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    Clinical Trial Results:
    A randomized patient-and-physician blinded, placebo-controlled, 24-week study to assess the safety, tolerability and efficacy of LMB763 in patients with diabetic nephropathy

    Summary
    EudraCT number
    		 2018-002491-40
    Trial protocol
    		 DE  
    Global end of trial date
    03 May 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 May 2022
    First version publication date
    13 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLMB763X2202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03804879
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharmaceuticals AG, 41 + 1 862 778 8300, Novartis.email@Novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharmaceuticals AG, 41 + 1 862 778 8300, Novartis.email@Novartis.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
    03 May 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the effect of nidufexor to placebo on albuminuria in patients with diabetic nephropathy already receiving treatment with ACEI or ARB. To assess the safety and tolerability of nidufexor.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Dec 2018
    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
    Argentina: 24
    Country: Number of subjects enrolled
    Czechia: 3
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Jordan: 10
    Country: Number of subjects enrolled
    Lebanon: 5
    Country: Number of subjects enrolled
    Turkey: 22
    Country: Number of subjects enrolled
    United States: 13
    Worldwide total number of subjects
    83
    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)
    50
    From 65 to 84 years
    33
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from 18 sites in 7 countries

    Pre-assignment
    Screening details
    		 Participants underwent a Screening period of up to 30 days which included screening and baseline assessments

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LMB763
    Arm description
    		 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nidufexor
    Investigational medicinal product code
    LMB763
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.

    Arm title
    		 Placebo
    Arm description
    		 Placebo was orally administered once daily for 24 weeks in addition to SoC.
    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
    Placebo was orally administered once daily for 24 weeks in addition to SoC.

    Number of subjects in period 1
    		LMB763 Placebo
    Started
    41
    42
    Pharmacokinetics (PK) analysis set
    41
    0 [1]
    Pharmacodynamics (PD) analysis set
    41
    41
    Completed
    25
    29
    Not completed
    16
    13
         Consent withdrawn by subject
    3
    1
         Adverse event, non-fatal
    3
    -
         Study Terminated By Sponsor
    10
    12
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Correct, for that analysis set placebo group is not entered

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LMB763
    Reporting group description
    		 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo was orally administered once daily for 24 weeks in addition to SoC.

    Reporting group values
    		 LMB763 Placebo Total
    Number of subjects
    		 41 42 83
    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)
    		 26 24 50
        From 65-84 years
    		 15 18 33
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 60.8 ( 8.95 ) 61.6 ( 8.36 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 13 10 23
        Male
    		 28 32 60
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 1 1
        White
    		 41 41 82
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    LMB763
    Reporting group description
    		 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo was orally administered once daily for 24 weeks in addition to SoC.

    Primary: Ratio to baseline in urinary albumin to creatinine ratio (UACR)

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    End point title
    		 Ratio to baseline in urinary albumin to creatinine ratio (UACR) [1]
    End point description
    UACR is a ratio between albumin and creatinine, and it estimates 24-hour urine albumin excretion. UACR (mg/mmol) = urine albumin [mg/L] / urine creatinine [mmol/L]. UACR was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement.
    End point type
    Primary
    End point timeframe
    Baseline and days 14, 29, 57, 85, 113, 141 and 169
    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: Correct, for that analysis set placebo group is not entered
    End point values
    		 LMB763 Placebo
    Number of subjects analysed
    41
    42
    Units: Ratio to baseline
    least squares mean (confidence interval 80%)
        Day 14 (n=39, 42)
    0.90 (0.79 to 1.02)
    1.06 (0.94 to 1.20)
        Day 29 (n=37, 39)
    0.83 (0.75 to 0.93)
    1.00 (0.90 to 1.12)
        Day 57 (n=34, 35)
    0.85 (0.76 to 0.94)
    1.05 (0.95 to 1.17)
        Day 85 (n=29, 35)
    0.84 (0.72 to 0.97)
    1.07 (0.93 to 1.23)
        Day 113 (n=26, 30)
    0.87 (0.73 to 1.04)
    1.07 (0.90 to 1.26)
        Day 141 (n=23, 27)
    0.84 (0.71 to 1.01)
    1.15 (0.98 to 1.35)
        Day 169 (n=26, 30)
    0.74 (0.61 to 0.89)
    0.92 (0.78 to 1.10)
    No statistical analyses for this end point

    Primary: Ratio to baseline in 24 hour urinary albumin at week 24 (day 169)

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    End point title
    		 Ratio to baseline in 24 hour urinary albumin at week 24 (day 169) [2]
    End point description
    Albuminuria describes the existence of albumin in the urine and the gold-standard to assess albuminuria is 24-hour urinary albumin excretion (milligram/24 hours). An analysis of covariance (ANCOVA) with treatment as the classification factor and log-transformed baseline as the covariate was conducted for log-transformed ratio to baseline 24-hour urinary albumin excretion. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement.
    End point type
    Primary
    End point timeframe
    Baseline and day 169
    Notes
    [2] - 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: Correct, for that analysis set placebo group is not entered
    End point values
    		 LMB763 Placebo
    Number of subjects analysed
    17
    21
    Units: Ratio to baseline
        least squares mean (confidence interval 80%)
    0.58 (0.45 to 0.74)
    0.91 (0.72 to 1.14)
    No statistical analyses for this end point

    Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [3]
    End point description
    Number of participants with AEs and SAEs including significant changes from baseline in vital signs, electrocardiograms and laboratory values qualifying and reported as AEs. The number of participants in each category is reported in the table.
    End point type
    Primary
    End point timeframe
    From the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days
    Notes
    [3] - 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: Correct, for that analysis set placebo group is not entered
    End point values
    		 LMB763 Placebo
    Number of subjects analysed
    41
    42
    Units: Participants
        AEs
    29
    25
        SAEs
    2
    2
    No statistical analyses for this end point

    Secondary: Ratio to Baseline in Estimated glomerular filtration rate (eGFR)

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    End point title
    		 Ratio to Baseline in Estimated glomerular filtration rate (eGFR)
    End point description
    Estimate Glomerular Filtration Rate (GFR) calculates estimated GFR (eGFR) from serum creatinine levels to assess kidney function. eGFR (milliliter/minute) was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A higher score in the ratio to baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline and days 14, 29, 57, 85, 113, 141 and 169
    End point values
    		 LMB763 Placebo
    Number of subjects analysed
    41
    41
    Units: Ratio to baseline
    least squares mean (confidence interval 80%)
        Day 14 (n=38, 41)
    0.95 (0.93 to 0.98)
    0.96 (0.94 to 0.99)
        Day 29 (n=36, 37)
    0.94 (0.91 to 0.97)
    0.94 (0.91 to 0.97)
        Day 57 (n=32, 32)
    0.98 (0.95 to 1.02)
    0.96 (0.93 to 1.00)
        Day 85 (n=28, 32)
    0.97 (0.93 to 1.01)
    0.94 (0.90 to 0.97)
        Day 113 (n=26, 23)
    0.96 (0.92 to 0.99)
    0.94 (0.91 to 0.98)
        Day 141 (n=22, 23)
    0.98 (0.95 to 1.02)
    0.93 (0.90 to 0.96)
        Day 169 (n=21, 25)
    0.93 (0.89 to 0.97)
    0.93 (0.90 to 0.97)
    No statistical analyses for this end point

    Secondary: Maximum Peak Observed Concentration (Cmax) of LMB763

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    End point title
    		 Maximum Peak Observed Concentration (Cmax) of LMB763 [4]
    End point description
    Pharmacokinetic (PK) parameters were calculated based on LMB763 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. Cmax was determined using non-compartmental methods. No methods for imputation of missing data were used.
    End point type
    Secondary
    End point timeframe
    pre-dose and 1, 2, 4 and 6 hours after LMB763 administration on Day 1 and Day 14
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Correct, for that analysis set placebo group is not entered
    End point values
    		 LMB763
    Number of subjects analysed
    41
    Units: Nanogram/milliliter
    arithmetic mean (standard deviation)
        Day 1 (n=41)
    1090 ( 665 )
        Day 14 (n=37)
    1300 ( 691 )
    No statistical analyses for this end point

    Secondary: Time to Reach Maximum Blood Concentrations (Tmax) of LMB763

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    End point title
    		 Time to Reach Maximum Blood Concentrations (Tmax) of LMB763 [5]
    End point description
    Pharmacokinetic (PK) parameters were calculated based on LMB763 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. Tmax was determined using non-compartmental methods. No methods for imputation of missing data were used.
    End point type
    Secondary
    End point timeframe
    pre-dose and 1, 2, 4 and 6 hours after LMB763 administration on Day 1 and Day 14
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Correct, for that analysis set placebo group is not entered
    End point values
    		 LMB763
    Number of subjects analysed
    41
    Units: Hour
    median (full range (min-max))
        Day 1 (n=41)
    3.25 (0.75 to 6)
        Day 14 (n=37)
    2 (0 to 6)
    No statistical analyses for this end point

