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    Clinical Trial Results:
    SB012 for the treatment of active ulcerative colitis (SECURE): a prospective, multi-centre, randomised, double-blind, placebo-controlled phase IIa clinical trial to evaluate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once daily

    Summary
    EudraCT number
    		 2013-004599-36
    Trial protocol
    		 DE  
    Global end of trial date
    20 Jun 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Dec 2021
    First version publication date
    25 Dec 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SB012/01/2013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02129439
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sterna biologicals GmbH & Co KG
    Sponsor organisation address
    Bismarckstraße 7, Marburg, Germany, 35037
    Public contact
    Clinical Trial Manager, Sterna biologicals GmbH & Co KG, clinicaltrials@sterna-biologicals.com
    Scientific contact
    Clinical Trial Manager, Sterna biologicals GmbH & Co KG, clinicaltrials@sterna-biologicals.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
    21 Dec 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this clinical trial is to evaluate the efficacy of SB012 enema in subjects with moderate to severe active ulcerative colitis at end of treatment. Subjects with moderate to severe active ulcerative colitis were randomised to treatment with either SB012 or placebo at a 2:1 ratio, in a multi-centre setting. Subjects were treated as out-patients and self-administered the IMP. The study consisted of a treatment and a follow-up phase. SB012 is a DNAzyme-based GATA-3 antagonist investigated in a major chronic inflammatory indication (ulcerative colitis). SB012 is enema-applied formulation for the potential treatment of ulcerative colitis The active principle hgd40 of the investigational medicinal product SB012 belongs to a new class of antisense oligonucleotide therapeutics, the 10-23 DNA(deoxyribonucleic acid)zymes (antisense oligonucleotide). DNAzymes are catalytically active nucleic acids that cleave complementary RNA (ribonucleic acid).
    Protection of trial subjects
    This trial was conducted in accordance with the ethical principles that have their origin in the currently valid Declaration of Helsinki, and are consistent with ICH-GCP (January 1997) and applicable regulatory requirements. All laboratory tests and procedures used during the study are well established and validated. Adverse events were monitored from the time of signing the informed consent to the end of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Jun 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Overall, 20 adult subjects both male and female, 18 to 75 years, with active ulcerative colitis were eligible for enrolment into the trial.

    Pre-assignment
    Screening details
    		 Adult male and female subjects (18 to 75 years) with active ulcerative colitis were eligible for enrolment into the trial. Subjects were screened according to inclusion and exclusion criteria. Written informed consent was obtained from patients prior to participation in the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SB012
    Arm description
    		 Subjects were exposed once daily over a 4-week treatment period (28 consecutive days) to SB012 enema. Rectal administration of IMPs (placebo enema: 30ml) was performed once daily (preferably at bedtime) by the subjects at home, after completing an instruction and training session at the trial centre on Day 1 (V3) — except for the first (Day 1/V3) and last (Day 29/V8) IMP administration, which were done at the trial centre.
    Arm type
    		 Placebo

    Investigational medicinal product name
    SB012
    Investigational medicinal product code
    Other name
    hgd40
    Pharmaceutical forms
    Rectal solution
    Routes of administration
    Rectal use
    Dosage and administration details
    SB012 (active substance: hgd40) Liquid solution, concentration of 7.5mg/ml hgd40 in 30ml phosphate buffered saline (PBS). Rectal administration of IMP (enema: plastic rectal tube, 30ml) once daily (preferably at bedtime) by the subject at home except for the first (Day 1/Visit [V] 3) and last (Day 28/V7) IMP administration which were performed at the trial centre in the morning, each.

    Arm title
    		 Placebo
    Arm description
    		 Subjects were exposed once daily over a 4-week treatment period (28 consecutive days) to placebo enema. Rectal administration of IMPs (placebo enema: 30ml) was performed once daily (preferably at bedtime) by the subjects at home, after completing an instruction and training session at the trial centre on Day 1 (V3) — except for the first (Day 1/V3) and last (Day 29/V8) IMP administration, which were done at the trial centre.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Rectal solution
    Routes of administration
    Rectal use
    Dosage and administration details
    Placebo Liquid solution Rectal administration of IMP (enema: plastic rectal tube, 30ml) once daily (preferably at bedtime) by the subject at home except for the first (Day 1/V3) and last (Day 28/V7) IMP administration which were performed at the trial centre in the morning, each.

