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Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis
Sponsor: Mannkind Corporation
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
210
Start Date
2026-06-30
Completion Date
2028-12
Last Updated
2026-07-01
Healthy Volunteers
No
Interventions
Nintedanib Dry Powder Inhalation
Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation.
Placebo
Placebo oral inhalation powder
Locations (1)
Mannkind Corporation
Danbury, Connecticut, United States