Dermatomyositis Interstitial Lung Disease (Dm-ILD)Phase 3NCT03857854
Efficacy and Safety of Pirfenidone in Patient With Dermatomyositis Interstitial Lung Disease (Dm-ILD)
A Phase 3 study testing Pirfenidone in people with Dermatomyositis Interstitial Lung Disease (Dm-ILD), run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of pirfenidone in subjects with dermatomyositis interstitial lung disease Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dermatomyositis Interstitial Lung Disease (Dm-ILD)
- What is being tested?
- Pirfenidone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2018to May 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male subjects aged between 18 and 65 years of age
- According to the 1975 Borhan and Peter inflammatory myopathy diagnosed as dermatomyositis classification criteria (dermatomyositis, DM); or according to the revised clinical criteria for diagnosis of Sontheimer disease dermatomyositis (CADM).
- The diagnosis of pulmonary related Interstitial Lung Disease confirmed by HRCT
- Forced vital capacity (FVC) 40% to 80% predicted(include 40% and80% )
- Carbon monoxide diffusing capacity (DLco) 30% to 89% of predicted normal(include 30% and89% )
- Has received Glucocorticoid (hereinafter referred to as the "hormone") and at least one immunosuppressive therapy for more than 3 months, the hormone dosage (prednisone equivalent dose calculation) should be less than 15mg/d for at least 1 months, should be immunosuppressant cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine and at least one of methotrexate in, and the type and dose of immunosuppressive agents should be at least stable more than 3 months. The hormone and immunosuppressant therapy scheme allows a reduction in the study period, but is not allowed to increase the volume.
- Women of childbearing age must agree and promise to use the form of medical care for at least 3 months after the trial, during the entire study period (including follow-up), and at the end of the trial.
- Patients volunteered to participate in the trial, with good compliance and ability to understand and sign informed consent before the study.
Who cannot join
- Subjects not fulfill all of the above inclusion criteria
- Combined with other rheumatic diseases such as systemic sclerosis, systemic lupus erythematosus, Sjogren's syndrome, mixed connective tissue disease, undifferentiated connective tissue disease, and systemic vasculitis, such as ANCA associated vasculitis.
- Combined with other muscle diseases and may cause symptoms of myasthenia gravis disease, including neurological diseases (such as muscular dystrophy, myasthenia gravis, amyotrophic lateral sclerosis, Guillain Barre syndrome), cancer, drugs (such as statins), infection, genetic diseases, endocrine disorders, electrolyte disorder rhabdomyolysis.
- The clinical history, signs, serological examination, HRCT and bronchoalveolar lavage results suggest that in addition to inflammatory myopathy and other diseases caused by ILD, such as CTD, systemic vasculitis, infection, tumor, allergic pneumonia caused by sarcoidosis or environmental factors.
- Combined viscera function significantly abnormal patient:
- Liver:AST, ALT >1.3ULN;Bilirubin >1.5 ULN; Cirrhosis of the liver class for Child Pugh C;
Show all 28Show fewer
- Kidney:Creatinine clearance <30 mL/min;
- Lung:Airway obstruction (pre-bronchodilator FEV1/FVC <0.7);Other clinically significant pulmonary abnormalities;
- Cardiovascular:i.Six weeks in severe hypertension, and out of control after treatment(≥160/100mmHg);ii.Myocardial infarction within six months;iii.A period of 6 Months in unstable angina;iv.pulmonary artery hypertension and right heart failure were significant;
- Gastrointestinal tract: with active peptic ulcer;
- Nervous system: Patients with psychiatric disorders;
- The blood coagulation function: History of thrombotic event within last year(Including stroke and transient ischemic attack).
- Researchers, for other diseases (not inflammatory myopathy, such as malignant tumor) and make the life expectancy of < 1 year of patients
- Allergic to test drugs or components (e.g. lactose)
- Patients with actinic dermatitis
- Previous treatment with nintedanib or pirfenidone
- Within 3 months to participate in other clinical trials;
- Combined medication: hormone > 15mg/d, were less than 1 months before a stable dose of patients; the use of other immunosuppressive agents (except cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, methotrexate and) patients; immunosuppression stable < 3 months; during the study of hormones and immunosuppressive agents are likely to increase patients.
- Major surgery is planned during the treatment period.
- Pregnancy or lactation or make a schedule during the trials.
- Give the drug 28 days before or after administration of the 3 month period, women of childbearing age * are unwilling or unable to use contraceptive methods highly effective (according to ICH M3 (R2)), a highly effective means in the correct and consistent application of a barrier method when the failure rate of less than 1% per year. * women of childbearing age is defined has undergone menarche and in line with "infertile women" standard "[female infertile women" is defined as: postmenopausal period (12 months without menstruation, no other medical reasons) or permanent sterilization (e.g., tubal occlusion, hysterectomy, bilateral ovarian resection or bilateral tubal resection women)].
- According to the researchers,exhibited evidence of alcohol or drug abuse.
- Patients who were unable to understand or comply with the study procedures, including the completion of a self-administered questionnaire in the absence of help, were less likely to complete the trial.
- Severe limb weakness or joint disease that affects the stability and endurance of a patient who is unable to perform a 6 minute walking test.
- Clinical signs of malabsorption or needing parenteral nutrition.
- Patients who were unable to cope with pulmonary function tests.
- With mental illness .
- Researchers determined that they did not participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhang, Ling
Beijing, Beijing Municipality, 100102
Ling Zhang, +86-13501209210, rlzhang1006@163.com
About this study
Official title: A Phase III, Randomized, Double-blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Pirfenidone in Subjects With Dermatomyositis Interstitial Lung Disease (Dm-ILD)
The purpose of this study is to evaluate the efficacy and safety of pirfenidone in subjects with dermatomyositis interstitial lung disease
- Being tested
- Pirfenidone, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
treatment group
PlacebosDrug
placebo group
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | pirfenidone group Receives: Drug: Pirfenidone |
| placebo group | Placebo comparator | control group Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change from baseline (%) of FVC
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start5 Jun 2018
- Primary completionFeb 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatomyositis Interstitial Lung Disease (Dm-ILD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857854
- Sponsor's protocol ID
- GNI-F647-1702
- Status last verified
- Feb 2019
- First submitted
- 26 Feb 2019
- Last updated
- 28 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Pirfenidone in Subjects With Dermatomyositis Interstitial Lung Disease (Dm-ILD)
- ClinicalTrials.gov ID
- NCT03857854
- Acronym / sponsor ID
- GNI-F647-1702
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of pirfenidone in subjects with dermatomyositis interstitial lung disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Pirfenidonepirfenidone group |
| placebo group | Placebo comparator | Drug: Placeboscontrol group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female or male subjects aged between 18 and 65 years of age
- According to the 1975 Borhan and Peter inflammatory myopathy diagnosed as dermatomyositis classification criteria (dermatomyositis, DM); or according to the revised clinical criteria for diagnosis of Sontheimer disease dermatomyositis (CADM).
- The diagnosis of pulmonary related Interstitial Lung Disease confirmed by HRCT
- Forced vital capacity (FVC) 40% to 80% predicted(include 40% and80% )
- Carbon monoxide diffusing capacity (DLco) 30% to 89% of predicted normal(include 30% and89% )
Key exclusion criteria (28 listed)
- Subjects not fulfill all of the above inclusion criteria
- Combined with other rheumatic diseases such as systemic sclerosis, systemic lupus erythematosus, Sjogren's syndrome, mixed connective tissue disease, undifferentiated connective tissue disease, and systemic vasculitis, such as ANCA associated vasculitis.
- Combined with other muscle diseases and may cause symptoms of myasthenia gravis disease, including neurological diseases (such as muscular dystrophy, myasthenia gravis, amyotrophic lateral sclerosis, Guillain Barre syndrome), cancer, drugs (such as statins), infection, genetic diseases, endocrine disorders, electrolyte disorder rhabdomyolysis.
- The clinical history, signs, serological examination, HRCT and bronchoalveolar lavage results suggest that in addition to inflammatory myopathy and other diseases caused by ILD, such as CTD, systemic vasculitis, infection, tumor, allergic pneumonia caused by sarcoidosis or environmental factors.
- Combined viscera function significantly abnormal patient:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pirfenidonetreatment group | Drug | treatment group |
| Placebosplacebo group | Drug | placebo group |
Primary outcome
Relative change from baseline (%) of FVC
Time frame: 52 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
Related trials for Dermatomyositis Interstitial Lung Disease (Dm-ILD)
Active, not recruitingObservational study
Construction of a Clinico-Imaging Collaborative Diagnostic Model for Dermatomyositis Combined With Interstitial Lung Disease Based on PET/CT Imaging Features and Clinical Parameters
Dermatomyositis (DM), ILD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pirfenidone in people with Dermatomyositis Interstitial Lung Disease (Dm-ILD), run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change from baseline (%) of FVC (time frame: 52 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.