Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorMannkind Corporation
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Nintedanib Dry Powder Inhalation
- Placebo
Treatment groups
210 Participants
are divided into 4 treatment groupsLocations
2Canada
Trial Management Group IncN8X1T3, WindsorOntario, Canada
United States
Mannkind Corporation06810, DanburyConnecticut, United States
Sponsors and collaborators
Mannkind Corporation
Lead sponsor
Source ClinicalTrials.gov