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    Clinical Trial Results:
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Combination of PI3Kδ Inhibitor Parsaclisib and Ruxolitinib in Participants With Myelofibrosis

    Summary
    EudraCT number
    		 2020-003130-21
    Trial protocol
    		 AT   DE   NO   FR   DK   FI   IT  
    Global end of trial date
    25 Nov 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    INCB 50465-313/LIMBER-313
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Incyte Corporation
    Sponsor organisation address
    1801 Augustine Cutoff, Wilmington, United States, 19803
    Public contact
    Study Director, Incyte Corporation, 1 8554633463, medinfo@incyte.com
    Scientific contact
    Study Director, Incyte Corporation, 1 8554633463, medinfo@incyte.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
    25 Nov 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Nov 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This study was conducted to evaluate and compare the efficacy of parsaclisib plus ruxolitinib versus placebo plus ruxolitinib on spleen volume at Week 24.
    Protection of trial subjects
    This study was performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and conducted in adherence to the study Protocol, applicable Good Clinical Practices, and applicable laws and country-specific regulations in which the study was conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 May 2021
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 5
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    China: 27
    Country: Number of subjects enrolled
    Denmark: 2
    Country: Number of subjects enrolled
    Finland: 1
    Country: Number of subjects enrolled
    France: 19
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Israel: 4
    Country: Number of subjects enrolled
    Italy: 38
    Country: Number of subjects enrolled
    Japan: 31
    Country: Number of subjects enrolled
    Korea, Republic of: 3
    Country: Number of subjects enrolled
    Norway: 9
    Country: Number of subjects enrolled
    Poland: 11
    Country: Number of subjects enrolled
    Spain: 24
    Country: Number of subjects enrolled
    Türkiye: 8
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    United States: 58
    Worldwide total number of subjects
    252
    EEA total number of subjects
    115
    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)
    129
    From 65 to 84 years
    122
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study was conducted at 93 study sites in Austria, Belgium, China, Denmark, Finland, France, Germany, Israel, Italy, Japan, Norway, Poland, South Korea, Spain, Turkey, the United Kingdom, and the United States.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Parsaclisib plus ruxolitinib
    Arm description
    		 Participants were randomized to receive parsaclisib plus ruxolitinib beginning on Day 1 and continued on this regimen as long as it was tolerated and the participants did not meet any discontinuation criteria. Participants with a Baseline platelet count ≥100 × 10^9/Liter received ruxolitinib 15 milligrams (mg) twice daily (BID). Participants with a Baseline platelet count of 50 to < 100 × 10^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the Dynamic International Prognostic Scoring System (DIPSS) risk category (high versus intermediate-2 versus intermediate-1). Participants received parsaclisib at a dose of 5 mg once daily (QD).
    Arm type
    		 Experimental

    Investigational medicinal product name
    parsaclisib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Unit dose strength(s)/dosage level(s): 5 mg tablets, 2.5 mg tablets, 1.0 mg tablets

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Unit dose strength(s)/dosage level(s): 5 mg tablets, 2.5 mg tablets, 1.0 mg tablets

    Investigational medicinal product name
    ruxolitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Unit dose strength(s)/dosage level(s): 5 mg tablets; 15 mg tablets (in some countries)

    Arm title
    		 Placebo plus ruxolitinib
    Arm description
    		 Participants were randomized to receive placebo plus ruxolitinib beginning on Day 1 and continued on this regimen until they left the study. Participants with a Baseline platelet count ≥100 × 10^9/Liter received ruxolitinib 15 mg BID. Participants with a Baseline platelet count of 50 to < 100 × 10^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the DIPSS risk category (high versus intermediate-2 versus intermediate-1). Participants received matching placebo at a dose of 5 mg QD. After 24 weeks, participants randomized to receive placebo plus ruxolitinib could have switched to treatment with parsaclisib plus ruxolitinib per the regimen received during the first 24 weeks of the study. Treatment continued for as long as the regimen was tolerated and the participant did not meet any discontinuation criteria.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ruxolitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Unit dose strength(s)/dosage level(s): 5 mg tablets; 15 mg tablets (in some countries)

