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   44358   clinical trials with a EudraCT protocol, of which   7384   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 1/2 Study of ANV419 as Monotherapy or in Combination With Anti PD-1 or Anti-CTLA-4 Antibody Following Anti PD 1/Anti-PD-L1 Antibody Treatment in Patients With Unresectable or Metastatic Cutaneous Melanoma

    Summary
    EudraCT number
    		 2021-006711-29
    Trial protocol
    		 DE   ES   IT  
    Global end of trial date
    01 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Jul 2025
    First version publication date
    27 Jul 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ANV419-101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05578872
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Anaveon AG
    Sponsor organisation address
    Technologiepark Basel, Hochbergerstrasse 60c, Basel, Switzerland, 4057
    Public contact
    Anaveon Medical Director, Anaveon AG, +41 615218383, AnaveonClinicalTrials@anaveon.com
    Scientific contact
    Anaveon Medical Director, Anaveon AG, +41 615218383, AnaveonClinicalTrials@anaveon.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
    01 Aug 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Aug 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this multi-site, open-label, randomized, parallel arm, Phase 1/2 adaptive study is to evaluate the efficacy and safety of ANV419 as a monotherapy and in combination with anti-PD1 antibody or anti-CTLA4 antibody in patients aged 18 years or older with advanced Cutaneous Melanoma who have previously been treated with an anti-PD-1/anti-PD-L1 antibody.
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki and with all applicable laws and regulations of the locales and countries where the study was conducted, and in compliance with Good Clinical Practice Guidelines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Dec 2022
    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
    United States: 2
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    France: 13
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Italy: 2
    Worldwide total number of subjects
    29
    EEA total number of subjects
    27
    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
    9
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This was a multi-center study with a total of 12 sites located in the United States, France, Spain, Italy and Germany. A total of 29 patients were enrolled in the study.

    Pre-assignment
    Screening details
    		 N/A

    Period 1
    Period 1 title
    ANV419 Monotherapy Dose Expansion (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ANV419 Single Agent, Dose 1
    Arm description
    		 ANV419 administered by intravenous (IV) infusion
    Arm type
    		 Experimental

    Investigational medicinal product name
    ANV419
    Investigational medicinal product code
    ANV419
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Concentrate for solution for infusion
    Dosage and administration details
    ANV419 administered by intravenous (IV) infusion.

    Arm title
    		 ANV419 Single Agent, Dose 2
    Arm description
    		 ANV419 administered by intravenous (IV) infusion
    Arm type
    		 Experimental

    Investigational medicinal product name
    ANV419
    Investigational medicinal product code
    ANV419
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Concentrate for solution for infusion
    Dosage and administration details
    ANV419 administered by intravenous (IV) infusion.

    Number of subjects in period 1
    		ANV419 Single Agent, Dose 1 ANV419 Single Agent, Dose 2
    Started
    14
    15
    Completed
    0
    0
    Not completed
    14
    15
         Consent withdrawn by subject
    2
    1
         Physician decision
    1
    2
         Adverse event, non-fatal
    1
    1
         Toxicity and patient's decision
    -
    1
         Progressive disease
    10
    9
         Sponsor decision
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    ANV419 Single Agent, Dose 1
    Reporting group description
    		 ANV419 administered by intravenous (IV) infusion

    Reporting group title
    ANV419 Single Agent, Dose 2
    Reporting group description
    		 ANV419 administered by intravenous (IV) infusion

    Reporting group values
    		 ANV419 Single Agent, Dose 1 ANV419 Single Agent, Dose 2 Total
    Number of subjects
    		 14 15 29
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 10 10 20
        From 65-84 years
    		 4 5 9
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.70 ( 14.15 ) 59.80 ( 13.92 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5 10
        Male
    		 9 10 19

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    ANV419 Single Agent, Dose 1
    Reporting group description
    		 ANV419 administered by intravenous (IV) infusion

    Reporting group title
    ANV419 Single Agent, Dose 2
    Reporting group description
    		 ANV419 administered by intravenous (IV) infusion

    Subject analysis set title
    ANV419 Single Agent, Dose 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The efficacy population included patients who receive at least 1 dose of study drug and have at least 1 post-baseline tumor assessment.

