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 BID, 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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Nintedanib Dry Powder Inhalation
DrugNintedanib DPI is a dry powder nintedanib formulation for oral inhalation.
Placebo
DrugPlacebo oral inhalation powder
Treatment groups
153 Participants
are divided into 4 treatment groupsGroup A: Nintedanib DPI 2X day 1st doseExperimental treatment 1 intervention
Group B: Placebo 2X day 1st dosePlacebo comparator 1 intervention
Group C: Nintedanib DPI 2X day 2nd doseExperimental treatment 1 intervention
Group D: Placebo 2X day 2nd dosePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Efficacy
Safety and tolerability of different doses and to confirm an optimal dose of Nintedanib Dry Powder Inhalation (DPI)
Time frame
From enrollment to the end of randomized treatment at 12 weeks2
Events of clinical bronchospasm
Events of clinical bronchospasm (e.g., treatment-emergent adverse event \[TEAE\] of wheezing or chest tightness immediately after inhalation)
Time frame
From enrollment to the end of open-label treatment at 36 weeks3
FEV1 change
Change in forced expiratory volume in 1 second (FEV1) (mL)
Time frame
From enrollment to the end of open-label treatment at 36 weeks4
Spirometry Change
Change in FEV1/forced vital capacity (FVC) ratio
Time frame
enrollment to end of open label at 36 weeksSecondary outcomes
1
Efficacy of Nintedanib DPI
To assess a potential efficacy signal of different doses of Nintedanib DPI over 12 weeks in patients with IPF.
Time frame
From enrollment to the end of randomized treatment at 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov