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    Clinical Trial Results:
    A Phase 2, Randomized, Double-blinded, Placebo-controlled, 5 Parallel-group Study of BMS-986166 or Branebrutinib for the Treatment of Patients with Moderate to Severe Atopic Dermatitis

    Summary
    EudraCT number
    		 2020-004767-77
    Trial protocol
    		 ES   DE   PL  
    Global end of trial date
    22 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Sep 2023
    First version publication date
    07 Sep 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IM018-005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05014438
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.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
    12 Dec 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Aug 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of BMS-986166 and of branebrutinib, each versus placebo at Week 16 in patients with moderate-to-severe AD.
    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 Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Aug 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    17
    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)
    17
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 17 participants randomized and treated

    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, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    POQD

    Arm title
    		 Treatment 1
    Arm description
    		 BMS-986166 0.25mg POQD
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986166
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0.25mg/0.25mg POQD

    Arm title
    		 Treatment 2
    Arm description
    		 BMS-986166 0.5mg POQD
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986166
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0.25mg/0.50mg POQD

    Arm title
    		 Treatment 3
    Arm description
    		 BMS-986166 0.75mg POQD
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986166
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0.25mg/0.75mg POQD

    Arm title
    		 Treatment 4
    Arm description
    		 Branebrutinib 9mg POQD
    Arm type
    		 Experimental

    Investigational medicinal product name
    Branebrutinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3mg/9mg POQD

    Number of subjects in period 1
    		Placebo Treatment 1 Treatment 2 Treatment 3 Treatment 4
    Started
    4
    3
    4
    3
    3
    Completed
    3
    3
    3
    1
    3
    Not completed
    1
    0
    1
    2
    0
         Discontinued Study
    1
    -
    1
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    Treatment 1
    Reporting group description
    		 BMS-986166 0.25mg POQD

    Reporting group title
    Treatment 2
    Reporting group description
    		 BMS-986166 0.5mg POQD

    Reporting group title
    Treatment 3
    Reporting group description
    		 BMS-986166 0.75mg POQD

    Reporting group title
    Treatment 4
    Reporting group description
    		 Branebrutinib 9mg POQD

    Reporting group values
    		 Placebo Treatment 1 Treatment 2 Treatment 3 Treatment 4 Total
    Number of subjects
    		 4 3 4 3 3 17
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 4 3 4 3 3 17
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 30.5 ± 11.3 36.0 ± 6.2 29.5 ± 14.6 46.7 ± 8.3 36.7 ± 17.8 -
    Sex: Female, Male
    Units:
        Female
    		 3 1 3 2 2 11
        Male
    		 1 2 1 1 1 6
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0
        Asian
    		 0 0 1 0 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0
        Black or African American
    		 0 0 1 0 0 1
        White
    		 3 3 2 3 3 14
        More than one race
    		 0 0 0 0 0 0
        Unknown or Not Reported
    		 1 0 0 0 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 0 0 1 1 4
        Not Hispanic or Latino
    		 2 3 3 2 2 12
        Unknown or Not Reported
    		 0 0 1 0 0 1

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    Treatment 1
    Reporting group description
    		 BMS-986166 0.25mg POQD

    Reporting group title
    Treatment 2
    Reporting group description
    		 BMS-986166 0.5mg POQD

    Reporting group title
    Treatment 3
    Reporting group description
    		 BMS-986166 0.75mg POQD

    Reporting group title
    Treatment 4
    Reporting group description
    		 Branebrutinib 9mg POQD

    Primary: Mean Percentage change from baseline in EASI Score at week 16

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    End point title
    		 Mean Percentage change from baseline in EASI Score at week 16 [1]
    End point description
    The Eczema Area and Severity Index (EASI) is a validated, composite scoring system assessed by the investigator based on the extent of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD and the intensity of each of 4 key signs of AD (erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). For each of the 4 body regions, the mean intensity of inflamed lesions for each of the 4 signs is recorded. Xerosis, scaling, urticaria, or post-inflammatory pigmentation changes are not included. The total EASI score ranges from 0 to 72. The lower the score the better. Here "99999" means NA
    End point type
    Primary
    End point timeframe
    From baseline to 16 weeks
    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 analysis done for this endpoint
    End point values
    		 Placebo Treatment 1 Treatment 2 Treatment 3 Treatment 4
    Number of subjects analysed
    1
    0 [2]
    0 [3]
    0 [4]
    1
    Units: Percentage
        arithmetic mean (standard deviation)
    -83.1 ± 99999
    ±
    ±
    ±
    -92.3 ± 99999
    Notes
    [2] - No participants analyzed
    [3] - No participants analyzed
    [4] - No participants analyzed
    No statistical analyses for this end point

    Secondary: Percentage of participants exhibiting a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (cleared) or 1 (almost cleared) AND a ≥ 2 point reduction from baseline at Week 16

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    End point title
    		 Percentage of participants exhibiting a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (cleared) or 1 (almost cleared) AND a ≥ 2 point reduction from baseline at Week 16
    End point description
    The vIGA-AD is a static 5-point assessment intended to assess the global severities of key acute clinical signs of AD, including erythema, induration/papulation, and oozing/crusting (lichenification excluded). The rating of cleared (0), almost cleared (1), mild (2), moderate (3), and severe (4) will be assessed.
    End point type
    Secondary
    End point timeframe
    From baseline to 16 weeks
    End point values
    		 Placebo Treatment 1 Treatment 2 Treatment 3 Treatment 4
    Number of subjects analysed
    4
    3
    4
    3
    3
    Units: Percentage of participants
        number (confidence interval 95%)
    0 (0.0 to 60.2)
    0 (0.0 to 70.8)
    0 (0.0 to 60.2)
    0 (0.0 to 70.8)
    0 (0.0 to 70.8)
    No statistical analyses for this end point

    Secondary: Percentage of participants exhibiting a ≥ 4-point improvement from baseline in Pruritus NRS at Week 16

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    End point title
    		 Percentage of participants exhibiting a ≥ 4-point improvement from baseline in Pruritus NRS at Week 16
    End point description
    Participants will complete a daily diary recording the intensity of their pruritus and the average quality of sleep they experienced during the preceding 24 hours. The intensity of pruritus will be assessed using a validated 11-point NRS, ranging from 0 (“no itching”) to 10 (“the worst itching imaginable”). The quality of sleep will be assessed using a validated 11-point NRS ranging from 0 (“the best possible sleep”) to 10 (“the worst possible sleep). The lower the score the better.
    End point type
    Secondary
    End point timeframe
    Frome baseline to 16 weeks
    End point values
    		 Placebo Treatment 1 Treatment 2 Treatment 3 Treatment 4
    Number of subjects analysed
    4
    3
    2
    2
    2
    Units: Percentage of participants
        number (confidence interval 95%)
    25.0 (0.6 to 80.6)
    0 (0.0 to 70.8)
    0 (0.0 to 84.2)
    50 (1.3 to 98.7)
    50 (1.3 to 98.7)
    No statistical analyses for this end point

    Secondary: Percentage of participants exhibiting a ≥ 50% (EASI-50) reduction from baseline in EASI score at Week 16

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    End point title
    		 Percentage of participants exhibiting a ≥ 50% (EASI-50) reduction from baseline in EASI score at Week 16
    End point description
    The Eczema Area and Severity Index (EASI) is a validated, composite scoring system assessed by the investigator based on the extent of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD and the intensity of each of 4 key signs of AD (erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). For each of the 4 body regions, the mean intensity of inflamed lesions for each of the 4 signs is recorded. Xerosis, scaling, urticaria, or post-inflammatory pigmentation changes are not included. The total EASI score ranges from 0 to 72. The lower the score the better.
    End point type
    Secondary
    End point timeframe
    Frome baseline to 16 weeks
    End point values
    		 Placebo Treatment 1 Treatment 2 Treatment 3 Treatment 4
    Number of subjects analysed
    4
    3
    4
    3
    3
    Units: Percentage of participants
        number (confidence interval 95%)
    25 (0.6 to 80.6)
    0 (0.0 to 70.8)
    0 (0.0 to 60.2)
    0 (0.0 to 70.8)
    33.3 (0.8 to 90.6)
    No statistical analyses for this end point