    Subject analysis set title
    ANV419 Single Agent, Dose 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The efficacy population included patients who receive at least 1 dose of study drug and have at least 1 post-baseline tumor assessment.

    Primary: Monotherapy Dose Expansion: Objective Response Rate (ORR) as Defined by RECIST v1.1

    		 Close Top of page
    End point title
    		 Monotherapy Dose Expansion: Objective Response Rate (ORR) as Defined by RECIST v1.1 [1]
    End point description
    Proportion of participants with a complete response (CR) or partial response (PR) to treatment as defined by RECIST v1.1 (ORR = CR + PR).
    End point type
    Primary
    End point timeframe
    Day 1 up to 12 months.
    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 patients achieved CR or PR.
    End point values
    		 ANV419 Single Agent, Dose 1 ANV419 Single Agent, Dose 2
    Number of subjects analysed
    14
    14
    Units: Count of Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Monotherapy Dose Expansion: Duration of Response (DOR) According to RECIST v1.1

    		 Close Top of page
    End point title
    		 Monotherapy Dose Expansion: Duration of Response (DOR) According to RECIST v1.1
    End point description
    Time from first time measurement criteria are met for complete response (CR) or (PR) until the progressive disease or death.
    End point type
    Secondary
    End point timeframe
    Day 1 up to 12 months.
    End point values
    		 ANV419 Single Agent, Dose 1 ANV419 Single Agent, Dose 2
    Number of subjects analysed
    14
    14
    Units: Count of Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Monotherapy Dose Expansion: Disease Control Rate (DCR) According to RECIST v1.1

    		 Close Top of page
    End point title
    		 Monotherapy Dose Expansion: Disease Control Rate (DCR) According to RECIST v1.1
    End point description
    Percentage of participants who have achieved Complete Response (CR), Partial Response (PR) and Stable Disease (SD).
    End point type
    Secondary
    End point timeframe
    Day 1 up to 12 months.
    End point values
    		 ANV419 Single Agent, Dose 1 ANV419 Single Agent, Dose 2
    Number of subjects analysed
    14
    14
    Units: Count of Participants
    5
    7
    No statistical analyses for this end point

    Secondary: Monotherapy Dose Expansion: Progression-free Survival (PFS) According to RECIST v1.1

    		 Close Top of page
    End point title
    		 Monotherapy Dose Expansion: Progression-free Survival (PFS) According to RECIST v1.1
    End point description
    Length of time participants lived with the disease without progressing (PD). The safety population is defined as all patients who receive at least 1 dose (or partial dose) of study drug(s).
    End point type
    Secondary
    End point timeframe
    Day 1 up to 12 months.
    End point values
    		 ANV419 Single Agent, Dose 1 ANV419 Single Agent, Dose 2
    Number of subjects analysed
    14
    15
    Units: Months
        median (full range (min-max))
    2.2 (1.8 to 2.6)
    2.4 (1.4 to 4.4)
    No statistical analyses for this end point

    Secondary: Monotherapy Dose Expansion: Overall Survival (OS) Rate

    		 Close Top of page
    End point title
    		 Monotherapy Dose Expansion: Overall Survival (OS) Rate
    End point description
    Proportion of participants who are alive at 6 months. This is an estimation based on Kaplan-Meier method. The Safety Population is defined as all patients who receive at least 1 dose (or partial dose) of study drug(s).
    End point type
    Secondary
    End point timeframe
    Day 1 up to 6 months
    End point values
    		 ANV419 Single Agent, Dose 1 ANV419 Single Agent, Dose 2
    Number of subjects analysed
    14
    15
    Units: Proportion of participants
        number (confidence interval 95%)
    0.8 (0.5 to 0.9)
    0.8 (0.5 to 0.9)
    No statistical analyses for this end point

    Secondary: Monotherapy Dose Expansion: Frequency of Treatment-Emergent Adverse Events (TEAEs)

    		 Close Top of page
    End point title
    		 Monotherapy Dose Expansion: Frequency of Treatment-Emergent Adverse Events (TEAEs)
    End point description
    Number of participants with TEAEs. The Safety Population is defined as all patients who receive at least 1 dose (or partial dose) of study drug(s).
    End point type
    Secondary
    End point timeframe
    Day 1 up to 13 months.
    End point values
    		 ANV419 Single Agent, Dose 1 ANV419 Single Agent, Dose 2
    Number of subjects analysed
    14
    15
    Units: Count of participants
    14
    15
    No statistical analyses for this end point

    Secondary: Monotherapy Dose Expansion: Severity of TEAEs

    		 Close Top of page
    End point title
    		 Monotherapy Dose Expansion: Severity of TEAEs
    End point description
    Number of participants with TEAEs Grade 3 or more. The Safety Population is defined as all patients who receive at least 1 dose (or partial dose) of study drug(s).
    End point type
    Secondary
    End point timeframe
    Day 1 up to 13 months
    End point values
    		 ANV419 Single Agent, Dose 1 ANV419 Single Agent, Dose 2
    Number of subjects analysed
    14
    15
    Units: Count of participants
    12
    13
    No statistical analyses for this end point

    Secondary: Monotherapy Dose Expansion: Prevalence of Specific Anti-ANV419 Antibodies (ADA) in Blood

    		 Close Top of page
    End point title
    		 Monotherapy Dose Expansion: Prevalence of Specific Anti-ANV419 Antibodies (ADA) in Blood
    End point description
    Number of patients with positive ADA at baseline and end of study. The Immunogenicity Population is defined as all patients who receive at least 1 dose of study drug and have at least 1 evaluable immunogenicity sample.
    End point type
    Secondary
    End point timeframe
    Day 1 up to end of study
    End point values
    		 ANV419 Single Agent, Dose 1 ANV419 Single Agent, Dose 2
    Number of subjects analysed
    14
    15
    Units: Count of participants
        Prevalence of ADA positive at baseline
    5
    5
        Prevalence of ADA positive at end of study
    12
    5
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    All AEs and SAEs were collected during the full study period from the signing of the ICF until the Safety Follow Up Visit (up to 90 days after last dose of study drug).
    Adverse event reporting additional description
    [Not specified]
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    ANV419 Single Agent, Dose 1
    Reporting group description
    		 -

    Reporting group title
    ANV419 Single Agent, Dose 2
    Reporting group description
    		 -

    Serious adverse events
    		 ANV419 Single Agent, Dose 1 ANV419 Single Agent, Dose 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 14 (71.43%)
    11 / 15 (73.33%)
         number of deaths (all causes)
    5
    5
         number of deaths resulting from adverse events
    0
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant melanoma
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 15 (13.33%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 5
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    General disorders and administration site conditions
    Condition aggravated
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Discomfort
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Influenza like illness
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    5 / 5
    1 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    6 / 14 (42.86%)
    3 / 15 (20.00%)
         occurrences causally related to treatment / all
    8 / 8
    5 / 5
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Respiratory, thoracic and mediastinal disorders
    Bronchial obstruction
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Hypoxia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Pleural effusion
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 14 (14.29%)
    2 / 15 (13.33%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 15 (13.33%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Blood bilirubin increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Sinus tachycardia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Nervous system disorders
    Dementia Alzheimer's type
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Blood and lymphatic system disorders
    Thrombocytopenic purpura
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Gastrointestinal disorders
    Fistula of small intestine
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Hepatobiliary disorders
    Jaundice cholestatic
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Musculoskeletal and connective tissue disorders
    Osteonecrosis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Infections and infestations
    Spinal cord infection
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 ANV419 Single Agent, Dose 1 ANV419 Single Agent, Dose 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 14 (100.00%)
    15 / 15 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Vascular disorders
    Capillary leak syndrome
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Flushing
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Hypotension
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    8 / 14 (57.14%)
    8 / 15 (53.33%)
         occurrences all number
    10
    12
    Chest pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Chills
         subjects affected / exposed
    3 / 14 (21.43%)
    3 / 15 (20.00%)
         occurrences all number
    6
    15
    Face oedema
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 15 (6.67%)
         occurrences all number
    4
    1
    General physical health deterioration
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Generalised oedema
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Influenza like illness
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Mucosal inflammation
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Oedema
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    4 / 14 (28.57%)
    2 / 15 (13.33%)
         occurrences all number
    4
    2
    Pain
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Pyrexia
         subjects affected / exposed
    5 / 14 (35.71%)
    8 / 15 (53.33%)
         occurrences all number
    13
    21
    Swelling face
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    7 / 14 (50.00%)
    8 / 15 (53.33%)
         occurrences all number
    16
    20
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Cough
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 15 (6.67%)
         occurrences all number
    4
    1
    Dysphonia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Dyspnoea
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Haemoptysis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Hypoxia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Interstitial lung disease
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Lung disorder
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Pleural effusion
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Productive cough
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Rhonchi
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Sneezing
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 15 (13.33%)
         occurrences all number
    1
    2
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 14 (28.57%)
    8 / 15 (53.33%)
         occurrences all number
    11
    18
    Amylase increased
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 14 (28.57%)
    8 / 15 (53.33%)
         occurrences all number
    8
    19
    Bilirubin conjugated increased
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Blood alkaline phosphatase decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    4 / 14 (28.57%)
    3 / 15 (20.00%)
         occurrences all number
    4
    4
    Blood bilirubin increased
         subjects affected / exposed
    3 / 14 (21.43%)
    4 / 15 (26.67%)
         occurrences all number
    4
    7
    Blood calcium decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Blood chloride decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 14 (7.14%)
    5 / 15 (33.33%)
         occurrences all number
    1
    5
    Blood fibrinogen decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    2 / 14 (14.29%)
    3 / 15 (20.00%)
         occurrences all number
    2
    3
    Blood phosphorus decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Blood triglycerides increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    3
    Blood urea increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Blood uric acid increased
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    C-reactive protein increased
         subjects affected / exposed
    2 / 14 (14.29%)
    6 / 15 (40.00%)
         occurrences all number
    4
    8
    Fibrin D dimer increased
         subjects affected / exposed
    1 / 14 (7.14%)
    5 / 15 (33.33%)
         occurrences all number
    1
    8
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    4 / 14 (28.57%)
    5 / 15 (33.33%)
         occurrences all number
    6
    17
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Lipase increased
         subjects affected / exposed
    2 / 14 (14.29%)
    2 / 15 (13.33%)
         occurrences all number
    4
    7
    Haematocrit decreased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    Lymphocyte count increased
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 15 (20.00%)
         occurrences all number
    0
    4
    Neutrophil count increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Platelet count decreased
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 15 (13.33%)
         occurrences all number
    1
    2
    Platelet count increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Protein total decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    5
    Protein urine present
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    4
    Prothrombin level decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Red blood cell count decreased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Transaminases increased