    Secondary: Area Under the Blood Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of LMB763

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    End point title
    		 Area Under the Blood Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of LMB763 [6]
    End point description
    Pharmacokinetic (PK) parameters were calculated based on LMB763 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. AUClast was determined using non-compartmental methods. No methods for imputation of missing data were used.
    End point type
    Secondary
    End point timeframe
    pre-dose and 1, 2, 4 and 6 hours after LMB763 administration on Day 1 and Day 14
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Correct, for that analysis set placebo group is not entered
    End point values
    		 LMB763
    Number of subjects analysed
    41
    Units: Hour*nanogram/milliliter
    arithmetic mean (standard deviation)
        Day 1
    3710 ( 2510 )
        Day 14
    4850 ( 2910 )
    No statistical analyses for this end point

    Secondary: Ratio to baseline in Free water clearance

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    End point title
    		 Ratio to baseline in Free water clearance
    End point description
    The free water clearance (mL/min) was calculated using the following formula: (Total Volume (mL) / Elapsed Date & Time (min)) * (1-24 hr Urine Osmolality (mOsmol/kg)/ Serum Osmolality (mOsmol/kg)) The result of free water clearance was rounded to one decimal place prior to statistical analysis. An analysis of covariance (ANCOVA) with treatment as the classification factor and log-transformed baseline as the covariate was conducted for log-transformed ratio to baseline free water clearance. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A higher score in the ratio to baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline and day 169
    End point values
    		 LMB763 Placebo
    Number of subjects analysed
    8
    11
    Units: Ratio to baseline
        least squares mean (confidence interval 80%)
    0.97 (0.86 to 1.10)
    0.97 (0.88 to 1.08)
    No statistical analyses for this end point

    Secondary: Ratio to baseline in Lipoprotein A

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    End point title
    		 Ratio to baseline in Lipoprotein A
    End point description
    Lipoprotein A (gram/liter) is a component of the lipid profile which is a panel of blood tests used to find abnormalities in lipids. Ratio to baseline in Lipoprotein A was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline and days 85 and 169
    End point values
    		 LMB763 Placebo
    Number of subjects analysed
    41
    41
    Units: Ratio to baseline
    least squares mean (confidence interval 80%)
        Day 85 (n=19, 24)
    0.72 (0.67 to 0.77)
    0.95 (0.90 to 1.01)
        Day 169 (n=12, 19)
    0.75 (0.66 to 0.85)
    0.89 (0.81 to 0.99)
    No statistical analyses for this end point

    Secondary: Change from baseline in weight

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    End point title
    		 Change from baseline in weight
    End point description
    Change from baseline in weight was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A negative score in the percent change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline and days 14, 29, 57, 85, 113, 141 and 169
    End point values
    		 LMB763 Placebo
    Number of subjects analysed
    41
    41
    Units: Percent change from baseline
    least squares mean (confidence interval 80%)
        Day 14 (n=39, 41)
    -0.08 (-0.45 to 0.29)
    -0.13 (-0.50 to 0.23)
        Day 29 (n=37, 38)
    -0.57 (-0.99 to -0.14)
    -0.03 (-0.45 to 0.39)
        Day 57 (n=34, 34)
    -0.69 (-1.35 to -0.04)
    -0.24 (-0.90 to 0.41)
        Day 85 (n=29, 34)
    -0.41 (-1.21 to 0.38)
    0.08 (-0.70 to 0.86)
        Day 113 (n=25, 29)
    -0.51 (-1.42 to 0.40)
    0.21 (-0.67 to 1.09)
        Day 141 (n=23, 26)
    -0.80 (-1.69 to 0.09)
    0.43 (-0.44 to 1.29)
        Day 169 (n=22, 28)
    -0.61 (-1.60 to 0.39)
    0.55 (-0.38 to 1.47)
    No statistical analyses for this end point

    Secondary: Change from baseline in body mass index (BMI)

