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    Clinical Trial Results:
    A Phase III Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis

    Summary
    EudraCT number
    2020-000791-38
    Trial protocol
    SE   CZ   DE   HU   GR   FI   PT   NO   DK   PL   NL   BE   IT  
    Global end of trial date
    10 Feb 2023

    Results information
    Results version number
    v1
    This version publication date
    18 Feb 2024
    First version publication date
    18 Feb 2024
    Other versions
    v2

    Trial information

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    Trial identification
    Sponsor protocol code
    WA42293
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04552899
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.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
    10 Feb 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Feb 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This phase III study was to evaluate the efficacy, safety and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, compared with placebo in participants with idiopathic pulmonary fibrosis (IPF).
    Protection of trial subjects
    All study subjects were required to read and sign and Informed Consent Form.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Mar 2021
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy
    Long term follow-up duration
    2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 13
    Country: Number of subjects enrolled
    New Zealand: 5
    Country: Number of subjects enrolled
    Singapore: 2
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    United States: 156
    Country: Number of subjects enrolled
    Belgium: 14
    Country: Number of subjects enrolled
    Czechia: 10
    Country: Number of subjects enrolled
    Denmark: 12
    Country: Number of subjects enrolled
    France: 50
    Country: Number of subjects enrolled
    Germany: 30
    Country: Number of subjects enrolled
    Greece: 18
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Italy: 57
    Country: Number of subjects enrolled
    Netherlands: 13
    Country: Number of subjects enrolled
    Norway: 9
    Country: Number of subjects enrolled
    Poland: 8
    Country: Number of subjects enrolled
    Portugal: 5
    Country: Number of subjects enrolled
    Spain: 45
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    Türkiye: 5
    Country: Number of subjects enrolled
    Switzerland: 1
    Country: Number of subjects enrolled
    Taiwan: 3
    Country: Number of subjects enrolled
    Australia: 44
    Country: Number of subjects enrolled
    Canada: 24
    Country: Number of subjects enrolled
    China: 27
    Country: Number of subjects enrolled
    Israel: 35
    Country: Number of subjects enrolled
    Japan: 41
    Country: Number of subjects enrolled
    Korea, Republic of: 24
    Country: Number of subjects enrolled
    South Africa: 4
    Worldwide total number of subjects
    664
    EEA total number of subjects
    276
    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)
    128
    From 65 to 84 years
    531
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 665 participants were enrolled across 275 investigative sites in 29 countries.

    Pre-assignment
    Screening details
    One participant who failed screening was enrolled in error and did not subsequently enter the study. Four participants who were randomized did not receive any treatment.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Zinpentraxin Alfa
    Arm description
    Participants received intravenous (IV) infusions of Zinpentraxin Alfa over 50-70 minutes on Days 1, 3 and 5, then followed by infusions every 4 weeks (Q4W) to Week 48.
    Arm type
    Experimental

    Investigational medicinal product name
    Zinpentraxin Alfa
    Investigational medicinal product code
    Other name
    PRM-151
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received a 10 mg/kg intravenous (IV) infusions of Zinpentraxin Alfa based on the participants weight. It was administered on Days 1, 3 and 5 followed by infusions Q4W to Week 48.

    Arm title
    Placebo
    Arm description
    Participants received IV infusions of placebo over 50-70 minutes on Days 1, 3 and 5, followed by infusions Q4W to Week 48.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received placebo matching Zinpentraxin Alfa administered by IV infusion on Days 1, 3 and 5, followed by infusions Q4W to Week 48.

    Number of subjects in period 1
    Zinpentraxin Alfa Placebo
    Started
    331
    333
    No Treatment
    1 [1]
    3 [2]
    Completed
    56
    49
    Not completed
    275
    284
         Lung Transplant
    4
    3
         Physician decision
    3
    4
         Consent withdrawn by subject
    15
    17
         Adverse Event
    4
    3
         Study Terminated By Sponsor
    237
    239
         Death
    4
    4
         Participant and physician wanted to withdraw
    -
    1
         Lost to follow-up
    8
    13
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: These participants were randomized but didn't receive any study treatment
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: These participants were randomized but didn't receive any study treatment

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Zinpentraxin Alfa
    Reporting group description
    Participants received intravenous (IV) infusions of Zinpentraxin Alfa over 50-70 minutes on Days 1, 3 and 5, then followed by infusions every 4 weeks (Q4W) to Week 48.