    Number of subjects in period 1
    		SB012 Placebo
    Started
    13
    7
    Completed
    12
    6
    Not completed
    1
    1
         Physician decision
    1
    -
         Adverse event, non-fatal
    -
    1
    Period 2
    Period 2 title
    Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SB012
    Arm description
    		 No treatment was administered during the Follow-up period. Patients were followed-up by phone call on day 42±3, to assess the Clinical Mayo score#; adverse events/serious adverse events; and concomitant medications. # The Clinical Mayo score represents a subscore of the Total Mayo score and comprises the components stool frequency and rectal bleeding. It ranges from 0 to 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SB012
    Investigational medicinal product code
    Other name
    hgd40
    Pharmaceutical forms
    Rectal solution
    Routes of administration
    Rectal use
    Dosage and administration details
    No treatment was administered during the Follow-up period.

    Arm title
    		 Placebo
    Arm description
    		 No treatment was administered during the Follow-up period. Patients were followed-up by phone call on day 42±3, to assess the Clinical Mayo score#; adverse events/serious adverse events; and concomitant medications. # The Clinical Mayo score represents a subscore of the Total Mayo score and comprises the components stool frequency and rectal bleeding. It ranges from 0 to 6.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Rectal solution
    Routes of administration
    Rectal use
    Dosage and administration details
    No treatment was administered during the Follow-up period.

    Number of subjects in period 2
    		SB012 Placebo
    Started
    12
    6
    Completed
    8
    2
    Not completed
    4
    4
         Physician decision
    3
    2
         Consent withdrawn by subject
    1
    -
         Protocol deviation
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SB012
    Reporting group description
    		 Subjects were exposed once daily over a 4-week treatment period (28 consecutive days) to SB012 enema. Rectal administration of IMPs (placebo enema: 30ml) was performed once daily (preferably at bedtime) by the subjects at home, after completing an instruction and training session at the trial centre on Day 1 (V3) — except for the first (Day 1/V3) and last (Day 29/V8) IMP administration, which were done at the trial centre.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were exposed once daily over a 4-week treatment period (28 consecutive days) to placebo enema. Rectal administration of IMPs (placebo enema: 30ml) was performed once daily (preferably at bedtime) by the subjects at home, after completing an instruction and training session at the trial centre on Day 1 (V3) — except for the first (Day 1/V3) and last (Day 29/V8) IMP administration, which were done at the trial centre.

    Reporting group values
    		 SB012 Placebo Total
    Number of subjects
    		 13 7 20
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 13 7 20
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.5 ( 13.1 ) 35.0 ( 12.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7 1 8
        Male
    		 6 6 12
    Race
    Units: Subjects
        Caucasian
    		 12 7 19
        Mixed (Black American-Caucasian)
    		 1 0 1
    Glucorticoid use at baseline
    Units: Subjects
        Yes
    		 7 1 8
        No
    		 6 6 12
    Body mass index
    Units: kg/m^2
        arithmetic mean (full range (min-max))
    		 24.29 (19.5 to 28.9) 24.50 (20.0 to 29.0) -
    Duration of colitis ulcerosa
    Units: year
        arithmetic mean (standard deviation)
    		 8.10 ( 8.00 ) 6.63 ( 3.21 ) -

    End points

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    End points reporting groups
    Reporting group title
    SB012
    Reporting group description
    		 Subjects were exposed once daily over a 4-week treatment period (28 consecutive days) to SB012 enema. Rectal administration of IMPs (placebo enema: 30ml) was performed once daily (preferably at bedtime) by the subjects at home, after completing an instruction and training session at the trial centre on Day 1 (V3) — except for the first (Day 1/V3) and last (Day 29/V8) IMP administration, which were done at the trial centre.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were exposed once daily over a 4-week treatment period (28 consecutive days) to placebo enema. Rectal administration of IMPs (placebo enema: 30ml) was performed once daily (preferably at bedtime) by the subjects at home, after completing an instruction and training session at the trial centre on Day 1 (V3) — except for the first (Day 1/V3) and last (Day 29/V8) IMP administration, which were done at the trial centre.
    Reporting group title
    SB012
    Reporting group description
    		 No treatment was administered during the Follow-up period. Patients were followed-up by phone call on day 42±3, to assess the Clinical Mayo score#; adverse events/serious adverse events; and concomitant medications. # The Clinical Mayo score represents a subscore of the Total Mayo score and comprises the components stool frequency and rectal bleeding. It ranges from 0 to 6.

    Reporting group title
    Placebo
    Reporting group description
    		 No treatment was administered during the Follow-up period. Patients were followed-up by phone call on day 42±3, to assess the Clinical Mayo score#; adverse events/serious adverse events; and concomitant medications. # The Clinical Mayo score represents a subscore of the Total Mayo score and comprises the components stool frequency and rectal bleeding. It ranges from 0 to 6.

