Phase 3
N=81
A Study to Test How Well a Medicine Called Nintedanib Helps People in China With Progressive Lung Fibrosis
Lung Diseases, Interstitial
Bottom Line
View on ClinicalTrials.gov: NCT05065190 ↗Enrolled (actual)
81
Serious AEs
39.5%
Results posted
May 2025
Primary outcome: Primary: Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks Expressed in Milliliter (mL) — -191.89; -85.32 Milliliter/year
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nintedanib (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks Expressed in Milliliter (mL) |
-191.89; -85.32 | — |
Summary
This study in China is open to people with progressive lung fibrosis (chronic fibrosing ILDs with progressive phenotype) who are at least 18 years old. The purpose of this study is to find out whether a medicine called nintedanib helps people with progressive lung fibrosis.
Participants are put into 2 groups randomly, which means by chance. 1 group gets nintedanib as capsules twice a day. The other group gets placebo as capsules twice a day. Placebo capsules look like nintedanib capsules but do not contain any medicine.
Participants are in the study for about 1 year. During this time, they visit the study site about 10 times. At some visits, participants perform a lung function test. The doctors check whether study treatment can slow down the loss of lung function. The doctors also regularly check participants' health and take note of any unwanted effects.
Eligibility Criteria
Inclusion Criteria
- Written Informed Consent consistent with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local laws signed prior to entry into the study (and prior to any study procedure including shipment of High-Resolution Computed Tomography (HRCT) to reviewer.
- Male or female patients aged ≥ 18 years at Visit 1.
- Patients with physician diagnosed Interstitial Lung Disease (ILD) who fulfil at least one of the following criteria for Progressive Phenotype within 24 months of screening visit (Visit 1) despite treatment with unapproved medications used in clinical practice to treat ILD, as assessed by the investigator:
- Clinically significant decline in Forced Vital Capacity (FVC) % predicted based on a relative decline of ≥10%
- Marginal decline in FVC % predicted based on a relative decline of ≥5- 10%, performed within 12 months of Visit 1 as confirmed by central readers.
- For patients with underlying Connective Tissue Disease (CTD): stable CTD as defined by no initiation of new therapy or withdrawal of therapy for CTD within 6 weeks prior to Visit 1.
- FVC ≥ 45% predicted at Visit 2.
Exclusion Criteria
- Aspartate Aminotransferase (AST) and / or Alanine Aminotransferase (ALT) > 1.5 x Upper Level of Normal (ULN) at Visit 1
- Bilirubin > 1.5 x ULN at Visit 1
- Creatinine clearance 20mg/day and the combination of OCS+AZA+ n-Acetylcysteine (NAC) within 4 weeks of Visit 2, cyclophosphamide within 8 weeks of Visit 2, rituximab within 6 months of Visit 2.
Note: Patients whose Regulatory Authority (RA)/Connective Tissue Disease (CTD) is managed by these medications should not be considered for participation in the current study unless change in RA/CTD medication is medically indicated.
Further exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT05065190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.