    Secondary: Mean Percentage change from baseline in Pruritus NRS score at Week 16

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    End point title
    		 Mean Percentage change from baseline in Pruritus NRS score at Week 16
    End point description
    Participants will complete a daily diary recording the intensity of their pruritus and the average quality of sleep they experienced during the preceding 24 hours. The intensity of pruritus will be assessed using a validated 11-point NRS, ranging from 0 (“no itching”) to 10 (“the worst itching imaginable”). The quality of sleep will be assessed using a validated 11-point NRS ranging from 0 (“the best possible sleep”) to 10 (“the worst possible sleep). The lower the score the better. Here "99999" means NA
    End point type
    Secondary
    End point timeframe
    Frome baseline to 16 weeks
    End point values
    		 Placebo Treatment 1 Treatment 2 Treatment 3 Treatment 4
    Number of subjects analysed
    1
    0 [5]
    0 [6]
    1
    1
    Units: Percentage
        arithmetic mean (standard deviation)
    -89.6 ± 99999
    ±
    ±
    -100 ± 99999
    -86.8 ± 99999
    Notes
    [5] - No participants analyzed
    [6] - No participants analyzed
    No statistical analyses for this end point

    Secondary: Mean change from baseline in percentage of affected BSA at Week 16

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    End point title
    		 Mean change from baseline in percentage of affected BSA at Week 16
    End point description
    A widely used method of measuring Body Surface Area (BSA) involvement by AD, is the rule of nines in which for each section of the body (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], genitals [1%]) and will be reported as a percentage of all major body sections combined. Here "99999" means NA
    End point type
    Secondary
    End point timeframe
    Frome baseline to 16 weeks
    End point values
    		 Placebo Treatment 1 Treatment 2 Treatment 3 Treatment 4
    Number of subjects analysed
    1
    0 [7]
    0 [8]
    0 [9]
    1
    Units: Percentage
        arithmetic mean (standard deviation)
    -17.00 ± 99999
    ±
    ±
    ±
    -12.10 ± 99999
    Notes
    [7] - No participants analyzed
    [8] - No participants analyzed
    [9] - No participants analyzed
    No statistical analyses for this end point

    Secondary: Number of participants with mild moderate or severe AEs

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    End point title
    		 Number of participants with mild moderate or severe AEs
    End point description
    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. Mild: An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that causes sufficient discomfort and interferes with normal everyday activities. Severe: An event that prevents normal everyday activities. An AE that is assessed as severe should not be confused with an SAE. Severe is a category utilized for rating the intensity of an event, and both AEs and SAEs can be assessed as severe.
    End point type
    Secondary
    End point timeframe
    From initial treatment to 30 days post discontinuation, approximately 29 weeks
    End point values
    		 Placebo Treatment 1 Treatment 2 Treatment 3 Treatment 4
    Number of subjects analysed
    4
    3
    4
    3
    3
    Units: Participants
        Mild
    1
    2
    1
    1
    1
        Moderate
    1
    3
    1
    1
    0
        Severe
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with mild moderate or severe SAEs

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    End point title
    		 Number of participants with mild moderate or severe SAEs
    End point description
    A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: -Results in death -is life threatening -Requires inpatient hospitalization or causes prolongation of existing hospitalization -Results in persistent or significant disability -Is a congenital anomaly/birth defect. -Is an important medical event
    End point type
    Secondary
    End point timeframe
    From initial treatment to 30 days post discontinuation, approximately 29 weeks
    End point values
    		 Placebo Treatment 1 Treatment 2 Treatment 3 Treatment 4
    Number of subjects analysed
    4
    3
    4
    3
    3
    Units: Participants
        Mild
    0
    0
    0
    0
    0
        Moderate
    0
    1
    0
    0
    0
        Severe
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with clinically relevant ECG abnormalities

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    End point title
    		 Number of participants with clinically relevant ECG abnormalities
    End point description
    12 Lead Electrocardiogram (ECG). The participant will remain supine for 5 to 10 minutes prior to the ECG and must have lab work done after the tracing so that the ECG results remain as accurate as possible.
    End point type
    Secondary
    End point timeframe
    Week 24 after initial treatment
    End point values
    		 Placebo Treatment 1 Treatment 2 Treatment 3 Treatment 4
    Number of subjects analysed
    4
    3
    4
    3
    3
    Units: Participants
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with clinically relevant OCT abnormalities

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    End point title
    		 Number of participants with clinically relevant OCT abnormalities
    End point description
    Optical coherence tomography (OCT) is a non-invasive imaging test. It uses light waves to take cross-section pictures of your retina. Diagnosis is made by an ophthalmologist.
    End point type
    Secondary
    End point timeframe
    Week 24 after initial treatment
    End point values
    		 Placebo Treatment 1 Treatment 2 Treatment 3 Treatment 4
    Number of subjects analysed
    4
    3
    4
    3
    3
    Units: Participants
    0
    0
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with clinically relevant PFT abnormalities

