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    Clinical Trial Results:
    A Phase III Open-label Extension Study to Evaluate Long-term Safety and Efficacy of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis (IPF)

    Summary
    EudraCT number
    		 2020-001429-30
    Trial protocol
    		 FR   CZ   DE   SE   GR   HU   PT   AT   FI   NO   DK   PL   NL   BE   IT  
    Global end of trial date
    10 Feb 2023

    Results information
    Results version number
    		 v2(current)
    This version publication date
    06 Apr 2024
    First version publication date
    18 Feb 2024
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    WA42294
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04594707
    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 study was evaulating the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to 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
    30 Aug 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 10
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Canada: 7
    Country: Number of subjects enrolled
    Czechia: 6
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    France: 12
    Country: Number of subjects enrolled
    Israel: 8
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    Norway: 1
    Country: Number of subjects enrolled
    New Zealand: 2
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    United States: 38
    Worldwide total number of subjects
    117
    EEA total number of subjects
    52
    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)
    11
    From 65 to 84 years
    102
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled across 48 investigative sites in 16 countries.

    Pre-assignment
    Screening details
    		 This OLE study enrolled eligible participants with IPF who took part in the Phase II Study PRM-151-202/WA42404 or and Phase III Study WA42293.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort A: Zinpentraxin Alfa
    Arm description
    		 Participants entered this Cohort following participation in study PRM-151-202.
    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 three loading doses of open-label PRM-151 on days 1, 3, and 5, then one infusion every 4 weeks (Q4W). 10 mg/kg of PRM 151 will be administered by intravenous (IV) infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks.

    Arm title
    		 Cohort B: Ex-Placebo
    Arm description
    		 Participants entered, following participation in study WA42293.
    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 until the end of the study.

    Arm title
    		 Cohort B: Zinpentraxin Alfa
    Arm description
    		 Participants entered, following participation in study WA42293.
    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 previously randomized to the placebo in WA42293 received study medication in the three loading doses on days 1, 3 and 5 in a blinded fashion. All three doses contained PRM-151. Participants previously randomized to the treatment arm in WA42293 received study medication in the three loading doses on days 1, 3 and 5 in a blinded fashion. One of the three doses contained PRM-151, whereas two doses contained placebo.

    Number of subjects in period 1
    		Cohort A: Zinpentraxin Alfa Cohort B: Ex-Placebo Cohort B: Zinpentraxin Alfa
    Started
    21
    49
    47
    Completed
    0
    0
    0
    Not completed
    21
    49
    47
         Consent withdrawn by subject
    1
    -
    2
         Lung Transplant
    -
    -
    1
         Grade 4 infusion related reaction (IRR)
    1
    -
    -
         Adverse Event
    -
    -
    1
         Study Terminated By Sponsor
    19
    47
    41
         Death
    -
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort A: Zinpentraxin Alfa
    Reporting group description
    		 Participants entered this Cohort following participation in study PRM-151-202.

    Reporting group title
    Cohort B: Ex-Placebo
    Reporting group description
    		 Participants entered, following participation in study WA42293.

    Reporting group title
    Cohort B: Zinpentraxin Alfa
    Reporting group description
    		 Participants entered, following participation in study WA42293.

    Reporting group values
    		 Cohort A: Zinpentraxin Alfa Cohort B: Ex-Placebo Cohort B: Zinpentraxin Alfa Total
    Number of subjects
    		 21 49 47 117
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 1 4 6 11
        From 65-84 years
    		 20 42 40 102
        85 years and over
    		 0 3 1 4
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 74.5 ± 5.5 74.6 ± 7.6 73.2 ± 6.8 -
    Gender Categorical
    Units: Subjects
        Female
    		 5 10 10 25
        Male
    		 16 39 37 92
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 3 2 2 7
        Not Hispanic or Latino
    		 18 47 45 110
    Race (NIH/OMB)
    Units: Subjects
        Asian
    		 0 0 1 1
        Black or African American
    		 1 1 0 2
        White
    		 19 47 43 109
        Multiple
    		 0 0 1 1
        Unknown
    		 1 1 2 4

    End points

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    End points reporting groups
    Reporting group title
    Cohort A: Zinpentraxin Alfa
    Reporting group description
    		 Participants entered this Cohort following participation in study PRM-151-202.

    Reporting group title
    Cohort B: Ex-Placebo
    Reporting group description
    		 Participants entered, following participation in study WA42293.

    Reporting group title
    Cohort B: Zinpentraxin Alfa
    Reporting group description
    		 Participants entered, following participation in study WA42293.

    Primary: Percentage of Participants with Adverse Events (AE)

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    End point title
    		 Percentage of Participants with Adverse Events (AE) [1]
    End point description
    An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product, regardless of causal attribution. Grading was completed according to the CTCAE, version 5.0. The safety-evaluable population included all enrolled participants who received at least one administration (full or partial dose) of study drug.
    End point type
    Primary
    End point timeframe
    From baseline until 8 weeks after the final dose, an average of 6 months
    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: The analysis of this safety endpoint would just be "descriptive summary of incidence of AEs"
    End point values
    		 Cohort A: Zinpentraxin Alfa Cohort B: Ex-Placebo Cohort B: Zinpentraxin Alfa
    Number of subjects analysed
    21
    49
    47
    Units: Percentage of participants
        number (not applicable)
    85.7
    51.0
    55.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Infusion Related Reactions (IRRs) and other AEs of Special Interest

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    End point title
    		 Percentage of Participants with Infusion Related Reactions (IRRs) and other AEs of Special Interest
    End point description
    IRRs were defined as AEs that occurred during or within 24 hours after study drug administration and were judged to be related to study drug infusion. The safety-evaluable population included all enrolled participants who received at least one administration (full or partial dose) of study drug.
    End point type
    Secondary
    End point timeframe
    From baseline until 8 weeks after the final dose, an average of 6 months
    End point values
    		 Cohort A: Zinpentraxin Alfa Cohort B: Ex-Placebo Cohort B: Zinpentraxin Alfa
    Number of subjects analysed
    21
    49
    47
    Units: Percentage of participants
        number (not applicable)
    9.5
    4.1
    8.5
    No statistical analyses for this end point

    Secondary: Annual Rate of Change in Forced Vital Capacity (FVC) (mL)

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    End point title
    		 Annual Rate of Change in Forced Vital Capacity (FVC) (mL)
    End point description
    The full analysis set included all enrolled participants who received at least one administration (full or partial dose) of study drug.
    End point type
    Secondary
    End point timeframe
    From baseline until study completion (up to approximately 1.5 years)
    End point values
    		 Cohort A: Zinpentraxin Alfa Cohort B: Ex-Placebo Cohort B: Zinpentraxin Alfa
    Number of subjects analysed
    21
    49
    47
    Units: Milliliter (mL)
        arithmetic mean (confidence interval 95%)
    -229.12 (-317.39 to 140.9)
    -272.96 (-698.97 to 153.06)
    -120.77 (-546.26 to 294.73)
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of of Participants Permanently Discontinuing Study Treatment due to AEs
    End point description
    The safety-evaluable population included all enrolled participants who received at least one administration (full or partial dose) of study drug.
    End point type
    Secondary
    End point timeframe
    From baseline until 8 weeks after the final dose, an average of 6 months
    End point values
    		 Cohort A: Zinpentraxin Alfa Cohort B: Ex-Placebo Cohort B: Zinpentraxin Alfa
    Number of subjects analysed
    21
    49
    47
    Units: Percentage of of participants
        number (not applicable)
    9.5
    4.1
    2.1
    No statistical analyses for this end point

    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. In the Ex-placebo arm, no participant was assessed for DLCO after baseline. 9999999 = Due to short length of follow-up, no DLCO assessment was collected at Week 48. At week 24, the standard deviation for Cohort B: Zinpentraxin Alfa could not be calculated from the data of 1 participant.
    End point type
    Secondary
    End point timeframe
    At Baseline, Week 24 and Week 48
    End point values
    		 Cohort A: Zinpentraxin Alfa Cohort B: Ex-Placebo Cohort B: Zinpentraxin Alfa
    Number of subjects analysed
    11
    36
    28
    Units: DLCO% Predicted
    arithmetic mean (standard deviation)
        Baseline (n=11,36,28)
    40.20 ± 16.29
    44.91 ± 10.94
    42.27 ± 11.14
        Week 24 (n=5,0,1)
    1.08 ± 4.05
    9999999 ± 9999999
    -1.55 ± 9999999
        Week 48 (n=5,0,0)
    -2.80 ± 3.76
    9999999 ± 9999999
    9999999 ± 9999999
    No statistical analyses for this end point

    Secondary: Annual Rate of Change in 6-Minute Walk Distance (6MWD)

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    End point title
    		 Annual Rate of 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 until study completion (up to approximately 1.5 years)
    End point values
    		 Cohort A: Zinpentraxin Alfa Cohort B: Ex-Placebo Cohort B: Zinpentraxin Alfa
    Number of subjects analysed
    21
    49
    47
    Units: Meters (m)
        arithmetic mean (confidence interval 95%)
    -86.95 (-170.80 to -3.10)
    64.64 (-98.62 to 227.90)
    -163.66 (-324.02 to -3.30)
    No statistical analyses for this end point

    Secondary: Annual Rate of Change in FVC% Predicted

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    End point title
    		 Annual Rate of 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 until study completion (up to approximately 1.5 years)
    End point values
    		 Cohort A: Zinpentraxin Alfa Cohort B: Ex-Placebo Cohort B: Zinpentraxin Alfa
    Number of subjects analysed
    21
    49
    47
    Units: Percent predicted
        arithmetic mean (confidence interval 95%)
    -6.96 (-9.70 to -4.22)
    -6.91 (-14.77 to 0.96)
    -3.37 (-11.18 to 4.44)
    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
    Time to first occurrence of >=10% absolute decline in % predicted FVC, >=15% relative decline in 6MWD, or death. 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 = Due to the low number of events and early termination of the study, the median and 95% CI weren't estimable.
    End point type
    Secondary
    End point timeframe
    From baseline until study completion (up to approximately 1.5 years)
    End point values
    		 Cohort A: Zinpentraxin Alfa Cohort B: Ex-Placebo Cohort B: Zinpentraxin Alfa
    Number of subjects analysed
    21
    49
    47
    Units: Months
        number (confidence interval 95%)
    5.6 (2.9 to 8.3)
    9999999 (9999999 to 9999999)
    9999999 (9999999 to 9999999)
    No statistical analyses for this end point

    Secondary: Survival

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    End point title
    		 Survival
    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 = Due to the low number of events, the median and 95% CI was not estimable.
    End point type
    Secondary
    End point timeframe
    Every 6 Months and at study completion (up to approximately 1.5 years)
    End point values
    		 Cohort A: Zinpentraxin Alfa Cohort B: Ex-Placebo Cohort B: Zinpentraxin Alfa
    Number of subjects analysed
    21
    49
    47
    Units: Months
        number (confidence interval 95%)
    9999999 (9999999 to 9999999)
    9999999 (9999999 to 9999999)
    9999999 (9999999 to 9999999)
    No statistical analyses for this end point

    Secondary: IPF-related Mortality

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    End point title
    		 IPF-related Mortality
    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 = Due to the low number of events, the median and 95% CI was not estimable.
    End point type
    Secondary
    End point timeframe
    Every 6 Months and at study completion (up to approximately 1.5 years)
    End point values
    		 Cohort A: Zinpentraxin Alfa Cohort B: Ex-Placebo Cohort B: Zinpentraxin Alfa
    Number of subjects analysed
    21
    49
    47
    Units: Months
        median (confidence interval 95%)
    9999999 (9999999 to 9999999)
    9999999 (9999999 to 9999999)
    9999999 (9999999 to 9999999)
    No statistical analyses for this end point

    Secondary: Respiratory-related Mortality

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    End point title
    		 Respiratory-related Mortality
    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 = Due to the low number of events, the median and 95% CI was not estimable.
    End point type
    Secondary
    End point timeframe
    Every 6 Months and at study completion (up to approximately 1.5 years)
    End point values
    		 Cohort A: Zinpentraxin Alfa Cohort B: Ex-Placebo Cohort B: Zinpentraxin Alfa
    Number of subjects analysed
    21
    49
    47
    Units: Months
        median (confidence interval 95%)
    9999999 (9999999 to 9999999)
    9999999 (9999999 to 9999999)
    9999999 (9999999 to 9999999)
    No statistical analyses for this end point

    Secondary: Plasma Concentrations of PRM-151 at Specified Timepoints

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    End point title
    		 Plasma Concentrations of PRM-151 at Specified Timepoints [2]
    End point description
    The pharmacokinetic 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 =At Baseline, no drug had been administered. Thus, there is no data to record for the plasma concentration of zinpentraxin alfa.
    End point type
    Secondary
    End point timeframe
    Days 1 and 5, Weeks 4, and 12
    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: Due to early termination of the study, only participants enrolled in Cohort A receiving at least one IV dose of zinpentraxin alfa had their plasma concentrations analyzed.
    End point values
    		 Cohort A: Zinpentraxin Alfa Cohort B: Zinpentraxin Alfa
    Number of subjects analysed
    21
    0 [3]
    Units: micrograms per millilitre (ug/mL)
    arithmetic mean (standard deviation)
        Day 1 -pre infusion (n=0)
    9999999 ± 9999999
    ±
        Day 1 - 2h Post Infusion (n=210)
    203.85 ± 55.72
    ±
        Day 5 - Pre Infusion (n=21)
    42.83 ± 18.89
    ±
        Day 5 - 2h Post Infusion (n=20)
    252.90 ± 53.42
    ±
        Week 4 - Pre Infusion (n=18)
    2.50 ± 0
    ±
        Week 4 - 2h Post Infusion (n=18)
    209.00 ± 42.93
    ±
        Week 12 - Pre Infusion (n=17)
    2.50 ± 0
    ±
        Week 12 - 2h Post Infusion (n=17)
    215.65 ± 50.47
    ±
    Notes
    [3] - Only participants in Cohort A who received at least one IV dose of zinpentraxin alfa were analyzed.
    No statistical analyses for this end point

    Secondary: Prevalence of Anti-drug Antibodies (ADAs) to PRM-151 at Baseline

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    End point title
    		 Prevalence of Anti-drug Antibodies (ADAs) to PRM-151 at Baseline
    End point description
    Due to early termination of the study, only ADA samples from participants in Cohort A were analyzed. The immunogenicity population included all randomized participants with at least one post-dose 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
    Baseline (Day 1)
    End point values
    		 Cohort A: Zinpentraxin Alfa Cohort B: Ex-Placebo Cohort B: Zinpentraxin Alfa
    Number of subjects analysed
    20
    0 [4]
    0 [5]
    Units: Participants
        number (not applicable)
    0
    Notes
    [4] - Due to early termination of the study, only ADA samples from participants in Cohort A were analyzed.
    [5] - Due to early termination of the study, only ADA samples from participants in Cohort A were analyzed.
    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
    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
    Weeks 4, 12 and 24
    End point values
    		 Cohort A: Zinpentraxin Alfa Cohort B: Ex-Placebo Cohort B: Zinpentraxin Alfa
    Number of subjects analysed
    20
    0 [6]
    0 [7]
    Units: Percentage of participants
        number (not applicable)
    0
    Notes
    [6] - Due to early termination of the study, only ADA samples from participants in Cohort A were analyzed.
    [7] - Due to early termination of the study, only ADA samples from participants in Cohort A were analyzed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline until 8 weeks after the final dose, an average of 6 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Cohort A: Zinpentraxin Alfa
    Reporting group description
    		 Participants entered this Cohort following participation in study PRM-151-202.

    Reporting group title
    Cohort B: Ex-Placebo
    Reporting group description
    		 Participants entered, following participation in study WA42293.

    Reporting group title
    Cohort B: Zinpentraxin Alfa
    Reporting group description
    		 Participants entered, following participation in study WA42293.

    Serious adverse events
    		 Cohort A: Zinpentraxin Alfa Cohort B: Ex-Placebo Cohort B: Zinpentraxin Alfa
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 21 (23.81%)
    8 / 49 (16.33%)
    6 / 47 (12.77%)
         number of deaths (all causes)
    0
    2
    2
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon neoplasm
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Microscopic polyangiitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 49 (4.08%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    Vascular stent thrombosis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Immune thrombocytopenia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Small intestinal obstruction
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 49 (4.08%)
    2 / 47 (4.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 49 (0.00%)
    2 / 47 (4.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort A: Zinpentraxin Alfa Cohort B: Ex-Placebo Cohort B: Zinpentraxin Alfa
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 21 (66.67%)
    16 / 49 (32.65%)
    14 / 47 (29.79%)
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 49 (4.08%)
    4 / 47 (8.51%)
         occurrences all number
    3
    4
    4
    Nervous system disorders
    Syncope
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    2
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 21 (9.52%)
    3 / 49 (6.12%)
    0 / 47 (0.00%)
         occurrences all number
    3
    3
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 21 (4.76%)
    3 / 49 (6.12%)
    3 / 47 (6.38%)
         occurrences all number
    1
    3
    4
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    5 / 21 (23.81%)
    0 / 49 (0.00%)
    2 / 47 (4.26%)
         occurrences all number
    5
    0
    2
    Sinus congestion
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    2
    0
    0
    Hypoxia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    2
    0
    0
    Cough
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 49 (2.04%)
    3 / 47 (6.38%)
         occurrences all number
    0
    1
    3
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    2
    0
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    4 / 21 (19.05%)
    6 / 49 (12.24%)
    4 / 47 (8.51%)
         occurrences all number
    4
    6
    4
    Acute sinusitis
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    2
    0
    0
    Bronchitis
         subjects affected / exposed
    2 / 21 (9.52%)
    3 / 49 (6.12%)
    2 / 47 (4.26%)
         occurrences all number
    2
    3
    2
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 21 (4.76%)
    4 / 49 (8.16%)
    1 / 47 (2.13%)
         occurrences all number
    1
    4
    1
    Metabolism and nutrition disorders
    Vitamin B12 deficiency
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    2
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Nov 2020
    This protocol was amended for the following reasons: 1) PK samples were to be collected as plasma instead of serum; 2) Participants in Cohort had all 3 initial loading doses blinded; 3) Clarification of the formulation of PRM-151; 4) Clarification that for loading or reloading doses, scheduled efficacy assessments would only be performed on the first of the three loading dose days; 5) Information regarding acute or suspected acute IPF exacerbation did not need to be recorded on the eCRF, instead be reported as an AE or SAE; 6) Serious hypersensitivity reactions and Grade 4 infusion-related reaction (IRR) or two Grade 3 IRRs were added as reasons for permanent study treatment discontinuation; 7) Sections on exploratory biomarker research and blood sample collection for genome or exome sequencing were removed; 8) Clarification that in order to consider treatment discontinuation after two Grade 3IRRs, the first occurrence of the Grade 3 IRR can be either in the Phase II Study PRM-151-202, Phase III Study WA42293 or in this study; 9) Acute or suspected exacerbation of idiopathic pulmonary fibrosis (IPF) has been added as an AESI; 10) Clarification that the safety evaluable population include all randomized participants who received at least one administration (full or partial dose) of study drug; 11) An iDMC was employed to review safety data from this study only up until the time the database for primary analysis for Study WA42293 was locked, and Study WA42293 was unblinded to the Sponsor; 12) Appendices were updated with the latest versions of the documents.
    01 Feb 2022
    Additional text was added to the protocol.
    28 Apr 2022
    Additional text was added to the protocol in this amendment to describe the following: the galectin-1 and galectin-3 host cell protein identified within first generation PRM-151 drug product, the sugar galactose- -1,3-galactose identified in first and second generation PRM-151 drug product and on the increased risk, and the potential risk of post-implantation fetal loss associated with PRM-151.

    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 due to the Sponsor's decision to terminate the parent study early.
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    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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