Nintedanib for Interstitial Lung Disease

(MINT Trial)

Recruiting at 17 trial locations

Overseen By Solciris Dominguez

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rohit Aggarwal, MD

Must be taking: Immunosuppressants, Glucocorticoids

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Severe lung disease, Pulmonary hypertension, Severe cardiovascular disease, Chronic liver disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

70 Participants Needed

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.

Will I have to stop taking my current medications?

The trial allows participants to continue certain medications, specifically up to two immunosuppressive drugs or one glucocorticoid and one immunosuppressive drug, as long as they have been stable for a specified period before the trial. However, some medications like cyclophosphamide and certain biological agents must be stopped before the trial. Please consult with the trial team for specific guidance on your medications.

What data supports the effectiveness of the drug Nintedanib for Interstitial Lung Disease?

Research shows that Nintedanib can slow the progression of lung diseases like idiopathic pulmonary fibrosis (IPF) by reducing the decline in lung function. It has also been effective in patients with progressive fibrosing interstitial lung diseases, helping to maintain lung capacity over time. ^{1 2 3 4 5}

Is Nintedanib safe for humans?

Nintedanib has been studied for safety in people with lung diseases like idiopathic pulmonary fibrosis and systemic sclerosis-associated interstitial lung disease. While it can cause side effects, most are manageable, and the treatment is generally considered safe for many patients. ^{2 6 7 8 9}

How is the drug Nintedanib unique for treating interstitial lung disease?

Nintedanib is unique because it is an oral medication that targets multiple pathways involved in fibrosis (scarring of lung tissue), and it has been shown to slow the progression of interstitial lung disease by reducing lung function decline. It is particularly notable for its use in conditions like idiopathic pulmonary fibrosis and systemic sclerosis-associated interstitial lung disease, where it helps manage disease progression. ^{1 3 10 11 12}

Research Team

Rohit Aggarwal, MD, MS

Principal Investigator

University of Pittsburgh

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo or nintedanib plus standard of care for 12 weeks, followed by open-label nintedanib for an additional 12 weeks

24 weeks

Multiple visits (in-person and remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Nintedanib
• Placebo
• Standard of Care

Trial Overview The 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

Group I: Nintedanib plus Standard of Care Active Control 2 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 Care Placebo Group 3 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.

Who Is Running the Clinical Trial?

Rohit Aggarwal, MD

Lead Sponsor

Trials

3

Recruited

100+

Boehringer Ingelheim

Industry Sponsor

Trials

2,566

Recruited

16,150,000+

Findings from Research

In the INBUILD trial involving 170 patients with fibrosing autoimmune disease-related interstitial lung diseases, nintedanib significantly slowed the decline in lung function (measured by forced vital capacity) compared to placebo, with a difference of 102.7 ml/year over 52 weeks.

While nintedanib was effective, it was associated with a higher incidence of adverse events, particularly diarrhea, affecting 63.4% of patients, though most side effects were manageable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nintedanib in Patients With Autoimmune Disease-Related Progressive Fibrosing Interstitial Lung Diseases: Subgroup Analysis of the INBUILD Trial. Matteson, EL., Kelly, C., Distler, JHW., et al.[2022]

Nintedanib is effective in slowing disease progression in patients with idiopathic pulmonary fibrosis (IPF), with a manageable safety profile observed in a pooled analysis of 1126 patients over an average treatment duration of 28 months.

Survival estimates suggest that nintedanib significantly extends life expectancy in IPF patients, with a mean survival of 11.6 years compared to 3.7 years for those on placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and survival data in patients with idiopathic pulmonary fibrosis treated with nintedanib: pooled data from six clinical trials. Lancaster, L., Crestani, B., Hernandez, P., et al.[2020]

In a study of 5578 Japanese patients with idiopathic pulmonary fibrosis (IPF), approximately 50% discontinued nintedanib treatment within 12 months, primarily due to adverse drug reactions (ADRs) such as hepatic function abnormalities and diarrhea.

Patients who continued nintedanib showed a smaller decline in lung function (forced vital capacity) compared to those who discontinued, indicating that ongoing treatment may help preserve lung function despite the risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Safety and Tolerability of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis: Interim Report of a Post-Marketing Surveillance in Japan. Ogura, T., Inoue, Y., Azuma, A., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Insights from the German Compassionate Use Program of Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Nintedanib in Patients With Autoimmune Disease-Related Progressive Fibrosing Interstitial Lung Diseases: Subgroup Analysis of the INBUILD Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Early clinical experiences with nintedanib in three UK tertiary interstitial lung disease centres. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Nintedanib in progressive interstitial lung diseases: data from the whole INBUILD trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Subgroup Analysis for Chinese Patients Included in the INPULSIS® Trials on Nintedanib in Idiopathic Pulmonary Fibrosis. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis: Global Pharmacovigilance Data. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Safety and survival data in patients with idiopathic pulmonary fibrosis treated with nintedanib: pooled data from six clinical trials. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of nintedanib in patients with systemic sclerosis-associated interstitial lung disease: data from the SENSCIS trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Real-World Safety and Tolerability of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis: Interim Report of a Post-Marketing Surveillance in Japan. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Delphi Consensus Recommendations on Management of Dosing, Adverse Events, and Comorbidities in the Treatment of Idiopathic Pulmonary Fibrosis with Nintedanib. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Rationale and protocol design for the TORG1835/NEXT-SHIP study: a phase II study of carboplatin, etoposide and nintedanib for unresectable limited/extensive disease small cell lung cancer with idiopathic pulmonary fibrosis. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease. [2021]