    Number of subjects in period 1
    		Parsaclisib plus ruxolitinib Placebo plus ruxolitinib
    Started
    125
    127
    Completed
    0
    0
    Not completed
    125
    127
         Adverse event, serious fatal
    5
    3
         Consent withdrawn by subject
    8
    2
         Physician decision
    2
    -
         Adverse event, non-fatal
    2
    -
         Sponsor Decision
    104
    117
         Lost to follow-up
    1
    -
         Mature Plasmacytoid Dendritic Cell Proliferation
    -
    1
         Transitioned to Rollover Study with Ruxolitinib
    2
    3
         Protocol deviation
    1
    -
         Lack of efficacy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Parsaclisib plus ruxolitinib
    Reporting group description
    		 Participants were randomized to receive parsaclisib plus ruxolitinib beginning on Day 1 and continued on this regimen as long as it was tolerated and the participants did not meet any discontinuation criteria. Participants with a Baseline platelet count ≥100 × 10^9/Liter received ruxolitinib 15 milligrams (mg) twice daily (BID). Participants with a Baseline platelet count of 50 to < 100 × 10^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the Dynamic International Prognostic Scoring System (DIPSS) risk category (high versus intermediate-2 versus intermediate-1). Participants received parsaclisib at a dose of 5 mg once daily (QD).

    Reporting group title
    Placebo plus ruxolitinib
    Reporting group description
    		 Participants were randomized to receive placebo plus ruxolitinib beginning on Day 1 and continued on this regimen until they left the study. Participants with a Baseline platelet count ≥100 × 10^9/Liter received ruxolitinib 15 mg BID. Participants with a Baseline platelet count of 50 to < 100 × 10^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the DIPSS risk category (high versus intermediate-2 versus intermediate-1). Participants received matching placebo at a dose of 5 mg QD. After 24 weeks, participants randomized to receive placebo plus ruxolitinib could have switched to treatment with parsaclisib plus ruxolitinib per the regimen received during the first 24 weeks of the study. Treatment continued for as long as the regimen was tolerated and the participant did not meet any discontinuation criteria.

    Reporting group values
    		 Parsaclisib plus ruxolitinib Placebo plus ruxolitinib Total
    Number of subjects
    		 125 127 252
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 67 62 129
        From 65-84 years
    		 58 64 122
        85 years and over
    		 0 1 1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.2 ( 10.34 ) 63.3 ( 10.90 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 49 49 98
        Male
    		 76 78 154
    Race/Ethnicity, Customized
    Units: Subjects
        White or Caucasian
    		 80 84 164
        Black or African American
    		 1 1 2
        Asian
    		 33 31 64
        Not Reported
    		 10 10 20
        "Not Hispanic, Latino or Spanish" in Database
    		 1 0 1
        Turkish
    		 0 1 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 7 7 14
        Not Hispanic or Latino
    		 103 110 213
        Unknown or Not Reported
    		 15 10 25

    End points

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    End points reporting groups
    Reporting group title
    Parsaclisib plus ruxolitinib
    Reporting group description
    		 Participants were randomized to receive parsaclisib plus ruxolitinib beginning on Day 1 and continued on this regimen as long as it was tolerated and the participants did not meet any discontinuation criteria. Participants with a Baseline platelet count ≥100 × 10^9/Liter received ruxolitinib 15 milligrams (mg) twice daily (BID). Participants with a Baseline platelet count of 50 to < 100 × 10^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the Dynamic International Prognostic Scoring System (DIPSS) risk category (high versus intermediate-2 versus intermediate-1). Participants received parsaclisib at a dose of 5 mg once daily (QD).

    Reporting group title
    Placebo plus ruxolitinib
    Reporting group description
    		 Participants were randomized to receive placebo plus ruxolitinib beginning on Day 1 and continued on this regimen until they left the study. Participants with a Baseline platelet count ≥100 × 10^9/Liter received ruxolitinib 15 mg BID. Participants with a Baseline platelet count of 50 to < 100 × 10^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the DIPSS risk category (high versus intermediate-2 versus intermediate-1). Participants received matching placebo at a dose of 5 mg QD. After 24 weeks, participants randomized to receive placebo plus ruxolitinib could have switched to treatment with parsaclisib plus ruxolitinib per the regimen received during the first 24 weeks of the study. Treatment continued for as long as the regimen was tolerated and the participant did not meet any discontinuation criteria.

