Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis

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. The primary focus is on safety-particularly bronchospasm events, lung function changes (FEV1, FEV1/FVC), and adverse event rates and assessing the effectiveness of nintedanib DPI in treating IPF.

Inclusion 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. Exclusion Criteria: * 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.