Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43870   clinical trials with a EudraCT protocol, of which   7289   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered GLPG3970 for 12 Weeks in Adult Subjects With Active Primary Sjögren’s Syndrome

    Summary
    EudraCT number
    		 2020-003298-22
    Trial protocol
    		 FR   DE   HU   GR   ES  
    Global end of trial date
    27 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GLPG3970-CL-207
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04700280
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galapagos NV
    Sponsor organisation address
    Generaal De Wittelaan L11 A3, Mechelen, Belgium, 2800
    Public contact
    Galapagos Medical Information, Galapagos NV, medicalinfo@glpg.com
    Scientific contact
    Galapagos Medical Information, Galapagos NV, medicalinfo@glpg.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
    28 Apr 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Dec 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the efficacy of GLPG3970 compared to placebo on the signs and symptoms of primary Sjogren's Syndrome (pSS). The study also evaluated the safety and tolerability of GLPG3970 compared to placebo.
    Protection of trial subjects
    This clinical study was conducted in accordance with the ethical principles that have their origin in the “Declaration of Helsinki” and its amendments in force at the time of the clinical study (2013 version). It was also carried out in conformity with the protocol, the International Council for Harmonisation for Good Clinical Practice (ICH-GCP) Guideline E6 (R2), and local ethical and legal requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jan 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Ukraine: 3
    Country: Number of subjects enrolled
    Poland: 23
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Greece: 1
    Country: Number of subjects enrolled
    Hungary: 3
    Worldwide total number of subjects
    31
    EEA total number of subjects
    28
    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)
    29
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were enrolled at 10 clinical study sites across 5 countries (1 in Germany, 1 in Greece, 1 in Hungary, 6 in Poland, and 1 in Ukraine).

    Pre-assignment
    Screening details
    		 A total of 69 participants were screened. Of these, 31 participants were randomized and treated in the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GLPG3970
    Arm description
    		 Participants received GLPG3970 400 milligram (mg) (2 *200 mg tablet), orally, once daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG3970
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GLPG3970 was administered per dose and schedule specified in the arm description.

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo matched to GLPG3970 tablet, orally, once daily for 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to GLPG3970 was administered per schedule specified in the arm description.

    Number of subjects in period 1
    		GLPG3970 Placebo
    Started
    20
    11
    Completed
    9
    8
    Not completed
    11
    3
         Adverse event, non-fatal
    4
    -
         Study terminated by sponsor
    5
    3
         Other than specified
    1
    -
         Lack of efficacy
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    GLPG3970
    Reporting group description
    		 Participants received GLPG3970 400 milligram (mg) (2 *200 mg tablet), orally, once daily for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo matched to GLPG3970 tablet, orally, once daily for 12 weeks.

    Reporting group values
    		 GLPG3970 Placebo Total
    Number of subjects
    		 20 11 31
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 19 10 29
        From 65-74 years
    		 1 1 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.6 ( 10.3 ) 47.4 ( 10.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 19 10 29
        Male
    		 1 1 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 0
        Not Hispanic or Latino
    		 20 11 31
        Unknown or Not Reported
    		 0 0 0
    Race
    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 0 0
        White
    		 20 11 31
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) Score
    ESSDAI includes 12 domains: constitutional, lymphadenopathy and lymphoma, glandular, articular, cutaneous, pulmonary,renal, muscular, peripheral nervous system, central nervous system [CNS], hematological, biological. Each of the domains was assessed for activity level: no, low, moderate, high. Each domain score was obtained by multiplying the activity level with domain weight (range: 1 to 6), and assigned a numerical score. Sum of all individual weighted domain scores = 0 (best) to 123 (worst activity). A higher score indicated more disease activity.
    Units: score on a scale
        arithmetic mean (standard deviation)
    		 12.5 ( 6.6 ) 8.3 ( 2.4 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    GLPG3970
    Reporting group description
    		 Participants received GLPG3970 400 milligram (mg) (2 *200 mg tablet), orally, once daily for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo matched to GLPG3970 tablet, orally, once daily for 12 weeks.

    Primary: Change From Baseline in ESSDAI Score at Week 12

    		 Close Top of page
    End point title
    		 Change From Baseline in ESSDAI Score at Week 12
    End point description
    ESSDAI, a systemic disease activity index to assess 12 domains (constitutional, lymphadenopathy and lymphoma, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral nervous system, central nervous system [CNS], hematological, biological) in participants with pSS. Each of the domains was assessed for activity level (no, low, moderate, high). Each domain score was obtained by multiplying the activity level with domain weight (range:1 to 6), and assigned a numerical score. Sum of all individual weighted domain scores was overall score (range:0[best] to 123[worst activity]), higher score indicated more disease activity. A clinically meaningful reduction from baseline (≥3 points) indicated improvement of symptoms. Least squares (LS) mean was calculated using mixed models for repeated measures (MMRM). Participants in the full analysis set (FAS: all randomized participants who received at least one dose of study drug) with available data were analyzed.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    End point values
    		 GLPG3970 Placebo
    Number of subjects analysed
    8
    5
    Units: score on a scale
        least squares mean (standard error)
    -4.4 ( 1.56 )
    -3.0 ( 2.03 )
    Statistical analysis title
    		 GLPG3970 vs Placebo
    Comparison groups
    GLPG3970 v Placebo
    Number of subjects included in analysis
    13
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.617
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -6.2
         upper limit
    		 3.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.69

    Primary: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) by Severity

    		 Close Top of page
    End point title
    		 Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) by Severity [1]
    End point description
    An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. The severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE) current version at the time of assessment. The maximum intensity of the AE were Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), or Grade 5 (fatal). A TEAE was any AE with an onset date on or after the first dose of GLPG3970 and no later than 30 days after last dose of GLPG3970, or any worsening of any AE on or after the GLPG3970 start date. The safety analysis set included all randomized participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not planned for primary endpoint related to safety.
    End point values
    		 GLPG3970 Placebo
    Number of subjects analysed
    20
    11
    Units: participants
        Mild
    3
    4
        Moderate
    5
    3
        Severe
    3
    0
        Life-threatening
    0
    0
        Death
    0
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Weeks 4, 8, and 12

    		 Close Top of page
    End point title
    		 Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Weeks 4, 8, and 12
    End point description
    The ESSPRI is a participant-reported questionnaire to assess subjective participant symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain was scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score was calculated as the mean of the 3 individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10. A higher score indicates worst symptom. A clinically significant reduction from baseline of the ESSPRI score (at least one point or 15% of the baseline value) indicated the improvement of symptoms. Participants in the FAS with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, and 12
    End point values
    		 GLPG3970 Placebo
    Number of subjects analysed
    19
    11
    Units: score on a scale
    least squares mean (standard error)
        Change at Week 4 (n=19, 11)
    -1.25 ( 0.37 )
    -0.60 ( 0.49 )
        Change at Week 8 (n=17, 8)
    -2.05 ( 0.41 )
    -1.28 ( 0.56 )
        Change at Week 12 (n=11, 8)
    -2.15 ( 0.59 )
    -1.79 ( 0.70 )
    Statistical analysis title
    		 Week 4: GLPG3970 vs Placebo
    Statistical analysis description
    Number of participants included in analysis were 30.
    Comparison groups
    GLPG3970 v Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3089
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.64
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 0.41
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.62
    Statistical analysis title
    		 Week 8: GLPG3970 vs Placebo
    Statistical analysis description
    Number of participants included in analysis were 25.
    Comparison groups
    GLPG3970 v Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2834
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.77
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.97
         upper limit
    		 0.43
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.71
    Statistical analysis title
    		 Week 12: GLPG3970 vs Placebo
    Statistical analysis description
    Number of participants included in analysis were 19.
    Comparison groups
    GLPG3970 v Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7109
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.36
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.02
         upper limit
    		 1.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.95

    Secondary: Change From Baseline in ESSDAI Score at Weeks 4, 8, and 12

    		 Close Top of page
    End point title
    		 Change From Baseline in ESSDAI Score at Weeks 4, 8, and 12
    End point description
    The ESSDAI is a systemic disease activity index to assess 12 domains (organ systems: constitutional, lymphadenopathy and lymphoma, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral nervous system, CNS, hematological, biological) in participants with pSS. Each of the domains was assessed for activity level (no, low, moderate, and high). Each domain score was obtained by multiplying the activity level with the domain weight, ranged from 1 to 6, and assigned a numerical score based on pre-determined weighting of each individual domain. The sum of all individual weighted domain scores was the overall score, ranged from 0 (best) to 123 (worst activity). A higher score indicated more disease activity. A clinically meaningful reduction from baseline (≥3 points) indicated the improvement of symptoms. Participants in the FAS with available data were analyzed. Results of Week 12 is presented in primary endpoint 1.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, and 12
    End point values
    		 GLPG3970 Placebo
    Number of subjects analysed
    15
    7
    Units: score on a scale
    least squares mean (standard error)
        Change at Week 4 (n=9, 6)
    -1.7 ( 1.17 )
    -1.4 ( 1.32 )
        Change at Week 8 (n=15, 7)
    -3.5 ( 1.28 )
    -4.0 ( 2.02 )
    Statistical analysis title
    		 Week 4: GLPG3970 vs Placebo
    Statistical analysis description
    Number of participants included in analysis were 15.
    Comparison groups
    GLPG3970 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.859
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 2.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.81
    Statistical analysis title
    		 Week 8: GLPG3970 vs Placebo
    Statistical analysis description
    Number of participants included in analysis were 22.
    Comparison groups
    GLPG3970 v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.837
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -3.8
         upper limit
    		 4.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.46

    Secondary: Observed Pre-dose Plasma Concentration (Ctrough) of GLPG3970

    		 Close Top of page
    End point title
    		 Observed Pre-dose Plasma Concentration (Ctrough) of GLPG3970 [2]
    End point description
    Plasma concentration of GLPG3970 observed at pre-dose in nanogram per milliliter (ng/mL), obtained directly from the observed concentration versus time data. The pharmacokinetic (PK) analysis set included all randomized participant who received at least 1 dose of study drug and for which plasma concentration data were available. Number of participants with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose (within 30 minutes prior to dosing) on Weeks 1, 4, 8, and 12
    Notes
    [2] - 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: The endpoint assessed plasma concentration (Ctrough) of GLPG3970. Therefore, it is applicable for GLPG3970 arm only.
    End point values
    		 GLPG3970
    Number of subjects analysed
    20
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Week 1 (n=16)
    77.6 ( 64.7 )
        Week 4 (n=15)
    70.4 ( 108 )
        Week 8 (n=9)
    65 ( 265 )
        Week 12 (n=7)
    66 ( 219 )
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    GLPG3970
    Reporting group description
    		 Participants received GLPG3970 400 mg (2 *200 mg tablet), orally, once daily for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo matched to GLPG3970 tablet, orally, once daily for 12 weeks.

    Serious adverse events
    		 GLPG3970 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    		 GLPG3970 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 20 (50.00%)
    7 / 11 (63.64%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Epstein-Barr virus antibody positive
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    International normalised ratio increased
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Lipase increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Pancreatic enzymes increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    2
    Thrombocytopenia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Oral mucosa erosion
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Liver injury
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Drug eruption
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Rash pruritic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Skin reaction
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    2
    Infections and infestations
    Fungal pharyngitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Oral herpes
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Otitis media
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Mar 2021
    The protocol was amended in alignment with the newly identified potential risk of QT prolongation.
    12 May 2021
    The protocol was amended to closer monitor the new potential risk of QT prolongation.

    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.
    There were limitations in the dataset, given the small number of participants completing the treatment period due to early termination of the study.
    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.

    European Medicines Agency © 1995-Wed May 01 09:32:40 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA