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Tyrosine Kinase Inhibitor

Nintedanib for Interstitial Lung Disease (MINT Trial)

Verified Trial
Phase 4
Recruiting
Research Sponsored by Rohit Aggarwal, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Do you live in the United States?
Do you have myositis or a blood test indicating myositis (or myositis antibodies)?
Must not have
Are you being evaluated for a lung transplant or have you had one in the past?
Do you currently require supplemental oxygen of 10L or more at rest?
Timeline
Screening 1 day
Treatment 24 weeks
Follow Up 52 weeks
Awards & highlights

MINT Trial Summary

This trial will evaluate whether nintedanib can improve symptoms in people with interstitial lung disease caused by myositis. Participants will have physical exams, tests, CT scans, blood draws, wear a physical activity monitor & complete questionnaires.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Nintedanib may cause side effects like diarrhea, liver enzyme elevation leading to potential liver damage, bleeding risk increase due to its effect on clotting mechanisms and possible heart attack or stroke.

MINT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have myositis or a positive test for myositis antibodies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am being considered for or have had a lung transplant.
Select...
I need more than 10L of oxygen at rest.
Select...
I am not planning any major surgeries that require anesthesia in the next 6 months.
Select...
I have used OFEV for my condition.

MINT Trial Timeline

Screening ~ 1 day
Treatment ~ 24 weeks
Follow Up ~52 weeks
This trial's timeline: 1 day for screening, 24 weeks for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Living with Pulmonary Fibrosis Symptoms and Impact Questionnaire (L-PF) Dyspnea score
Secondary outcome measures
Absolute and relative change in Forced Vital Capacity (FVC) (mL) from baseline to 12 weeks
Absolute and relative change in Forced Vital Capacity (FVC) (mL) from baseline to 24 weeks
Absolute and relative change in Forced Vital Capacity FVC (%) from baseline to week 12
+13 more
Other outcome measures
Absolute and relative change in DLCO
Absolute and relative change in FEV1
Adverse events (AEs) and tolerance
+16 more

MINT Trial Design

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.

Find a Location

Who is running the clinical trial?

Rohit Aggarwal, MDLead Sponsor
2 Previous Clinical Trials
32 Total Patients Enrolled
1 Trials studying Myositis
20 Patients Enrolled for Myositis
Boehringer IngelheimIndustry Sponsor
2,507 Previous Clinical Trials
11,340,773 Total Patients Enrolled

Media Library

Nintedanib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05799755 — Phase 4
Myositis Research Study Groups: Placebo plus Standard of Care, then Nintedanib plus Standard of Care, Nintedanib plus Standard of Care
Myositis Clinical Trial 2023: Nintedanib Highlights & Side Effects. Trial Name: NCT05799755 — Phase 4
Nintedanib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05799755 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous sites in North America that are executing this research?

"At present, the trial is recruiting from 15 clinics based in cities such as Denver, Tampa and Chicago. To reduce travel costs associated with participation, we recommend selecting a clinic close to your location."

Answered by AI

Could you elucidate the potential risks of administering Nintedanib in conjunction with Standard of Care?

"Our team considers nintedanib plus Standard of Care to be a safe treatment, so it earned a rating of 3. This is because the trial has reached stage 4 approval - indicating that this method has been proven both effective and secure."

Answered by AI

Is the recruitment process for this trial currently open?

"The information hosted on clinicaltrials.gov indicates that this particular medical trial is not accepting patients at the moment, despite being posted for recruitment in April of 2023 and receiving its most recent update 22nd March 2023. Fortunately, 307 other studies are still actively recruiting participants."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
0
What site did they apply to?
Vanderbilt University Medical Center
University of Florida
University of Texas Southwestern Medical Center
Other

Why did patients apply to this trial?

I thought I would qualify. Hopefully get off oxygen!!!! I was diagnosed with IPF August of 2019.
PatientReceived 1 prior treatment
I have been on OFEV since July 6, 2033. I feel so awful all the time and can’t catch my breath.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Yes, what is this trial about? Will there be many overnight stays ?
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Phone Call
Most responsive sites:
  1. University of Florida: < 48 hours
  2. University of Pittsburgh: < 48 hours
  3. Vanderbilt University Medical Center: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Myositis Interstitial Lung Disease Nintedanib Trial
Rohit Aggarwal, MD 2023. "Myositis Interstitial Lung Disease Nintedanib Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05799755.
All > Myositis > Ofev
~63 spots leftby Jan 2025
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