Trial · NCT05321069
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
NCT05321069, Phase 3, Completed, Boehringer Ingelheim; results first posted 2025-09-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF). Trials, record NCT05321069. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05321069
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
- NCT number
- NCT05321069
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,177 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- BI 1015550, Placebo
- First posted
- 2022-04-11
- Last updated
- 2025-10-20
- Other registries' IDs
- eudract:2022-001091-34
- Results first posted
- 2025-09-12
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change From Baseline in Forced Vital Capacity (FVC) [mL] at Week 52 | The MMRM model is a longitudinal analysis, and it incorporated FVC measurements from baseline (Week -8 to Week -1) and Week 2, Week 6, Week 12, Week 18, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52 | The absolute change from baseline in Forced Vital Capacity (FVC) \[mL\] at Week 52 is reported. The absolute change from baseline in forced vital capacity (FVC) at Week 52 was analyzed using a restricted maximum likelihood (REML)-based mixed model with repeated measures (MMRM). The model included fixed categorical effects of treatment and baseline antifibrotic use at each visit, as well as the continuous effect of baseline FVC. Visit was treated as a repeated measure, with an unstructured covariance structure for within-patient variability. |
| Secondary | Key Secondary Endpoint: Time to the First Occurrence of Any of the Components of the Composite Endpoint: Time to First Acute IPF Exacerbation, First Hospitalization for Respiratory Cause, or Death (Whichever Occurs First) Over the Duration of the Trial | From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months. | Time to the first occurrence of any component of the composite endpoint-acute IPF exacerbation, hospitalization for a respiratory cause, or death (whichever occurred first)-is reported as the number of participants who experienced one or more of these events during the trial. Acute IPF is defined as an acute, clinically significant respiratory deterioration characterized by evidence of new, widespread alveolar abnormality, with all of the following: Acute worsening or development of dyspnea, typically of less than 1 month's duration. Computed tomography showing new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with IPF. Deterioration not fully explained by cardiac failure or fluid overload. If more than one component occurred on the same day, the patient was counted under the first event according to the following hierarchy: acute IPF exacerbation, hospitalization, death. |
| Secondary | Time to First Acute IPF Exacerbation or Death Over the Duration of the Trial | From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months. | The time to first acute IPF exacerbation or death during the trial is reported as the number of participants who experienced either event. Acute IPF is defined as an acute, clinically significant respiratory deterioration characterized by evidence of new, widespread alveolar abnormality, with all of the following: Acute worsening or development of dyspnea, typically of less than 1 month's duration. Computed tomography showing new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with IPF. Deterioration not fully explained by cardiac failure or fluid overload. If more than one component occurred on the same day, the patient was counted under the first event according to the following hierarchy: acute IPF exacerbation followed by death. |
| Secondary | Time to Hospitalization for Respiratory Cause or Death Over the Duration of the Trial | From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months. | Time to hospitalization for respiratory cause or death over the duration of the trial is reported as the number of participants who experienced either event. Hospitalizations due to respiratory causes were recorded on a specific non-elective hospitalization CRF page. This page captured the hospitalization date, confirmation of a respiratory cause, and the primary admission diagnosis. If more than one component occurred on the same day, the patient was counted under the first event according to the hierarchy: hospitalization for respiratory cause, followed by death. |
| Secondary | Time to Absolute Decline in Forced Vital Capacity (FVC) % Predicted of >10% From Baseline or Death Over the Duration of the Trial | From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months. | The time to absolute decline of more than 10% from baseline in forced vital capacity (FVC) percent predicted, or death, over the duration of the trial is reported as the number of participants who experienced either event. If more than one component occurred on the same day, the patient was counted under the first event according to the hierarchy; Absolute decline in FVC % predicted of \> 10% followed by death. |
| Secondary | Time to Absolute Decline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Percentage Predicted by More Than 15% From Baseline or Death, Measured Over the Duration of the Trial | From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months. | The time to absolute decline of more than 15% from baseline in diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted, or death, over the duration of the trial is reported as the number of participants who experienced either event. Predicted DLCO value was corrected for hemoglobin (Hb). If more than one component occurred on the same day, the patient was counted under the first event according to the hierarchy: Absolute decline in DLCO % predicted of \> 15%, followed by Death. |
| Secondary | Time to Death Over the Duration of the Trial | From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months. | Time to death over the duration of the trial is reported as the number of participants who died. Time to death will be based either on the date of death on the AE report for patients with AEs leading to death or will be based on the information from the vital status assessment. |
| Secondary | Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Dyspnea Domain Score at Week 52 | The MMRM model is a longitudinal analysis and it incorporated L-PF measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52. | The absolute change from baseline in the Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52 is reported. This endpoint was analyzed using a Mixed Model for Repeated Measures (MMRM). The model included fixed effects for treatment, baseline use of antifibrotic therapy, and baseline dyspnea score at each visit, with an unstructured covariance structure to model repeated measures. The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44-item tool consisting of two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module yields three domain scores: Dyspnea, Cough, and Fatigue, as well as a Total Symptoms score. Scoring is based on the mean of item ratings within each domain, multiplied by 100. Scores range from 0 to 100, with higher scores indicating greater impairment. |
| Secondary | Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score at Week 52 | The MMRM model is a longitudinal analysis and it incorporated L-PF measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52. | The absolute change from baseline in the L-PF Cough domain score at Week 52 is reported. This endpoint was analyzed using a Mixed Model for Repeated Measures (MMRM). The model included fixed effects for treatment, baseline antifibrotic therapy, and baseline L-PF Cough score at each visit, with an unstructured covariance matrix for repeated measures. The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44-item tool consisting of two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module yields three domain scores: Dyspnea, Cough, and Fatigue, as well as a Total Symptoms score. Scoring is based on the mean of item ratings within each domain, multiplied by 100. Scores range from 0 to 100, with higher scores indicating greater impairment. |
| Secondary | Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Fatigue Domain Score at Week 52 | The MMRM model is a longitudinal analysis and it incorporated L-PF measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52. | The absolute change from baseline in the Living with Pulmonary Fibrosis (L-PF) Fatigue domain score at Week 52 is reported. The analysis used a mixed model for repeated measures (MMRM) with fixed categorical effects for treatment, baseline antifibrotic (AF) therapy, and the fixed continuous effect of baseline L-PF score. Covariance was unstructured. Baseline AF therapy was a covariate. The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44-item tool consisting of two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module yields three domain scores: Dyspnea, Cough, and Fatigue, as well as a Total Symptoms score. Scoring is based on the mean of item ratings within each domain, multiplied by 100. Scores range from 0 to 100, with higher scores indicating greater impairment. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change From Baseline in Forced Vital Capacity (FVC) [mL] at Week 52 | The MMRM model is a longitudinal analysis, and it incorporated FVC measurements from baseline (Week -8 to Week -1) and Week 2, Week 6, Week 12, Week 18, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52 | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. only patients with baseline measurement and at least one post-baseline measurement are included. | Milliliters (mL) | LEAST_SQUARES_MEAN |
| SECONDARY | Key Secondary Endpoint: Time to the First Occurrence of Any of the Components of the Composite Endpoint: Time to First Acute IPF Exacerbation, First Hospitalization for Respiratory Cause, or Death (Whichever Occurs First) Over the Duration of the Trial | From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months. | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Acute IPF Exacerbation or Death Over the Duration of the Trial | From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months. | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Hospitalization for Respiratory Cause or Death Over the Duration of the Trial | From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months. | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Absolute Decline in Forced Vital Capacity (FVC) % Predicted of >10% From Baseline or Death Over the Duration of the Trial | From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months. | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Absolute Decline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Percentage Predicted by More Than 15% From Baseline or Death, Measured Over the Duration of the Trial | From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months. | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Death Over the Duration of the Trial | From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months. | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Dyspnea Domain Score at Week 52 | The MMRM model is a longitudinal analysis and it incorporated L-PF measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52. | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. Only patients with baseline measurement and at least one post-baseline measurement are included. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score at Week 52 | The MMRM model is a longitudinal analysis and it incorporated L-PF measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52. | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. Only patients with baseline measurement and at least one post-baseline measurement are included. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Fatigue Domain Score at Week 52 | The MMRM model is a longitudinal analysis and it incorporated L-PF measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52. | Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. Only patients with baseline measurement and at least one post-baseline measurement are included. | Score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change From Baseline in Forced Vital Capacity (FVC) [mL] at Week 52 | Placebo | -183.48 | 95% Confidence Interval -210.86 to -156.10 | Milliliters (mL) | |
| Absolute Change From Baseline in Forced Vital Capacity (FVC) [mL] at Week 52 | Nerandomilast 9 mg BID | -138.60 | 95% Confidence Interval -165.59 to -111.61 | Milliliters (mL) | |
| Absolute Change From Baseline in Forced Vital Capacity (FVC) [mL] at Week 52 | Nerandomilast 18 mg BID | -114.65 | 95% Confidence Interval -141.81 to -87.50 | Milliliters (mL) | |
Key Secondary Endpoint: Time to the First Occurrence of Any of the Components of the Composite Endpoint: Time to First Acute IPF Exacerbation, First Hospitalization for Respiratory Cause, or Death (Whichever Occurs First) Over the Duration of the Trial | Placebo | Acute IPF exacerbation as the first event | 38 | Participants | |
Key Secondary Endpoint: Time to the First Occurrence of Any of the Components of the Composite Endpoint: Time to First Acute IPF Exacerbation, First Hospitalization for Respiratory Cause, or Death (Whichever Occurs First) Over the Duration of the Trial | Nerandomilast 9 mg BID | Acute IPF exacerbation as the first event | 32 | Participants | |
Key Secondary Endpoint: Time to the First Occurrence of Any of the Components of the Composite Endpoint: Time to First Acute IPF Exacerbation, First Hospitalization for Respiratory Cause, or Death (Whichever Occurs First) Over the Duration of the Trial | Nerandomilast 18 mg BID | Acute IPF exacerbation as the first event | 38 | Participants | |
Key Secondary Endpoint: Time to the First Occurrence of Any of the Components of the Composite Endpoint: Time to First Acute IPF Exacerbation, First Hospitalization for Respiratory Cause, or Death (Whichever Occurs First) Over the Duration of the Trial | Placebo | Hospitalisation for respiratory cause as the first event | 49 | Participants | |
Key Secondary Endpoint: Time to the First Occurrence of Any of the Components of the Composite Endpoint: Time to First Acute IPF Exacerbation, First Hospitalization for Respiratory Cause, or Death (Whichever Occurs First) Over the Duration of the Trial | Nerandomilast 9 mg BID | Hospitalisation for respiratory cause as the first event | 45 | Participants | |
Key Secondary Endpoint: Time to the First Occurrence of Any of the Components of the Composite Endpoint: Time to First Acute IPF Exacerbation, First Hospitalization for Respiratory Cause, or Death (Whichever Occurs First) Over the Duration of the Trial | Nerandomilast 18 mg BID | Hospitalisation for respiratory cause as the first event | 47 | Participants | |
Key Secondary Endpoint: Time to the First Occurrence of Any of the Components of the Composite Endpoint: Time to First Acute IPF Exacerbation, First Hospitalization for Respiratory Cause, or Death (Whichever Occurs First) Over the Duration of the Trial | Placebo | Death as the first event | 16 | Participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 393 | |
| Overall Study | STARTED | Nerandomilast 9 mg BID | 392 | |
| Overall Study | STARTED | Nerandomilast 18 mg BID | 392 | |
| Overall Study | Completed Treatment Period A (52 Weeks) | Placebo | 320 | |
| Overall Study | Completed Treatment Period A (52 Weeks) | Nerandomilast 9 mg BID | 324 | |
| Overall Study | Completed Treatment Period A (52 Weeks) | Nerandomilast 18 mg BID | 318 | |
| Overall Study | COMPLETED | Placebo | 292 | |
| Overall Study | COMPLETED | Nerandomilast 9 mg BID | 298 | |
| Overall Study | COMPLETED | Nerandomilast 18 mg BID | 299 | |
| Overall Study | NOT COMPLETED | Placebo | 101 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,140
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 | Placebo | 75 | 393 | |
| other | Diarrhoea | Gastrointestinal disorders | Nera 9 mg BID | 130 | 392 | |
| other | Diarrhoea | Gastrointestinal disorders | Nera 18 mg BID | 166 | 392 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 28 | 393 | |
| other | Nausea | Gastrointestinal disorders | Nera 9 mg BID | 39 | 392 | |
| other | Nausea | Gastrointestinal disorders | Nera 18 mg BID | 33 | 392 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 19 | 393 | |
| other | Vomiting | Gastrointestinal disorders | Nera 9 mg BID | 19 | 392 | |
| other | Vomiting | Gastrointestinal disorders | Nera 18 mg BID | 21 | 392 | |
| other | Condition aggravated | General disorders | Placebo | 27 | 393 |
1 to 10 of 1,140Source ClinicalTrials.gov
See all 1,140 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 42 | 393 |
| Total, all-cause mortality | Nera 9 mg BID | 36 | 392 |
| Total, all-cause mortality | Nera 18 mg BID | 26 | 392 |
| Total, other adverse events | Placebo | 316 | 393 |
| Total, other adverse events | Nera 9 mg BID | 319 | 392 |
| Total, other adverse events | Nera 18 mg BID | 337 | 392 |
| Total, serious adverse events | Placebo | 181 | 393 |
| Total, serious adverse events | Nera 9 mg BID | 159 | 392 |
| Total, serious adverse events | Nera 18 mg BID | 165 | 392 |
Source ClinicalTrials.gov
Papers4
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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