    Primary: Percentage of participants achieving ≥35% reduction in spleen volume from Baseline to Week 24 as measured by magnetic resonance imaging [MRI] (or computed tomography [CT] scan in applicable participants)

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    End point title
    		 Percentage of participants achieving ≥35% reduction in spleen volume from Baseline to Week 24 as measured by magnetic resonance imaging [MRI] (or computed tomography [CT] scan in applicable participants)
    End point description
    Participants had an MRI of the upper and lower abdomen and pelvis to determine the spleen volume. A CT scan was substituted for participants who were not candidates for MRI or when MRI was not readily available. Determination of spleen length below the left costal margin was measured by palpation, using a flexible ruler provided by the sponsor. Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups were defined according to the treatment assignment at randomization regardless of the actual study drug the participant took during their participation. Participants who had both Baseline and Week 24 measurements, or discontinued treatment before 27APR2023, or reached Week 24 before 27APR2023 but were missing Week 24 assessments were analyzed.
    End point type
    Primary
    End point timeframe
    Baseline; Week 24
    End point values
    		 Parsaclisib plus ruxolitinib Placebo plus ruxolitinib
    Number of subjects analysed
    89 [1]
    92 [2]
    Units: percentage of participants
        number (not applicable)
    52.8
    46.7
    Notes
    [1] - ITT Population
    [2] - ITT Population
    Statistical analysis title
    		 ≥35% reduction in spleen volume
    Comparison groups
    Parsaclisib plus ruxolitinib v Placebo plus ruxolitinib
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.4224 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 2.26
    Notes
    [3] - calculated from Cochran Mantel-Haenszel test stratified by Baseline platelet count ≥100 x 10^9/Liters versus 50 to <100 x 10^9/Liters inclusive

    Secondary: Percentage of participants who had a ≥50% reduction in Total Symptom Score (TSS) from Baseline to Week 24 as measured by the Myelofibrosis (MF) Symptom Assessment Form v4.0 (MFSAF v4.0) diary

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    End point title
    		 Percentage of participants who had a ≥50% reduction in Total Symptom Score (TSS) from Baseline to Week 24 as measured by the Myelofibrosis (MF) Symptom Assessment Form v4.0 (MFSAF v4.0) diary
    End point description
    Symptoms of MF were assessed using the MFSAF v4.0 diary, composed of 7 individual symptom scores (SSs) (fatigue, night sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone pain), collected daily using a 0- (no symptoms) to 10-point (worst imaginable symptoms) scale. The daily TSS (0-70)=sum of the 7 individual symptom scores (SSs) collected on the same day. Higher TSS indicate more severe symptoms. The TSS was missing if there were any missing individual scores. Observations with missing dates were excluded from the analysis. The Baseline (BL)/Week (W) 24 total score (TS)=the average of the daily TSs from the last 7 days before the first dose of parsaclisib, placebo, or ruxolitinib/the Week 24 visit. The Baseline/W24 TS was missing if there were ≥4 missing out of the 7 daily TSs. Participants who had both BL and W24 measurements, or discontinued treatment before 27APR2023, or reached W24 before 27APR2023 but were missing W24 assessments were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 24
    End point values
    		 Parsaclisib plus ruxolitinib Placebo plus ruxolitinib
    Number of subjects analysed
    89 [4]
    98 [5]
    Units: percentage of participants
        number (not applicable)
    34.8
    38.8
    Notes
    [4] - ITT Population
    [5] - ITT Population
    Statistical analysis title
    		 ≥50% reduction in Total Symptom Score (TSS)
    Comparison groups
    Parsaclisib plus ruxolitinib v Placebo plus ruxolitinib
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5728 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 1.53
    Notes
    [6] - calculated from Cochran Mantel-Haenszel test stratified by Baseline platelet count ≥100 x 10^9/Liters versus 50 to <100 x 10^9/Liters inclusive

    Secondary: Change in TSS from Baseline to Week 24 as measured by the MFSAF v4.0 diary

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    End point title
    		 Change in TSS from Baseline to Week 24 as measured by the MFSAF v4.0 diary
    End point description
    Symptoms of myelofibrosis were assessed using the MFSAF v4.0 diary. The MFSAF v4.0 is composed of 7 individual symptom scores (fatigue, night sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone pain), each collected daily using a 0- (no symptoms) to 10-point (worst imaginable symptoms) scale. The daily TSS (0 to 70) is the sum of the 7 individual symptom scores collected on the same day. Higher TSS indicate more severe symptoms. The TSS was missing if there were any missing individual scores. Observations with missing dates were excluded from the analysis. The Baseline/Week 24 total score was defined as the average of the daily total scores from the last 7 days before the first dose of parsaclisib, placebo, or ruxolitinib/the Week 24 visit. The Baseline/Week 24 total scores was missing if there were ≥4 missing out of the 7 daily total scores. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 24
    End point values
    		 Parsaclisib plus ruxolitinib Placebo plus ruxolitinib
    Number of subjects analysed
    119 [7]
    125 [8]
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline, n=119, 125
    19.8 ( 14.29 )
    19.6 ( 13.07 )
        Change from Baseline at Week 24, n=75, 89
    -6.6 ( 12.36 )
    -6.8 ( 10.74 )
    Notes
    [7] - ITT Population. Only participants with available data were analyzed.
    [8] - ITT Population. Only participants with available data were analyzed.
    No statistical analyses for this end point

    Secondary: Time to the first ≥50% reduction in TSS as measured by the MFSAF v4.0 diary

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    End point title
    		 Time to the first ≥50% reduction in TSS as measured by the MFSAF v4.0 diary
    End point description
    Symptoms of MF were assessed using the MFSAF v4.0 diary, composed of 7 individual SSs, collected daily using a 0- (no symptoms) to 10-point (worst imaginable symptoms) scale. The daily TSS (0-70) is the sum of the 7 individual SSs collected on the same day. Higher TSS indicate more severe symptoms. The TSS was missing if there were any missing individual scores. Observations with missing dates were excluded from the analysis. The BL/W24 TS was defined as the average of the daily TSs from the last 7 days before the first dose of parsaclisib, placebo, or ruxolitinib/the W24 visit. The BL/W24 TS was missing if there were ≥4 missing out of the 7 daily TSs. Censored participants didn’t have a response at any time up to the last assessment date. Participants who didn’t have a >=50% reduction in TSS was censored at the time of the last assessment. Participants with a DIPSS risk level of Low Risk Level (0 prognostic points) were excluded from the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline; up to Week 24
    End point values
    		 Parsaclisib plus ruxolitinib Placebo plus ruxolitinib
    Number of subjects analysed
    125 [9]
    127 [10]
    Units: days
        median (confidence interval 95%)
    67.0 (27.0 to 131.0)
    69.0 (35.0 to 143.0)
    Notes
    [9] - ITT Population, including censored participants
    [10] - ITT Population, including censored participants
    Statistical analysis title
    		 Time to the first ≥50% reduction in TSS
    Comparison groups
    Parsaclisib plus ruxolitinib v Placebo plus ruxolitinib
    Number of subjects included in analysis
    252
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.949 [11]
    Method
    		 Logrank
    Confidence interval
    Notes
    [11] - calculated from log-rank test stratified by Baseline platelet count ≥100 × 10^9/Liters versus 50 to <100 × 10^9/Liters inclusive

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    Overall survival was defined as the interval between the randomization date and the date of death due to any cause. Due to participants rolling over to another study (NCT02955940), the follow-up time was not long enough to estimate the median and the upper and lower limits of the confidence interval.
    End point type
    Secondary
    End point timeframe
    up to 749 days
    End point values
    		 Parsaclisib plus ruxolitinib Placebo plus ruxolitinib
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: days
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [12] - ITT Population
    [13] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of participants with any treatment-emergent adverse event (TEAE)

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    End point title
    		 Number of participants with any treatment-emergent adverse event (TEAE)
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 to 35 days after the last dose of parsaclisib/matching placebo or ruxolitinib. Safety Population: all participants who received at least 1 dose of parsaclisib, placebo, or ruxolitinib. Treatment groups for this population were determined according to the actual treatment the participant received regardless of assigned study drug treatment.
    End point type
    Secondary
    End point timeframe
    up to 960 days
    End point values
    		 Parsaclisib plus ruxolitinib Placebo plus ruxolitinib
    Number of subjects analysed
    125 [14]
    127 [15]
    Units: participants
    117
    119
    Notes
    [14] - Safety Population
    [15] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of participants with any Grade 3 or Higher TEAE

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    End point title
    		 Number of participants with any Grade 3 or Higher TEAE
    End point description
    An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 to 35 days after the last dose of parsaclisib/matching placebo or ruxolitinib. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local or noninvasive intervention indicated; limiting instrumental activities of daily living (ADL). Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4: life-threatening urgent intervention indicated. Grade 5: death related to AE.
    End point type
    Secondary
    End point timeframe
    up to 960 days
    End point values
    		 Parsaclisib plus ruxolitinib Placebo plus ruxolitinib
    Number of subjects analysed
    125 [16]
    127 [17]
    Units: participants
    75
    75
    Notes
    [16] - Safety Population
    [17] - Safety Population
    No statistical analyses for this end point

    Secondary: Time of onset of a ≥35% reduction in spleen volume

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    End point title
    		 Time of onset of a ≥35% reduction in spleen volume
    End point description
    The time to the first ≥35% reduction in spleen volume is defined as the time from randomization to the first time participants had ≥35% reduction in spleen volume. Censored participants didn’t have a response at any time up to the last assessment date. Participants who didn’t have a >=35% reduction in spleen volume were censored at the time of the last assessment. Participants with a DIPSS risk level of Low Risk Level (0 prognostic points) were excluded from the analysis. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method with log-log transformation.
    End point type
    Secondary
    End point timeframe
    up to 925 days
    End point values
    		 Parsaclisib plus ruxolitinib Placebo plus ruxolitinib
    Number of subjects analysed
    125 [18]
    127 [19]
    Units: days
        median (confidence interval 95%)
    88.0 (86.0 to 99.0)
    92.0 (87.0 to 253.0)
    Notes
    [18] - ITT Population, including censored participants
    [19] - ITT Population, including censored participants
    Statistical analysis title
    		 Time of onset of a ≥35% reduction in spleen volume
    Comparison groups
    Placebo plus ruxolitinib v Parsaclisib plus ruxolitinib
    Number of subjects included in analysis
    252
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1085 [20]
    Method
    		 Logrank
    Confidence interval
    Notes
    [20] - calculated from log-rank test stratified by Baseline platelet count ≥100 × 10^9/Liters versus 50 to <100 × 10^9/Liters inclusive

    Secondary: Duration of maintenance (DoM) of a ≥35% reduction in spleen volume

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    End point title
    		 Duration of maintenance (DoM) of a ≥35% reduction in spleen volume
    End point description
    The duration of ≥35% reduction from Baseline in spleen volume was defined as the interval between the first spleen volume measurement that was a ≥35% reduction from Baseline and the date of the first measurement that was no longer a ≥35% reduction from Baseline. Participants with DIPSS risk level being low risk level (0 prognostic points) have been excluded from the analysis. Only those participants with a ≥35% reduction in spleen volume who then had a loss of ≥35% reduction in spleen volume with a 25% increase from NADIR were analyzed. If the maintenance end date was not observed before the database cutoff, the duration was censored at the last assessment. 9999=The upper limit of the confidence interval was not estimable because too few participants lost a >=35% reduction in spleen volume at the time of rollover to another study (NCT02955940).
    End point type
    Secondary
    End point timeframe
    up to 925 days
    End point values
    		 Parsaclisib plus ruxolitinib Placebo plus ruxolitinib
    Number of subjects analysed
    73 [21]
    61 [22]
    Units: days
        median (confidence interval 95%)
    505.0 (339.0 to 9999)
    9999 (337.0 to 9999)
    Notes
    [21] - ITT Population
    [22] - ITT Population
    Statistical analysis title
    		 DoM of a ≥35% reduction in spleen volume
    Comparison groups
    Parsaclisib plus ruxolitinib v Placebo plus ruxolitinib
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.6127 [23]
    Method
    		 Logrank
    Confidence interval
    Notes
    [23] - calculated from log-rank test stratified by Baseline platelet count ≥100 × 10^9/Liters versus 50 to <100 × 10^9/Liters inclusive

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to 960 days
    Adverse event reporting additional description
    Treatment-emergent adverse events, defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until 30 to 35 days after the last dose of parsaclisib/matching placebo or ruxolitinib, have been reported for the Safety Population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Placebo plus ruxolitinib
    Reporting group description
    		 Participants were randomized to receive placebo plus ruxolitinib beginning on Day 1 and continued on this regimen until they left the study. Participants with a Baseline platelet count ≥100 × 10^9/Liter received ruxolitinib 15 mg BID. Participants with a Baseline platelet count of 50 to < 100 × 10^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the DIPSS risk category (high versus intermediate-2 versus intermediate-1). Participants received matching placebo at a dose of 5 mg QD. After 24 weeks, participants randomized to receive placebo plus ruxolitinib could have switched to treatment with parsaclisib plus ruxolitinib per the regimen received during the first 24 weeks of the study. Treatment continued for as long as the regimen was tolerated and the participant did not meet any discontinuation criteria.

    Reporting group title
    Parsaclisib plus ruxolitinib
    Reporting group description
    		 Participants were randomized to receive parsaclisib plus ruxolitinib beginning on Day 1 and continued on this regimen as long as it was tolerated and the participants did not meet any discontinuation criteria. Participants with a Baseline platelet count ≥100 × 10^9/Liter received ruxolitinib 15 milligrams (mg) twice daily (BID). Participants with a Baseline platelet count of 50 to < 100 × 10^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the Dynamic International Prognostic Scoring System (DIPSS) risk category (high versus intermediate-2 versus intermediate-1). Participants received parsaclisib at a dose of 5 mg once daily (QD).

