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    Clinical Trial Results:
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients with Moderate to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee

    Summary
    EudraCT number
    2017-001943-12
    Trial protocol
    GB   HU   ES  
    Global end of trial date
    03 May 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    15 May 2020
    First version publication date
    15 May 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    R475-PN-1612
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03285646
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Acronym: FACT CLBP 1
    Sponsors
    Sponsor organisation name
    Regeneron Pharmaceuticals, Inc.
    Sponsor organisation address
    777 Old Saw Mill River Rd., Tarrytown, United States, 10591
    Public contact
    Study Director, Regeneron Pharmaceuticals, Inc., clinicaltrials@regeneron.com
    Scientific contact
    Study Director, Regeneron Pharmaceuticals, Inc., clinicaltrials@regeneron.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
    05 Jun 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of fasinumab in relieving chronic low back pain (CLBP) as compared to placebo in subjects with a clinical diagnosis of moderate-to-severe non-radicular CLBP and osteoarthritis (OA) of the knee or hip when treated for up to 16 weeks.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with the International Conference on Harmonisation (ICH) guidelines for Good Clinical Practice (GCP) and applicable regulatory requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    30 Oct 2017
    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
    United States: 63
    Worldwide total number of subjects
    63
    EEA total number of subjects
    0
    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)
    45
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were screened for study eligibility across the United States. Of the 377 subjects screened, 63 met eligibility criteria. The most frequently reported reason for non-randomization was inclusion criteria not met and/ or exclusion criteria met (224 subjects):139 did not meet inclusion criteria, 86 subjects met exclusion criteria.

    Pre-assignment
    Screening details
    The study consisted of a screening period of up to 30 days and a 7 (+3 day)-day pre-randomization period during which all pain medication except study-provided rescue medication was discontinued.

    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, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    fasinumab-matching placebo
    Arm description
    Subjects received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) during the treatment period (day 1 through week 16). Subjects were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±3 days)
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered SC injection of placebo matched to fasinumab Q4W into abdomen, thigh or upper arm

    Arm title
    fasinumab 3 mg SC Q4W
    Arm description
    Subjects received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) during the treatment period (day 1 through week 16). Subjects were permitted to use only acetaminophen/ paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±3 days)
    Arm type
    Experimental

    Investigational medicinal product name
    Fasinumab
    Investigational medicinal product code
    REGN475
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered 3 mg SC injection of fasinumab Q4W into abdomen, thigh or upper arm

    Number of subjects in period 1
    fasinumab-matching placebo fasinumab 3 mg SC Q4W
    Started
    32
    31
    Completed
    19
    27
    Not completed
    13
    4
         Adverse event, non-fatal
    1
    -
         Investigator/Sponsor Decision
    -
    1
         Consent withdrawn by subject
    10
    2
         Lost to follow-up
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    fasinumab-matching placebo
    Reporting group description
    Subjects received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) during the treatment period (day 1 through week 16). Subjects were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±3 days)

    Reporting group title
    fasinumab 3 mg SC Q4W
    Reporting group description
    Subjects received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) during the treatment period (day 1 through week 16). Subjects were permitted to use only acetaminophen/ paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±3 days)

    Reporting group values
    fasinumab-matching placebo fasinumab 3 mg SC Q4W Total
    Number of subjects
    32 31 63
    Age categorical
    Units: Subjects
        Adults <65 years of age
    24 21 45
        Adults >=65 years of age
    8 10 18
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    57.7 ± 9.88 60.0 ± 10.52 -
    Sex: Female, Male
    Units:
        Female
    21 18 39
        Male
    11 13 24
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    1 3 4
        Not Hispanic or Latino
    31 28 59
        Unknown or Not Reported
    0 0 0
    Race/Ethnicity, Customized
    Units: Subjects
        White
    15 17 32
        Black or African American
    15 14 29
        American Indian or Alaskan
    1 0 1
        Native Hawaiian or Other Pacific Islander
    1 0 1
    Average Daily Low Back Pain Intensity (LBPI) Numerical Rating Scale (NRS) Score
    Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Subjects described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    6.66 ± 1.475 6.81 ± 1.338 -
    Roland Morris Disability Questionnaire (RMDQ) Total Score
    The RMDQ is a self-administered, widely used health status measure for lower back pain (LBP). It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The score of the RMDQ is the total number of items checked - that is from a minimum of 0 (no disability) to a maximum of 24 (maximum disability), where lower scores indicative of better function.
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    11.03 ± 5.445 10.90 ± 5.492 -

    End points

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    End points reporting groups
    Reporting group title
    fasinumab-matching placebo
    Reporting group description
    Subjects received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) during the treatment period (day 1 through week 16). Subjects were permitted to use only acetaminophen/paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±3 days)

    Reporting group title
    fasinumab 3 mg SC Q4W
    Reporting group description
    Subjects received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) during the treatment period (day 1 through week 16). Subjects were permitted to use only acetaminophen/ paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±3 days)

    Primary: Change from Baseline to Week 16 in the Average Daily Low Back Pain Intensity (LBPI) Numeric Rating Scale (NRS) Score

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    End point title
    Change from Baseline to Week 16 in the Average Daily Low Back Pain Intensity (LBPI) Numeric Rating Scale (NRS) Score [1]
    End point description
    Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.
    End point type
    Primary
    End point timeframe
    Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16
    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 descriptive statistics were reported.
    End point values
    fasinumab-matching placebo fasinumab 3 mg SC Q4W
    Number of subjects analysed
    32
    31
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Change from Baseline to Week 1 (n=32,31)
    -0.73 ± 1.424
    -1.62 ± 2.037
        Change from Baseline to Week 2 (n=29,31)
    -0.98 ± 1.588
    -2.15 ± 2.067
        Change from Baseline to Week 4 (n=28,29)
    -1.28 ± 1.878
    -2.64 ± 2.038
        Change from Baseline to Week 8 (n=20,21)
    -1.21 ± 1.568
    -2.82 ± 1.963
        Change from Baseline to Week 12 (n=9,13)
    -2.12 ± 1.582
    -3.18 ± 2.046
        Change from Baseline to Week 16 (n=2,7)
    -0.77 ± 1.943
    -2.32 ± 1.367
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 16 in the Roland Morris Disability Questionnaire (RMDQ) Total Score

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    End point title
    Change from Baseline to Week 16 in the Roland Morris Disability Questionnaire (RMDQ) Total Score
    End point description
    The RMDQ is a self-administered, widely used health status measure for lower back pain (LBP). It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The score of the RMDQ is the total number of items checked - that is from a minimum of 0 (no disability) to a maximum of 24 (maximum disability), where lower scores indicative of better function.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
    End point values
    fasinumab-matching placebo fasinumab 3 mg SC Q4W
    Number of subjects analysed
    32
    31
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Change from Baseline to Week 2 (n=27,24)
    -2.70 ± 5.120
    -2.54 ± 4.836
        Change from Baseline to Week 4 (n=24,23)
    -1.92 ± 4.529
    -3.09 ± 3.884
        Change from Baseline to Week 8 (n=19,17)
    0.37 ± 4.487
    -4.18 ± 5.015
        Change from Baseline to Week 12 (n=9,13)
    0.83 ± 3.061
    -3.33 ± 4.301
        Change from Baseline to Week 16 (n=2,7)
    -1.00 ± 99999
    -5.75 ± 3.948
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 16 in Patient Global Assessment (PGA) of Low Back Pain (LBP) Score

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    End point title
    Change from Baseline to Week 16 in Patient Global Assessment (PGA) of Low Back Pain (LBP) Score
    End point description
    The PGA of LBP is a subject assessed 5 point Likert scale of LBP ranging from 1-5 where 1 = very well; 2 = well; 3 = fair; 4 = poor; and 5 = very poor.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
    End point values
    fasinumab-matching placebo fasinumab 3 mg SC Q4W
    Number of subjects analysed
    32
    31
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Change from Baseline to Week 2 (n=27,29)
    -0.44 ± 0.751
    -0.76 ± 0.786
        Change from Baseline to Week 4 (n=25,25)
    -0.60 ± 0.957
    -1.04 ± 0.676
        Change from Baseline to Week 8 (n=20,20)
    -0.55 ± 0.945
    -1.10 ± 1.021
        Change from Baseline to Week 12 (n=7,10)
    -0.57 ± 1.134
    -1.00 ± 1.333
        Change from Baseline to Week 16 (n=1,4)
    0.00 ± 99999
    -0.75 ± 0.500
    No statistical analyses for this end point

    Secondary: Number of Subjects Achieving ≥30% Reduction from Baseline to Week 16 in Average Daily LBPI NRS Score

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    End point title
    Number of Subjects Achieving ≥30% Reduction from Baseline to Week 16 in Average Daily LBPI NRS Score
    End point description
    Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Subjects described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    fasinumab-matching placebo fasinumab 3 mg SC Q4W
    Number of subjects analysed
    32
    31
    Units: Subjects
    12
    21
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 16 in the Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Score

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    End point title
    Change from Baseline to Week 16 in the Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Score
    End point description
    The BPI-sf is a self-administered questionnaire (for subjects to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. With a recall period of 24 hours, the questionnaire contains the front and back body diagrams, the 4 pain severity items and 7 pain interference items rated on 0–10 scales (0, does not interfere; 10 completely interferes), and the question about percentage of pain relief by analgesics. The BPI pain interference is typically scored as the mean of the 7 interference items.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
    End point values
    fasinumab-matching placebo fasinumab 3 mg SC Q4W
    Number of subjects analysed
    32
    31
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Change from Baseline to Week 2 (n=27,29)
    -1.55 ± 2.306
    -1.94 ± 2.255
        Change from Baseline to Week 4 (n=25,25)
    -1.49 ± 2.390
    -2.15 ± 2.157
        Change from Baseline to Week 8 (n=20,20)
    -1.31 ± 2.119
    -2.70 ± 2.774
        Change from Baseline to Week 12 (n=7,10)
    -1.63 ± 2.096
    -1.84 ± 1.976
        Change from Baseline to Week 16 (n=1,4)
    -1.14 ± 99999
    -1.29 ± 3.017
    No statistical analyses for this end point

    Secondary: Number of Adjudicated Arthropathy (AA) Events

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    End point title
    Number of Adjudicated Arthropathy (AA) Events
    End point description
    Adjudicated arthropathy is an umbrella term that encompasses the following conditions; Rapidly progressive OA type 1 and 2, Subchondral insufficiency fractures, Primary Osteonecrosis, and Destructive arthropathy
    End point type
    Secondary
    End point timeframe
    Up to Week 36
    End point values
    fasinumab-matching placebo fasinumab 3 mg SC Q4W
    Number of subjects analysed
    32
    31
    Units: events
    0
    2
    No statistical analyses for this end point

    Secondary: Number of Destructive Arthropathy (DA) Events

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    End point title
    Number of Destructive Arthropathy (DA) Events
    End point description
    Destructive arthropathy (DA) is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA.
    End point type
    Secondary
    End point timeframe
    Up to Week 36
    End point values
    fasinumab-matching placebo fasinumab 3 mg SC Q4W
    Number of subjects analysed
    32
    31
    Units: events
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    Number of Treatment-Emergent Adverse Events (TEAEs)
    End point description
    Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.
    End point type
    Secondary
    End point timeframe
    Up to week 16
    End point values
    fasinumab-matching placebo fasinumab 3 mg SC Q4W
    Number of subjects analysed
    32
    31
    Units: events
    33
    14
    No statistical analyses for this end point

    Secondary: Number of Sympathetic Nervous System (SNS) Dysfunction Events

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    End point title
    Number of Sympathetic Nervous System (SNS) Dysfunction Events
    End point description
    Potential events of sympathetic nervous system (SNS) dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction were only diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist.
    End point type
    Secondary
    End point timeframe
    Up to Week 36
    End point values
    fasinumab-matching placebo fasinumab 3 mg SC Q4W
    Number of subjects analysed
    32
    31
    Units: events
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Peripheral Sensory AEs that Require a Neurology Consultation

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    End point title
    Number of Peripheral Sensory AEs that Require a Neurology Consultation
    End point description
    Any peripheral sensory AE (eg, paraesthesia and hypoaesthesia) that, per the investigator’s judgment, requires a neurology consultation.
    End point type
    Secondary
    End point timeframe
    Up to Week 36
    End point values
    fasinumab-matching placebo fasinumab 3 mg SC Q4W
    Number of subjects analysed
    32
    31
    Units: events
        Total number of Hypoaesthesia events
    1
    0
        Total number of Paraesthesia events
    1
    0
    No statistical analyses for this end point

    Secondary: Number of All-Cause Joint Replacement (JR) Surgery Events

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    End point title
    Number of All-Cause Joint Replacement (JR) Surgery Events
    End point description
    All joint replacement surgery events regardless of cause.
    End point type
    Secondary
    End point timeframe
    Up to Week 36
    End point values
    fasinumab-matching placebo fasinumab 3 mg SC Q4W
    Number of subjects analysed
    32
    31
    Units: events
    1
    1
    No statistical analyses for this end point

    Secondary: Number of Joint Replacement Surgery Events Reported at Telephone Survey After Last Dose of Study Drug

