Myositis Associated Interstitial Lund Disease (MA-ILD)Phase 4MINTNCT05799755

Myositis Interstitial Lung Disease Nintedanib Trial

A Phase 4 study testing Nintedanib in people with Myositis Associated Interstitial Lund Disease (MA-ILD), run by Rohit Aggarwal, MD at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This research study will evaluate safety and how well the study drug, nintedanib improve symptoms in participants with myositis associated interstitial lung disease (MA-ILD). Interstitial lung disease is a disorder caused by the abnormal accumulation of cells structures between air sacs of the lungs resulting in… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myositis Associated Interstitial Lund Disease (MA-ILD)
What is being tested?: Nintedanib
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 62 participants
Where: 10 sitesUnited States
Study dates: 1 Aug 2023to 31 Dec 2025
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has provided written informed consent
Approval from local treating physician (done at pre-screening only for remote patients as well as for local site patients not actively being managed at the local site).
Subject lives in the United States
Adult: Age ≥ 18 years
Subject can speak, read, and understand English or Spanish
Subject is willing and capable of performing all study procedures.

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Validity/repeatability of home spirometry confirmed by PFT lab technician/MD through telemedicine as per American Thoracic Society guidelines.
Men and women of reproductive potential must agree to use 2 reliable methods of birth control during the trial period.
Clinical diagnosis of myositis or presence of one of the following myositis-specific or -associated autoantibodies).
Anti-synthetase autoantibody (Anti-Jo-1, -PL-7, -PL-12, -EJ, -OJ, -KS, -Tyr, -Zo)
Anti-MDA5, TIF1-gamma, Mi-2, NXP2/MJ, SAE, HMGCR, SRP
Anti-PM/Scl, Ku, U1RNP, Ro5,2/60, or SSA (in absence of clinical diagnosis of systemic sclerosis or primary Sjogren syndrome).
Fibrosing Interstitial Lung Disease (ILD):
HRCT chest within 12 months of screening visit with fibrosing ILD (reticular changes, traction bronchiectasis, and/or honeycombing)
No other identifiable cause of fibrosis
The following co-existing features are expected and accepted: ground glass opacity, upper lung or peri-bronchovascular predominance, mosaic attenuation, air trapping, consolidation, and centrilobular nodules.
Progressive ILD: Defined as meeting ≥1 of the following criteria within 24 months of the screening visit.
≥10% relative decline in FVC% predicted (%pred)
≥5 but <10% relative decline in FVC %pred with worsening dyspnea.
≥5 but <10% relative decline in FVC %pred with worsening chest HRCT fibrotic changes
Worsening dyspnea with worsening chest HRCT fibrosis
Worsening dyspenea with FCV% </= 70%
Standard of care (SOC) therapy: (See: SOC immunosuppression and washout under section 6.2 for details)
Allowable SOC includes a maximum of 2: 1 glucocorticoid (GC) and 1 Non-GC immunosuppressive medication (IS) Or 2 Non-GC immunosuppressive medications.
Allowable IS component of SOC regimen must have been started at least 12 weeks prior and be stable for at least 4 weeks before baseline visit.
In case a patient is not on any of the SOC immunosuppression, patient can be enrolled if at least 2 SOC immunosuppression are either previously failed or had intolerance or are contra-indicated.
Allowable GC component of SOC regimen must have been started at least 4 weeks prior and be stable for at least 2 weeks before baseline visit.
Allowable IS and GC:
Glucocorticoid (maximum dose ≤20 mg/day; prednisone equivalent). Mycophenolate mofetil (max dose 3 gm/day) Mycophenolic acid (max dose 2,160 mg/day) Azathioprine (max dose 2.5 mg/kg/day) Methotrexate (max dose 25 mg/week Tacrolimus (max dose 10 mg/day) Cyclosporine (max dose 200 mg/day) Leflunomide (max dose 20 mg/day) Sulfasalazine (max dose 3 gm/day) JAK inhibitors (tofacitinib max does 11 mg/day, upadacitinib max dose 15 mg/day, baricitinib max does 4 mg/day) IVIG (Intravenous immunoglobulin) or SQIG (subcutaneous immunoglobulin) (max dose 2 gm/kg/month) is allowed and not considered as SOC IS therapy Rituximab (maximum dose 1000 mg x 2 (2 weeks apart) or 375mg/m2 weekly dose x 4, repeated every > 4 months) Hydroxychloroquine is allowed and not considered as SOC IS therapy. Orencia (max dose of 125 mg SQ once a week or 1 gm monthly IV infusion)
Inhaled medication(s) for lung disease is allowed if started > 4 weeks before screening.
Should remain stable throughout the study.
Negative pregnancy test

Who cannot join

Planned major surgical procedures within the trial period of 24 weeks.
Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Women of childbearing potential* not willing or able to use at least two highly effective methods of birth control.
For females of reproductive potential: use of highly effective contraception for at least 1 month before study drug administration and agreement to use such a method during study participation and for an additional 28 days after the end of study drug administration.
For males of reproductive potential**: use of condoms or other methods to ensure effective contraception with a partner
Highly effective contraception examples are:

