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    Clinical Trial Results:
    A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis

    Summary
    EudraCT number
    		 2018-004142-42
    Trial protocol
    		 DE   BE   NL   CZ   ES   GB   IT  
    Global end of trial date
    17 Sep 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Oct 2022
    First version publication date
    04 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IM011-073
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03943147
    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
    29 Oct 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Sep 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objectives are to assess the safety and tolerability of BMS-986165 in participants with lupus nephritis and to evaluate the efficacy of BMS-986165 compared with placebo with regard to proteinuria.
    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 participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jul 2019
    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
    China: 1
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    Mexico: 2
    Country: Number of subjects enrolled
    Russian Federation: 1
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    United States: 7
    Worldwide total number of subjects
    16
    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)
    0
    Adults (18-64 years)
    16
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants with an inadequate renal response to MMF may be randomized to blinded study treatment BMS-986165 3 mg BID, BMS-986165 6 mg BID, or placebo BID, as add-on therapy to MMF in Part B. No participants were randomized to receive BMS-986165 3 mg BID or placebo BID due to low enrollment.

    Period 1
    Period 1 title
    Open-Label MMF Run-in (Part A)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Open Label MMF
    Arm description
    		 All study participants receive Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day for 12 weeks. The following suggested target doses of MMF should be reached by the time of randomization: - 1.5 to 2.0 g/day for participants self-described as Asian or of Asian descent - 3.0 g/day for participants self-described as Black, African American, or of African descent - 2.0 g/day for all others
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mycophenolate Mofetil (MMF)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose of 1.5 to 3.0 g/day

    Number of subjects in period 1
    		Open Label MMF
    Started
    16
    Completed
    6
    Not completed
    10
         Adverse event, non-fatal
    1
         Protocol-specified withdrawal criterion met
    1
         Non-compliance with study drug
    1
         Study terminated by sponsor
    3
         Other reasons
    4
    Period 2
    Period 2 title
    Blinded Treatment (Part B)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Open Label MMF
    Arm description
    		 After participants receive Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day for 12 weeks in Part A, Participants who meet the criteria to continue in Part B but do not meet the randomization criteria may continue on open-label MMF with or without corticosteroids.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mycophenolate Mofetil (MMF)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose of 1.5 to 3.0 g/day

    Arm title
    		 Open Label MMF + BMS-986165
    Arm description
    		 After participants receive Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day for 12 weeks in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986165
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    6 mg twice daily (BID)

    Investigational medicinal product name
    Mycophenolate Mofetil (MMF)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose of 1.5 to 3.0 g/day

    Number of subjects in period 2
    		Open Label MMF Open Label MMF + BMS-986165
    Started
    5
    1
    Completed
    2
    1
    Not completed
    3
    0
         Study terminated by sponsor
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Open Label MMF
    Reporting group description
    		 All study participants receive Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day for 12 weeks. The following suggested target doses of MMF should be reached by the time of randomization: - 1.5 to 2.0 g/day for participants self-described as Asian or of Asian descent - 3.0 g/day for participants self-described as Black, African American, or of African descent - 2.0 g/day for all others

    Reporting group values
    		 Open Label MMF Total
    Number of subjects
    		 16 16
    Age Categorical
    Units: Participants
        <=18 years
    		 0 0
        Between 18 and 65 years
    		 16 16
        >=65 years
    		 0 0
    Sex: Female, Male
    Units: Participants
        Female
    		 10 10
        Male
    		 6 6
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 5 5
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 3 3
        White
    		 6 6
        More than one race
    		 0 0
        Unknown or Not Reported
    		 2 2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 6 6
        Not Hispanic or Latino
    		 9 9
        Unknown or Not Reported
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Open Label MMF
    Reporting group description
    		 All study participants receive Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day for 12 weeks. The following suggested target doses of MMF should be reached by the time of randomization: - 1.5 to 2.0 g/day for participants self-described as Asian or of Asian descent - 3.0 g/day for participants self-described as Black, African American, or of African descent - 2.0 g/day for all others
    Reporting group title
    Open Label MMF
    Reporting group description
    		 After participants receive Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day for 12 weeks in Part A, Participants who meet the criteria to continue in Part B but do not meet the randomization criteria may continue on open-label MMF with or without corticosteroids.

    Reporting group title
    Open Label MMF + BMS-986165
    Reporting group description
    		 After participants receive Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day for 12 weeks in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.

    Primary: The Number of Participants Experiencing Averse Events in the Blinded Treatment Period (Part B)

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    End point title
    		 The Number of Participants Experiencing Averse Events in the Blinded Treatment Period (Part B) [1]
    End point description
    An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
    End point type
    Primary
    End point timeframe
    From baseline up to 52 weeks after first dose in Part B
    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: Only summary statistics planned for this endpoint
    End point values
    		 Open Label MMF + BMS-986165
    Number of subjects analysed
    1
    Units: Participants
    1
    No statistical analyses for this end point

    Primary: The Number of Participants with Clinically Significant ECG Abnormalities in the Blinded Treatment Period (Part B)

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    End point title
    		 The Number of Participants with Clinically Significant ECG Abnormalities in the Blinded Treatment Period (Part B) [2]
    End point description
    The number of participants with clinically significant abnormalities in electrocardiograms (ECGs) parameters. The following ECG parameters will be measured: HR, PR-interval, QRS-duration, QT-interval, QTc-interval. A single 12-lead ECG will be recorded after the participant has been supine for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
    End point type
    Primary
    End point timeframe
    From baseline up to 52 weeks after first dose in Part B
    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: Only summary statistics planned for this endpoint
    End point values
    		 Open Label MMF + BMS-986165
    Number of subjects analysed
    1
    Units: Participants
    0
    No statistical analyses for this end point

    Primary: The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B)

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    End point title
    		 The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B) [3]
    End point description
    The percent change from baseline in Vital sign measurements including: blood pressure, heart rate, respiratory rate, and temperature. Blood pressure and heart rate are measured after the participant has been resting quietly for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
    End point type
    Primary
    End point timeframe
    From baseline up to 52 weeks after first dose in Part B
    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: Only summary statistics planned for this endpoint
    End point values
    		 Open Label MMF + BMS-986165
    Number of subjects analysed
    1
    Units: Percent change from baseline
    number (not applicable)
        Diastolic Blood Pressure(mmHg)
    -3.45
        Systolic Blood Pressure(mmHg
    5.22
        Heart Rate(beats/min)
    16.87
        Respiratory Rate(breaths/min)
    6.25
        Temperature(C)
    -1.35
    No statistical analyses for this end point

    Primary: Percent Change from Baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR) at Week 24 in the Blinded Treatment Period (Part B)

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    End point title
    		 Percent Change from Baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR) at Week 24 in the Blinded Treatment Period (Part B) [4]
    End point description
    The percent change from baseline in UPCR based on 24-hour urine collections. 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 24.
    End point type
    Primary
    End point timeframe
    Week 24
    Notes
    [4] - 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: Only summary statistics planned for this endpoint
    End point values
    		 Open Label MMF + BMS-986165
    Number of subjects analysed
    1
    Units: Percent change from baseline
        number (not applicable)
    -34.86
    No statistical analyses for this end point

    Primary: The Number of Participants with Abnormal Laboratory Parameters of Clinical Significance in the Blinded Treatment Period (Part B)

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    End point title
    		 The Number of Participants with Abnormal Laboratory Parameters of Clinical Significance in the Blinded Treatment Period (Part B) [5]
    End point description
    The number of participants with abnormal laboratory parameters (Chemistry, hematology, coagulation, immunohematology) that have been considered clinically significant. Clinically relevant laboratory results are determined by the investigator. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
    End point type
    Primary
    End point timeframe
    From baseline up to 52 weeks after first dose in Part B
    Notes
    [5] - 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: Only summary statistics planned for this endpoint
    End point values
    		 Open Label MMF + BMS-986165
    Number of subjects analysed
    1
    Units: Participants
    0
    No statistical analyses for this end point

    Secondary: The Number of Participants with Partial Renal Response (PRR) at Week 24 in the Blinded Treatment Period (Part B)

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    End point title
    		 The Number of Participants with Partial Renal Response (PRR) at Week 24 in the Blinded Treatment Period (Part B)
    End point description
    The number of participants with partial renal response (PRR) defined as ≥ 50% reduction from baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR). 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 24.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Open Label MMF + BMS-986165
    Number of subjects analysed
    1
    Units: Participants
    0
    No statistical analyses for this end point

