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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, efficacy and pharmacokinetics of GLPG3970, administered orally for 6 weeks in adult subjects with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate

    Summary
    EudraCT number
    		 2020-000658-83
    Trial protocol
    		 BG  
    Global end of trial date
    07 Apr 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Apr 2022
    First version publication date
    06 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GLPG3970-CL-209
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04577781
    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
    07 Apr 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of GLPG3970 compared to placebo on the signs and symptoms of Rheumatoid Arthritis (RA) in participants with moderately to severely active RA and an inadequate response to methotrexate (MTX).
    Protection of trial subjects
    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 Harmonization for Good Clinical Practice (ICH-GCP) Guideline E6 (R2), and local ethical and legal requirements. The investigator informed the subjects of the risks and benefits of the clinical study. The subjects were informed that they could withdraw from the clinical study at any time for any reason. Consent was obtained in writing prior to any clinical study-related activities; the investigator retained a copy of the ICFs, which are available to the sponsor for review. The subjects were covered by the sponsor’s insurance according to local legal requirements.
    Background therapy
    		 Participants remained on a stable dose (10 to 20 mg/week) of MTX as background medication.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Oct 2020
    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
    Poland: 1
    Country: Number of subjects enrolled
    Bulgaria: 4
    Country: Number of subjects enrolled
    Georgia: 6
    Country: Number of subjects enrolled
    Ukraine: 17
    Worldwide total number of subjects
    28
    EEA total number of subjects
    5
    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)
    28
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was conducted across 4 countries (Georgia, Poland, Bulgaria, and Ukraine).

    Pre-assignment
    Screening details
    		 A total of 54 participants were screened, out of which 28 were randomized and treated.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GLPG3970
    Arm description
    		 Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG3970
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 400 mg GLPG3970 reconstituted oral solution, QD for a period of 6 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received GLPG3970 matching placebo reconstituted oral solution, QD for a period of 6 weeks.

    Number of subjects in period 1
    		GLPG3970 Placebo
    Started
    16
    12
    Completed
    13
    10
    Not completed
    3
    2
         Physician decision
    1
    -
         Adverse event, non-fatal
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GLPG3970
    Reporting group description
    		 Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.

    Reporting group values
    		 GLPG3970 Placebo Total
    Number of subjects
    		 16 12 28
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.9 ± 11.3 41.4 ± 8.6 -
    Gender categorical
    Units: Subjects
        Female
    		 11 8 19
        Male
    		 5 4 9
    Race
    Units: Subjects
        White
    		 16 12 28
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 16 12 28
    Disease Activity Score Based on 28 Joints C-reactive Protein [DAS28 (CRP)]
    The DAS28 (CRP) is a derived measurement with differential weighting given to each component such as Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), patient's global assessment of disease activity, and serum CRP level. DAS28 (CRP) = 0.56 x square root of TJC28 + 0.28 x square root of SJC28 + 0.36 x Ln[1+CRP(in mg/L)] + 0.014 x patient's disease activity VAS (in mm) + 0.96. A lower score is considered as better disease activity.
    Units: Score on a scale
        arithmetic mean (standard deviation)
    		 6.13 ± 0.87 5.68 ± 0.88 -

    End points

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    End points reporting groups
    Reporting group title
    GLPG3970
    Reporting group description
    		 Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.