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An approved hormonal contraceptive such as oral contraceptives, emergency contraception used as directed, patches, implants, injections, rings, hormonally-impregnated intrauterine device (IUD), or nonhormonal IUD.
Abstinence
Condoms
A woman is considered of childbearing potential, i.e. fertile, following menarche, and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, tubal occlusion, and bilateral oophorectomy.
A man is considered permanently sterile if a vasectomy has been performed.
Severe lung disease is defined by the following within the last 6 months before the screening:
FVC ≤40 percent predicted
DLCO <30% of percent predicted (corrected for Hb)
O2 requirement of ≥10 L at rest based on home oxygen prescription.
Patient listed for lung transplant or actively going through lung transplant evaluation.
Moderate to severe active muscle disease from myositis as per any one of the criteria:
Creatine kinase (CK) > 2000 U/mL.
Moderate to severe dermatomyositis rashes as per investigator evaluation (if rash present)
Moderate to severe arthritis as per investigator evaluation
Moderate to severe muscle weakness as per Sit to Stand 30 seconds of < 7.
History of or ongoing serious active, chronic, or recurrent infection within 4 weeks of screening
Significant Pulmonary Hypertension (PH) is defined by any of the following:
Current clinical diagnosis of moderate to severe PH or significant right heart failure.
History of echocardiographic evidence of significant right heart failure or moderate to severe PH (TR jet >= 2.9 m/s and signs of right ventricle (RV) dysfunction; or TR jet > 3.4; or an right ventricle systolic pressure (RVSP) > 40-55 with evidence of RV strain or dysfunction; or RVSP > 55 regardless.
History of right heart catheterization showing a cardiac index ≤ 2.2 l/min/m² or severity of pulmonary hypertension (mPAP) >40 millimeters of mercury (mmHg) with a pulmonary capillary wedge pressure (PCWP) <15mmHg
PH requiring oral, IV, or inhaled therapy (such as epoprostenol, treprostinil, iloprost, bosentan, ambrisentan, sildenafil, and tadalafil).
Increased bleeding risk, defined by any of the following:
Patients who require
Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, factor Xa inhibitors, low molecular weight heparin)
High dose antiplatelet therapy (>325mg acetylsalicylic acid or >75mg clopidogrel).
History of hemorrhagic central nervous system (CNS) event within 12 months of screening.
Any of the following within 3 months of screening:
Hemoptysis or hematuria
Active gastrointestinal (GI) bleeding or active GI ulcers.
Coagulation parameters: International normalized ratio (INR) >2, prolongation of prothrombin time (PT) and by >1.5 x ULN at screening.
History of a thrombotic event (including stroke and transient ischemic attack) within 12 months of screening.
Severe Cardiovascular disease, any of the following:
Severe hypertension, uncontrolled under treatment (≥160/100 mmHg), within 6 months of screening.
Myocardial infarction or unstable cardiac angina within 6 months of screening.
Patients with underlying chronic liver disease (Child-Pugh A, B, or C hepatic impairment).
Known hypersensitivity to the trial medication or its components (i.e. soya lecithin)
Other diseases that may interfere with testing procedures or in the judgment of the Investigator may interfere with trial participation (such as significant GI issues like irritable bowel syndrome, inflammatory bowel disease, recent abdominal surgery, diverticular disease), or significant other lung diseases (such as severe obstructive lung disease such as severe asthma or severe chronic obstructive pulmonary disease, etc.) or may put the patient at risk when participating in this trial.
Life expectancy for a disease other than ILD < 2.5 years (Investigator assessment).
In the opinion of the investigator, any condition precluding participation and completion of the study, including active alcohol and drug abuse or patients not able to understand or follow trial procedures.
Other investigational therapy was received within 1 month or 6 half-lives (whichever was greater) before the screening visit.
Current treatment with nintedanib or pirfenidone (taken the drug within 3 months of randomization or history of intolerance/side effects)
Current or recent use of one or more of the following medications (See: SOC immunosuppression and washout under section 6.2 for details)
Cyclophosphamide within 3 months of baseline.
Anti-tumor necrosis factor (infliximab, golimumab, or certolizumab) within 8 weeks or adalimumab within 4 weeks, and etanercept within 2 weeks of baseline.
Anakinra within 1 week of baseline.
Other biological agents such as tocilizumab, etc. within 4 weeks of baseline.
Safety laboratory abnormality as any one of below
Aspartate transferase (AST), alanine aminotransferase (ALT) > 1.5 x ULN at screening, unless deemed due to active myositis by investigator, in which case CK is also abnormally elevated and the ratio of AST or ALT by CK levels (adjusted as x ULN) should be < 2.0 and gamma-glutamyl transferase < 2.0 x ULN.
Bilirubin > 1.5 x ULN at screening
Creatinine clearance <30 mL/min calculated by Cockcroft-Gault formula at screening.
Hgb < 9.0
Platelet count < 100,000/mm3
White blood cells < 3000/mm3
-

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

University of Alabama
Birmingham, Alabama, 35294
University of Chicago
Chicago, Illinois, 60637
National Jewish Health
Denver, Colorado, 80206
University of Kansas Medical Center
Kansas City, Kansas, 66160
Columbia University Irving Medical Center
New York, New York, 10032
Northwell Health
New York, New York, 11021
University of Pittsburgh
Pittsburgh, Pennsylvania, 15216
University of Utah Health Sciences Center
Salt Lake City, Utah, 84112
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
University of South Florida
Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Nintedanib Plus Standard of Care Immunosuppression Versus Standard of Care Immunosuppression Alone in Patients With Progressive Fibrotic Myositis Associated - Interstitial Lung Disease: A Randomized, Double-Blind, Exploratory Trial

This study will enroll a total of 134 participants across 15 clinical sites located in the United States. A subset of participants will be enrolled remotely via telemedicine utilizing certified mobile home research nurses and various remote monitoring devices.

The research visits may include a physical exam, vital signs (such as blood pressure, heart rate, etc.), pulmonary function tests (PFT and/or home spirometry), Computerized Tomography (or CT) scans of the chest, blood draws, wearing a physical activity monitor and completing questionnaires. Some of these events may be done at home, at a local facility or remotely (via telemedicine).

Read the detailed description

Participants enrolled in the study will receive either study drug or placebo for 12 weeks plus the participant's normal standard of care medication for the participant's disease. Placebo is an inactive substance that contains no medicine. Following the initial treatment phase, participants will receive the active study drug (nintedanib) for an additional 12-week period.