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    End point title
    		 Change from baseline in body mass index (BMI)
    End point description
    BMI was determined by height and weight measurements: Body weight (kg)/ [Height (m)]^2. Change from baseline in BMI was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A negative score in the percent change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline and days 14, 29, 57, 85, 113, 141 and 169
    End point values
    		 LMB763 Placebo
    Number of subjects analysed
    41
    41
    Units: Percent change from baseline
    least squares mean (confidence interval 80%)
        Day 14 (n=39, 41)
    -0.01 (-0.12 to 0.10)
    -0.05 (-0.16 to 0.06)
        Day 29 (n=37, 38)
    -0.19 (-0.32 to -0.05)
    -0.02 (-0.15 to 0.12)
        Day 57 (n=34, 34)
    -0.23 (-0.44 to -0.02)
    -0.07 (-0.28 to 0.14)
        Day 85 (n=29, 34)
    -0.13 (-0.40 to 0.13)
    0.03 (-0.22 to 0.29)
        Day 113 (n=25, 29)
    -0.18 (-0.47 to 0.12)
    0.07 (-0.21 to 0.35)
        Day 141 (n=23, 26)
    -0.31 (-0.60 to -0.01)
    0.16 (-0.12 to 0.45)
        Day 169 (n=22, 28)
    -0.29 (-0.61 to 0.04)
    0.16 (-0.15 to 0.47)
    No statistical analyses for this end point

    Secondary: Change from baseline in waist-to-hip ratio

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    End point title
    		 Change from baseline in waist-to-hip ratio
    End point description
    Waist-to-hip ratio was derived using waist circumference and hip circumference, which was measured at the greatest protrusion of the buttocks. Change from baseline in waist-to-hip ratio was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A negative score in the change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline and days 14, 29, 57, 85, 113, 141 and 169
    End point values
    		 LMB763 Placebo
    Number of subjects analysed
    41
    41
    Units: Ratio
    least squares mean (confidence interval 80%)
        Day 14 (n=39, 41)
    -0.00 (-0.01 to 0.00)
    -0.00 (-0.01 to 0.00)
        Day 29 (n=37, 37)
    -0.00 (-0.01 to 0.00)
    0.00 (-0.00 to 0.01)
        Day 57 (n=34, 34)
    -0.00 (-0.01 to 0.00)
    0.00 (-0.01 to 0.01)
        Day 85 (n=29, 34)
    -0.00 (-0.01 to 0.00)
    0.01 (-0.00 to 0.01)
        Day 113 (n=25, 29)
    -0.00 (-0.01 to 0.01)
    0.01 (0.00 to 0.02)
        Day 141 (n=24, 26)
    -0.00 (-0.01 to 0.01)
    0.02 (0.01 to 0.03)
        Day 169 (n=22, 28)
    -0.00 (-0.01 to 0.01)
    -0.00 (-0.01 to 0.00)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events
    Adverse event reporting additional description
    Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    LMB763 50 mg
    Reporting group description
    		 LMB763 50 mg

    Reporting group title
    Total
    Reporting group description
    		 Total

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 LMB763 50 mg Total Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 41 (4.88%)
    4 / 83 (4.82%)
    2 / 42 (4.76%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal disorder
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Erysipelas
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 LMB763 50 mg Total Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 41 (68.29%)
    51 / 83 (61.45%)
    23 / 42 (54.76%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 41 (4.88%)
    4 / 83 (4.82%)
    2 / 42 (4.76%)
         occurrences all number
    2
    4
    2
    Hypotension
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 83 (2.41%)
    1 / 42 (2.38%)
         occurrences all number
    1
    2
    1
    Fatigue
         subjects affected / exposed
    2 / 41 (4.88%)
    2 / 83 (2.41%)
    0 / 42 (0.00%)
         occurrences all number
    2
    2
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Pain
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Reproductive system and breast disorders
    Pruritus genital
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Asthma
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Blood bicarbonate decreased
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    4 / 41 (9.76%)
    7 / 83 (8.43%)
    3 / 42 (7.14%)
         occurrences all number
    4
    7
    3
    Blood fibrinogen increased
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    1
    Blood glucose increased
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 83 (2.41%)
    2 / 42 (4.76%)
         occurrences all number
    0
    2
    2
    Blood uric acid increased
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Glycosylated haemoglobin increased
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    1
    Serum ferritin decreased
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    1
    Ultrasound scan abnormal
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Urine albumin/creatinine ratio increased
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 83 (3.61%)
    3 / 42 (7.14%)
         occurrences all number
    0
    4
    4
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Injury
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    1
    Postoperative wound complication
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    1
    Rib fracture
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    1
    Scratch
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    3
    3
    0
    Soft tissue injury
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    5
    5
    Bradycardia
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Nervous system disorders
    Cerebral artery stenosis
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Headache
         subjects affected / exposed
    2 / 41 (4.88%)
    4 / 83 (4.82%)
    2 / 42 (4.76%)
         occurrences all number
    4
    7
    3
    Neuropathy peripheral
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    1
    Sciatica
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 83 (2.41%)
    1 / 42 (2.38%)
         occurrences all number
    1
    2
    1
    Somnolence
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    2
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 83 (2.41%)
    1 / 42 (2.38%)
         occurrences all number
    1
    3
    2
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Nephrogenic anaemia
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    2 / 41 (4.88%)
    3 / 83 (3.61%)
    1 / 42 (2.38%)
         occurrences all number
    2
    4
    2
    Colitis
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 83 (2.41%)
    1 / 42 (2.38%)
         occurrences all number
    1
    3
    2
    Constipation
         subjects affected / exposed
    2 / 41 (4.88%)
    3 / 83 (3.61%)
    1 / 42 (2.38%)
         occurrences all number
    2
    3
    1
    Diarrhoea
         subjects affected / exposed
    2 / 41 (4.88%)
    2 / 83 (2.41%)
    0 / 42 (0.00%)
         occurrences all number
    2
    2
    0
    Dry mouth
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    1
    Flatulence
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Gastritis
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Hyperchlorhydria
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    1
    Pruritus
         subjects affected / exposed
    13 / 41 (31.71%)
    19 / 83 (22.89%)
    6 / 42 (14.29%)
         occurrences all number
    17
    25
    8
    Urticaria
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    1
    Chronic kidney disease
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    1
    Dysuria
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    1
    Renal colic
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 83 (2.41%)
    1 / 42 (2.38%)
         occurrences all number
    1
    2
    1
    Back pain
         subjects affected / exposed
    3 / 41 (7.32%)
    5 / 83 (6.02%)
    2 / 42 (4.76%)
         occurrences all number
    3
    7
    4
    Myalgia
         subjects affected / exposed
    2 / 41 (4.88%)
    2 / 83 (2.41%)
    0 / 42 (0.00%)
         occurrences all number
    6
    6
    0
    Pain in extremity
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Infections and infestations
    Abdominal wall abscess
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Acarodermatitis
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 83 (2.41%)
    1 / 42 (2.38%)
         occurrences all number
    1
    2
    1
    Adenoviral conjunctivitis
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Bronchitis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    1
    Cystitis
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 83 (2.41%)
    2 / 42 (4.76%)
         occurrences all number
    0
    4
    4
    Erysipelas
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 83 (2.41%)
    1 / 42 (2.38%)
         occurrences all number
    1
    2
    1
    Gastroenteritis
         subjects affected / exposed
    2 / 41 (4.88%)
    3 / 83 (3.61%)
    1 / 42 (2.38%)
         occurrences all number
    3
    4
    1
    Influenza
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 83 (2.41%)
    1 / 42 (2.38%)
         occurrences all number
    1
    2
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 41 (2.44%)
    3 / 83 (3.61%)
    2 / 42 (4.76%)
         occurrences all number
    1
    3
    2
    Sinusitis
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Soft tissue infection
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 41 (4.88%)
    3 / 83 (3.61%)
    1 / 42 (2.38%)
         occurrences all number
    3
    4
    1
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 83 (2.41%)
    1 / 42 (2.38%)
         occurrences all number
    1
    2
    1
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 83 (2.41%)
    2 / 42 (4.76%)
         occurrences all number
    0
    2
    2
    Hyperglycaemia
         subjects affected / exposed
    3 / 41 (7.32%)
    5 / 83 (6.02%)
    2 / 42 (4.76%)
         occurrences all number
    3
    6
    3
    Hyperkalaemia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 83 (1.20%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    Iron deficiency
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 83 (1.20%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Dec 2018
    The purpose of this amendment was to address non-hold comments in the study-may-proceed letter from FDA.
    20 Mar 2019
    The purpose of this amendment was to address requests and comments raised by the German Health Authority during the review of the original Clinical Trial Application for this study.
    27 Oct 2020
    The purpose of this amendment was to incorporate brief changes based on investigator feedback.

    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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