Myositis Interstitial Lung Disease Nintedanib Trial

Completed · Phase 4 · Has a placebo group

Conditions studied: Myositis Associated Interstitial Lund Disease (MA-ILD)

In brief

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 thickening, stiffness and scarring of the tissues of the lung. 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).

Key facts

Study ID

NCT05799755

Run by

Rohit Aggarwal, MD

People needed

49

Starts

2023-08-01

Expected to finish

2025-12-31

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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:
• 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.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• National Jewish Health — Denver, Colorado, United States
• University of South Florida — Tampa, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Northwell Health — New York, New York, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Utah Health Sciences Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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