Nintedanib is a drug that is currently used and has been approved by the Food and Drug Administration (FDA) for the treatment of idiopathic pulmonary fibrosis (IPF), and has been shown to slow the rate of decline in pulmonary function among patients with IPF as well as interstitial lung disease (ILD) associated with systemic sclerosis or scleroderma. In addition, in March 2020, the FDA approved nintedanib oral capsules to treat patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait).

The original trial registration listed an outcome measure for change in non-primary L-PF scores from Week 12 to Week 24. This did not appear in the final SAP and was removed from the outcome measures list. Additionally, the outcome measure of "L-PF Total Score" was included in the approved SAP, however we were informed a Total Score was not to be generated from the Symptoms and Impacts module scores. L-PF Total Score was included in the SAP in error and was not analyzed.

Conditions: Myositis Associated Interstitial Lund Disease (MA-ILD)
Being tested: Nintedanib, Placebo, Standard of Care
Keywords: Myositis associated interstitial lung disease (Myositis ILD), Interstitial Lung Disease (ILD), Myositis
Medical subject headings: Lung Diseases, Interstitial, Myositis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NintedanibDrug
Also called OFEV
Nintedanib 150 mg BID
PlaceboDrug
Placebo comparator
Standard of CareDrug
Patients may receive up to 2 standard-of-care immunosuppressants (IS): either 1 glucocorticoid (GC) + 1 non-GC IS, or 2 non-GC IS if not on GC. IS must be used ≥12 weeks (≥4 weeks for GC) with stable doses ≥4 weeks (≥2 weeks for GC) before screening.
Allowed therapies and max doses: GC ≤20 mg/day, mycophenolate mofetil 3 g/day, mycophenolic acid 2160 mg/day, azathioprine 2.5 mg/kg/day, methotrexate 25 mg/week, tacrolimus 10 mg/day, cyclosporine 200 mg/day, leflunomide 20 mg/day, sulfasalazine 3 g/day, JAK inhibitors (tofacitinib 11 mg/day, upadacitinib 15 mg/day, baricitinib 4 mg/day), rituximab (1000 mg ×2 or 375 mg/m² weekly ×4 every >4 months), Orencia 125 mg SQ weekly or 1 g IV monthly.
IVIG/SQIG and hydroxychloroquine are allowed but not considered SOC IS therapy. Inhaled lung medications allowed if started >4 weeks before screening and remain stable.

Study groups in NCT05799755
Study group	Role	What they receive
Placebo plus Standard of Care, then Nintedanib plus Standard of Care	Placebo comparator	Placebo twice a day (BID) plus standard of care (SOC) Immunosuppressive Therapy for 12 weeks followed by open-label Nintedanib 150 mg BID + SOC Immunosuppressive Therapy for additional 12 weeks. Receives: Drug: Nintedanib; Drug: Placebo; Drug: Standard of Care
Nintedanib plus Standard of Care	Active comparator	Nintedanib 150 mg BID + SOC Immunosuppressive Therapy for 12 weeks followed by open-label Nintedanib 150mg BID + SOC Immunosuppressive Therapy for additional 12 weeks. Receives: Drug: Nintedanib; Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Living With Pulmonary Fibrosis Symptoms and Impact Questionnaire (L-PF) Dyspnea Score
The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules: Symptoms (23 items) and Impacts (21 items).
The Symptoms module yields three domain scores: 1) dyspnea, 2) cough, and 3) energy.The Impacts module yields a single Impacts score.
Dyspnea domain score. Scoring is performed as a summary score. Summary score range from 0-100, the higher the score the greater the impairment.
Measured: Baseline (week 0) to week 12

Secondary outcomes (30)

Change in Living With Pulmonary Fibrosis Dyspnea Score
The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules: Symptoms (23 items) and Impacts (21 items).
The Symptoms module yields three domain scores: 1) dyspnea, 2) cough, and 3) energy.The Impacts module yields a single Impacts score.
Dyspnea domain score. Scoring is performed as a summary score. Summary score range from 0-100, the higher the score the greater the impairment.
Measured: Baseline (week 0) to week 24
Change in Living With Pulmonary Fibrosis Dyspnea Score
The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules: Symptoms (23 items) and Impacts (21 items).
The Symptoms module yields three domain scores: 1) dyspnea, 2) cough, and 3) energy.The Impacts module yields a single Impacts score.
Dyspnea domain score. Scoring is performed as a summary score. Summary score range from 0-100, the higher the score the greater the impairment.
Measured: Week 12 to week 24
Change in Living With Pulmonary Fibrosis Cough Score
The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules: Symptoms (23 items) and Impacts (21 items).
The Symptoms module yields three domain scores: 1) dyspnea, 2) cough, and 3) energy.The Impacts module yields a single Impacts score.
Cough domain score. Scoring is performed as a summary score. Summary score range from 0-100, the higher the score the greater the impairment.
Measured: Baseline (week 0) to week 12
Change in Living With Pulmonary Fibrosis Cough Score
The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules: Symptoms (23 items) and Impacts (21 items).
The Symptoms module yields three domain scores: 1) dyspnea, 2) cough, and 3) energy.The Impacts module yields a single Impacts score.
Cough domain score. Scoring is performed as a summary score. Summary score range from 0-100, the higher the score the greater the impairment.
Measured: Baseline (week 0) to week 24
Change in Living With Pulmonary Fibrosis Energy Score
The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules: Symptoms (23 items) and Impacts (21 items).
The Symptoms module yields three domain scores: 1) dyspnea, 2) cough, and 3) energy.The Impacts module yields a single Impacts score.
Energy domain score. Scoring is performed as a summary score. Summary score range from 0-100, the higher the score the greater the impairment.
Measured: Baseline (week 0) to week 12
Change in Living With Pulmonary Fibrosis Energy Score
The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules: Symptoms (23 items) and Impacts (21 items).
The Symptoms module yields three domain scores: 1) dyspnea, 2) cough, and 3) energy.The Impacts module yields a single Impacts score.
Energy domain score. Scoring is performed as a summary score. Summary score range from 0-100, the higher the score the greater the impairment.
Measured: Baseline (week 0) to week 24
Change in Living With Pulmonary Fibrosis Symptoms Score
The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules: Symptoms (23 items) and Impacts (21 items).
The Symptoms module yields three domain scores: 1) dyspnea, 2) cough, and 3) energy.The Impacts module yields a single Impacts score.
Symptoms module score. Scoring is performed as a summary score. Summary score range from 0-100, the higher the score the greater the impairment.
Measured: Baseline (week 0) to week 12
Change in Living With Pulmonary Fibrosis Symptoms Score
The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules: Symptoms (23 items) and Impacts (21 items).
The Symptoms module yields three domain scores: 1) dyspnea, 2) cough, and 3) energy.The Impacts module yields a single Impacts score.
Symptoms module score. Scoring is performed as a summary score. Summary score range from 0-100, the higher the score the greater the impairment.
Measured: Baseline (week 0) to week 24
Change in Living With Pulmonary Fibrosis Impacts Score
The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules: Symptoms (23 items) and Impacts (21 items).
The Symptoms module yields three domain scores: 1) dyspnea, 2) cough, and 3) energy.The Impacts module yields a single Impacts score.
Impacts module score. Scoring is performed as a summary score. Summary score range from 0-1, the higher the score the greater the impairment.
Measured: Baseline (week 0) to week 12
Change in Living With Pulmonary Fibrosis Impacts Score
The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules: Symptoms (23 items) and Impacts (21 items).
The Symptoms module yields three domain scores: 1) dyspnea, 2) cough, and 3) energy.The Impacts module yields a single Impacts score.
Impacts module score. Scoring is performed as a summary score. Summary score range from 0-1, the higher the score the greater the impairment.
Measured: Baseline (week 0) to week 24
Change in Immunosuppressive (IS) Regimen
Percentage of patients requiring an increased dose or a change in their glucocorticoid (GC) / immunosuppression (IS) agent for clinical worsening/flare of MA-ILD
Measured: Baseline (Week 0) to week 12
Absolute Change in Forced Vital Capacity (FVC) (mL) From Baseline to 12 Weeks
FVC (ml) is forced vital capacity parameter derived from a pulmonary function study (PFT) in volume as mL.
Absolute change is final value - initial value.
Measured: Baseline (week 0) to week 12
Relative Change in Forced Vital Capacity (FVC) (mL) From Baseline to 12 Weeks
FVC (ml) is forced vital capacity parameter derived from a pulmonary function study (PFT) in volume as mL.
Relative change is (final value / initial value)*100.
Measured: Baseline (week 0) to week 12
Absolute Change in Forced Vital Capacity (FVC) (mL) From Baseline to 24 Weeks
FVC (mL) is forced vital capacity parameter derived from a pulmonary function study (PFT) in volume as mL.
Absolute change is final value - initial value.
Measured: Baseline (week 0) to week 24
Relative Change in Forced Vital Capacity (FVC) (mL) From Baseline to 24 Weeks
FVC (mL) is forced vital capacity parameter derived from a pulmonary function study (PFT) in volume as mL.
Relative change is (final value / initial value)*100.
Measured: Baseline (week 0) to week 24
Absolute Change in Forced Vital Capacity FVC (%) From Baseline to Week 12
FVC (%) is forced vital capacity parameter derived from a pulmonary function study (PFT) as percentage predicted of healthy standards.
Absolute change is final value - initial value.
Measured: Baseline (week 0) to week 12
Relative Change in Forced Vital Capacity FVC (%) From Baseline to Week 12
FVC (%) is forced vital capacity parameter derived from a pulmonary function study (PFT) as percentage predicted of healthy standards.
Relative change is (final value / initial value)*100.
Measured: Baseline (week 0) to week 12
Absolute Change in Forced Vital Capacity FVC (%) From Baseline to Week 24
FVC (%) is forced vital capacity parameter derived from a pulmonary function study (PFT) as percentage predicted of healthy standards.
Absolute change is final value - initial value.
Measured: Baseline (week 0) to week 24
Relative Change in Forced Vital Capacity FVC (%) From Baseline to Week 24
FVC (%) is forced vital capacity parameter derived from a pulmonary function study (PFT) as percentage predicted of healthy standards.
Relative change is (final value / initial value)*100.
Measured: Baseline (week 0) to week 24
Percentage of Patients With a Relative Decline From Baseline in FVC (mL) of ≥10%, ≥7.5%, and ≥ 5%
FVC (mL) is forced vital capacity parameter derived from a pulmonary function study (PFT) in volume as mL.
Percent change is calculated based on change from baseline to a follow up visit.
Participants may be included in multiple categories (i.e. a decline ≥10% will be counted as ≥10%, ≥7.5%, and ≥5%).
Measured: Week 12
Percentage of Patients With a Relative Decline From Baseline in FVC (mL) of ≥10%, ≥7.5%, and ≥ 5%
FVC (mL) is forced vital capacity parameter derived from a pulmonary function study (PFT) in volume as mL.
Percent change is calculated based on change from baseline to a follow up visit.
Participants may be included in multiple categories (i.e. a decline ≥10% will be counted as ≥10%, ≥7.5%, and ≥5%).
Measured: Week 24
Percentage of Patients With a Relative Decline From Baseline in FVC (%) of ≥10%, ≥7.5%, and ≥ 5%
FVC (%) is forced vital capacity parameter derived from a pulmonary function study (PFT) in volume as percentage predicted of healthy standards.
Percent change is calculated based on change from baseline to a follow up visit.
Participants may be included in multiple categories (i.e. a decline ≥10% will be counted as ≥10%, ≥7.5%, and ≥5%).
Measured: Week 12
Percentage of Patients With a Relative Decline From Baseline in FVC (%) of ≥10%, ≥7.5%, and ≥ 5%
FVC (%) is forced vital capacity parameter derived from a pulmonary function study (PFT) in volume as percentage predicted of healthy standards.
Percent change is calculated based on change from baseline to a follow up visit.
Participants may be included in multiple categories (i.e. a decline ≥10% will be counted as ≥10%, ≥7.5%, and ≥5%).
Measured: Week 24
Percentage of Patients With Stable (+/- < 5%) or Improved FVC (≥ 5, ≥ 7.5, ≥ 10%) (mL) From Baseline to Week 12
FVC (mL) is forced vital capacity parameter derived from a pulmonary function study (PFT) in volume as mL.
Percent change is calculated based on change from baseline to a follow up visit.
Participants may be included in multiple categories (i.e. an improvement ≥10% will be counted as ≥10%, ≥7.5%, and ≥5%).
Measured: Week 12
Percentage of Patients With Stable (+/- < 5%) or Improved FVC (≥ 5, ≥ 7.5, ≥ 10%) (mL) From Baseline to Week 24
FVC (mL) is forced vital capacity parameter derived from a pulmonary function study (PFT) in volume as mL.
Percent change is calculated based on change from baseline to a follow up visit.
Participants may be included in multiple categories (i.e. an improvement ≥10% will be counted as ≥10%, ≥7.5%, and ≥5%).
Measured: Week 24
Percentage of Patients With Stable (+/- < 5%) or Improved FVC (≥ 5, ≥ 7.5, ≥ 10%) (%) From Baseline to Week 12
FVC (%) is forced vital capacity parameter derived from a pulmonary function study (PFT) in volume as percentage predicted of healthy standards.
Percent change is calculated based on change from baseline to a follow up visit.
Participants may be included in multiple categories (i.e. an improvement ≥10% will be counted as ≥10%, ≥7.5%, and ≥5%).
Measured: Week 12
Percentage of Patients With Stable (+/- < 5%) or Improved FVC (≥ 5, ≥ 7.5, ≥ 10%) (%) From Baseline to Week 24
FVC (%) is forced vital capacity parameter derived from a pulmonary function study (PFT) in volume as percentage predicted of healthy standards.
Percent change is calculated based on change from baseline to a follow up visit.
Participants may be included in multiple categories (i.e. an improvement ≥10% will be counted as ≥10%, ≥7.5%, and ≥5%).
Measured: Week 24
Time to FVC (mL) Improvement and Decline From Baseline by (≥5%, 7.5%, 10%)
FVC (mL) is forced vital capacity parameter derived from a pulmonary function study (PFT) in volume as mL.
Time to designated change is calculated based on change from baseline to a follow up visit and time since baseline.
Measured: Baseline (week 0) to 24 weeks
Time to FVC (%) Improvement and Decline From Baseline by (≥5%, 7.5%, 10%)
FVC (%) is forced vital capacity parameter derived from a pulmonary function study (PFT) in volume as percentage predicted of healthy standards. Time to designated change is calculated based on change from baseline to a follow up visit and time since baseline.
Measured: Baseline (week 0) to 24 weeks
Time to Progression
Defined as either time for event a, b or c. Event a. ≥ 10% decline in FVC (mL) or death or transplant. Event b. ILD worsening definition (per protocol) or death or transplant. Event c. non-elective hospitalization for ILD worsening/flare or death or lung transplant.
Measured: Baseline (week 0) to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202331 Dec 2025

