
    		 Percentage of Participants With Immunological Complete Response (ICR)
    End point description
    ICR was defined as the reduction of anti-PLA2R antibody titers to less than 14.0 relative unit/milliliter (RU/mL). Full Analysis Set (FAS) included all participants who were randomized into the study. Here, ‘Number of subjects analyzed’ = participants evaluable for this endpoint. ‘n’ = participants evaluable at the specified time point.
    End point type
    Secondary
    End point timeframe
    Months 3, 6, 12 and 24
    End point values
    		 MOR202 - 5 Doses MOR202 - 2 Doses
    Number of subjects analysed
    10
    13
    Units: Percentage of participants
    number (confidence interval 95%)
        Month 3 (n = 10, 13)
    10 (0.3 to 44.5)
    0 (0.0 to 24.7)
        Month 6 (n = 9, 11)
    0 (0.0 to 33.6)
    9.1 (0.1 to 41.3)
        Month 12 (n = 9, 11)
    0 (0.0 to 33.6)
    9.1 (0.1 to 42.3)
        Month 24 (n = 9, 13)
    0 (0.0 to 33.6)
    23.1 (5.0 to 53.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Overall Proteinuria Response (OPR)

    		 Close Top of page
    End point title
    		 Percentage of Participants With Overall Proteinuria Response (OPR)
    End point description
    OPR was defined as the sum of participants with Proteinuria complete response (Prot-CR): reduction of proteinuria to less than 0.5 grams (g)/g, serum albumin within the reference range of the central laboratory and stable estimated glomerular filtration rate (eGFR) + Proteinuria partial response (Prot-PR): reduction by at least 50% of Urine protein to creatinine ratio (UPCR) at a given visit compared to baseline, proteinuria below 3.0 g/g and stable eGFR , but not meeting Prot-CR. FAS included all participants who were randomized into the study. Here, ‘Number of subjects analyzed’ = participants evaluable for this endpoint. ‘n’ = participants evaluable at the specified time point.
    End point type
    Secondary
    End point timeframe
    Months 6, 12 and 24
    End point values
    		 MOR202 - 5 Doses MOR202 - 2 Doses
    Number of subjects analysed
    9
    11
    Units: Percentage of participants
    number (confidence interval 95%)
        Month 6 (n = 9, 11)
    0 (0.0 to 33.6)
    0 (0.0 to 28.5)
        Month 12 (n = 9, 11)
    0 (0.0 to 33.6)
    0 (0.0 to 28.5)
        Month 24 (n = 8, 10)
    0 (0.0 to 33.6)
    40 (12.2 to 73.8)
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    		 Close Top of page
    End point title
    		 Number of Participants With Treatment Emergent Adverse Events (TEAEs)
    End point description
    An Adverse Event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A Serious Adverse Event (SAE) was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), important medical event or reaction. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the ‘Reported Adverse Events’ Section. Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    First dose of study drug up to 48 months
    End point values
    		 MOR202 - 5 Doses MOR202 - 2 Doses
    Number of subjects analysed
    11
    13
    Units: Participants
    9
    9
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax)

    		 Close Top of page
    End point title
    		 Maximum Observed Plasma Concentration (Cmax)
    End point description
    Pharmacokinetic (PK) Analysis Set included all participants with any available quantifiable MOR202 serum concentration data. Here, ‘n’ = participants evaluable at the specified time point.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 30 minutes post-dose on Days 1 and 15
    End point values
    		 MOR202 - 5 Doses MOR202 - 2 Doses
    Number of subjects analysed
    11
    13
    Units: nanogram(s)/mL
    arithmetic mean (standard deviation)
        Day 1 Pre-Dose (n = 11, 13)
    0.0 ( 0.00 )
    16.9 ( 61.02 )
        Day 1 30 Minutes Post-Dose (n = 11, 13)
    422454.5 ( 154966.68 )
    434384.6 ( 149604.78 )
        Day 15 Pre-Dose (n = 8, 13)
    205975.0 ( 96879.33 )
    64307.7 ( 41671.14 )
        Day 15 30 Minutes Post-Dose (n = 8, 12)
    556625.0 ( 158399.98 )
    474416.7 ( 183682.76 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Anti-Drug Antibodies (ADA)

    		 Close Top of page
    End point title
    		 Number of Participants With Anti-Drug Antibodies (ADA)
    End point description
    Immunogenicity Analysis Set included all participants with at least one MOR202 ADA sample. Here, ‘Number of subjects analyzed’ = participants evaluable for this endpoint. ‘n’ = participants evaluable at the specified time point.
    End point type
    Secondary
    End point timeframe
    First dose of study drug up to 24 months
    End point values
    		 MOR202 - 5 Doses MOR202 - 2 Doses
    Number of subjects analysed
    11
    13
    Units: participants
    2
    8
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    First dose of study drug up to 48 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    MOR202 - 5 Doses
    Reporting group description
    		 Participants received 5 doses of MOR202 on Days 1, 8, 15, 29 and 57.

    Reporting group title
    MOR202 - 2 Doses
    Reporting group description
    		 Participants received 2 doses of MOR202 on Days 1 and 15.

    Serious adverse events
    		 MOR202 - 5 Doses MOR202 - 2 Doses
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 11 (27.27%)
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Renal and urinary disorders
    Chronic kidney disease
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epiglottitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MOR202 - 5 Doses MOR202 - 2 Doses
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 11 (54.55%)
    9 / 13 (69.23%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Sensation of foreign body
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Blood immunoglobulin G increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Vitamin D decreased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 11 (9.09%)
    4 / 13 (30.77%)
         occurrences all number
    1
    4
    Procedural nausea
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Procedural vomiting
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Eosinophilia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Retinopathy proliferative
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    3
    Renal and urinary disorders
    Nephrotic syndrome
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Renal impairment
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Herpes zoster
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Oct 2021
    The purpose of this amendment is to obtain further safety information on infusion related reaction (IRRs) in all felzartamab treated participants by lengthening the observational period after the first three infusions to two hours. Utilization of Histamine-Type 2 receptor antagonist shall be added globally as premedication for all participants.

    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
    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.

    European Medicines Agency © 1995-Sat May 10 01:19:22 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA