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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled, Multicenter Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants with Sickle Cell Disease and Recurrent Vaso-occlusive Crises

    Summary
    EudraCT number
    		 2020-005287-60
    Trial protocol
    		 DE   IT  
    Global end of trial date
    24 Nov 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jun 2024
    First version publication date
    13 Jun 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GBT2104-132 (C5361002)
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04927247
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer ClinicalTrials.gov Call Center
    Sponsor organisation address
    235E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquires@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.govCall Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquires@pfizer.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Mar 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Nov 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Nov 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the safety and efficacy of a single dose of inclacumab compared to placebo to reduce the incidence of re-admissions to a healthcare facility for a vaso-occlusive crisis (VOC) after an index VOC in participants with sickle cell disease (SCD).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Dec 2021
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety, Efficacy, Safety
    Long term follow-up duration
    		 5 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 10
    Country: Number of subjects enrolled
    Colombia: 3
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Kenya: 17
    Country: Number of subjects enrolled
    Lebanon: 7
    Country: Number of subjects enrolled
    Nigeria: 29
    Country: Number of subjects enrolled
    Oman: 1
    Country: Number of subjects enrolled
    Türkiye: 4
    Worldwide total number of subjects
    72
    EEA total number of subjects
    1
    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)
    9
    Adults (18-64 years)
    63
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In this study, participants with SCD, aged greater than or equal to (>=) 12 years were randomised to receive either inclacumab or placebo for reducing the frequency of re-admissions due to VOC after an index VOC.

    Pre-assignment
    Screening details
    		 A total of 72 participants were enrolled and randomised in the study.

    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
    		 Investigator, Carer, Subject, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants were administered with placebo intravenous (IV) infusion on Day 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received placebo IV infusion on Day 1.

    Arm title
    		 Inclacumab 30 mg/kg
    Arm description
    		 Participants were administered with inclacumab 30 milligram per kilogram (mg/kg) IV infusion on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Inclacumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received inclacumab 30 mg/kg IV infusion on Day 1.

    Number of subjects in period 1
    		Placebo Inclacumab 30 mg/kg
    Started
    35
    37
    Completed
    33
    34
    Not completed
    2
    3
         Adverse event, serious fatal
    -
    1
         Physician decision
    1
    -
         Other
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were administered with placebo intravenous (IV) infusion on Day 1.

    Reporting group title
    Inclacumab 30 mg/kg
    Reporting group description
    		 Participants were administered with inclacumab 30 milligram per kilogram (mg/kg) IV infusion on Day 1.

    Reporting group values
    		 Placebo Inclacumab 30 mg/kg Total
    Number of subjects
    		 35 37 72
    Age Categorical
    Units: Participants
        Adolescents (12-17 years)
    		 3 6 9
        Adults (18-64 years)
    		 32 31 63
    Gender Categorical
    Units: Participants
        Female
    		 17 22 39
        Male
    		 18 15 33
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 2 3 5
        Not Hispanic or Latino
    		 33 33 66
        Not Reported
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were administered with placebo intravenous (IV) infusion on Day 1.

    Reporting group title
    Inclacumab 30 mg/kg
    Reporting group description
    		 Participants were administered with inclacumab 30 milligram per kilogram (mg/kg) IV infusion on Day 1.

    Primary: Percentage of Participants With at Least 1 VOC That Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication Within 90 Days of Randomisation

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    End point title
    		 Percentage of Participants With at Least 1 VOC That Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication Within 90 Days of Randomisation
    End point description
    An admission for a VOC included a hospital admission, or an admission to an emergency room, observation unit, or infusion center for >/= 12 hours, or 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period. An acute episode of pain with no other cause other than a vaso-occlusive event included: uncomplicated VOC, acute chest syndrome, hepatic sequestration, splenic sequestration, or priapism. All on-study VOCs were adjudicated by an independent, blinded VOC Adjudication Committee comprised of experts in SCD. The intent-to-treat (ITT) population included all randomised participants. Participants without an observed VOC who discontinued the study prior to Day 91 were assumed to have experienced at least one VOC.
    End point type
    Primary
    End point timeframe
    From Day 1 through Day 91
    End point values
    		 Placebo Inclacumab 30 mg/kg
    Number of subjects analysed
    35
    37
    Units: Percentage of participants
        number (confidence interval 95%)
    37.5 (20.7 to 54.3)
    45.4 (28.7 to 62.2)
    Statistical analysis title
    		 Inclacumab 30mg/kg vs. Placebo
    Comparison groups
    Inclacumab 30 mg/kg v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6302
    Method
    		 Exact Cochran-Mantel-Haenszel test
    Parameter type
    		 Difference in percentage
    Point estimate
    7.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.8
         upper limit
    		 31.7

