Nintedanib for Interstitial Lung Disease
(MINT Trial)

Recruiting in Palo Alto (17 mi)

+17 other locations

Overseen byRohit Aggarwal, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Rohit Aggarwal, MD

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests nintedanib, a drug that slows lung damage, in patients with myositis-associated interstitial lung disease. It works by blocking proteins that cause lung inflammation and scarring. Nintedanib has been approved for treating certain lung diseases and has shown positive results in various conditions.

Eligibility Criteria

This trial is for people living in the U.S. who have myositis-associated interstitial lung disease, can speak English or Spanish, and haven't used OFEV for treatment. It's not for those needing high levels of oxygen (10L+), planning major surgery within 6 months, undergoing evaluation or past recipients of a lung transplant, or women who are pregnant/lactating or planning pregnancy soon.

Inclusion Criteria

I have myositis or a positive test for myositis antibodies.

Do you live in the United States?

I can speak, read, and understand English or Spanish.

Exclusion Criteria

I need more than 10L of oxygen at rest.

I have used OFEV for my condition.

I am not planning any major surgeries that require anesthesia in the next 6 months.

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Treatment Details

Interventions

Nintedanib (Tyrosine Kinase Inhibitor)
Placebo (Other)
Standard of Care (Other)

Trial OverviewThe study tests if nintedanib can improve symptoms in patients with MA-ILD compared to a placebo alongside standard care. Participants will undergo physical exams, pulmonary function tests, CT scans, blood draws and use activity monitors; some activities may be done remotely via telemedicine.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Nintedanib plus Standard of CareActive Control2 Interventions

Nintedanib 150 mg BID + SOC Immunosuppressive Therapy for 12 weeks followed by open-label Nintedanib 150mg BID + SOC Immunosuppressive Therapy for additional 12 weeks.

Group II: Placebo plus Standard of Care, then Nintedanib plus Standard of CarePlacebo Group3 Interventions

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.