Trial · NCT04552899
A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
NCT04552899, Phase 3, Terminated, Hoffmann-La Roche; results first posted 2024-04-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis. Trials, record NCT04552899. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04552899
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
- NCT number
- NCT04552899
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 665 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- PRM-151 (Zinpentraxin Alfa), Placebo
- First posted
- 2020-09-17
- Last updated
- 2024-04-18
- Other registries' IDs
- eudract:2020-000791-38
- Results first posted
- 2024-04-18
- Limitations and caveats
- This study was terminated early based on the futility analysis which concluded that zinpentraxin alfa was unlikely to meet its primary endpoint.
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change in Forced Vital Capacity (FVC [mL]) | From Baseline up to Week 52 | |
| Secondary | Absolute Change in 6-minute Walk Distance (6MWD) | From Baseline up to Week 52 | |
| Secondary | Absolute Change in FVC% Predicted | From Baseline up to Week 52 | |
| Secondary | Time to Disease Progression | From Baseline up to 1 year | |
| Secondary | Time to First Respiratory-related Hospitalizations | From Baseline up to 1 year | |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF) | From Baseline up to 1 year | |
| Secondary | Change in Carbon Monoxide Diffusing Capacity (DLCO) | At Baseline, Week 12, Week 24, Week 36 and Week 52 | |
| Secondary | Survival | From Baseline up to 1 year | Survival is measured by all-cause mortality |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change in Forced Vital Capacity (FVC [mL]) | From Baseline up to Week 52 | 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. | Milliliters (mL) | MEAN |
| SECONDARY | Absolute Change in 6-minute Walk Distance (6MWD) | From Baseline up to Week 52 | 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. | Meters (m) | MEAN |
| SECONDARY | Absolute Change in FVC% Predicted | From Baseline up to Week 52 | 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. | Percent predicted | MEAN |
| SECONDARY | Time to Disease Progression | From Baseline up to 1 year | 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. | Months | MEDIAN |
| SECONDARY | Time to First Respiratory-related Hospitalizations | From Baseline up to 1 year | 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. | Months | MEDIAN |
| SECONDARY | 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 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. | Score on a scale | MEAN |
| SECONDARY | Change in St. George Respiratory Questionnaire (SGRQ) Total Score | At Baseline, Week 12, Week 24, Week 36 and Week 52 | 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. | Score on a scale | MEAN |
| SECONDARY | Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF) | From Baseline up to 1 year | 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. | Months | MEDIAN |
| SECONDARY | Change in Carbon Monoxide Diffusing Capacity (DLCO) | At Baseline, Week 12, Week 24, Week 36 and Week 52 | 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. | DLCO% Predicted | MEAN |
| SECONDARY | Survival | From Baseline up to 1 year | 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. | Months | MEDIAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group67
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change in Forced Vital Capacity (FVC [mL]) | Zinpentraxin Alfa | -235.72 | 95% Confidence Interval -283.07 to -188.4 | Milliliters (mL) | |
| Absolute Change in Forced Vital Capacity (FVC [mL]) | Placebo | -214.89 | 95% Confidence Interval -262.44 to -167.3 | Milliliters (mL) | |
| Absolute Change in 6-minute Walk Distance (6MWD) | Zinpentraxin Alfa | -33.64 | 95% Confidence Interval -48.71 to -18.57 | Meters (m) | |
| Absolute Change in 6-minute Walk Distance (6MWD) | Placebo | -24.19 | 95% Confidence Interval -39.29 to -9.10 | Meters (m) | |
| Absolute Change in FVC% Predicted | Zinpentraxin Alfa | -6.22 | 95% Confidence Interval -7.46 to -4.98 | Percent predicted | |
| Absolute Change in FVC% Predicted | Placebo | -5.72 | 95% Confidence Interval -6.96 to -4.47 | Percent predicted | |
| Time to Disease Progression | Zinpentraxin Alfa | 6.6 | 95% Confidence Interval 5.6 to 9.1 | Months | |
| Time to Disease Progression | Placebo | 8.2 | 95% Confidence Interval 6.5 to 10.9 | Months | |
| Time to First Respiratory-related Hospitalizations | Zinpentraxin Alfa | NA | 95% Confidence Interval NA to NA | Months | |
| Time to First Respiratory-related Hospitalizations | Placebo | NA | 95% Confidence Interval NA to NA | Months |
1 to 10 of 67Source ClinicalTrials.gov
See all 67 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zinpentraxin Alfa | 331 | |
| Overall Study | STARTED | Placebo | 333 | |
| Overall Study | No Treatment | Zinpentraxin Alfa | 1 | |
| Overall Study | No Treatment | Placebo | 3 | |
| Overall Study | COMPLETED | Zinpentraxin Alfa | 56 | |
| Overall Study | COMPLETED | Placebo | 49 | |
| Overall Study | NOT COMPLETED | Zinpentraxin Alfa | 275 | |
| Overall Study | NOT COMPLETED | Placebo | 284 |
Source ClinicalTrials.gov
Adverse events138
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Zinpentraxin Alfa | 35 | 331 | 48 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 34 | 329 | 39 |
| other | Fatigue | General disorders | Zinpentraxin Alfa | 17 | 331 | 22 |
| other | Fatigue | General disorders | Placebo | 14 | 329 | 14 |
| other | COVID-19 | Infections and infestations | Zinpentraxin Alfa | 57 | 331 | 59 |
| other | COVID-19 | Infections and infestations | Placebo | 57 | 329 | 60 |
| other | Infusion related reaction | Injury, poisoning and procedural complications | Zinpentraxin Alfa | 31 | 331 | 42 |
| other | Infusion related reaction | Injury, poisoning and procedural complications | Placebo | 29 | 329 | 55 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Zinpentraxin Alfa | 42 | 331 | 46 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo | 38 | 329 | 42 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zinpentraxin Alfa | 4 | 331 |
| Total, all-cause mortality | Placebo | 4 | 333 |
| Total, other adverse events | Zinpentraxin Alfa | 140 | 331 |
| Total, other adverse events | Placebo | 128 | 329 |
| Total, serious adverse events | Zinpentraxin Alfa | 46 | 331 |
| Total, serious adverse events | Placebo | 40 | 329 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Zinpentraxin Alfa vs Placebo: Percentage of Participants With Adverse Events (AEs) | Trial comparisons |
| Zinpentraxin Alfa vs Placebo: Percentage of Participants With Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest | Trial comparisons |
| Zinpentraxin Alfa vs Placebo: deaths from any cause | Trial comparisons |
| Zinpentraxin Alfa vs Placebo: Percentage of Participants Permanently Discontinuing Study Treatment Due to AEs | Trial comparisons |
| Zinpentraxin Alfa vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04552899
GET https://conductscience.org/api/trials/v1/NCT04552899/results?page=2