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A Study to Test How Well a Medicine Called Nintedanib Helps People in China With Progressive Lung Fibrosis

Primary Purpose

Lung Diseases, Interstitial

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
nintedanib
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases, Interstitial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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% combined with worsening of respiratory symptoms
    • Marginal decline in FVC % predicted based on a relative decline of ≥5-<10% combined with increasing extent of fibrotic changes on chest imaging
    • Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging [Note: Changes attributable to comorbidities e.g. infection, heart failure must be excluded. Unapproved medications used in the clinical practice to treat ILD include but are not limited to corticosteroid, azathioprine, mycophenolate mofetil (MMF), n-Acetylcysteine (NAC), rituximab, cyclophosphamide, cyclosporine, tacrolimus].
  • Fibrosing lung disease on HRCT, defined as reticular abnormality with traction bronchiectasis with or without honeycombing, with disease extent of >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 <30 milliliter (mL)/minute (min) calculated by Cockcroft-Gault formula at Visit 1.

[Note: Laboratory parameters from Visit 1 have to satisfy the laboratory threshold values as shown above. Visit 2 laboratory results will be available only after randomization. In case at Visit 2 the results do no longer satisfy the entry criteria, the Investigator has to decide whether it is justified that the patient remains on study drug. The justification for decision needs to be documented. Laboratory parameters that are found to be abnormal at Visit 1 are allowed to be re-tested (once) if it is thought to be a measurement error (i.e. there was no abnormal result of this test in the recent history of the patient and there is no related clinical sign) or the result of a temporary and reversible medical condition, once that condition is resolved].

  • Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic impairment).
  • Previous treatment with nintedanib or pirfenidone.
  • Other investigational therapy received within 1 month or 6 half-lives (whichever was greater) prior to screening visit (Visit 1).
  • Use of any of the following medications for the treatment of Interstitial Lung Disease (ILD): azathioprine (AZA), cyclosporine, Mycophenolate Mofetil (MMF), tacrolimus, oral corticosteroids (OCS) >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.

Sites / Locations

  • China-Japan Friendship Hospital
  • The Second Hospital of Jilin University
  • Xiangya Hospital, Central South University
  • West China Hospital
  • First Affiliated Hospital of Guangzhou Medical University
  • Hangzhou First People's Hospital
  • The Second Affiliated Hospital Zhejiang University School of Medicine
  • Zhejiang Hospital
  • Nanjing Drum Tower Hospital
  • Shanghai Chest Hospital
  • Huashan Hospital, Fudan University
  • Shanghai Pulmonary Hospital
  • Tianjin Medical University General Hospital
  • The First Affiliated Hospital of Wenzhou Med College
  • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
  • General Hospital of Ningxia Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

nintedanib

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Annual rate of decline in Forced Vital Capacity
Forced Vital Capacity (FVC); expressed in milliliter (mL)

Secondary Outcome Measures

Full Information

First Posted
September 30, 2021
Last Updated
September 18, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT05065190
Brief Title
A Study to Test How Well a Medicine Called Nintedanib Helps People in China With Progressive Lung Fibrosis
Official Title
A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nintedanib Over 52 Weeks in Chinese Patients With Chronic Fibrosing ILDs With a Progressive Phenotype
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 25, 2021 (Actual)
Primary Completion Date
May 14, 2024 (Anticipated)
Study Completion Date
May 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Interstitial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nintedanib
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
nintedanib
Intervention Description
nintedanib
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Annual rate of decline in Forced Vital Capacity
Description
Forced Vital Capacity (FVC); expressed in milliliter (mL)
Time Frame
up to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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% combined with worsening of respiratory symptoms Marginal decline in FVC % predicted based on a relative decline of ≥5-<10% combined with increasing extent of fibrotic changes on chest imaging Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging [Note: Changes attributable to comorbidities e.g. infection, heart failure must be excluded. Unapproved medications used in the clinical practice to treat ILD include but are not limited to corticosteroid, azathioprine, mycophenolate mofetil (MMF), n-Acetylcysteine (NAC), rituximab, cyclophosphamide, cyclosporine, tacrolimus]. Fibrosing lung disease on HRCT, defined as reticular abnormality with traction bronchiectasis with or without honeycombing, with disease extent of >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 <30 milliliter (mL)/minute (min) calculated by Cockcroft-Gault formula at Visit 1. [Note: Laboratory parameters from Visit 1 have to satisfy the laboratory threshold values as shown above. Visit 2 laboratory results will be available only after randomization. In case at Visit 2 the results do no longer satisfy the entry criteria, the Investigator has to decide whether it is justified that the patient remains on study drug. The justification for decision needs to be documented. Laboratory parameters that are found to be abnormal at Visit 1 are allowed to be re-tested (once) if it is thought to be a measurement error (i.e. there was no abnormal result of this test in the recent history of the patient and there is no related clinical sign) or the result of a temporary and reversible medical condition, once that condition is resolved]. Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic impairment). Previous treatment with nintedanib or pirfenidone. Other investigational therapy received within 1 month or 6 half-lives (whichever was greater) prior to screening visit (Visit 1). Use of any of the following medications for the treatment of Interstitial Lung Disease (ILD): azathioprine (AZA), cyclosporine, Mycophenolate Mofetil (MMF), tacrolimus, oral corticosteroids (OCS) >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.
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
The Second Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130041
Country
China
Facility Name
Xiangya Hospital, Central South University
City
Changsha
ZIP/Postal Code
410008
Country
China
Facility Name
West China Hospital
City
Chengdu
ZIP/Postal Code
610042
Country
China
Facility Name
First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
ZIP/Postal Code
310006
Country
China
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Facility Name
Zhejiang Hospital
City
Hangzhou
ZIP/Postal Code
310013
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
ZIP/Postal Code
210008
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Huashan Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
30052
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Med College
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Facility Name
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
ZIP/Postal Code
750004
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
IPD Sharing Time Frame
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD Sharing Access Criteria
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
https://www.mystudywindow.com/
Description
Related Info

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A Study to Test How Well a Medicine Called Nintedanib Helps People in China With Progressive Lung Fibrosis

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