    Primary: Change From Baseline in DAS28 (CRP) at Week 6

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    End point title
    		 Change From Baseline in DAS28 (CRP) at Week 6
    End point description
    The DAS28 (CRP) is a derived measurement with differential weighting given to each component such as TJC28, SJC28, patient's global assessment of disease activity, and serum CRP level. TJC28 ranges from 0-28 SJC28 ranges from 0-28 High sensitivity C-reactive protein (hsCRP) (in mg/L) Patient's disease activity VAS (in mm) (ranges from 0 = best to 100 = worst) The DAS28 (CRP) score was calculated using the below formula: DAS28 (CRP) = 0.56 x square root of TJC28 + 0.28 x square root of SJC28 + 0.36 x Ln[1+CRP(in mg/L)] + 0.014 x patient's disease activity VAS (in mm) + 0.96. A lower score is considered as better disease activity. Analysis population: Full analysis set (FAS) consisted of all randomized participants who had been administered at least 1 dose of investigational product. Participants with available data at specified timepoint were included.
    End point type
    Primary
    End point timeframe
    Baseline and Week 6
    End point values
    		 GLPG3970 Placebo
    Number of subjects analysed
    13
    10
    Units: Score on a scale
        least squares mean (standard error)
    -1.29 ± 0.224
    -1.24 ± 0.258
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    GLPG3970 v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.885 [1]
    Method
    		 MMRM
    Parameter type
    		 Least Squares (LS) Mean difference
    Point estimate
    -0.05
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.66
         upper limit
    		 0.55
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.353
    Notes
    [1] - Mixed model repeated measure (MMRM) with treatment-by-visit interaction and baseline-by-visit interaction as fixed effects (with an unstructured variance-covariance matrix).

    Secondary: Number of Participants With Treatment Emergent Adverse Events

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    End point title
    		 Number of Participants With Treatment Emergent Adverse Events
    End point description
    Treatment-Emergent Adverse Events (TEAE) were defined as • Any adverse event (AE) with an onset date on or after the IP start date and no later than 14 days after last dose of IP, or worsening of any AE on or after the IP start date. • Improvement or no change of any ongoing AEs on or after the IP start date are not considered treatment-emergent. If an AE was ongoing at the time of first IP intake and if there was no change or an improvement in its toxicity grade or its seriousness status, this AE was not considered as treatment-emergent. Serious TEAE was defined as a TEAE that • Resulted in death and was life-threatening; • Required in-patient hospitalization or prolongation of existing hospitalization; • Resulted in persistent or significant disability/incapacity; • Was a congenital anomaly / birth defect; • Was medically significant; Analysis population: Participants in the safety analysis set.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug until end of the study (up to 8 weeks)
    End point values
    		 GLPG3970 Placebo
    Number of subjects analysed
    16
    12
    Units: Participants
        TEAE
    6
    2
        Serious TEAE
    0
    0
        TEAE leading to death
    0
    0
        Treatment related TEAE
    4
    1
        TEAEs leading to study drug discontinuation
    2
    0
    No statistical analyses for this end point

    Secondary: Plasma Concentration (Ctrough) of GLPG3970

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    End point title
    		 Plasma Concentration (Ctrough) of GLPG3970 [2]
    End point description
    Ctrough was defined as plasma concentration level at the end of the dosing interval. Analysis Population: Pharmacokinetic analysis set (PKAS) consisted all participants who received at least 1 dose of investigational product with available plasma concentration data. Participants with available plasma concentration at specified time point were included.
    End point type
    Secondary
    End point timeframe
    Day 15: pre-dose; Day 29: pre-dose; Day 43: pre-dose
    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
    11 [3]
    Units: Nanogram per milliliter
    geometric mean (geometric coefficient of variation)
        Day 15: Pre-dose
    95.3 ± 115
        Day 29: Pre-dose
    103 ± 73.8
        Day 43: Pre-dose
    49.8 ± 697
    Notes
    [3] - n = 11 at day 15, 9 at day 29, 9 at day 43
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug until end of the study (up to 8 weeks)
    Adverse event reporting additional description
    Safety analysis set
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.

    Reporting group title
    GLPG3970
    Reporting group description
    		 Participants received 400 mg GLPG3970 oral solution, QD for a period of 6 weeks.

    Serious adverse events
    		 Placebo GLPG3970
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo GLPG3970
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 12 (16.67%)
    6 / 16 (37.50%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Lipase increased
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Hepatitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    COVID-19
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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