    Serious adverse events
    		 Placebo plus ruxolitinib Parsaclisib plus ruxolitinib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 127 (14.17%)
    26 / 125 (20.80%)
         number of deaths (all causes)
    3
    6
         number of deaths resulting from adverse events
    1
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myxofibrosarcoma
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 125 (1.60%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Respiratory failure
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood fibrinogen decreased
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Extradural haematoma
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Intracranial mass
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelitis transverse
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 127 (0.79%)
    4 / 125 (3.20%)
         occurrences causally related to treatment / all
    1 / 1
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular hole
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 127 (0.00%)
    3 / 125 (2.40%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varices oesophageal
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hypoparathyroidism
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster meningomyelitis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 127 (1.57%)
    4 / 125 (3.20%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 4
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 125 (1.60%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo plus ruxolitinib Parsaclisib plus ruxolitinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    109 / 127 (85.83%)
    109 / 125 (87.20%)
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 127 (1.57%)
    11 / 125 (8.80%)
         occurrences all number
    2
    12
    Aspartate aminotransferase increased
         subjects affected / exposed
    10 / 127 (7.87%)
    22 / 125 (17.60%)
         occurrences all number
    12
    38
    Alanine aminotransferase increased
         subjects affected / exposed
    11 / 127 (8.66%)
    18 / 125 (14.40%)
         occurrences all number
    14
    29
    Blood creatinine increased
         subjects affected / exposed
    6 / 127 (4.72%)
    11 / 125 (8.80%)
         occurrences all number
    6
    13
    Neutrophil count decreased
         subjects affected / exposed
    7 / 127 (5.51%)
    7 / 125 (5.60%)
         occurrences all number
    11
    14
    Weight increased
         subjects affected / exposed
    5 / 127 (3.94%)
    7 / 125 (5.60%)
         occurrences all number
    7
    7
    White blood cell count decreased
         subjects affected / exposed
    5 / 127 (3.94%)
    8 / 125 (6.40%)
         occurrences all number
    5
    16
    Platelet count decreased
         subjects affected / exposed
    19 / 127 (14.96%)
    29 / 125 (23.20%)
         occurrences all number
    38
    48
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    4 / 127 (3.15%)
    8 / 125 (6.40%)
         occurrences all number
    4
    9
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 127 (3.94%)
    8 / 125 (6.40%)
         occurrences all number
    8
    8
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    7 / 127 (5.51%)
    6 / 125 (4.80%)
         occurrences all number
    7
    6
    Headache
         subjects affected / exposed
    11 / 127 (8.66%)
    7 / 125 (5.60%)
         occurrences all number
    14
    7
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    11 / 127 (8.66%)
    11 / 125 (8.80%)
         occurrences all number
    14
    13
    Fatigue
         subjects affected / exposed
    12 / 127 (9.45%)
    11 / 125 (8.80%)
         occurrences all number
    14
    13
    Pyrexia
         subjects affected / exposed
    8 / 127 (6.30%)
    9 / 125 (7.20%)
         occurrences all number
    8
    11
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    68 / 127 (53.54%)
    57 / 125 (45.60%)
         occurrences all number
    94
    70
    Neutropenia
         subjects affected / exposed
    5 / 127 (3.94%)
    11 / 125 (8.80%)
         occurrences all number
    6
    15
    Thrombocytopenia
         subjects affected / exposed
    21 / 127 (16.54%)
    26 / 125 (20.80%)
         occurrences all number
    33
    31
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    8 / 127 (6.30%)
    8 / 125 (6.40%)
         occurrences all number
    9
    10
    Abdominal distension
         subjects affected / exposed
    7 / 127 (5.51%)
    0 / 125 (0.00%)
         occurrences all number
    9
    0
    Constipation
         subjects affected / exposed
    11 / 127 (8.66%)
    8 / 125 (6.40%)
         occurrences all number
    11
    8
    Diarrhoea
         subjects affected / exposed
    21 / 127 (16.54%)
    21 / 125 (16.80%)
         occurrences all number
    30
    28
    Nausea
         subjects affected / exposed
    10 / 127 (7.87%)
    6 / 125 (4.80%)
         occurrences all number
    13
    7
    Vomiting
         subjects affected / exposed
    8 / 127 (6.30%)
    8 / 125 (6.40%)
         occurrences all number
    10
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    10 / 127 (7.87%)
    8 / 125 (6.40%)
         occurrences all number
    11
    10
    Dyspnoea
         subjects affected / exposed
    7 / 127 (5.51%)
    7 / 125 (5.60%)
         occurrences all number
    9
    8
    Epistaxis
         subjects affected / exposed
    5 / 127 (3.94%)
    10 / 125 (8.00%)
         occurrences all number
    6
    11
    Skin and subcutaneous tissue disorders
    Night sweats
         subjects affected / exposed
    5 / 127 (3.94%)
    7 / 125 (5.60%)
         occurrences all number
    5
    8
    Pruritus
         subjects affected / exposed
    9 / 127 (7.09%)
    7 / 125 (5.60%)
         occurrences all number
    10
    8
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    7 / 127 (5.51%)
    3 / 125 (2.40%)
         occurrences all number
    9
    3
    Pain in extremity
         subjects affected / exposed
    8 / 127 (6.30%)
    3 / 125 (2.40%)
         occurrences all number
    9
    4
    Infections and infestations
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 127 (0.79%)
    9 / 125 (7.20%)
         occurrences all number
    1
    9
    COVID-19
         subjects affected / exposed
    15 / 127 (11.81%)
    26 / 125 (20.80%)
         occurrences all number
    16
    27
    Urinary tract infection
         subjects affected / exposed
    7 / 127 (5.51%)
    5 / 125 (4.00%)
         occurrences all number
    7
    5
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    7 / 127 (5.51%)
    5 / 125 (4.00%)
         occurrences all number
    8
    5
    Hyperuricaemia
         subjects affected / exposed
    7 / 127 (5.51%)
    5 / 125 (4.00%)
         occurrences all number
    9
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Oct 2021
    The primary purpose of this amendment was to address changes requested by different national regulatory agencies and ethics committees.
    14 Oct 2022
    The primary purpose of this amendment was to update safety information for parsaclisib, including information regarding COVID-19, and the potential impact of parsaclisib therapy on infection risk, vaccine effectiveness, and severity of disease.

    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.
    Due to participants rolling over to another study (NCT02955940), no participants randomized to receive placebo plus ruxolitinib switched to treatment with parsaclisib plus ruxolitinib.
    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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