A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial of the Efficacy and Safety of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis Followed by an Open-Label Extension
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.
• 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.