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    End point title
    		 Number of participants with clinically relevant PFT abnormalities
    End point description
    Pulmonary function tests (PFT) include: forced expiratory volume (FEV1), percent predicted FEV1, forced vital capacity (FVC), percent predicted FVC, and Diffusion capacity of carbon monoxide (DLCO).
    End point type
    Secondary
    End point timeframe
    Week 24 after initial treatment
    End point values
    		 Placebo Treatment 1 Treatment 2 Treatment 3 Treatment 4
    Number of subjects analysed
    4
    3
    4
    3
    3
    Units: Participants
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with clinically meaningful changes in vital signs

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    End point title
    		 Number of participants with clinically meaningful changes in vital signs
    End point description
    The following vital signs will be assessed: systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and body temperature.
    End point type
    Secondary
    End point timeframe
    Week 24 after initial treatment
    End point values
    		 Placebo Treatment 1 Treatment 2 Treatment 3 Treatment 4
    Number of subjects analysed
    4
    3
    4
    3
    3
    Units: Participants
        Respiratory Rate
    2
    1
    2
    3
    3
        Heart Rate
    0
    0
    0
    0
    0
        Diastolic Blood Pressure
    0
    0
    0
    0
    0
        Systolic Blood Pressure
    0
    0
    0
    0
    0
        Body Temperature
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with clinically relevant changes in LFTs

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    End point title
    		 Number of participants with clinically relevant changes in LFTs
    End point description
    Liver Function Tests (LFTs) will include the following measurements: -ALT OR AST > 3 X ULN -ALT OR AST > 5 X ULN -ALT OR AST > 8 X ULN -TOTAL BILIRUBIN > 2 X ULN -ALT OR AST > 3 X ULN AND (TOTAL BILIRUBIN > 2 X ULN OR INR >1.5) (labeled as "Assessment 5") -ALT OR AST > 5 X ULN WITH CONFIRMATION, WITHIN 2 WEEKS (labeled as "Assessment 6") AST = aspartate aminotransferase ALT = alanine aminotransferase ULN = Upper limit number INR = International Normalized Ratio
    End point type
    Secondary
    End point timeframe
    Week 24 after initial treatment
    End point values
    		 Placebo Treatment 1 Treatment 2 Treatment 3 Treatment 4
    Number of subjects analysed
    4
    3
    4
    3
    3
    Units: Participants
        ALT OR AST > 3 X ULN
    0
    0
    0
    0
    0
        ALT OR AST > 5 X ULN
    0
    0
    0
    0
    0
        ALT OR AST > 8 X ULN
    0
    0
    0
    0
    0
        TOTAL BILIRUBIN > 2 X ULN
    0
    0
    0
    0
    0
        Assessment 5
    0
    0
    0
    0
    0
        Assessment 6
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events and Serious Adverse Events: (From first dose to last dose + 8 weeks follow up): Approximately 24 Weeks All-Cause mortality (From randomization to end of study): Approximately 29 Weeks
    Adverse event reporting additional description
    The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    Treatment 1
    Reporting group description
    		 BMS-986166 0.25mg POQD

    Reporting group title
    Treatment 2
    Reporting group description
    		 BMS-986166 0.5mg POQD

    Reporting group title
    Treatment 3
    Reporting group description
    		 BMS-986166 0.75mg POQD

    Reporting group title
    Treatment 4
    Reporting group description
    		 Branebrutinib 9mg POQD

    Serious adverse events
    		 Placebo Treatment 1 Treatment 2 Treatment 3 Treatment 4
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Eczema herpeticum
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Treatment 1 Treatment 2 Treatment 3 Treatment 4
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 4 (50.00%)
    3 / 3 (100.00%)
    2 / 4 (50.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Nodule
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Eye disorders
    Macular degeneration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Visual impairment
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Skin mass
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Infections and infestations
    Furuncle
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Skin bacterial infection
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Hyperuricaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jun 2021
    The purpose of this amendment is to incorporate comments from the United States Food and Drug Administration (FDA) and to provide guidance on how to manage the increasing availability of coronavirus disease 2019 (COVID-19) vaccines and their impact on screening and the conduct of the study. This amendment also provides updated branebrutinib clinical pharmacology drug-drug interaction (DDI) data. The EudraCT and UTN regulatory agency identifier numbers were also added to the title page.

    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.

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