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    Clinical Trial Results:
    A Phase 2b, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose-Ranging Study to Evaluate the Efficacy and Safety Profile of PF-06700841 in Participants With Active Systemic Lupus Erythematosus (SLE)

    Summary
    EudraCT number
    		 2018-004175-12
    Trial protocol
    		 BE   HU   GB   CZ   RO   BG   PT   DE   PL   ES   IT  
    Global end of trial date
    05 Oct 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jul 2024
    First version publication date
    14 Jul 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    B7931028
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03845517
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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
    26 Apr 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of 3 once daily (QD) dose levels of PF-06700841 compared to placebo in participants with active SLE.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Apr 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 4
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Czechia: 6
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Hungary: 10
    Country: Number of subjects enrolled
    Japan: 19
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    China: 4
    Country: Number of subjects enrolled
    Portugal: 1
    Country: Number of subjects enrolled
    Bulgaria: 25
    Country: Number of subjects enrolled
    Colombia: 24
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    Poland: 25
    Country: Number of subjects enrolled
    Serbia: 19
    Country: Number of subjects enrolled
    Romania: 11
    Country: Number of subjects enrolled
    Taiwan: 17
    Country: Number of subjects enrolled
    Ukraine: 33
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    Mexico: 51
    Country: Number of subjects enrolled
    United States: 70
    Country: Number of subjects enrolled
    Greece: 4
    Worldwide total number of subjects
    350
    EEA total number of subjects
    96
    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)
    341
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 350 participants with active SLE were enrolled and randomized in the study.

    Pre-assignment
    Screening details
    		 The study was conducted at approximately 185 sites in the 24 countries from 18 April 2019 to 05 October 2023.

    Period 1
    Period 1 title
    Treatment Period (TP) (52 Weeks)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants were randomised to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
    Arm type
    		 Placebo

    Investigational medicinal product name
    PF-06700841
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received placebo matched to PF-06700841 QD for 52 weeks.

    Arm title
    		 PF-06700841 15 mg
    Arm description
    		 Participants were randomised to receive PF-06700841 15 milligram (mg) tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06700841
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received PF-06700841 15 mg QD for 52 weeks.

    Arm title
    		 PF-06700841 30 mg
    Arm description
    		 Participants were randomised to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06700841
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received PF-06700841 30 mg QD for 52 weeks.

    Arm title
    		 PF-06700841 45 mg
    Arm description
    		 Participants were randomised to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06700841
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received PF-06700841 45 mg QD for 52 weeks.

    Number of subjects in period 1
    		Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Started
    100
    50
    101
    99
    Completed
    68
    36
    78
    71
    Not completed
    32
    14
    23
    28
         Consent withdrawn by subject
    4
    6
    6
    5
         Adverse event, non-fatal
    12
    7
    10
    17
         Death
    -
    -
    1
    -
         Pregnancy
    1
    -
    -
    1
         Non-compliance with study drug
    1
    -
    -
    -
         Site Terminated by Sponsor
    2
    -
    -
    -
         Unspecified
    2
    -
    -
    -
         Lost to follow-up
    2
    -
    1
    -
         Lack of efficacy
    8
    1
    3
    4
         Physician's decision
    -
    -
    1
    -
         Protocol deviation
    -
    -
    1
    1
    Period 2
    Period 2 title
    Follow-up Period (FU P) (4 Weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Placebo
    Arm description
    		 Participants were randomised to receive placebo matched to PF-06700841 once daily (QD) for 52 weeks. Participants were followed up for 4 weeks after last dose.
    Arm type
    		 Placebo

    Investigational medicinal product name
    PF-06700841
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received placebo matched to PF-06700841 QD for 52 weeks.

    Arm title
    		 PF-06700841 15 mg
    Arm description
    		 Participants were randomised to receive PF-06700841 15 milligram (mg) tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06700841
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received PF-06700841 15 mg QD for 52 weeks.

    Arm title
    		 PF-06700841 30 mg
    Arm description
    		 Participants were randomised to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06700841
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received PF-06700841 30 mg QD for 52 weeks.

    Arm title
    		 PF-06700841 45 mg
    Arm description
    		 Participants were randomised to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06700841
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received PF-06700841 45 mg QD for 52 weeks.

    Number of subjects in period 2
    		Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Started
    68
    36
    78
    71
    Completed
    89
    42
    89
    92
    Not completed
    11
    8
    12
    7
         Consent withdrawn by subject
    3
    5
    7
    1
         Adverse event, non-fatal
    4
    2
    -
    2
         Death
    -
    -
    1
    1
         Pregnancy
    1
    -
    -
    -
         Study terminated by sponsor
    -
    -
    -
    1
         Unspecified
    1
    -
    1
    -
         Lost to follow-up
    2
    1
    2
    -
         Physician's decision
    -
    -
    1
    1
         Protocol deviation
    -
    -
    -
    1
    Joined
    32
    14
    23
    28
         Continue to follow up
    32
    14
    23
    28

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomised to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

    Reporting group title
    PF-06700841 15 mg
    Reporting group description
    		 Participants were randomised to receive PF-06700841 15 milligram (mg) tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

    Reporting group title
    PF-06700841 30 mg
    Reporting group description
    		 Participants were randomised to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

    Reporting group title
    PF-06700841 45 mg
    Reporting group description
    		 Participants were randomised to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

    Reporting group values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg Total
    Number of subjects
    		 100 50 101 99 350
    Age categorical
    Units: Participants
        Adults (18-64 years)
    		 100 49 97 95 341
        From 65-84 years
    		 0 1 4 4 9
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 42.5 ( 9.60 ) 41.5 ( 11.79 ) 42.8 ( 12.71 ) 41.0 ( 11.47 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 94 45 97 91 327
        Male
    		 6 5 4 8 23
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 2 0 7 2 11
        Asian
    		 14 9 11 13 47
        Black or African American
    		 6 4 6 7 23
        White
    		 71 31 69 68 239
        More than one race
    		 2 0 0 0 2
        Unknown or Not Reported
    		 5 6 8 9 28
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 29 17 34 35 115
        Not Hispanic or Latino
    		 71 32 67 62 232
        Unknown or Not Reported
    		 0 1 0 2 3

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomised to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

    Reporting group title
    PF-06700841 15 mg
    Reporting group description
    		 Participants were randomised to receive PF-06700841 15 milligram (mg) tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

    Reporting group title
    PF-06700841 30 mg
    Reporting group description
    		 Participants were randomised to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

    Reporting group title
    PF-06700841 45 mg
    Reporting group description
    		 Participants were randomised to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomised to receive placebo matched to PF-06700841 once daily (QD) for 52 weeks. Participants were followed up for 4 weeks after last dose.

    Reporting group title
    PF-06700841 15 mg
    Reporting group description
    		 Participants were randomised to receive PF-06700841 15 milligram (mg) tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

    Reporting group title
    PF-06700841 30 mg
    Reporting group description
    		 Participants were randomised to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

    Reporting group title
    PF-06700841 45 mg
    Reporting group description
    		 Participants were randomised to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

    Primary: Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52

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    End point title
    		 Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52
    End point description
    SRI-4 components: SLEDAI-2K,BILAG 2004 and PhGA. Participants were classified as SRI-4 responders, if they met all of criteria compared with baseline:1)>= 4 point reduction in SLEDAI-2K score; 2)no new BILAG A organ domain score or 2 new BILAG B organ domain scores; 3)no worsening < 0.3 point increase) in PhGA score. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity in individual organ system (range: A [severe] to E [no disease]; higher score = less severity). PhGA: assesses worsening in participant's general health status (range: 0 [none] to 3 [severe]; higher score = higher severity). Full analysis set (FAS):all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here “Number of Subjects Analyzed” signifies participants at Week 52 with Non-Responder Imputation (NRI) and Last Observation Carried Forward from Week 48 (LOCF48) applied.
    End point type
    Primary
    End point timeframe
    Week 52
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    96
    47
    99
    92
    Units: Percentage of participants
        number (confidence interval 95%)
    64.6 (54.5 to 74.7)
    57.4 (42.2 to 72.6)
    69.7 (60.1 to 79.3)
    66.3 (56.1 to 76.5)
    Statistical analysis title
    		 Placebo versus PF-06700841 15 mg
    Comparison groups
    Placebo v PF-06700841 15 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.8076 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -7.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.5
         upper limit
    		 9.5
    Notes
    [1] - One sided p-value.
    Statistical analysis title
    		 Placebo versus PF-06700841 45 mg
    Comparison groups
    PF-06700841 45 mg v Placebo
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.401 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.8
         upper limit
    		 15.3
    Notes
    [2] - One sided p-value.
    Statistical analysis title
    		 Placebo versus PF-06700841 30 mg
    Comparison groups
    PF-06700841 30 mg v Placebo
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.2189 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.9
         upper limit
    		 18.3
    Notes
    [3] - One sided p-value.

    Secondary: Percentage of Participants Achieving British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52

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    End point title
    		 Percentage of Participants Achieving British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52
    End point description
    BICLA included: BILAG-2004, SLEDAI-2K and PhGA. Participants were classified as responders, if they met all the following criteria: BILAG-2004 improvement (all A scores at baseline improved to B/C/D and all B scores improved to C or D); no worsening in disease activity (no new BILAG-2004 A scores or =<1 new B score); no worsening of total SLEDAI-2K score; no significant deterioration (<10 percent [%] worsening) in analogue PhGA. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity in individual organ system (range: A [severe] to E [no disease]; higher score = less severity). PhGA: assesses worsening in participant's general health status (range: 0 [none] to 3 [severe]; higher score = higher severity). FAS was included. Here “Number of Subjects Analyzed” signifies participants at Week 52 with NRI and LOCF48 applied.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    96
    47
    99
    92
    Units: Percentage of participants
        number (confidence interval 95%)
    43.8 (33.3 to 54.2)
    42.6 (27.4 to 57.8)
    52.5 (42.2 to 62.9)
    53.3 (42.5 to 64.0)
    Statistical analysis title
    		 Placebo versus PF-06700841 15 mg
    Comparison groups
    Placebo v PF-06700841 15 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.595 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.1
         upper limit
    		 14.9
    Notes
    [4] - One sided p-value.
    Statistical analysis title
    		 Placebo versus PF-06700841 30 mg
    Comparison groups
    Placebo v PF-06700841 30 mg
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.1125 [5]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    8.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.3
         upper limit
    		 22.6
    Notes
    [5] - One sided p-value.
    Statistical analysis title
    		 Placebo versus PF-06700841 45 mg
    Comparison groups
    Placebo v PF-06700841 45 mg
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0891 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    9.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.4
         upper limit
    		 23.6
    Notes
    [6] - One sided p-value.

    Secondary: Percentage of Participants Achieving a Reduction in Prednisone (or Equivalent) Dose to <=7.5 mg/day and Sustained for 12 Weeks Prior to Week 52 in Participants on Prednisone >7.5 mg/day (or Equivalent) at Baseline

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    End point title
    		 Percentage of Participants Achieving a Reduction in Prednisone (or Equivalent) Dose to <=7.5 mg/day and Sustained for 12 Weeks Prior to Week 52 in Participants on Prednisone >7.5 mg/day (or Equivalent) at Baseline
    End point description
    In this outcome measure data is reported for participants who achieved a reduction in prednisone (or equivalent) dose to <=7.5 mg/day and sustained for 12 Weeks prior at Week 52 and they also sustained this dose reduction for 12 weeks prior to Week 52 (Week 40 to Week 52). FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Number of participants in FAS with baseline Prednisone or equivalent >7.5 mg/day were analyzed. Here, “Number of Subjects Analyzed” signifies participants at Week 52 with NRI applied.
    End point type
    Secondary
    End point timeframe
    Week 52 for achieving reduction in dose along with Week 42 to Week 52 for sustained dosing
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    53
    33
    46
    43
    Units: Percentage of participants
        number (confidence interval 95%)
    26.4 (13.6 to 39.2)
    36.4 (18.4 to 54.3)
    37.0 (21.9 to 52.0)
    41.9 (26.0 to 57.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52

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    End point title
    		 Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52
    End point description
    LLDAS was defined as SLE disease activity index (SLEDAI-2k <=4, with no activity in major organ systems [renal, central nervous system, cardiopulmonary, vasculitis, fever]) and no haemolytic anaemia or gastrointestinal activity; no new lupus disease activity compared with the previous assessment; a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI PhGA (scale 0-3; higher scores = higher severity) <=1; a current prednisolone (or equivalent) dose <=7.5 milligram per day (mg/daily); and well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Data from participants from few sites were excluded from FAS. Here “Number of Subjects Analyzed” signifies participants at Week 52 with NRI applied.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    93
    47
    97
    88
    Units: Percentage of participants
        number (confidence interval 95%)
    22.6 (13.5 to 31.6)
    21.3 (8.5 to 34.0)
    35.1 (25.0 to 45.1)
    34.1 (23.6 to 44.6)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving a SRI-4 Response With Prednisone Dose Reduced to <=7.5 mg/day and Sustained for 12 Weeks at Week 52 in Participants on Prednisone >7.5 mg/day (or Equivalent) at Baseline

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    End point title
    		 Percentage of Participants Achieving a SRI-4 Response With Prednisone Dose Reduced to <=7.5 mg/day and Sustained for 12 Weeks at Week 52 in Participants on Prednisone >7.5 mg/day (or Equivalent) at Baseline
    End point description
    In this outcome measure data is reported for participants who achieved a reduction a SRI-4 response with prednisone dose reduced to <=7.5 mg/day and sustained for 12 weeks at Week 52. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Number of participants in FAS with baseline Prednisone or equivalent >7.5 mg/day were analyzed. Here, “Number of Subjects Analyzed” signifies participants at Week 52 with NRI applied.
    End point type
    Secondary
    End point timeframe
    12 Weeks prior at Week 52 (Week 40 to Week 52)
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    53
    33
    46
    43
    Units: Percentage of participants
        number (confidence interval 95%)
    20.8 (8.9 to 32.6)
    30.3 (13.1 to 47.5)
    32.6 (18.0 to 47.2)
    32.6 (17.4 to 47.7)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With >= 50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 52 in Participants With Baseline CLASI-A Score >=10

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    End point title
    		 Percentage of Participants With >= 50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 52 in Participants With Baseline CLASI-A Score >=10
    End point description
    CLASI is an validated measurement instrument for lupus erythematosus developed for use in clinical studies that consists of separate scores for the activity of the disease (CLASI-A). The CLASI activity score is calculated on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI activity score ranges from 0-70, with higher scores indicating more severe skin disease. Severity categories based on the CLASI activity score are as follows: mild (0-9), moderate (10-20), and severe (21-70). FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Number of participants in FAS with baseline CLASI-A score >= 10 were analyzed. Here, “Number of Subjects Analyzed” signifies participants at Week 52 with NRI applied.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    23
    12
    27
    16
    Units: Percentage of participants
        number (confidence interval 95%)
    73.9 (53.8 to 94.0)
    58.3 (26.3 to 90.4)
    77.8 (60.2 to 95.3)
    56.3 (28.8 to 83.7)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Total Scores of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52

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    End point title
    		 Change From Baseline in Total Scores of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52
    End point description
    The FACIT-F Scale is a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue). FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, “Number of Subjects Analyzed” signifies participants evaluable with observed data at Week 52.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    66
    36
    75
    64
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    4.6 (2.5 to 6.6)
    7.4 (4.5 to 10.2)
    5.8 (3.8 to 7.8)
    7.6 (5.5 to 9.7)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Physical Health Domain Scores of Lupus Quality of Life (LupusQoL) at Week 52

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    End point title
    		 Change From Baseline in Physical Health Domain Scores of Lupus Quality of Life (LupusQoL) at Week 52
    End point description
    The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others; measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Physical health domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, “Number of Subjects Analyzed” signifies participants evaluable for this outcome measure with observed data at the specified visit.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    66
    36
    75
    64
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    11.585 (7.475 to 15.695)
    10.892 (5.241 to 16.544)
    12.371 (8.464 to 16.278)
    14.875 (10.748 to 19.002)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Emotional Health Domain Scores of LupusQoL at Week 52

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    End point title
    		 Change From Baseline in Emotional Health Domain Scores of LupusQoL at Week 52
    End point description
    The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Emotional health domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, “Number of Subjects Analyzed” signifies participants evaluable for this outcome measure with observed data at the specified visit.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    66
    36
    75
    64
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    8.113 (4.132 to 12.093)
    10.469 (4.968 to 15.969)
    7.547 (3.749 to 11.346)
    11.823 (7.806 to 15.840)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Body Image Domain Scores of LupusQoL at Week 52

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    End point title
    		 Change From Baseline in Body Image Domain Scores of LupusQoL at Week 52
    End point description
    The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Body image domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, “Number of Subjects Analyzed” signifies participants evaluable for this outcome measure with observed data at the specified visit.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    62
    32
    66
    50
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    9.207 (4.352 to 14.062)
    10.935 (4.070 to 17.799)
    8.169 (3.448 to 12.890)
    15.599 (10.355 to 20.843)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Pain Domain Scores of LupusQoL at Week 52

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    End point title
    		 Change From Baseline in Pain Domain Scores of LupusQoL at Week 52
    End point description
    The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Pain domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, “Number of Subjects Analyzed” signifies participants evaluable for this outcome measure with observed data at the specified visit.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    66
    36
    75
    64
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    15.065 (10.470 to 19.659)
    15.480 (9.132 to 21.828)
    16.855 (12.488 to 21.223)
    24.418 (19.790 to 29.047)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fatigue Domain Scores of LupusQoL at Week 52

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    End point title
    		 Change From Baseline in Fatigue Domain Scores of LupusQoL at Week 52
    End point description
    The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Fatigue domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, “Number of Subjects Analyzed” signifies participants evaluable for this outcome measure with observed data at the specified visit.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    66
    36
    75
    64
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    10.317 (5.951 to 14.683)
    11.893 (5.892 to 17.894)
    11.701 (7.550 to 15.853)
    16.443 (12.036 to 20.850)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Planning Domain Scores of LupusQoL at Week 52

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    End point title
    		 Change From Baseline in Planning Domain Scores of LupusQoL at Week 52
    End point description
    The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Planning domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, “Number of Subjects Analyzed” signifies participants evaluable for this outcome measure with observed data at the specified visit.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    66
    36
    75
    64
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    14.168 (9.423 to 18.912)
    12.013 (5.487 to 18.538)
    10.335 (5.826 to 14.843)
    20.310 (15.523 to 25.097)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Intimate Relationship Domain Scores of LupusQoL at Week 52

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    End point title
    		 Change From Baseline in Intimate Relationship Domain Scores of LupusQoL at Week 52
    End point description
    The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Intimate relationship domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, “Number of Subjects Analyzed” signifies participants evaluable for this outcome measure with observed data at the specified visit.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    56
    25
    59
    42
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    12.430 (6.842 to 18.019)
    12.625 (4.112 to 21.139)
    6.494 (0.960 to 12.027)
    15.363 (9.078 to 21.647)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Burden to Others Domain Scores of LupusQoL at Week 52

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    End point title
    		 Change From Baseline in Burden to Others Domain Scores of LupusQoL at Week 52
    End point description
    The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Burden to others domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, “Number of Subjects Analyzed” signifies participants evaluable for this outcome measure with observed data at the specified visit.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    66
    36
    75
    64
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    12.535 (7.227 to 17.842)
    17.739 (10.412 to 25.065)
    11.560 (6.500 to 16.621)
    18.878 (13.523 to 24.233)
    No statistical analyses for this end point

    Secondary: Incidence Rate of Severe Flare Event

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    End point title
    		 Incidence Rate of Severe Flare Event
    End point description
    Incidence rate was defined as the number of participants with events per 100 participant-years. FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    96
    47
    100
    97
    Units: Participants per 100 participant-years
        number (confidence interval 95%)
    8.32 (3.35 to 17.15)
    6.92 (1.43 to 20.23)
    3.24 (0.67 to 9.46)
    6.95 (2.55 to 15.13)
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment-Emergent Adverse Events (AE)

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    End point title
    		 Number of Participants With Treatment-Emergent Adverse Events (AE)
    End point description
    An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are events from first dose of study intervention to 4 weeks after last dose of study intervention that were absent before treatment or that worsened relative to pre-treatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all non-SAEs. Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    100
    50
    101
    99
    Units: Participants
    80
    38
    88
    83
    No statistical analyses for this end point

    Secondary: Number of Participants With Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants With Serious Adverse Events (SAEs)
    End point description
    An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    100
    50
    101
    99
    Units: Participants
    8
    4
    8
    9
    No statistical analyses for this end point

    Secondary: Number of Participants With Adverse Events Leading to Discontinuation From Study

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    End point title
    		 Number of Participants With Adverse Events Leading to Discontinuation From Study
    End point description
    An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. In this endpoint, participants with adverse events leading to discontinuation from study were reported. Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    100
    50
    101
    99
    Units: Participants
    6
    2
    1
    3
    No statistical analyses for this end point

    Secondary: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

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    End point title
    		 Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
    End point description
    Clinical significance in ECG abnormalities was judged by investigator. Safety analysis set (SAS) included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    100
    50
    101
    99
    Units: Participants
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Clinically Significant Vital Signs Abnormalities

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    End point title
    		 Number of Participants With Clinically Significant Vital Signs Abnormalities
    End point description
    Vital signs included blood pressure, pulse rate, respiratory rate, and temperature. Clinical significance in vital signs abnormalities was judged by investigator. Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    100
    50
    101
    99
    Units: Participants
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Laboratory Test Abnormalities

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    End point title
    		 Number of Participants With Laboratory Test Abnormalities
    End point description
    Hematology (Hemoglobin[hgb],hematocrit,erythrocytes[ery]:<0.8*lower limit of normal[LLN];reticulocytes,reticulocytes/ery:<0.5*LLN,>1.5*upper LN[ULN];ery mean corpuscular volume[EMC], EMC hgb:<0.9*LLN,>1.5*ULN;EMC hgb concentration:<0.9* LLN;platelet:<0.5*LLN;leukocytes[leu]:<0.6*LLN,>1.5*ULN;lymphocytes, lymphocytes/leu, neutrophils, neutrophils/leu:<0.8* LLN,>1.2*ULN;basophils, basophils/leu, eosinophils, eosinophils/leu, monocytes, monocytes/leu:>1.2*ULN;activated partial thromboplastin time[PTT], PTT, prothrombin time:>1.1*ULN);Clinical chemistry(Total/direct/indirect bilirubin, glucose-fasting:>1.5*ULN; aspartate aminotransferase[AT], alanine AT:>3.0*ULN; protein, albumin, HDL cholesterol:<0.8*LLN;urea nitrogen, creatinine, triglyceride, cholesterol:>1.3*ULN;urate,LDL cholesterol:>1.2*ULN;potassium:<0.9*LLN,>1.1*ULN;calcium, bicarbonate:<0.9*LLN;creatine kinase:>2.0*ULN);Urinalysis (pH<4.5;glucose, protein, hgb, ketones, nitrite, leu esterase, granular/hyaline/WBCs casts:>1).SAS.
    End point type
    Secondary
    End point timeframe
    Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)
    End point values
    		 Placebo PF-06700841 15 mg PF-06700841 30 mg PF-06700841 45 mg
    Number of subjects analysed
    100
    50
    101
    99
    Units: Participants
    96
    48
    99
    97
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
    Adverse event reporting additional description
    Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorised as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

    Reporting group title
    PF-06700841 30 mg
    Reporting group description
    		 Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

    Reporting group title
    PF-06700841 45 mg
    Reporting group description
    		 Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

    Reporting group title
    PF-06700841 15 mg
    Reporting group description
    		 Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.

    Serious adverse events
    		 Placebo PF-06700841 30 mg PF-06700841 45 mg PF-06700841 15 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 100 (8.00%)
    8 / 101 (7.92%)
    9 / 99 (9.09%)
    4 / 50 (8.00%)
         number of deaths (all causes)
    0
    1
    1
    0
         number of deaths resulting from adverse events
    0
    1
    1
    0
    Investigations
    Transaminases increased
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    1 / 99 (1.01%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive breast carcinoma
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cutaneous T-cell lymphoma
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    1 / 99 (1.01%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 99 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Nervous system disorders
    Lupus encephalitis
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    1 / 99 (1.01%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thalamic stroke
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 99 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    1 / 99 (1.01%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal strangulation
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 99 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Lupus pleurisy
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Ureterolithiasis
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    1 / 99 (1.01%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lupus nephritis
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Systemic lupus erythematosus
         subjects affected / exposed
    2 / 100 (2.00%)
    1 / 101 (0.99%)
    2 / 99 (2.02%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 99 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    1 / 99 (1.01%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    1 / 99 (1.01%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 99 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    1 / 99 (1.01%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo PF-06700841 30 mg PF-06700841 45 mg PF-06700841 15 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 100 (47.00%)
    53 / 101 (52.48%)
    47 / 99 (47.47%)
    19 / 50 (38.00%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 101 (0.99%)
    4 / 99 (4.04%)
    3 / 50 (6.00%)
         occurrences all number
    1
    1
    5
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 100 (5.00%)
    17 / 101 (16.83%)
    9 / 99 (9.09%)
    4 / 50 (8.00%)
         occurrences all number
    6
    20
    9
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 100 (0.00%)
    6 / 101 (5.94%)
    2 / 99 (2.02%)
    0 / 50 (0.00%)
         occurrences all number
    0
    6
    2
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 100 (5.00%)
    7 / 101 (6.93%)
    6 / 99 (6.06%)
    1 / 50 (2.00%)
         occurrences all number
    5
    11
    6
    1
    Nausea
         subjects affected / exposed
    5 / 100 (5.00%)
    3 / 101 (2.97%)
    7 / 99 (7.07%)
    4 / 50 (8.00%)
         occurrences all number
    5
    3
    9
    4
    Vomiting
         subjects affected / exposed
    1 / 100 (1.00%)
    4 / 101 (3.96%)
    4 / 99 (4.04%)
    3 / 50 (6.00%)
         occurrences all number
    1
    4
    4
    3
    Infections and infestations
    Cystitis
         subjects affected / exposed
    3 / 100 (3.00%)
    2 / 101 (1.98%)
    2 / 99 (2.02%)
    3 / 50 (6.00%)
         occurrences all number
    3
    2
    3
    8
    Nasopharyngitis
         subjects affected / exposed
    7 / 100 (7.00%)
    6 / 101 (5.94%)
    8 / 99 (8.08%)
    5 / 50 (10.00%)
         occurrences all number
    10
    8
    9
    5
    Oral candidiasis
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    6 / 99 (6.06%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    7
    0
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 100 (7.00%)
    11 / 101 (10.89%)
    8 / 99 (8.08%)
    1 / 50 (2.00%)
         occurrences all number
    7
    12
    11
    1
    Urinary tract infection
         subjects affected / exposed
    11 / 100 (11.00%)
    10 / 101 (9.90%)
    11 / 99 (11.11%)
    1 / 50 (2.00%)
         occurrences all number
    13
    11
    12
    2
    COVID-19
         subjects affected / exposed
    17 / 100 (17.00%)
    11 / 101 (10.89%)
    10 / 99 (10.10%)
    9 / 50 (18.00%)
         occurrences all number
    17
    11
    10
    10

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Mar 2021
    The following modifications were made to PA4 as a result of the updated PF-06700841 Investigational Brochure (IB). The following changes were added and/or modified to the overview of the MoA and the safety profile of the product: Section 2.2.2. Clinical Overview Added study C2501007, an ongoing study in hidradenitis suppurativa. Updated to include additional guidance to the sites to encourage randomized participants to remain in the study at least through to the end of the double-blind period to complete safety and efficacy assessments.
    28 Sep 2021
    The overall rationale for B7931028 protocol amendment 6 is to address the Quantiferon gold test results which are not negative. The amendment will allow specific safety monitoring to be put into place to allow participants with latent TB (not active TB) to be eligible for the B7931028 study provided the protocol criteria can be met. China is having the biggest impact on enrolling participants into the study because of this eligibility criteria; however, once the next global protocol amendment is required, this language will be added as well.
    06 Jun 2022
    The overall rationale for B7931028 Protocol Amendment 7 is to decrease the sample size for the study from 448 participants to 350 participants, and to allow eligibility of participants with latent TB (positive quantiferon gold tests) who agree to receiving treatment with INH and Vitamin B6. This amendment also included the administrative changes made in Protocol Amendment 5 (requested during the EU Voluntary Harmonization Procedure (VHP) review of Amendment 4, countries submitting their initial clinical trial application with Amendment 5 (Italy and Argentina), and to any country requiring new protocol amendments to be submitted (Taiwan); and Protocol Amendment 6 (China only amendment) to be globally implemented. Furthermore, this change will allow specific safety monitoring to be put into place to allow participants with latent TB (not active TB) to be eligible for the study provided the protocol inclusion/exclusion criteria can be met.
    15 Jun 2023
    The driver for B7931028 Protocol Amendment 8 is to modify the key secondary endpoint of ‘time to first severe SLE flare’ and replace it with an exploratory endpoint of ‘BICLA response at Week 52’. ‘ Time to first severe SLE flare’ will remain as a secondary endpoint, just not the ‘key’ secondary endpoint and the data will be summarized as a secondary endpoint. The estimands for the associated endpoints have been updated to reflect these changes. E2, has been updated to align with the revised ‘Key’ secondary endpoint of ‘BICLA response at Week 52’ as was E7, the estimand for 'time to first severe SLE flare’.

    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.
    For the PF-06700841 30 mg, there was a total of 1 death which was reported in both on-treatment and follow-up phases in subject disposition section.
    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.

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