    Primary: 1_Total Mayo score -- After 4 weeks -- Change from baseline

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    End point title
    		 1_Total Mayo score -- After 4 weeks -- Change from baseline
    End point description
    Change from baseline Change in Total Mayo score# after 4 weeks of treatment (Week 4, Day 28) compared with baseline value in the active treatment group (SB012) and in the Placebo group. # The Total Mayo score is a 13-point ordinal scale for the assessment of concurrent severity of ulcerative colitis. It comprises of four components: stool frequency, rectal bleeding, endoscopic findings, and physician’s global assessment of disease severity. Each component has four grades ranging from 0 to 3. The Total Mayo score ranges from 0 to 12, with 12 representing the most severe disease (disease severity scores: 0-2=Remission, 3-5=Mild, 6-10=Moderate, 11-12=Severe)
    End point type
    Primary
    End point timeframe
    Baseline (pre treatment), after treatment at week 4 (Day 28). Baseline=Last observation collected prior to application of first dose of IMP
    End point values
    		 SB012 Placebo
    Number of subjects analysed
    13 [1]
    6 [2]
    Units: score
        arithmetic mean (standard deviation)
    -1.8 ( 1.6 )
    -1.0 ( 1.3 )
    Notes
    [1] - Per protocol set
    [2] - Per protocol set
    Statistical analysis title
    		 Treatment effect -- Between groups
    Comparison groups
    SB012 v Placebo
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2864 [3]
    Method
    		 Wilcoxon rank-sum test
    Parameter type
    		 Hodges-Lehmann estimate
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 1
    Notes
    [3] - Two-sided exact Wilcoxon signed-rank test

    Primary: 2_Total Mayo score -- After 4 weeks -- Actual values

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    End point title
    		 2_Total Mayo score -- After 4 weeks -- Actual values [4]
    End point description
    Actual values Total Mayo score after 4 weeks of treatment (Week 4, Day 28) in the active treatment group (SB012) and in the Placebo group. Details regarding the Total Mayo score are presented in the description for end point 1.
    End point type
    Primary
    End point timeframe
    Baseline (pre treatment), after treatment at week 4 (Day 28).
    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: The statistical evaluation for the actual Total Mayo score results was not performed. Please refer to the statistical analysis shown for end point 1 (Total Mayo score -- Change from baseline).
    End point values
    		 SB012 Placebo
    Number of subjects analysed
    13 [5]
    6 [6]
    Units: score
        arithmetic mean (standard deviation)
    6.5 ( 2.6 )
    9.0 ( 1.3 )
    Notes
    [5] - Per protocol set
    [6] - Per protocol set
    No statistical analyses for this end point

    Secondary: 3_Total Mayo score -- After 8 weeks -- Change from baseline

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    End point title
    		 3_Total Mayo score -- After 8 weeks -- Change from baseline
    End point description
    Change in Total Mayo score# 8 weeks after start of treatment (week 8, Day 56, end of study) compared with baseline value in the active treatment group (SB012) and in the Placebo group # Details regarding the Total Mayo score are presented in the description for end point 1. For secondary efficacy end points, the analyses were performed descriptively.
    End point type
    Secondary
    End point timeframe
    Baseline (pre treatment), after treatment at week 8 (Day 56). Baseline=Last observation collected prior to application of first dose of IMP
    End point values
    		 SB012 Placebo
    Number of subjects analysed
    7 [7]
    2 [8]
    Units: score
        arithmetic mean (standard deviation)
    -3.0 ( 1.6 )
    -1.5 ( 2.1 )
    Notes
    [7] - Per protocol set
    [8] - Per protocol set
    No statistical analyses for this end point

    Secondary: 4_Total Mayo score -- After 8 weeks -- Actual values

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    End point title
    		 4_Total Mayo score -- After 8 weeks -- Actual values
    End point description
    Actual values Total Mayo score after 8 weeks of treatment (Week 8, Day 56) in the active treatment group (SB012) and in the Placebo group. Details regarding the Total Mayo score are presented in the description for end point 1.
    End point type
    Secondary
    End point timeframe
    Baseline (pre treatment), after treatment at week 8 (Day 56).
    End point values
    		 SB012 Placebo
    Number of subjects analysed
    7 [9]
    2 [10]
    Units: score
        arithmetic mean (standard deviation)
    5.0 ( 3.5 )
    9.0 ( 1.4 )
    Notes
    [9] - Per protocol set
    [10] - Per protocol set
    No statistical analyses for this end point