    Secondary: Time to First VOC That Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication Within 90 Days of Randomisation

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    End point title
    		 Time to First VOC That Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication Within 90 Days of Randomisation
    End point description
    Time to first VOC that required admission to a healthcare facility and treatment with parenteral pain medication within 90 days was defined as the time between randomisation date and onset date of first VOC event. For participants who did not experience a protocol-defined VOC within 90 days of randomization, time to first VOC was censored at the end of their time at risk (participant’s end of study date or Study Day 91, whichever was earlier). An admission for a VOC included a hospital admission, or an admission to an emergency room, observation unit, or infusion center for >/= 12 hours, or 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period. All on-study VOCs were adjudicated by an independent, blinded VOC Adjudication Committee comprised of experts in SCD. ITT population evaluated. Here '99999' and '-99999' indicates that data could not be estimated due to insufficient number of participants with event. Kaplan-Meier method used for analysis.
    End point type
    Secondary
    End point timeframe
    Day 1 through Day 91
    End point values
    		 Placebo Inclacumab 30 mg/kg
    Number of subjects analysed
    35
    37
    Units: Days
        median (confidence interval 95%)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    Statistical analysis title
    		 Inclacumab 30mg/kg vs. Placebo
    Comparison groups
    Inclacumab 30 mg/kg v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9382
    Method
    		 Stratified log-rank test
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 2.16

    Secondary: Percentage of Participants With at Least 1 VOC That Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication Within 30 Days of Randomisation

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    End point title
    		 Percentage of Participants With at Least 1 VOC That Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication Within 30 Days of Randomisation
    End point description
    An admission for a VOC included a hospital admission, or an admission to an emergency room, observation unit, or infusion center for >/= 12 hours, or 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period. An acute episode of pain with no other cause other than a vaso-occlusive event included: uncomplicated VOC, acute chest syndrome, hepatic sequestration, splenic sequestration, or priapism. All on-study VOCs were adjudicated by an independent, blinded VOC Adjudication Committee comprised of experts in SCD. The ITT population included all randomised participants. Participants without an observed VOC who discontinued the study prior to Day 31 were assumed to have experienced at least one VOC.
    End point type
    Secondary
    End point timeframe
    Day 1 through Day 31
    End point values
    		 Placebo Inclacumab 30 mg/kg
    Number of subjects analysed
    35
    37
    Units: Percentage of participants
        number (confidence interval 95%)
    25.0 (9.6 to 40.4)
    8.2 (0.0 to 17.3)
    Statistical analysis title
    		 Inclacumab 30 mg/kg vs. Placebo
    Comparison groups
    Inclacumab 30 mg/kg v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1143
    Method
    		 Exact Cochran-Mantel-Haenszel test
    Parameter type
    		 Difference in percentage
    Point estimate
    -16.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -34.4
         upper limit
    		 0.8

    Secondary: Rate of VOCs Leading to a Healthcare Visit That Requires Parenteral Pain Medication or an Increase in Treatment With Oral Narcotics Within 90 Days Following Randomisation