    Reporting group title
    Placebo
    Reporting group description
    Participants received IV infusions of placebo over 50-70 minutes on Days 1, 3 and 5, followed by infusions Q4W to Week 48.

    Reporting group values
    Zinpentraxin Alfa Placebo Total
    Number of subjects
    331 333 664
    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)
    64 64 128
        From 65-84 years
    266 265 531
        85 years and over
    1 4 5
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    70.8 ( 7.3 ) 70.6 ( 7.6 ) -
    Gender Categorical
    Units: Subjects
        Female
    61 70 131
        Male
    270 263 533
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    20 27 47
        Not Hispanic or Latino
    302 299 601
        Not Stated
    6 6 12
        Unknown
    3 1 4
    Race (NIH/OMB)
    Units: Subjects
        Asian
    52 56 108
        Black or African American
    1 4 5
        White
    274 270 544
        Multiple
    1 0 1
        Unknown
    3 3 6

    End points

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    End points reporting groups
    Reporting group title
    Zinpentraxin Alfa
    Reporting group description
    Participants received intravenous (IV) infusions of Zinpentraxin Alfa over 50-70 minutes on Days 1, 3 and 5, then followed by infusions every 4 weeks (Q4W) to Week 48.

    Reporting group title
    Placebo
    Reporting group description
    Participants received IV infusions of placebo over 50-70 minutes on Days 1, 3 and 5, followed by infusions Q4W to Week 48.

    Primary: Absolute Change in Forced Vital Capacity (FVC [mL])

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    End point title
    Absolute Change in Forced Vital Capacity (FVC [mL]) [1]
    End point description
    The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization.
    End point type
    Primary
    End point timeframe
    From Baseline up to Week 52
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses was conducted for this endpoint
    End point values
    Zinpentraxin Alfa Placebo
    Number of subjects analysed
    330
    330
    Units: Milliliters (mL)
        number (confidence interval 95%)
    -235.72 (-283.07 to -188.4)
    -214.89 (-262.44 to -167.3)
    No statistical analyses for this end point

    Secondary: Absolute Change in 6-minute Walk Distance (6MWD)

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    End point title
    Absolute Change in 6-minute Walk Distance (6MWD)
    End point description
    The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 52
    End point values
    Zinpentraxin Alfa Placebo
    Number of subjects analysed
    330
    330
    Units: Meters (m)
        number (confidence interval 95%)
    -33.64 (-48.71 to -18.57)
    -24.19 (-39.29 to -9.10)
    No statistical analyses for this end point

    Secondary: Absolute Change in FVC% Predicted

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    End point title
    Absolute Change in FVC% Predicted
    End point description
    The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 52
    End point values
    Zinpentraxin Alfa Placebo
    Number of subjects analysed
    330
    330
    Units: Percent predicted
        number (confidence interval 95%)
    -6.22 (-7.46 to -4.98)
    -5.72 (-6.96 to -4.47)
    No statistical analyses for this end point

    Secondary: Time to Disease Progression

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    End point title
    Time to Disease Progression
    End point description
    The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization.
    End point type
    Secondary
    End point timeframe
    From Baseline up to approximately 2 years
    End point values
    Zinpentraxin Alfa Placebo
    Number of subjects analysed
    330
    330
    Units: Months
        median (confidence interval 95%)
    6.6 (5.6 to 9.1)
    8.2 (6.5 to 10.9)
    Statistical analysis title
    Zinpentraxin Alfa
    Comparison groups
    Zinpentraxin Alfa v Placebo
    Number of subjects included in analysis
    660
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2512
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.91
         upper limit
    1.47

    Secondary: Time to First Respiratory-related Hospitalizations

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    End point title
    Time to First Respiratory-related Hospitalizations
    End point description
    The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization. 9999999 = Not enough events available for estimation.
    End point type
    Secondary
    End point timeframe
    From Baseline up to approximately 2 years
    End point values
    Zinpentraxin Alfa Placebo
    Number of subjects analysed
    330
    330
    Units: Months
        median (confidence interval 95%)
    9999999 (9999999 to 9999999)
    9999999 (9999999 to 9999999)
    Statistical analysis title
    Zinpentraxin Alfa
    Comparison groups
    Zinpentraxin Alfa v Placebo
    Number of subjects included in analysis
    660
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9833
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.51
         upper limit
    1.97

    Secondary: Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ)

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    End point title
    Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ)
    End point description
    The UCSD-SOBQ is a 24-item questionnaire used to assess dyspnea severity during specific activities (21 items) and limitations caused by dyspnea in daily life (4 items). Items are assessed using a 6-point scale. Total scores, once summed, can range from 0-120 with a higher score reflecting greater dyspnea severity. The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 52
    End point values
    Zinpentraxin Alfa Placebo
    Number of subjects analysed
    276
    271
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Baseline (n=276, 271)
    28.9 ( 22.2 )
    29.9 ( 22.6 )
        Week 12 (n=147, 151)
    0.8 ( 13.0 )
    4.0 ( 17.4 )
        Week 24 (n=106, 110)
    3.2 ( 16.0 )
    4.7 ( 16.8 )
        Week 36 (n=97, 96)
    5.4 ( 17.5 )
    6.9 ( 17.7 )
        Week 52 (n=37, 35)
    11.1 ( 21.2 )
    4.8 ( 14.8 )
    No statistical analyses for this end point

    Secondary: Change in St. George Respiratory Questionnaire (SGRQ) Total Score

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    End point title
    Change in St. George Respiratory Questionnaire (SGRQ) Total Score
    End point description
    The SGRQ is a 50-item respiratory-specific quality-of-life questionnaire. The questions assess the impact of disease on activity, functionality and symptoms. Each scale is scored from 0-100. A total score represents the weighted average of these three subscores. A lower score indicates best health while a higher score indicates worst health. The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 52
    End point values
    Zinpentraxin Alfa Placebo
    Number of subjects analysed
    299
    299
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Baseline (n=229, 299)
    36.73 ( 18.63 )
    37.66 ( 18.45 )
        Week 12 (n=172, 179)
    1.03 ( 9.98 )
    0.81 ( 10.55 )
        Week 24 (n=121, 122)
    3.50 ( 11.05 )
    1.39 ( 13.94 )
        Week 36 (n=110, 110)
    3.21 ( 11.38 )
    2.15 ( 13.42 )
        Week 52 (n=46, 43)
    6.15 ( 13.87 )
    3.09 ( 11.51 )
    No statistical analyses for this end point

    Secondary: Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF)

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    End point title
    Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF)
    End point description
    The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization. 9999999 = Not enough events available for estimation.
    End point type
    Secondary
    End point timeframe
    From Baseline up to approximately 2 years
    End point values
    Zinpentraxin Alfa Placebo
    Number of subjects analysed
    330
    330
    Units: Months
        median (confidence interval 95%)
    9999999 (9999999 to 9999999)
    9999999 (9999999 to 9999999)
    Statistical analysis title
    Zinpentraxin Alfa
    Comparison groups
    Zinpentraxin Alfa v Placebo
    Number of subjects included in analysis
    660
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.7005
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.86
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.4
         upper limit
    1.86

    Secondary: Change in Carbon Monoxide Diffusing Capacity (DLCO)

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    End point title
    Change in Carbon Monoxide Diffusing Capacity (DLCO)
    End point description
    The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 52
    End point values
    Zinpentraxin Alfa Placebo
    Number of subjects analysed
    318
    313
    Units: DLCO% Predicted
    arithmetic mean (standard deviation)
        Baseline (n=318, 313)
    51.73 ( 17.73 )
    51.66 ( 14.78 )
        Week 12 (n=153, 165)
    -1.19 ( 11.89 )
    -2.78 ( 9.86 )
        Week 24 (n=110, 108)
    -4.68 ( 7.93 )
    -4.01 ( 9.75 )
        Week 36 (n=95, 90)
    -5.83 ( 8.49 )
    -4.66 ( 7.10 )
        Week 52 (n=32, 36)
    -6.30 ( 9.56 )
    -6.68 ( 9.28 )
    No statistical analyses for this end point

    Secondary: Survival

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    End point title
    Survival
    End point description
    Survival is measured by all-cause mortality. The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization. 9999999 = Not enough events available for estimation.
    End point type
    Secondary
    End point timeframe
    From Baseline up to approximately 2 years
    End point values
    Zinpentraxin Alfa Placebo
    Number of subjects analysed
    330
    330
    Units: Months
        median (confidence interval 95%)
    9999999 (9999999 to 9999999)
    9999999 (9999999 to 9999999)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Adverse Events (AEs)

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    End point title
    Percentage of Participants with Adverse Events (AEs)
    End point description
    The safety population included all randomized participants who received at least one administration (full or partial dose) of study drug and were grouped according to the actual treatment received.
    End point type
    Secondary
    End point timeframe
    From Baseline up to approximately 2 years
    End point values
    Zinpentraxin Alfa Placebo
    Number of subjects analysed
    331
    329
    Units: Percentage of participants
        number (not applicable)
    74.6
    72.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest

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    End point title
    Percentage of Participants with Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest
    End point description
    The safety population included all randomized participants who received at least one administration (full or partial dose) of study drug and were grouped according to the actual treatment received.
    End point type
    Secondary
    End point timeframe
    From Baseline up to approximately 2 years
    End point values
    Zinpentraxin Alfa Placebo
    Number of subjects analysed
    331
    329
    Units: Percentage of participants
        number (not applicable)
    3.6
    1.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants Permanently Discontinuing Study Treatment due to AEs

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    End point title
    Percentage of Participants Permanently Discontinuing Study Treatment due to AEs
    End point description
    The safety population included all randomized participants who received at least one administration (full or partial dose) of study drug and were grouped according to the actual treatment received.
    End point type
    Secondary
    End point timeframe
    From Baseline up to approximately 2 years
    End point values
    Zinpentraxin Alfa Placebo
    Number of subjects analysed
    331
    329
    Units: Percentage of participants
        number (not applicable)
    2.7
    1.8
    No statistical analyses for this end point

    Secondary: Plasma Concentrations of PRM-151

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    End point title
    Plasma Concentrations of PRM-151 [2]
    End point description
    The pharmacokinetic (PK) population included all randomized participants who received at least one administration (full or partial dose) of zinpentraxin alfa and at least one evaluable postdose PK sample that was above the lower limit of quantification (LLOQ). 9999999 = NA. At Baseline, no drug had been administered. Thus, there is no data to record for the plasma concentration of zinpentraxin alfa. 9999999 = NA at Weeks, 4, 12 and 24 pre infusion as the drug level was below the limit of quantification of the assay.
    End point type
    Secondary
    End point timeframe
    Days 1, 5 and Weeks 4, 12, and 24
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo group didn't receive the study drug, thus was no eligible to be analyzed for this endpoint.
    End point values
    Zinpentraxin Alfa
    Number of subjects analysed
    310
    Units: micrograms per millilitre (ug/mL)
    arithmetic mean (standard deviation)
        Day 1 -pre infusion (n=300)
    9999999 ( 9999999 )
        Day 1 - 1h Post Infusion (n=33)
    198 ( 56.8 )
        Day 1 - 2h Post Infusion (n=310)
    203 ( 68.4 )
        Day 1 - 4h Post Infusion (n=33)
    168 ( 48.0 )
        Day 1 - 8h Post Infusion (n=15)
    118 ( 37.8 )
        Day 1 - 10h Post Infusion (n=18)
    158 ( 35.8 )
        Day 1 - 12h Post Infusion (n=15)
    95.9 ( 31.5 )
        Day 1 - 24h Post Infusion (n=33)
    81.8 ( 26.2 )
        Day 5 - Pre Infusion (n=303)
    39.6 ( 21.5 )
        Day 5 - 2h Post Infusion (n=301)
    244 ( 75.6 )
        Week 4 - Pre Infusion (n=276)
    9999999 ( 9999999 )
        Week 4 - 2h Post Infusion (n=280)
    212 ( 105 )
        Week 12 - Pre Infusion (n=180)
    9999999 ( 9999999 )
        Week 12 - 2h Post Infusion (n=180)
    177 ( 72.7 )
        Week 24 - Pre Infusion (n=133)
    9999999 ( 9999999 )
    No statistical analyses for this end point

    Secondary: Prevalence of Anti-drug Antibodies (ADAs) at Baseline

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    End point title
    Prevalence of Anti-drug Antibodies (ADAs) at Baseline [3]
    End point description
    The immunogenicity population included all randomized participants with at least one postdose ADA assessment and were grouped according to treatment received or, if no treatment is received prior to study discontinuation, according to treatment assigned.
    End point type
    Secondary
    End point timeframe
    Day 1
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo group didn't receive the study drug, thus was no eligible to be analyzed for this endpoint.
    End point values
    Zinpentraxin Alfa
    Number of subjects analysed
    255
    Units: Participants
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ADAs During the Study

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    End point title
    Percentage of Participants with ADAs During the Study [4]
    End point description
    The immunogenicity population included all randomized participants with at least one postdose ADA assessment and were grouped according to treatment received or, if no treatment is received prior to study discontinuation, according to treatment assigned.
    End point type
    Secondary
    End point timeframe
    Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The placebo group didn't receive the study drug, thus was no eligible to be analyzed for this endpoint.
    End point values
    Zinpentraxin Alfa
    Number of subjects analysed
    280
    Units: Percentage of participants
        number (not applicable)
    1.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to approximately 2 years
    Adverse event reporting additional description
    Total # of deaths was reported based on randomized population =all randomized participants. SAEs & other AEs reported based on safety-evaluable population which included all randomized participants who received at least one administration (full or partial dose) of study drug and were grouped according to the actual treatment received.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Zinpentraxin Alfa
    Reporting group description
    Participants received intravenous (IV) infusions of Zinpentraxin Alfa over 50-70 minutes on Days 1, 3 and 5, then followed by infusions every 4 weeks (Q4W) to Week 48.

    Reporting group title
    Placebo
    Reporting group description
    Participants received IV infusions of placebo over 50-70 minutes on Days 1, 3 and 5, followed by infusions Q4W to Week 48.

    Serious adverse events
    Zinpentraxin Alfa Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    46 / 331 (13.90%)
    40 / 329 (12.16%)
         number of deaths (all causes)
    5
    4
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Non-small cell lung cancer
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 331 (0.60%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microscopic polyangiitis
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    1 / 331 (0.30%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 331 (0.30%)
    3 / 329 (0.91%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Wheezing
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    2 / 331 (0.60%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    12 / 331 (3.63%)
    8 / 329 (2.43%)
         occurrences causally related to treatment / all
    1 / 12
    0 / 8
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Respiratory failure
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 331 (0.30%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 331 (0.30%)
    2 / 329 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device dislocation
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Subdural haemorrhage
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic ulcer
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle injury
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention postoperative
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery occlusion
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (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
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 331 (0.30%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 331 (0.30%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 331 (0.00%)
    2 / 329 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 331 (0.30%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Retinal vein occlusion
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric artery embolism
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal embolism
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal infarct
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    3 / 331 (0.91%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    5 / 331 (1.51%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory tract infection
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         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
    1 / 331 (0.30%)
    0 / 329 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 329 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Zinpentraxin Alfa Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    140 / 331 (42.30%)
    128 / 329 (38.91%)
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    31 / 331 (9.37%)
    29 / 329 (8.81%)
         occurrences all number
    42
    55
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    17 / 331 (5.14%)
    14 / 329 (4.26%)
         occurrences all number
    22
    14
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    35 / 331 (10.57%)
    34 / 329 (10.33%)
         occurrences all number
    48
    39
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    27 / 331 (8.16%)
    20 / 329 (6.08%)
         occurrences all number
    29
    22
    Cough
         subjects affected / exposed
    42 / 331 (12.69%)
    38 / 329 (11.55%)
         occurrences all number
    46
    42
    Infections and infestations
    COVID-19
         subjects affected / exposed
    57 / 331 (17.22%)
    57 / 329 (17.33%)
         occurrences all number
    59
    60

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jun 2020
    This protocol was amended for the following reasons: 1. Changes to the Sponsor, Medical Monitor, PFT parameters; 2. To clarify: that participants with chronic medical issues may be at higher risk for serious illness from COVID-19, that participants who require high-resolution computed tomography (HRCT) scan during screening will have an additional one at Week 52, that reloading of 3 doses of PRM-151 would be required on the resumption of study treatment if a dose was missed, the use of pirfenidone or nintedanib treatment was permitted, that baseline serum concentration would be analyzed for all participants, that body weight should be measured at the start of each dosing period, administration of study drug could be permitted in other settings if participants couldn’t attend study site, that precautions are to be taken when performing pulmonary function tests, 6-MW test should be followed by other tests, what events were recorded as health care utilization, blood PAXgene was not applicable for Chinese participants enrolled in mainland China, participants should be followed up by telephone if they couldn’t attend the study site, that screening for infections prior to and during the study should be considered during a pandemic, the safety evaluable population, and the number of sites participating in the study; 3. Placebo was included as an IMP; 4.Updates to the permitted and prohibited therapy; 5.The sequence of assessments, pregnancy safety requirements, AE reporting period, efficacy and biomarker analyses were amended; 6. Medical history requirements were updated; 7. Oxygen saturation was included as part of vital sign measurements; 8. An independent, blinded Adjudication Committee was added; 9. SARS-CoV-2 serology testing was added as a lab assessment; 10. Serum sample for tryptase has been added in case of IRRs; 11.Clinically significant ECG abnormalities would be reported as AEs; 12. A statistician was added to the iDMC; 13. Appendices were updated.
    13 Nov 2020
    This protocol was amended for the following reasons: 1) PK samples were to be collected as plasma instead of serum; 2) Clarification that lung biopsies should be submitted; 3) Clarification of the formulation of PRM-151; 4) Clarification that clarified that for loading or reloading doses, scheduled efficacy assessments would only be performed on the first of the three loading dose days; 5) Language was added to indicate that acceptability of the spirometry and diffusing capacity for carbon monoxide data was determined by over-readers blinded to study drug treatment; 6) Information regarding acute or suspected acute IPF exacerbation would no longer need to be recorded; 7) Serious hypersensitivity reactions and Grade 4 IRR or two Grade 3 IRRs were added as reasons for permanent study treatment discontinuation; 8) After the end of the AE reporting period, all deaths did not need to be reported on the eCRF; 9) Clarification regarding suspected and unsuspected SAEs reporting; 10) Additional details regarding iDMC reviews were added; 11) Appendices were amended.
    28 Apr 2022
    This protocol was amended for the following reasons: 1) Additional text was added throughout the protocol to further clarify or explain information in more detail; 2) “Progression-free survival”was updated to “Time to disease progression” in secondary efficacy objective; 3) Exclusion criteria was updated; 4) Clarification of vital sign measurements at dosing visits; 5) Clarification that all past anti fibrotic therapy would be recorded; 6) Clarification that participants who had high-resolution computed tomography (HRCT) at screening received further HRCT imaging at Week 52; 7) Clarification that medical occurrences that began before the start of study treatment but after obtaining informed consent would be recorded on the electronic case report form (eCRF); 8) Clarification that DLCO assessments would be performed using local equipment; 9) Clarification that oxygen titration procedures would be conducted as per local standard of care; 10) Clarification that blood sample for a serum tryptase sample and complement C3 test would be collected at the time of a suspected anaphylaxis or hypersensitivity event whenever possible; 10) Additional information was provided on sample collection; 11) Assessments following hospitalization for COVID-19 would be collected and analysed; 12) The supplementary estimand was removed; 13) Clarification that an external global Steering Committee provided oversight of Studies WA42293 and WA42294; 14) The international non-proprietary name replaced the RO number throughout the protocol.

    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.
    This study was terminated early based on the futility analysis which concluded that zinpentraxin alfa was unlikely to meet its primary endpoint.
    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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