Nintedanib for Interstitial Lung Disease

(MINT Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the safety and effectiveness of nintedanib, a medication, in improving symptoms for people with myositis-associated interstitial lung disease (MA-ILD). This condition thickens and scars lung tissue, making breathing difficult. Participants will either receive a placebo followed by nintedanib or start directly with nintedanib, both combined with standard care. Those with progressive lung issues due to MA-ILD and increasing difficulty in breathing may be suitable for this trial. As a Phase 4 trial, this research helps determine how the already FDA-approved treatment benefits more patients.

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 is the safety track record for these treatments?

Research shows that nintedanib is usually well-tolerated by people with interstitial lung diseases. However, some studies have found that stomach issues, like diarrhea, are common side effects. One study found serious side effects in about 44.3% of patients taking nintedanib, compared to 49.5% of those taking a placebo. This suggests that the risk of serious side effects may not be much higher with nintedanib than with a placebo.

Nintedanib is already approved by the FDA for other lung diseases, which provides some confidence about its safety. Prospective trial participants should discuss any concerns with a healthcare professional. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Nintedanib is unique because it targets the underlying processes of scarring in interstitial lung disease, rather than just managing symptoms like some standard treatments. Most current therapies focus on reducing inflammation, but Nintedanib works by inhibiting pathways that lead to fibrosis, which is the thickening and scarring of lung tissue. Researchers are excited because this mechanism of action could slow down the progression of the disease, offering hope for improved long-term outcomes for patients.

What evidence suggests that this trial's treatments could be effective for interstitial lung disease?

Research has shown that nintedanib can slow the progression of interstitial lung disease (ILD) in various conditions. Studies have found that nintedanib significantly slows the decline in lung function for individuals with idiopathic pulmonary fibrosis (IPF) and ILD related to systemic sclerosis, helping to maintain lung function over time. For those with progressive fibrosing ILD, nintedanib also slowed the disease's progression over a year. In this trial, participants will receive either nintedanib plus standard of care or a placebo plus standard of care, followed by nintedanib. These findings suggest that nintedanib may improve symptoms for individuals with myositis-associated ILD by reducing lung scarring and stiffness. ^{3 4 5 6 7}

Who Is on the Research Team?

Rohit Aggarwal, MD, MS

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9405731/

The Effectiveness of Nintedanib in Patients with Idiopathic ... Results: nintedanib treatment significantly reduced the FVC decline rate in IPF and PF-ILD subgroups, but not in FPF subjects. No significant ...

2. publications.ersnet.org publications.ersnet.org/content/erj/59/3/2004538

Nintedanib in progressive interstitial lung diseases: data from ... Nintedanib reduces the rate of progression of interstitial lung disease (ILD) over 52 weeks in patients with idiopathic pulmonary fibrosis (IPF).

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1903076

Nintedanib for Systemic Sclerosis–Associated Interstitial ... The results showed that the rate of decline in FVC over 52 weeks among patients with ILD associated with systemic sclerosis was lower for those who received ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10682577/

Efficacy and Safety of Nintedanib in Patients with Interstitial ... Nintedanib is effective for ILD with or without SSc. However, it increased the incidence of AEs and withdrawals due to AEs.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02999178

NCT02999178 | Efficacy and Safety of Nintedanib in ... The aim of the current study is to investigate the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39466587/

Safety and Tolerability of Nintedanib in Patients with ... The results of clinical trials showed that the most frequent adverse events seen in patients treated with nintedanib are gastrointestinal events, particularly ...

7. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-022-01974-2

Safety and tolerability of nintedanib in ... - Respiratory Research Serious adverse events were reported in 44.3% of patients in the nintedanib group and 49.5% of patients in the placebo group. The most common ...