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    End point title
    		 Rate of VOCs Leading to a Healthcare Visit That Requires Parenteral Pain Medication or an Increase in Treatment With Oral Narcotics Within 90 Days Following Randomisation
    End point description
    VOC was defined as: VOC leading to a healthcare visit (hospital, emergency room, clinic visit, or remote contact with a healthcare provider) that required parenteral pain medication (eg,parenteral narcotic agents or parenteral nonsteroidal anti-inflammatory drugs [NSAIDs]),or an increased treatment with oral narcotics.Complicated VOCs included acute chest syndrome (ACS),hepatic sequestration, splenic sequestration, and priapism. For each participant, the time period at risk for evaluation of VOCs was from date of randomisation to the participant’s end of study date or Study Day 91, whichever was earlier. In this endpoint adjusted rates of VOCs (percentages) reported were based on estimate from a negative binomial model with the independent variable of treatment group (inclacumab, placebo) and adjusted for baseline hydroxyurea use (yes, no). All on-study VOCs were adjudicated by an independent, blinded VOC Adjudication Committee comprised of experts in SCD. ITT population evaluated.
    End point type
    Secondary
    End point timeframe
    Day 1 through Day 91
    End point values
    		 Placebo Inclacumab 30 mg/kg
    Number of subjects analysed
    35
    37
    Units: Percentage of VOCs
        number (confidence interval 95%)
    0.76 (0.51 to 1.14)
    0.83 (0.57 to 1.21)
    Statistical analysis title
    		 Inclacumab 30 mg/kg vs. Placebo
    Comparison groups
    Inclacumab 30 mg/kg v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7549
    Method
    		 Negative binomial model
    Parameter type
    		 Rate ratio
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.89

    Other pre-specified: Number of Participants With Treatment-Emergent Adverse Events (TEAEs).

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    End point title
    		 Number of Participants With Treatment-Emergent Adverse Events (TEAEs).
    End point description
    An adverse event (AE) was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. A TEAE was defined as an adverse event with an onset after the initiation of dosing for the first dose of study drug. Safety population included randomised participants who received treatment with study drug.
    End point type
    Other pre-specified
    End point timeframe
    Day 1 through Day 161
    End point values
    		 Placebo Inclacumab 30 mg/kg
    Number of subjects analysed
    33
    36
    Units: Participants
    11
    21
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 through Day 161
    Adverse event reporting additional description
    Safety population included randomised participants who received treatment with study drug.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were administered with placebo intravenous (IV) infusion on Day 1.

    Reporting group title
    Inclacumab 30 mg/kg
    Reporting group description
    		 Participants were administered with inclacumab 30 milligram per kilogram (mg/kg) IV infusion on Day 1.

    Serious adverse events
    		 Placebo Inclacumab 30 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 33 (3.03%)
    4 / 36 (11.11%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    1
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Haemothorax
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Malaria
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         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: 0%
    Non-serious adverse events
    		 Placebo Inclacumab 30 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 33 (33.33%)
    20 / 36 (55.56%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Peripheral swelling
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Hypothermia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Chest pain
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Menstruation irregular
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    2
    Nervous system disorders
    Presyncope
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    1 / 33 (3.03%)
    4 / 36 (11.11%)
         occurrences all number
    1
    5
    Dizziness
         subjects affected / exposed
    1 / 33 (3.03%)
    2 / 36 (5.56%)
         occurrences all number
    1
    2
    Blood and lymphatic system disorders
    Sickle cell anaemia with crisis
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    3
    Leukocytosis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Splenomegaly
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear disorder
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Odynophagia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Spinal pain
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    2 / 33 (6.06%)
    1 / 36 (2.78%)
         occurrences all number
    3
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Bone pain
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Osteonecrosis
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Arthralgia
         subjects affected / exposed
    1 / 33 (3.03%)
    2 / 36 (5.56%)
         occurrences all number
    2
    3
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Cellulitis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 33 (6.06%)
    2 / 36 (5.56%)
         occurrences all number
    2
    3
    Malaria
         subjects affected / exposed
    3 / 33 (9.09%)
    5 / 36 (13.89%)
         occurrences all number
    3
    6
    Gastroenteritis viral
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Acarodermatitis
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Sexually transmitted disease
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Rhinovirus infection
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Oral candidiasis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Mar 2021
    Change in duration for contraception after completion of dosing from 90 days to at least 165 days to prevent pregnancies in female participants and female partners of male participants for approx. 5 half-lives of inclacumab.
    17 Feb 2022
    Clarified rules for management of infusion related reactions or hypersensitivity reactions Grade 3 or higher during administration from rule allowing pause with potential reinitiation of infusion to rule to discontinue without further treatment on study.

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

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