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    End point title
    Number of Joint Replacement Surgery Events Reported at Telephone Survey After Last Dose of Study Drug
    End point description
    An end of study phone contact will be conducted approximately 52 weeks following the last dose of study drug to evaluate the number of subjects who have undergone or are scheduled for JR surgery.
    End point type
    Secondary
    End point timeframe
    Up to Week 64
    End point values
    fasinumab-matching placebo fasinumab 3 mg SC Q4W
    Number of subjects analysed
    32
    31
    Units: events
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With at Least One Positive Anti-Drug Antibody (ADA) Assay

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    End point title
    Number of Subjects With at Least One Positive Anti-Drug Antibody (ADA) Assay
    End point description
    Samples for Anti-Drug Antibody (ADA) evaluation were collected at baseline and at subsequent study visits. ADA variables include ADA status (+ or -) and titer as follows: Total subjects negative in the ADA assay at all time points analyzed. Pre-existing immunoreactivity - positive response at baseline with all post-dose results negative, or a positive response at baseline with all post-dose responses less than 9-fold over baseline titer levels. Treatment emergent - post-dose positive result when baseline results were negative. Persistent - A positive result detected in at least 2 consecutive post baseline samples separated by at least a 16-week post baseline period, with no negative results in-between. Indeterminate - A positive result at the last collection time point analyzed only. Transient - Not persistent or indeterminate regardless of any missing samples. Treatment boosted - any post-dose positive result at least 9-fold over the baseline level when baseline is positive.
    End point type
    Secondary
    End point timeframe
    16 Weeks
    End point values
    fasinumab-matching placebo fasinumab 3 mg SC Q4W
    Number of subjects analysed
    31
    31
    Units: Subjects
        Negative/Pre-Existing
    31
    31
        Treatment Boosted
    0
    0
        Treatment-Emergent
    0
    0
        Treatment-Emergent: Persistent
    0
    0
        Treatment-Emergent: Transient
    0
    0
        Treatment-Emergent: Indeterminate
    0
    0
    No statistical analyses for this end point

    Secondary: Serum Concentration of Functional Fasinumab Over Time

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    End point title
    Serum Concentration of Functional Fasinumab Over Time [2]
    End point description
    Summary of mean concentration of functional fasinumab are presented by nominal time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, Week 4, Week 8, Week 16
    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: Placebo subjects were not included in the concentration analysis.
    End point values
    fasinumab 3 mg SC Q4W
    Number of subjects analysed
    31
    Units: Milligram per Liter (mg/L)
    arithmetic mean (standard deviation)
        Baseline (n=31)
    0 ± 0
        Week 2 (n=23)
    0.262 ± 0.0992
        Week 4 (n=25)
    0.176 ± 0.0679
        Week 8 (n=18)
    0.247 ± 0.130
        Week 16 (n=3)
    0.192 ± 0.0932
    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 to the day of the last dose of study drug + 4 weeks (Week 16)
    Adverse event reporting additional description
    Reported AEs are Treatment-Emergent Adverse Events which are AEs that developed/worsened during the ‘On Treatment’ period ( from the administration of first dose of study drug up to Week 16)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    fasinumab-matching placebo
    Reporting group description
    Subjects received fasinumab-matching placebo subcutaneously (SC) every 4 weeks (Q4W) during the treatment period (day 1 through week 16). Subjects were permitted to use only acetaminophen/ paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±3 days)

    Reporting group title
    fasinumab 3 mg SC Q4W
    Reporting group description
    Subjects received fasinumab 3 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) during the treatment period (day 1 through week 16). Subjects were permitted to use only acetaminophen/ paracetamol as rescue medication. The treatment period included both study visits and a phone contact on day 8 (±3 days)

    Serious adverse events
    fasinumab-matching placebo fasinumab 3 mg SC Q4W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 31 (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: 5%
    Non-serious adverse events
    fasinumab-matching placebo fasinumab 3 mg SC Q4W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 32 (28.13%)
    1 / 31 (3.23%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 32 (12.50%)
    1 / 31 (3.23%)
         occurrences all number
    5
    1
    Back pain
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1

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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? Yes
    Date
    Interruption
    Restart date
    03 May 2018
    In May 2018, the sponsor implemented an urgent safety measure. As a result, enrollment into R475-PN-1612 was stopped on 03 May 2018; subjects already enrolled in the study immediately discontinued study drug and entered the 20-week follow-up period.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    As a result of an urgent safety measure and discontinuation of study drug, the small number of participants enrolled in this study limited the interpretability of the efficacy results
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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