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New treatment option for Idiopathic Pulmonary Fibrosis
Official title Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis
ClinicalTrials.gov ID: NCT07679893
What this study is testing
What is Nintedanib Dry Powder Inhalation?
Nintedanib Dry Powder Inhalation is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for idiopathic pulmonary fibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial is a randomized, double-blind, placebo-controlled study evaluating the safety and preliminary efficacy of inhaled Nintedanib Dry Powder Inhalation (DPI) in adults with idiopathic pulmonary fibrosis (IPF). Participants are randomized to receive either 2 mg QID, 4 mg BID, or matching placebo for 12 weeks, followed by a 24-week open-label extension in which all participants receive active treatment.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 40-80 years old when signing consent and entering screening.
- Diagnosed with IPF based on current ATS/ERS/JRS/ALAT guidelines.
- Either new to treatment or on a stable dose of pirfenidone and/or nerandomilast for at least 3 months before screening.
- Weighs more than 40 kg (88 lb) at screening.
- Women who can become pregnant:
You likely can't join if
- Has a lung disease caused by something other than IPF.
- Has a connective tissue or autoimmune disease (such as lupus, scleroderma, or rheumatoid arthritis).
- Has another condition that significantly affects breathing.
- Has serious heart or blood vessel disease.
- Has a recent or current infection.
- Was recently hospitalized for COVID-19, an IPF flare-up, or a lung infection.
See the full eligibility criteria
- 40-80 years old when signing consent and entering screening.
- Diagnosed with IPF based on current ATS/ERS/JRS/ALAT guidelines.
- Either new to treatment or on a stable dose of pirfenidone and/or nerandomilast for at least 3 months before screening.
- Weighs more than 40 kg (88 lb) at screening.
- Women who can become pregnant:
- Must have a negative pregnancy test at screening.
- Must use an approved birth control method from screening until at least 1 month after the last study dose.
- Men who can father a child and are sexually active with women who can become pregnant:
- Must use an approved birth control method during treatment and for at least 3 months after the last study dose.
- Must not donate sperm during treatment and for at least 3 months after the last study dose.
- Willing to follow all study rules and restrictions.
- Willing and able to attend study visits and complete study procedures.
- Able to perform spirometry (lung function testing) as required by the study.
- Has a lung disease caused by something other than IPF.
- Has a connective tissue or autoimmune disease (such as lupus, scleroderma, or rheumatoid arthritis).
- Has another condition that significantly affects breathing.
- Has serious heart or blood vessel disease.
- Has a recent or current infection.
- Was recently hospitalized for COVID-19, an IPF flare-up, or a lung infection.
- Has a history of asthma (except childhood asthma that has resolved).
- Has another medical condition or abnormal test result that may affect study participation or safety.
- Cannot perform high-quality spirometry testing.
- Has obstructive lung disease.
- Has abnormal liver function tests.
- Has moderate to severe liver disease.
- Has severe kidney disease.
- Has recently used high-dose steroids or other immune-suppressing medications.
- Has active cancer or recent cancer treatment.
- Is on, or expected to be added to, a transplant list.
- Had major surgery recently or has planned procedures that could interfere with the study.
- Has had a severe reaction to nintedanib or cannot take nintedanib safely.
- Has recently used certain medications that may interact with the study drug.
- Is currently using, or plans to use, prohibited medications during the study.
- Has recently participated in another clinical trial.
- Has current alcohol or drug abuse issues.
- Donated a significant amount of blood recently.
- Received a live vaccine recently.
- Currently smokes, recently smoked, or quit smoking less than 1 year ago.
- Requires more than 6 L/min of oxygen while at rest.
The study team makes the final eligibility decision.
Where it's taking place
- Danbury, Connecticut, United States
- Windsor, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Danbury, Connecticut, United States; Windsor, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.