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Clinical Trials/NCT05321069
NCT05321069CompletedPhase 3

A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Boehringer Ingelheim334 sites in 6 countries1,177 target enrollmentStarted: October 6, 2022Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
1,177
Locations
334
Primary Endpoint
Absolute Change From Baseline in Forced Vital Capacity (FVC) [mL] at Week 52
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar TrialsRelated News

Study Overview

Brief Summary

This study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). People can join the study if they are 40 years or older. If they already take nintedanib or pirfenidone for their IPF, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with IPF.

Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine.

Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Nerandomilast 9 mg BID

Experimental

Participants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.

Intervention: BI 1015550 (Drug)

Nerandomilast 18 mg BID

Experimental

Participants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.

Intervention: BI 1015550 (Drug)

Placebo

Placebo Comparator

Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Absolute Change From Baseline in Forced Vital Capacity (FVC) [mL] at Week 52

Time Frame: 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 Outcomes

  • 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 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.)
  • 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 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.)
  • 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.)
  • Time to Death Over the Duration of the Trial(From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.)
  • 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.)
  • 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.)
  • 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.)
  • Absolute Change From Baseline in Forced Vital Capacity Percent Predicted at Week 52(The MMRM model is a longitudinal analysis, and it incorporated FVC measurements from baseline (Week -8 to Week -1) and Week 1, 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.)
  • Absolute Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide Percent Predicted at Week 52(The MMRM model is a longitudinal analysis and it incorporated DLCO measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, and Week 52. The data represent the Least Squares Mean at Week 52.)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (334)

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Related News

Nerandomilast Shows Promise in Phase 3 Trial for Idiopathic Pulmonary Fibrosis- Boehringer Ingelheim's nerandomilast met its primary endpoint in the Phase 3 FIBRONEER-IPF trial, demonstrating improved lung function in IPF patients. - The trial is the first in a decade to meet its primary endpoint, offering hope for a new treatment option for this progressive disease. - Nerandomilast, a phosphodiesterase 4B inhibitor, aims to reduce inflammation and fibrosis in the lungs, addressing a high unmet need. - Full data will be presented in the first half of 2025, with plans for regulatory submissions to the FDA and other agencies.last yearNerandomilast Meets Primary Endpoint in Phase III FIBRONEER-IPF Trial• Boehringer Ingelheim's nerandomilast met the primary endpoint in the Phase III FIBRONEER-IPF trial, showing a significant absolute change from baseline in Forced Vital Capacity (FVC) at week 52 compared to placebo. • The FIBRONEER-IPF trial, the largest IPF trial to date, recruited patients from over 330 sites across more than 30 countries, demonstrating broad global participation. • Boehringer Ingelheim plans to submit a new drug application to the FDA and other health authorities for nerandomilast as a treatment for idiopathic pulmonary fibrosis (IPF). • Nerandomilast, an oral phosphodiesterase 4B (PDE4B) inhibitor, has received Breakthrough Therapy Designation from the FDA for IPF and is being investigated in two Phase III trials.last yearBoehringer Ingelheim Seeks Approval for Nerandomilast After Positive Phase III IPF Trial• Boehringer Ingelheim is seeking regulatory approval for nerandomilast after its Phase III FIBRONEER-IPF trial met the primary endpoint of improving forced vital capacity in patients with idiopathic pulmonary fibrosis (IPF). • The FIBRONEER-IPF trial, involving 1,177 patients, demonstrated that nerandomilast significantly improved lung function compared to placebo over 52 weeks; full data will be presented in H1 2025. • Nerandomilast, a preferential phosphodiesterase 4B (PDE4B) inhibitor, received breakthrough therapy designation from the FDA in 2022 and is also being investigated for progressive fibrosing interstitial lung diseases. • With limited FDA-approved treatments for IPF, nerandomilast represents a potential new option, as the trial is the first successful late-stage IPF trial in a decade.last yearNerandomilast Meets Primary Endpoint in Phase III FIBRONEER-IPF Trial for Idiopathic Pulmonary Fibrosis• Boehringer Ingelheim's FIBRONEER-IPF trial met its primary endpoint, demonstrating a statistically significant change in Forced Vital Capacity (FVC) at week 52 compared to placebo. • Nerandomilast, an oral phosphodiesterase 4B (PDE4B) inhibitor, is under investigation for treating Idiopathic Pulmonary Fibrosis (IPF) and has received FDA Breakthrough Therapy Designation. • The FIBRONEER-IPF trial, involving 1177 patients across 30 countries, is the largest IPF trial to date, with full data to be presented in H1 2025. • Boehringer Ingelheim plans to submit a new drug application to the FDA and other health authorities based on these positive results, addressing a high unmet need in IPF treatment.last yearNerandomilast Meets Primary Endpoint in Phase III FIBRONEER-IPF Trial• Boehringer Ingelheim's nerandomilast met the primary endpoint in the Phase III FIBRONEER-IPF trial, showing a significant change in Forced Vital Capacity (FVC) at week 52 compared to placebo. • The FIBRONEER-IPF trial, the largest IPF trial to date, recruited patients from over 330 sites across more than 30 countries, demonstrating broad global participation. • Nerandomilast, an oral phosphodiesterase 4B (PDE4B) inhibitor, has received FDA Breakthrough Therapy Designation for IPF, with a new drug application planned for submission. • Full efficacy and safety data from the FIBRONEER-IPF trial will be presented in the first half of 2025, offering a comprehensive understanding of the drug's potential.2 years ago

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