    Secondary: 5_Endoscopic Mayo score -- After 4 weeks -- Change from baseline

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    End point title
    		 5_Endoscopic Mayo score -- After 4 weeks -- Change from baseline
    End point description
    Change in Endoscopic Mayo score# 4 weeks (Day 28) after start of treatment compared with baseline value in the active treatment group (SB012) vs. Placebo. Results show the number of subjects achieving an Endoscopic Mayo score change from baseline of -1, 0, or 1. # The Endoscopic Mayo score represents a subscore of the Total Mayo score and consists of the endoscopic findings. It ranges from 0 to 3 (0 = normal or inactive disease, 1=Mild disease [erythema, decreased vascular pattern, mild friability], 2=Moderate disease [marked erythema, absent vascular pattern, friability, erosions], 3=Severe disease [spontaneous bleeding, ulceration]). Secondary efficacy analyses were performed descriptively.
    End point type
    Secondary
    End point timeframe
    Baseline (pre treatment), after treatment at week 4 (Day 28). Baseline=Last observation collected prior to application of first dose of IMP
    End point values
    		 SB012 Placebo
    Number of subjects analysed
    13 [11]
    6 [12]
    Units: subjects
        Change from baseline of -1
    2
    1
        Change from baseline of 0
    10
    5
        Change from baseline of 1
    1
    0
        Missing
    0
    0
    Notes
    [11] - Per protocol set
    [12] - Per protocol set
    No statistical analyses for this end point

    Secondary: 6_Endoscopic Mayo score -- After 8 weeks -- Change from baseline

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    End point title
    		 6_Endoscopic Mayo score -- After 8 weeks -- Change from baseline
    End point description
    Change in Endoscopic Mayo score* 8 weeks (Day 56) after start of treatment compared with baseline value in the active treatment group (SB012) vs. Placebo. Results show the number of subjects achieving an Endoscopic Mayo score change from baseline of -1, 0, or 1. * The Endoscopic Mayo score represents a subscore of the Total Mayo score and consists of the endoscopic findings. It ranges from 0 to 3 (0 = normal or inactive disease, 1=Mild disease [erythema, decreased vascular pattern, mild friability], 2=Moderate disease [marked erythema, absent vascular pattern, friability, erosions], 3=Severe disease [spontaneous bleeding, ulceration]). Secondary efficacy analyses were performed descriptively.
    End point type
    Secondary
    End point timeframe
    Baseline (pre treatment), after treatment at week 8 (Day 56). Baseline=Last observation collected prior to application of first dose of IMP
    End point values
    		 SB012 Placebo
    Number of subjects analysed
    7 [13]
    2 [14]
    Units: subjects
        Change from baseline of -1
    4
    1
        Change from baseline of 0
    3
    1
        Change from baseline of 1
    0
    0
        Missing
    6
    4
    Notes
    [13] - Per protocol set
    [14] - Per protocol set
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study: from the time when the informed consent form was signed until end of study visit (V10, Day 56±3 days), or up to study discontinuation visit.
    Adverse event reporting additional description
    An AE was any untoward medical occurrence in a subject using the investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. TEAEs were regarded as “treatment emergent” AEs, if not seen before treatment or, if already present before treatment, worsened after start of treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    SB012
    Reporting group description
    		 Subjects exposed once daily over a 4-week treatment period (28 consecutive days) to SB012 enema.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were exposed once daily over a 4-week treatment period (28 consecutive days) to placebo enema.

    Serious adverse events
    		 SB012 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 SB012 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 13 (76.92%)
    5 / 7 (71.43%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 13 (23.08%)
    3 / 7 (42.86%)
         occurrences all number
    4
    3
    Tension headache
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    Malaise
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Pyrexia
         subjects affected / exposed
    3 / 13 (23.08%)
    1 / 7 (14.29%)
         occurrences all number
    3
    1
    General physical health deterioration
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Colitis ulcerative
         subjects affected / exposed
    3 / 13 (23.08%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    Diarrhoea
         subjects affected / exposed
    3 / 13 (23.08%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    Dyspepsia
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 7 (14.29%)
         occurrences all number
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Renal pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Infections and infestations
    Herpes zoster
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 7 (28.57%)
         occurrences all number
    0
    3
    Metabolism and nutrition disorders
    Iron deficiency
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Dec 2015
    Protocol amendment 3 was submitted to the leading EC as clinical trial protocol version 3.0 because the following changes were instituted: inclusion of a second trial centre to facilitate timely enrolment of subjects, change of the trial design from single- to multi-centre, and a more precise description of the subject replacement procedure.

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

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