    Secondary: The Number of Participants with Complete Renal Response (CRR) at Week 24 in the Blinded Treatment Period (Part B)

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    End point title
    		 The Number of Participants with Complete Renal Response (CRR) at Week 24 in the Blinded Treatment Period (Part B)
    End point description
    The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Open Label MMF + BMS-986165
    Number of subjects analysed
    1
    Units: Participants
    0
    No statistical analyses for this end point

    Secondary: The Number of Participants with Partial Renal Response (PRR) at Week 52 in the Blinded Treatment Period (Part B)

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    End point title
    		 The Number of Participants with Partial Renal Response (PRR) at Week 52 in the Blinded Treatment Period (Part B)
    End point description
    The number of participants with partial renal response (PRR) defined as ≥ 50% reduction from baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR). 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 52.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Open Label MMF + BMS-986165
    Number of subjects analysed
    1
    Units: Participants
    0
    No statistical analyses for this end point

    Secondary: The Number of Participants with Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to ≤ 7.5 mg/day at Week 24 in the Blinded Treatment Period (Part B)

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    End point title
    		 The Number of Participants with Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to ≤ 7.5 mg/day at Week 24 in the Blinded Treatment Period (Part B)
    End point description
    The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline who was also able to successfully taper corticosteroid use to ≤ 7.5 mg/day.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Open Label MMF + BMS-986165
    Number of subjects analysed
    1
    Units: Participants
    0
    No statistical analyses for this end point

    Secondary: The Number of Participants with Complete Renal Response (CRR) at Week 52 in the Blinded Treatment Period (Part B)

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    End point title
    		 The Number of Participants with Complete Renal Response (CRR) at Week 52 in the Blinded Treatment Period (Part B)
    End point description
    The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Open Label MMF + BMS-986165
    Number of subjects analysed
    1
    Units: Participants
    0
    No statistical analyses for this end point

    Secondary: The Number of Participants with Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to ≤ 7.5 mg/day at Week 52 in the Blinded Treatment Period (Part B)

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    End point title
    		 The Number of Participants with Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to ≤ 7.5 mg/day at Week 52 in the Blinded Treatment Period (Part B)
    End point description
    The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline who was also able to successfully taper corticosteroid use to ≤ 7.5 mg/day.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Open Label MMF + BMS-986165
    Number of subjects analysed
    1
    Units: Participants
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Open Label MMF
    Reporting group description
    		 All study participants receive Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day for 12 weeks in Part A. Participants who meet the criteria to continue in Part B but do not meet the randomization criteria may continue on open-label MMF with or without corticosteroids. The following suggested target doses of MMF should be reached by the time of randomization: - 1.5 to 2.0 g/day for participants self-described as Asian or of Asian descent - 3.0 g/day for participants self-described as Black, African American, or of African descent - 2.0 g/day for all others

    Reporting group title
    Open Label MMF + BMS-986165
    Reporting group description
    		 All participants that met randomization criteria for Part B. Participants received BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.

    Serious adverse events
    		 Open Label MMF Open Label MMF + BMS-986165
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 1 (100.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Open Label MMF Open Label MMF + BMS-986165
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 16 (43.75%)
    1 / 1 (100.00%)
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Blood pressure increased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    International normalised ratio increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Prothrombin time prolonged
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Weight increased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Deafness neurosensory
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Abdominal distension
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Haematochezia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Gallbladder polyp
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Flank pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Arthralgia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Sep 2019
    Modified several inclusion and exclusion criteria. Clarified that subjects may begin treatment with non-study-supplied MMF during the screening period.
    06 Aug 2020
    Added a 52-week Long-term Extension (LTE) period. Modified study objectives and endpoints, including new primary and secondary efficacy endpoints. Updated statistical considerations based on updated endpoints and addition of LTE period. Modified inclusion/exclusion criteria details and previous and concomitant therapy allowed and prohibited.

    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.
    Due to low enrollment, the Sponsor chose to terminate the study on 01-Jul-2021. There is limited data available therefore no formal statistical analyses of endpoints were conducted.
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    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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