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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05065190
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lung Diseases, Interstitial
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: nintedanib

Placebo Comparator: Placebo

Interventions

Drug: - nintedanib

nintedanib

Drug: - Placebo

Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

China-Japan Friendship Hospital, Beijing, China

Status

Recruiting

Address

China-Japan Friendship Hospital

Beijing, , 100029

Site Contact

Boehringer Ingelheim

[email protected]

4001200553

The Second Hospital of Jilin University, Changchun, China

Status

Recruiting

Address

The Second Hospital of Jilin University

Changchun, , 130041

Site Contact

Boehringer Ingelheim

[email protected]

4001200553

Changsha, China

Status

Recruiting

Address

Xiangya Hospital, Central South University

Changsha, , 410008

Site Contact

Boehringer Ingelheim

[email protected]

4001200553

West China Hospital, Chengdu, China

Status

Recruiting

Address

West China Hospital

Chengdu, , 610042

Site Contact

Boehringer Ingelheim

[email protected]

4001200553

Guangzhou, China

Status

Recruiting

Address

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, , 510120

Site Contact

Boehringer Ingelheim

[email protected]

4001200553

Hangzhou First People's Hospital, Hangzhou, China

Status

Recruiting

Address

Hangzhou First People's Hospital

Hangzhou, , 310006

Site Contact

Boehringer Ingelheim

[email protected]

4001200553

Hangzhou, China

Status

Recruiting

Address

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, , 310009

Site Contact

Boehringer Ingelheim

[email protected]

4001200553

Zhejiang Hospital, Hangzhou, China

Status

Recruiting

Address

Zhejiang Hospital

Hangzhou, , 310013

Site Contact

Boehringer Ingelheim

[email protected]

4001200553

Nanjing Drum Tower Hospital, Nanjing, China

Status

Recruiting

Address

Nanjing Drum Tower Hospital

Nanjing, , 210008

Site Contact

Boehringer Ingelheim

[email protected]

4001200553

Shanghai Chest Hospital, Shanghai, China

Status

Recruiting

Address

Shanghai Chest Hospital

Shanghai, , 200030

Site Contact

Boehringer Ingelheim

[email protected]

4001200553

Huashan Hospital, Fudan University, Shanghai, China

Status

Recruiting

Address

Huashan Hospital, Fudan University

Shanghai, , 200040

Site Contact

Boehringer Ingelheim

[email protected]

4001200553

Shanghai Pulmonary Hospital, Shanghai, China

Status

Recruiting

Address

Shanghai Pulmonary Hospital

Shanghai, , 200433

Site Contact

Boehringer Ingelheim

[email protected]

4001200553

Tianjin, China

Status

Recruiting

Address

Tianjin Medical University General Hospital

Tianjin, , 30052

Site Contact

Boehringer Ingelheim

[email protected]

4001200553

Wenzhou, China

Status

Recruiting

Address

The First Affiliated Hospital of Wenzhou Med College

Wenzhou, , 325000

Site Contact

Boehringer Ingelheim

[email protected]

4001200553

Wuhan, China

Status

Recruiting

Address

Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T

Wuhan, , 430030

Site Contact

Boehringer Ingelheim

[email protected]

4001200553

Yinchuan, China

Status

Recruiting

Address

General Hospital of Ningxia Medical University

Yinchuan, , 750004

Site Contact

Boehringer Ingelheim

[email protected]

4001200553