First posted5 Apr 2023
Study start1 Aug 2023
Primary completion17 Mar 2025
Study completion31 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Myositis Associated Interstitial Lund Disease (MA-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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Randomization will be 1:1 for nintedanib: placebo and stratified by underlying immunosuppressive therapy (mycophenolate vs. others). All patients must be on the standard of care (SOC) immunosuppression (IS) at screening as per the protocol and should remain on stable doses throughout the trial. After 12 weeks both arms will receive an additional 12 weeks of nintedanib (150 mg twice a day, maximum dose of 300 mg a day) through week 24 (final study visit).
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05799755
Sponsor's protocol ID: STUDY22090061
Acronym: MINT
Status last verified: Sep 2026
First submitted: 15 Feb 2023
Last updated: 15 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Sharing of individual participant data will require written approval from sponsor and steering committee.

Publications

Distler O, Highland KB, Gahlemann M, Azuma A, Fischer A, Mayes MD, Raghu G, Sauter W, Girard M, Alves M, Clerisme-Beaty E, Stowasser S, Tetzlaff K, Kuwana M, Maher TM; SENSCIS Trial Investigators. Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease. N Engl J Med. 2019 Jun 27;380(26):2518-2528. doi: 10.1056/NEJMoa1903076. Epub 2019 May 20.
PubMed 31112379
Flaherty KR, Wells AU, Cottin V, Devaraj A, Walsh SLF, Inoue Y, Richeldi L, Kolb M, Tetzlaff K, Stowasser S, Coeck C, Clerisme-Beaty E, Rosenstock B, Quaresma M, Haeufel T, Goeldner RG, Schlenker-Herceg R, Brown KK; INBUILD Trial Investigators. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases. N Engl J Med. 2019 Oct 31;381(18):1718-1727. doi: 10.1056/NEJMoa1908681. Epub 2019 Sep 29.
PubMed 31566307
Wilfong EM, Aggarwal R. Role of antifibrotics in the management of idiopathic inflammatory myopathy associated interstitial lung disease. Ther Adv Musculoskelet Dis. 2021 Dec 9;13:1759720X211060907. doi: 10.1177/1759720X211060907. eCollection 2021.
PubMed 34917177
Shen L, Yan Q, Chen X. Efficacy of Combination Therapy With Pirfenidone and Low-Dose Cyclophosphamide for Refractory Interstitial Lung Disease Associated With Connective Tissue Disease: A Case-Series of Seven Patients. Arch Rheumatol. 2019 Aug 26;35(2):180-188. doi: 10.46497/ArchRheumatol.2020.7381. eCollection 2020 Jun.
PubMed 32851366
Li T, Guo L, Chen Z, Gu L, Sun F, Tan X, Chen S, Wang X, Ye S. Pirfenidone in patients with rapidly progressive interstitial lung disease associated with clinically amyopathic dermatomyositis. Sci Rep. 2016 Sep 12;6:33226. doi: 10.1038/srep33226.
PubMed 27615411
Khanna D, Mittoo S, Aggarwal R, Proudman SM, Dalbeth N, Matteson EL, Brown K, Flaherty K, Wells AU, Seibold JR, Strand V. Connective Tissue Disease-associated Interstitial Lung Diseases (CTD-ILD) - Report from OMERACT CTD-ILD Working Group. J Rheumatol. 2015 Nov;42(11):2168-71. doi: 10.3899/jrheum.141182. Epub 2015 Mar 1.
PubMed 25729034
Liang J, Cao H, Yang Y, Ke Y, Yu Y, Sun C, Yue L, Lin J. Efficacy and Tolerability of Nintedanib in Idiopathic-Inflammatory-Myopathy-Related Interstitial Lung Disease: A Pilot Study. Front Med (Lausanne). 2021 Feb 3;8:626953. doi: 10.3389/fmed.2021.626953. eCollection 2021.
PubMed 33614683
Aggarwal R, Oddis CV, Sullivan DI, Moghadam-Kia S, Saygin D, Kass DJ, Koontz DC, Li P, Conoscenti CS, Olson AL; MINT investigators. Design of a randomised controlled hybrid trial of nintedanib in patients with progressive myositis-associated interstitial lung disease. BMC Pulm Med. 2024 Oct 30;24(1):544. doi: 10.1186/s12890-024-03314-0.
PubMed 39478532

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nintedanib Plus Standard of Care Immunosuppression Versus Standard of Care Immunosuppression Alone in Patients With Progressive Fibrotic Myositis Associated - Interstitial Lung Disease: A Randomized, Double-Blind, Exploratory Trial
ClinicalTrials.gov ID: NCT05799755
Acronym / sponsor ID: MINT / STUDY22090061
Conditions: Myositis Associated Interstitial Lund Disease (MA-ILD)
Keywords: Myositis associated interstitial lung disease (Myositis ILD), Interstitial Lung Disease (ILD), Myositis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Rohit Aggarwal, MDUniversity, hospital or other
Collaborators: Boehringer Ingelheim
Study start: 1 Aug 2023 (actual)
Primary completion: 17 Mar 2025 (actual)
Study completion: 31 Dec 2025 (actual)
First posted: 5 Apr 2023 (actual)
Results: Posted 15 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomization will be 1:1 for nintedanib: placebo and stratified by underlying immunosuppressive therapy (mycophenolate vs. others). All patients must be on the standard of care (SOC) immunosuppression (IS) at screening as per the protocol and should remain on stable doses throughout the trial. After 12 weeks both arms will receive an additional 12 weeks of nintedanib (150 mg twice a day, maximum dose of 300 mg a day) through week 24 (final study visit).

Arm	Type	Receives
Placebo plus Standard of Care, then Nintedanib plus Standard of Care	Placebo comparator	Drug: Nintedanib, Drug: Placebo, Drug: Standard of CarePlacebo twice a day (BID) plus standard of care (SOC) Immunosuppressive Therapy for 12 weeks followed by open-label Nintedanib 150 mg BID + SOC Immunosuppressive Therapy for additional 12 weeks.
Nintedanib plus Standard of Care	Active comparator	Drug: Nintedanib, Drug: Standard of CareNintedanib 150 mg BID + SOC Immunosuppressive Therapy for 12 weeks followed by open-label Nintedanib 150mg BID + SOC Immunosuppressive Therapy for additional 12 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (32 listed)

Subject has provided written informed consent
Approval from local treating physician (done at pre-screening only for remote patients as well as for local site patients not actively being managed at the local site).
Subject lives in the United States
Adult: Age ≥ 18 years
Subject can speak, read, and understand English or Spanish

Key exclusion criteria (60 listed)

Planned major surgical procedures within the trial period of 24 weeks.
Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Women of childbearing potential* not willing or able to use at least two highly effective methods of birth control.
Severe lung disease is defined by the following within the last 6 months before the screening:
Moderate to severe active muscle disease from myositis as per any one of the criteria:

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
NintedanibAlso: OFEVNintedanib 150 mg BID	Drug	Nintedanib plus Standard of Care, Placebo plus Standard of Care, then Nintedanib plus Standard of Care
PlaceboPlacebo comparator	Drug	Placebo plus Standard of Care, then Nintedanib plus Standard of Care
Standard of CarePatients may receive up to 2 standard-of-care immunosuppressants (IS): either 1 glucocorticoid (GC) + 1 non-GC IS, or 2 non-GC IS if not on GC. IS must be used ≥12 weeks (≥4 weeks for GC) with stable doses ≥4 weeks (≥2 weeks for GC) before screening. Allowed therapies and max doses: GC ≤20 mg/day, mycophenolate mofetil 3 g/day, mycophenolic acid 2160 mg/day, azathioprine 2.5 mg/kg/day, methotrexate 25 mg/week, tacrolimus 10 mg/day, cyclosporine 200 mg/day, leflunomide 20 mg/day, sulfasalazine 3 g/day, JAK inhibitors (tofacitinib 11 mg/day, upadacitinib 15 mg/day, baricitinib 4 mg/day), rituximab (1000 mg ×2 or 375 mg/m² weekly ×4 every >4 months), Orencia 125 mg SQ weekly or 1 g IV monthly. IVIG/SQIG and hydroxychloroquine are allowed but not considered SOC IS therapy. Inhaled lung medications allowed if started >4 weeks before screening and remain stable.	Drug	Nintedanib plus Standard of Care, Placebo plus Standard of Care, then Nintedanib plus Standard of Care

Primary outcome

Change in Living With Pulmonary Fibrosis Symptoms and Impact Questionnaire (L-PF) Dyspnea Score
Time frame: Baseline (week 0) to week 12
The Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules: Symptoms (23 items) and Impacts (21 items). The Symptoms module yields three domain scores: 1) dyspnea, 2) cough, and 3) energy.The Impacts module yields a single Impacts score. Dyspnea domain score. Scoring is performed as a summary score. Summary score range from 0-100, the higher the score the greater the impairment.

30 secondary outcomes

Change in Living With Pulmonary Fibrosis Dyspnea Score
Time frame: Baseline (week 0) to week 24
Change in Living With Pulmonary Fibrosis Dyspnea Score
Time frame: Week 12 to week 24
Change in Living With Pulmonary Fibrosis Cough Score
Time frame: Baseline (week 0) to week 12
Change in Living With Pulmonary Fibrosis Cough Score
Time frame: Baseline (week 0) to week 24
Change in Living With Pulmonary Fibrosis Energy Score
Time frame: Baseline (week 0) to week 12
Change in Living With Pulmonary Fibrosis Energy Score
Time frame: Baseline (week 0) to week 24
Change in Living With Pulmonary Fibrosis Symptoms Score
Time frame: Baseline (week 0) to week 12
Change in Living With Pulmonary Fibrosis Symptoms Score
Time frame: Baseline (week 0) to week 24
Change in Living With Pulmonary Fibrosis Impacts Score
Time frame: Baseline (week 0) to week 12
Change in Living With Pulmonary Fibrosis Impacts Score
Time frame: Baseline (week 0) to week 24
Change in Immunosuppressive (IS) Regimen
Time frame: Baseline (Week 0) to week 12
Absolute Change in Forced Vital Capacity (FVC) (mL) From Baseline to 12 Weeks
Time frame: Baseline (week 0) to week 12
Relative Change in Forced Vital Capacity (FVC) (mL) From Baseline to 12 Weeks
Time frame: Baseline (week 0) to week 12
Absolute Change in Forced Vital Capacity (FVC) (mL) From Baseline to 24 Weeks
Time frame: Baseline (week 0) to week 24
Relative Change in Forced Vital Capacity (FVC) (mL) From Baseline to 24 Weeks
Time frame: Baseline (week 0) to week 24
Absolute Change in Forced Vital Capacity FVC (%) From Baseline to Week 12
Time frame: Baseline (week 0) to week 12
Relative Change in Forced Vital Capacity FVC (%) From Baseline to Week 12
Time frame: Baseline (week 0) to week 12
Absolute Change in Forced Vital Capacity FVC (%) From Baseline to Week 24
Time frame: Baseline (week 0) to week 24
Relative Change in Forced Vital Capacity FVC (%) From Baseline to Week 24
Time frame: Baseline (week 0) to week 24
Percentage of Patients With a Relative Decline From Baseline in FVC (mL) of ≥10%, ≥7.5%, and ≥ 5%
Time frame: Week 12
Percentage of Patients With a Relative Decline From Baseline in FVC (mL) of ≥10%, ≥7.5%, and ≥ 5%
Time frame: Week 24
Percentage of Patients With a Relative Decline From Baseline in FVC (%) of ≥10%, ≥7.5%, and ≥ 5%
Time frame: Week 12
Percentage of Patients With a Relative Decline From Baseline in FVC (%) of ≥10%, ≥7.5%, and ≥ 5%
Time frame: Week 24
Percentage of Patients With Stable (+/- < 5%) or Improved FVC (≥ 5, ≥ 7.5, ≥ 10%) (mL) From Baseline to Week 12
Time frame: Week 12
Percentage of Patients With Stable (+/- < 5%) or Improved FVC (≥ 5, ≥ 7.5, ≥ 10%) (mL) From Baseline to Week 24
Time frame: Week 24
Percentage of Patients With Stable (+/- < 5%) or Improved FVC (≥ 5, ≥ 7.5, ≥ 10%) (%) From Baseline to Week 12
Time frame: Week 12
Percentage of Patients With Stable (+/- < 5%) or Improved FVC (≥ 5, ≥ 7.5, ≥ 10%) (%) From Baseline to Week 24
Time frame: Week 24
Time to FVC (mL) Improvement and Decline From Baseline by (≥5%, 7.5%, 10%)
Time frame: Baseline (week 0) to 24 weeks
Time to FVC (%) Improvement and Decline From Baseline by (≥5%, 7.5%, 10%)
Time frame: Baseline (week 0) to 24 weeks
Time to Progression
Time frame: Baseline (week 0) to week 24

Results and safety

Results posted to the registry on 15 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Plus Standard of Care, Then Nintedanib Plus Standard of Care	24	22
Nintedanib Plus Standard of Care	25	22

Primary outcome: Change in Living With Pulmonary Fibrosis Symptoms and Impact Questionnaire (L-PF) Dyspnea Score

Time frame: Baseline (week 0) to week 12. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo Plus Standard of Care, Then Nintedanib Plus Standard of Care n = 22	Nintedanib Plus Standard of Care n = 22
Actual Baseline	17.1 (18.8)	20.9 (16.0)
Change Baseline to 12 Weeks	0.6 (10.6)	2.1 (11.4)

Placebo Plus Standard of Care, Then Nintedanib Plus Standard of Care vs Nintedanib Plus Standard of Care: p = 0.624, Wilcoxon (Mann-Whitney)
Placebo Plus Standard of Care, Then Nintedanib Plus Standard of Care vs Nintedanib Plus Standard of Care: p = 0.666, t-test, 2 sided
Placebo Plus Standard of Care, Then Nintedanib Plus Standard of Care vs Nintedanib Plus Standard of Care: Mean Difference (Net): 1.44 (95% CI -5.42 to 8.3), p = 0.679, Mixed Models Analysis

Population analysed: Participants of trial who completed from Baseline (week 0) to week 12 with available data.

30 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline (Week 0) to end of study (Week 24) plus 28 day follow-up. 28 week observation period total.. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental Phase: Nintedanib Plus Standard of Care	6 of 25 (24%)	21 of 25 (84%)	0 of 25
Experimental Phase: Placebo Plus Standard of Care	0 of 24 (0%)	16 of 24 (66.7%)	0 of 24
Open Label Phase: Nintedanib Plus Standard of Care	5 of 44 (11.4%)	36 of 44 (81.8%)	0 of 44

Limitations and caveats (from the sponsor): A limitation of the study is small sample size that affects statistical power to determine statistical significance in differences between treatment arms.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31112379Distler O, Highland KB, Gahlemann M, Azuma A, Fischer A, Mayes MD, Raghu G, Sauter W, Girard M, Alves M, Clerisme-Beaty E, Stowasser S, Tetzlaff K, Kuwana M, Maher TM; SENSCIS Trial Investigators. Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease. N Engl J Med. 2019 Jun 27;380(26):2518-2528. doi: 10.1056/NEJMoa1903076. Epub 2019 May 20.
Background: PubMed 31566307Flaherty KR, Wells AU, Cottin V, Devaraj A, Walsh SLF, Inoue Y, Richeldi L, Kolb M, Tetzlaff K, Stowasser S, Coeck C, Clerisme-Beaty E, Rosenstock B, Quaresma M, Haeufel T, Goeldner RG, Schlenker-Herceg R, Brown KK; INBUILD Trial Investigators. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases. N Engl J Med. 2019 Oct 31;381(18):1718-1727. doi: 10.1056/NEJMoa1908681. Epub 2019 Sep 29.
Background: PubMed 34917177Wilfong EM, Aggarwal R. Role of antifibrotics in the management of idiopathic inflammatory myopathy associated interstitial lung disease. Ther Adv Musculoskelet Dis. 2021 Dec 9;13:1759720X211060907. doi: 10.1177/1759720X211060907. eCollection 2021.
Background: PubMed 32851366Shen L, Yan Q, Chen X. Efficacy of Combination Therapy With Pirfenidone and Low-Dose Cyclophosphamide for Refractory Interstitial Lung Disease Associated With Connective Tissue Disease: A Case-Series of Seven Patients. Arch Rheumatol. 2019 Aug 26;35(2):180-188. doi: 10.46497/ArchRheumatol.2020.7381. eCollection 2020 Jun.
Background: PubMed 27615411Li T, Guo L, Chen Z, Gu L, Sun F, Tan X, Chen S, Wang X, Ye S. Pirfenidone in patients with rapidly progressive interstitial lung disease associated with clinically amyopathic dermatomyositis. Sci Rep. 2016 Sep 12;6:33226. doi: 10.1038/srep33226.
Background: PubMed 25729034Khanna D, Mittoo S, Aggarwal R, Proudman SM, Dalbeth N, Matteson EL, Brown K, Flaherty K, Wells AU, Seibold JR, Strand V. Connective Tissue Disease-associated Interstitial Lung Diseases (CTD-ILD) - Report from OMERACT CTD-ILD Working Group. J Rheumatol. 2015 Nov;42(11):2168-71. doi: 10.3899/jrheum.141182. Epub 2015 Mar 1.
Background: PubMed 33614683Liang J, Cao H, Yang Y, Ke Y, Yu Y, Sun C, Yue L, Lin J. Efficacy and Tolerability of Nintedanib in Idiopathic-Inflammatory-Myopathy-Related Interstitial Lung Disease: A Pilot Study. Front Med (Lausanne). 2021 Feb 3;8:626953. doi: 10.3389/fmed.2021.626953. eCollection 2021.
Derived from this study: PubMed 39478532Aggarwal R, Oddis CV, Sullivan DI, Moghadam-Kia S, Saygin D, Kass DJ, Koontz DC, Li P, Conoscenti CS, Olson AL; MINT investigators. Design of a randomised controlled hybrid trial of nintedanib in patients with progressive myositis-associated interstitial lung disease. BMC Pulm Med. 2024 Oct 30;24(1):544. doi: 10.1186/s12890-024-03314-0.
Individual participant dataSharing planned: Yes. Sharing of individual participant data will require written approval from sponsor and steering committee.

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.

Rohit Aggarwal, MD principal investigator

University of Pittsburgh

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nintedanib in people with Myositis Associated Interstitial Lund Disease (MA-ILD), run by Rohit Aggarwal, MD at 10 sites in United States.

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 32 inclusion and 60 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: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Living With Pulmonary Fibrosis Symptoms and Impact Questionnaire (L-PF) Dyspnea Score (time frame: Baseline (week 0) to week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05799755, which also lists 8 linked publications.

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 15 Oct 2026.