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    4
    0
    Troponin T increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Troponin increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Urine protein/creatinine ratio increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    4
    Weight decreased
         subjects affected / exposed
    3 / 14 (21.43%)
    0 / 15 (0.00%)
         occurrences all number
    4
    0
    Weight increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    White blood cell count increased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Fall
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Infusion related reaction
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 15 (13.33%)
         occurrences all number
    2
    3
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Sinus tachycardia
         subjects affected / exposed
    1 / 14 (7.14%)
    3 / 15 (20.00%)
         occurrences all number
    2
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Dysgeusia
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    1
    3
    Headache
         subjects affected / exposed
    2 / 14 (14.29%)
    2 / 15 (13.33%)
         occurrences all number
    4
    5
    Neuralgia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Paraesthesia
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 14 (21.43%)
    7 / 15 (46.67%)
         occurrences all number
    4
    17
    Coagulopathy
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Leukocytosis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    3
    Lymphadenopathy
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Lymphocytosis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    10
    Lymphopenia
         subjects affected / exposed
    1 / 14 (7.14%)
    6 / 15 (40.00%)
         occurrences all number
    1
    16
    Neutropenia
         subjects affected / exposed
    3 / 14 (21.43%)
    2 / 15 (13.33%)
         occurrences all number
    3
    4
    Neutrophilia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    1 / 14 (7.14%)
    3 / 15 (20.00%)
         occurrences all number
    1
    3
    Eye disorders
    Blindness unilateral
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Abdominal pain lower
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Colitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 15 (6.67%)
         occurrences all number
    3
    2
    Diarrhoea
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Dry mouth
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    3
    Gastritis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    2 / 14 (14.29%)
    9 / 15 (60.00%)
         occurrences all number
    9
    20
    Paraesthesia oral
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Post-tussive vomiting
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Toothache
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Vomiting
         subjects affected / exposed
    2 / 14 (14.29%)
    5 / 15 (33.33%)
         occurrences all number
    3
    23
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Hepatic cytolysis
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 15 (13.33%)
         occurrences all number
    1
    2
    Hyperbilirubinaemia
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Dermatitis psoriasiform
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Eczema
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Erythema
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Granuloma skin
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    1
    3
    Pruritus
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    2 / 14 (14.29%)
    2 / 15 (13.33%)
         occurrences all number
    2
    3
    Rash erythematous
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Rash macular
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Rash maculo-papular
         subjects affected / exposed
    0 / 14 (0.00%)
    4 / 15 (26.67%)
         occurrences all number
    0
    5
    Rash papular
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Rash pruritic
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Urticaria
         subjects affected / exposed
    2 / 14 (14.29%)
    2 / 15 (13.33%)
         occurrences all number
    3
    3
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 14 (14.29%)
    2 / 15 (13.33%)
         occurrences all number
    3
    2
    Chromaturia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Haematuria
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 15 (6.67%)
         occurrences all number
    2
    2
    Polyuria
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Proteinuria
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    8
    Vitiligo
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Bone pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Groin pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Joint swelling
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Muscular weakness
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    Myalgia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 15 (13.33%)
         occurrences all number
    2
    2
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Erysipelas
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Fungal infection
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Herpes zoster
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Sepsis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
    3 / 15 (20.00%)
         occurrences all number
    1
    4
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    Vascular device infection
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 14 (7.14%)
    3 / 15 (20.00%)
         occurrences all number
    3
    6
    Dehydration
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Hyperchloraemia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Hyperferritinaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 15 (13.33%)
         occurrences all number
    1
    6
    Hypocalcaemia
         subjects affected / exposed
    1 / 14 (7.14%)
    3 / 15 (20.00%)
         occurrences all number
    1
    5
    Hypokalaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    3
    Hypomagnesaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    3
    Hyponatraemia
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 15 (13.33%)
         occurrences all number
    1
    3
    Hypophagia
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Hypophosphataemia
         subjects affected / exposed
    1 / 14 (7.14%)
    4 / 15 (26.67%)
         occurrences all number
    1
    4
    Polydipsia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         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
    23 May 2022
    Global amendment, protocol version 2.0
    26 Jul 2022
    Country-specific amendment in Germany. Protocol version 2.1.
    28 Jul 2022
    Global amendment, protocol version 3.0.
    28 Jul 2022
    Country-specific amendment in France. Protocol version 2.1.
    12 Sep 2022
    Country-specific amendment in Germany. Protocol version 3.1.
    07 Mar 2023
    Global amendment, protocol version 4.0.
    07 Mar 2023
    Country-specific amendment in Germany. Protocol version 4.1.
    28 Apr 2023
    Country-specific amendment in France. Protocol version 4.1.

    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-Thu Sep 04 06:43:41 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA