Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
This phase III study will 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).
Interventions
A 10 mg/kg IV infusion of PRM-151 based on the participants weight will be administered on Days 1, 3 and 5 followed by infusions Q4W to Week 48.
DRUGPlacebo
Placebo matching PRM-151 will be administered by IV infusion on Days 1, 3 and 5, followed by infusions Q4W to Week 48.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Documented diagnosis of IPF per the 2018 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) Clinical Practice Guideline * High-resolution computed tomography (HRCT) pattern consistent with the diagnosis of IPF, confirmed by central review of Chest HRCT and central review of any available lung biopsy (LB) * Minimum 6 minute walk distance (6MWD) of 150 meters with maximum use of 6 L/min at sea-level and up-to 8 L/min at altitude of supplemental oxygen while maintaining oxygen saturation of greater than or equal to (\>/= )83% during the 6 minute walk test (6MWT) during screening * FVC \>/= 45% predicted during screening as determined by the over-reader * Forced expiratory volume in 1 second (FEV1)/FVC ratio greater than (\>) 0.70 during screening determined by the over-reader * Diffusing capacity for carbon monoxide (DLCO) \>/= 30% and less than or equal to (\</=) 90% of predicted at screening as determined by the over-reader * If receiving pirfenidone or nintedanib treatment for IPF, the participant must have been on treatment for at least 3 months and a stable dose for at least 4 weeks prior to screening, and during screening * If not currently receiving nintedanib or pirfenidone treatment (either treatment naïve or having previously taken and discontinued) must have discontinued such treatment \>/= 4 weeks prior to screening and during screening * Anticipated life expectancy of at least 12 months at baseline * Participant and investigator considered all medicinal treatment options and/or possibly lung transplantation prior to considering participation in the study. * For women of childbearing potential (excluding participant enrolling in Japan): agreement to remain abstinent or use contraception * For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm * Anticipated life expectancy of at least 12 months at baseline, according to the investigator's judgment * For participant enrolled in the extended China enrollment phase: current resident of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry
Exclusion criteria
* Evidence of other known causes of Interstitial Lung Disease (ILD) * FVC% predicted value showing repeated increase in the 6 months period prior to screening and including screening value * Emphysema present on greater than or equal to (\>/=) 50% of the HRCT, or the extent of emphysema is greater than the extent of fibrosis, according to central review of the HRCT * Receiving nintedanib in combination with pirfenidone * Received cytotoxic, immunosuppressive, cytokine modulating, or receptor antagonist agents (including but not limited to methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine or other steroid sparing agent) within 4 weeks prior to or during screening * Receiving systemic corticosteroids equivalent to prednisone \> 10 mg/day or equivalent within 2 weeks prior to or during screening * Acute respiratory or systemic bacterial, viral, or fungal infection either during screening or prior to screening and not successfully resolved 4 weeks prior to screening visit * Participants with active or latent tuberculosis (confirmed within the 6 months prior to or during screening, by a positive screening test \[interferon gamma release assay\]) * Resting oxygen saturation of \< 89% using up to 4 L/min of supplemental oxygen at sea level and up to 6 L/min at altitude (\>/= 5000 feet \[1524 meters\] above sea level) during screening * Class IV New York Heart Association chronic heart failure * Historical evidence of left ventricular ejection fraction \< 35% * Presence of pulmonary hypertension that, in the investigator's opinion, would substantially limit the ability to comply with study requirements or may influence any of the safety or efficacy assessments included in the study * Cardiopulmonary rehabilitation program based on exercise training that has been completed within 8 weeks prior to screening or planned to start during the participant enrollment in this trial * History of smoking, alcohol or substance abuse disorder, or a malignancy * Previous treatment with PRM-151 * Clinically significant abnormality on ECG during screening that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant including prolonged corrected QT interval \> 450 ms (for men) or \> 470 ms (for women) on ECG during screening based on the Fridericia correction formula * Clinically significant laboratory test abnormalities during screening (hematology, serum chemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant * Pregnant or breastfeeding, or become pregnant during the study or within 8 weeks after the final dose of PRM-151 * Women of childbearing potential (Only for participants enrolling in Japan)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute Change in Forced Vital Capacity (FVC [mL]) | From Baseline up to Week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in FVC% Predicted | From Baseline up to Week 52 | — |
| Time to Disease Progression | From Baseline up to 1 year | — |
| Time to First Respiratory-related Hospitalizations | From Baseline up to 1 year | — |
| Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) | At Baseline, Week 12, Week 24, Week 36 and Week 52 | 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. |
| Change in St. George Respiratory Questionnaire (SGRQ) Total Score | At Baseline, Week 12, Week 24, Week 36 and Week 52 | 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. |
| Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF) | From Baseline up to 1 year | — |
| Change in Carbon Monoxide Diffusing Capacity (DLCO) | At Baseline, Week 12, Week 24, Week 36 and Week 52 | — |
| Absolute Change in 6-minute Walk Distance (6MWD) | From Baseline up to Week 52 | — |
| Percentage of Participants With Adverse Events (AEs) | From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year) | — |
| Percentage of Participants With Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest | From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year) | — |
| Percentage of Participants Permanently Discontinuing Study Treatment Due to AEs | From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year) | — |
| Plasma Concentrations of PRM-151 | Days 1, 5 and Weeks 4, 12, and 24 | — |
| Prevalence of Anti-drug Antibodies (ADAs) at Baseline | At Baseline | — |
| Percentage of Participants With ADAs During the Study | Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56 | — |
| Survival | From Baseline up to 1 year | Survival is measured by all-cause mortality |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Recruitment details
A total of 665 participants were enrolled across 275 investigative sites in 29 countries.
Pre-assignment details
One participant who failed screening was enrolled in error and did not subsequently enter the study.
Participants by arm
| Arm | Count |
|---|---|
| Zinpentraxin Alfa 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. | 331 |
| Placebo Participants received IV infusions of placebo over 50-70 minutes on Days 1, 3 and 5, followed by infusions Q4W to Week 48. | 333 |
| Total | 664 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 3 |
| Overall Study | Death | 4 | 4 |
| Overall Study | Lost to Follow-up | 8 | 13 |
| Overall Study | Lung Transplant | 4 | 3 |
| Overall Study | Participant and physician wanted to withdraw participant from study | 0 | 1 |
| Overall Study | Physician Decision | 3 | 4 |
| Overall Study | Study Terminated By Sponsor | 237 | 239 |
| Overall Study | Withdrawal by Subject | 15 | 17 |
Baseline characteristics
| Characteristic | Placebo | Total | Zinpentraxin Alfa |
|---|---|---|---|
| Age, Continuous | 70.6 Years STANDARD_DEVIATION 7.6 | 70.7 Years STANDARD_DEVIATION 7.4 | 70.8 Years STANDARD_DEVIATION 7.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 47 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 299 Participants | 601 Participants | 302 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 16 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 56 Participants | 108 Participants | 52 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) White | 270 Participants | 544 Participants | 274 Participants |
| Sex: Female, Male Female | 70 Participants | 131 Participants | 61 Participants |
| Sex: Female, Male Male | 263 Participants | 533 Participants | 270 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 331 | 4 / 333 |
| other Total, other adverse events | 140 / 331 | 128 / 329 |
| serious Total, serious adverse events | 46 / 331 | 40 / 329 |
Outcome results
Primary
Absolute Change in Forced Vital Capacity (FVC [mL])
Time frame: From Baseline up to Week 52
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Zinpentraxin Alfa | Absolute Change in Forced Vital Capacity (FVC [mL]) | -235.72 Milliliters (mL) |
| Placebo | Absolute Change in Forced Vital Capacity (FVC [mL]) | -214.89 Milliliters (mL) |
p-value: 0.5495% CI: [-87.94, 46.29]RCRM
Secondary
Absolute Change in 6-minute Walk Distance (6MWD)
Time frame: From Baseline up to Week 52
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Zinpentraxin Alfa | Absolute Change in 6-minute Walk Distance (6MWD) | -33.64 Meters (m) |
| Placebo | Absolute Change in 6-minute Walk Distance (6MWD) | -24.19 Meters (m) |
Secondary
Absolute Change in FVC% Predicted
Time frame: From Baseline up to Week 52
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Zinpentraxin Alfa | Absolute Change in FVC% Predicted | -6.22 Percent predicted |
| Placebo | Absolute Change in FVC% Predicted | -5.72 Percent predicted |
Secondary
Change in Carbon Monoxide Diffusing Capacity (DLCO)
Time frame: At Baseline, Week 12, Week 24, Week 36 and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zinpentraxin Alfa | Change in Carbon Monoxide Diffusing Capacity (DLCO) | Week 12 | -1.19 DLCO% Predicted | Standard Deviation 11.89 |
| Zinpentraxin Alfa | Change in Carbon Monoxide Diffusing Capacity (DLCO) | Week 36 | -5.83 DLCO% Predicted | Standard Deviation 8.49 |
| Zinpentraxin Alfa | Change in Carbon Monoxide Diffusing Capacity (DLCO) | Week 24 | -4.68 DLCO% Predicted | Standard Deviation 7.93 |
| Zinpentraxin Alfa | Change in Carbon Monoxide Diffusing Capacity (DLCO) | Week 52 | -6.30 DLCO% Predicted | Standard Deviation 9.56 |
| Zinpentraxin Alfa | Change in Carbon Monoxide Diffusing Capacity (DLCO) | Baseline | 51.73 DLCO% Predicted | Standard Deviation 17.73 |
| Placebo | Change in Carbon Monoxide Diffusing Capacity (DLCO) | Week 52 | -6.68 DLCO% Predicted | Standard Deviation 9.28 |
| Placebo | Change in Carbon Monoxide Diffusing Capacity (DLCO) | Baseline | 51.66 DLCO% Predicted | Standard Deviation 14.78 |
| Placebo | Change in Carbon Monoxide Diffusing Capacity (DLCO) | Week 12 | -2.78 DLCO% Predicted | Standard Deviation 9.86 |
| Placebo | Change in Carbon Monoxide Diffusing Capacity (DLCO) | Week 24 | -4.01 DLCO% Predicted | Standard Deviation 9.75 |
| Placebo | Change in Carbon Monoxide Diffusing Capacity (DLCO) | Week 36 | -4.66 DLCO% Predicted | Standard Deviation 7.1 |
Secondary
Change in St. George Respiratory Questionnaire (SGRQ) Total Score
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.
Time frame: At Baseline, Week 12, Week 24, Week 36 and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zinpentraxin Alfa | Change in St. George Respiratory Questionnaire (SGRQ) Total Score | Week 12 | 1.03 Score on a scale | Standard Deviation 9.98 |
| Zinpentraxin Alfa | Change in St. George Respiratory Questionnaire (SGRQ) Total Score | Week 36 | 3.21 Score on a scale | Standard Deviation 11.38 |
| Zinpentraxin Alfa | Change in St. George Respiratory Questionnaire (SGRQ) Total Score | Week 24 | 3.50 Score on a scale | Standard Deviation 11.05 |
| Zinpentraxin Alfa | Change in St. George Respiratory Questionnaire (SGRQ) Total Score | Week 52 | 6.15 Score on a scale | Standard Deviation 13.87 |
| Zinpentraxin Alfa | Change in St. George Respiratory Questionnaire (SGRQ) Total Score | Baseline | 36.73 Score on a scale | Standard Deviation 18.63 |
| Placebo | Change in St. George Respiratory Questionnaire (SGRQ) Total Score | Week 52 | 3.09 Score on a scale | Standard Deviation 11.51 |
| Placebo | Change in St. George Respiratory Questionnaire (SGRQ) Total Score | Baseline | 37.66 Score on a scale | Standard Deviation 18.45 |
| Placebo | Change in St. George Respiratory Questionnaire (SGRQ) Total Score | Week 12 | 0.81 Score on a scale | Standard Deviation 10.55 |
| Placebo | Change in St. George Respiratory Questionnaire (SGRQ) Total Score | Week 24 | 1.39 Score on a scale | Standard Deviation 13.94 |
| Placebo | Change in St. George Respiratory Questionnaire (SGRQ) Total Score | Week 36 | 2.15 Score on a scale | Standard Deviation 13.42 |
Secondary
Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ)
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.
Time frame: At Baseline, Week 12, Week 24, Week 36 and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zinpentraxin Alfa | Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) | Week 12 | 0.8 Score on a scale | Standard Deviation 13 |
| Zinpentraxin Alfa | Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) | Week 36 | 5.4 Score on a scale | Standard Deviation 17.5 |
| Zinpentraxin Alfa | Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) | Week 24 | 3.2 Score on a scale | Standard Deviation 16 |
| Zinpentraxin Alfa | Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) | Week 52 | 11.1 Score on a scale | Standard Deviation 21.2 |
| Zinpentraxin Alfa | Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) | Baseline | 28.9 Score on a scale | Standard Deviation 22.2 |
| Placebo | Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) | Week 52 | 4.8 Score on a scale | Standard Deviation 14.8 |
| Placebo | Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) | Baseline | 29.9 Score on a scale | Standard Deviation 22.6 |
| Placebo | Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) | Week 12 | 4.0 Score on a scale | Standard Deviation 17.4 |
| Placebo | Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) | Week 24 | 4.7 Score on a scale | Standard Deviation 16.8 |
| Placebo | Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) | Week 36 | 6.9 Score on a scale | Standard Deviation 17.7 |
Secondary
Percentage of Participants Permanently Discontinuing Study Treatment Due to AEs
Time frame: From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zinpentraxin Alfa | Percentage of Participants Permanently Discontinuing Study Treatment Due to AEs | 9 Participants |
| Placebo | Percentage of Participants Permanently Discontinuing Study Treatment Due to AEs | 6 Participants |
Secondary
Percentage of Participants With ADAs During the Study
Time frame: Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56
Population: 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. There is no data reported for the Placebo Arm as that group never received any study drug. As such, we cannot measure anti-drug antibodies for that group of participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zinpentraxin Alfa | Percentage of Participants With ADAs During the Study | 3 Participants |
Secondary
Percentage of Participants With Adverse Events (AEs)
Time frame: From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zinpentraxin Alfa | Percentage of Participants With Adverse Events (AEs) | 247 Participants |
| Placebo | Percentage of Participants With Adverse Events (AEs) | 238 Participants |
Secondary
Percentage of Participants With Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest
Time frame: From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zinpentraxin Alfa | Percentage of Participants With Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest | 12 Participants |
| Placebo | Percentage of Participants With Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest | 5 Participants |
Secondary
Plasma Concentrations of PRM-151
Time frame: Days 1, 5 and Weeks 4, 12, and 24
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zinpentraxin Alfa | Plasma Concentrations of PRM-151 | Week 24 - Pre Infusion | NA micrograms per millilitre (ug/mL) | — |
| Zinpentraxin Alfa | Plasma Concentrations of PRM-151 | Day 1 - 1h Post Infusion | 198 micrograms per millilitre (ug/mL) | Standard Deviation 56.8 |
| Zinpentraxin Alfa | Plasma Concentrations of PRM-151 | Day 1 - 2h Post Infusion | 203 micrograms per millilitre (ug/mL) | Standard Deviation 68.4 |
| Zinpentraxin Alfa | Plasma Concentrations of PRM-151 | Day 1 - 4h Post Infusion | 168 micrograms per millilitre (ug/mL) | Standard Deviation 48 |
| Zinpentraxin Alfa | Plasma Concentrations of PRM-151 | Day 1 - 8h Post Infusion | 118 micrograms per millilitre (ug/mL) | Standard Deviation 37.8 |
| Zinpentraxin Alfa | Plasma Concentrations of PRM-151 | Day 1 - 10h Post Infusion | 158 micrograms per millilitre (ug/mL) | Standard Deviation 35.8 |
| Zinpentraxin Alfa | Plasma Concentrations of PRM-151 | Day 1 - 12h Post Infusion | 95.9 micrograms per millilitre (ug/mL) | Standard Deviation 31.5 |
| Zinpentraxin Alfa | Plasma Concentrations of PRM-151 | Day 1 - 24h Post Infusion | 81.8 micrograms per millilitre (ug/mL) | Standard Deviation 26.2 |
| Zinpentraxin Alfa | Plasma Concentrations of PRM-151 | Day 5 - Pre Infusion | 39.6 micrograms per millilitre (ug/mL) | Standard Deviation 21.5 |
| Zinpentraxin Alfa | Plasma Concentrations of PRM-151 | Day 5 - 2h Post Infusion | 244 micrograms per millilitre (ug/mL) | Standard Deviation 75.6 |
| Zinpentraxin Alfa | Plasma Concentrations of PRM-151 | Week 4 - Pre Infusion | NA micrograms per millilitre (ug/mL) | — |
| Zinpentraxin Alfa | Plasma Concentrations of PRM-151 | Week 4 - 2h Post Infusion | 212 micrograms per millilitre (ug/mL) | Standard Deviation 105 |
| Zinpentraxin Alfa | Plasma Concentrations of PRM-151 | Week 12 - Pre Infusion | NA micrograms per millilitre (ug/mL) | — |
| Zinpentraxin Alfa | Plasma Concentrations of PRM-151 | Week 12 - 2h Post Infusion | 177 micrograms per millilitre (ug/mL) | Standard Deviation 72.7 |
| Unknown | Plasma Concentrations of PRM-151 | Day 1 -pre infusion | — micrograms per millilitre (ug/mL) | — |
Secondary
Prevalence of Anti-drug Antibodies (ADAs) at Baseline
Time frame: At Baseline
Population: 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. There is no data reported for the Placebo Arm as that group never received any study drug. As such, we cannot measure anti-drug antibodies for that group of participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zinpentraxin Alfa | Prevalence of Anti-drug Antibodies (ADAs) at Baseline | 0 Participants |
Secondary
Survival
Survival is measured by all-cause mortality
Time frame: From Baseline up to 1 year
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zinpentraxin Alfa | Survival | NA Months |
| Placebo | Survival | NA Months |
Secondary
Time to Disease Progression
Time frame: From Baseline up to 1 year
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zinpentraxin Alfa | Time to Disease Progression | 6.6 Months |
| Placebo | Time to Disease Progression | 8.2 Months |
p-value: 0.251295% CI: [0.91, 1.47]Log Rank
Secondary
Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF)
Time frame: From Baseline up to 1 year
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zinpentraxin Alfa | Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF) | NA Months |
| Placebo | Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF) | NA Months |
p-value: 0.700595% CI: [0.4, 1.86]Log Rank
Secondary
Time to First Respiratory-related Hospitalizations
Time frame: From Baseline up to 1 year
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zinpentraxin Alfa | Time to First Respiratory-related Hospitalizations | NA Months |
| Placebo | Time to First Respiratory-related Hospitalizations | NA Months |
p-value: 0.983395% CI: [0.51, 1.97]Log Rank