NCT07679893 · Mannkind Corporation
Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis
(INFLO-2)
What this study is about
This trial is a randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment study evaluating the safety and preliminary effectiveness of inhaled Nintedanib Dry Powder Inhalation (DPI) in adults with idiopathic pulmonary fibrosis (IPF).
View original scientific description
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.
Interventions
DRUG
Nintedanib Dry Powder Inhalation
Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation.
DRUG
Placebo
Placebo oral inhalation powder
Primary outcome measures
Safety and Efficacy
Time frame: From enrollment to the end of randomized treatment at 12 weeks
Safety and tolerability of different doses and to confirm an optimal dose of Nintedanib Dry Powder Inhalation (DPI)
Events of clinical bronchospasm
Time frame: From enrollment to the end of open-label treatment at 36 weeks
Events of clinical bronchospasm (e.g., treatment-emergent adverse event \[TEAE\] of wheezing or chest tightness immediately after inhalation)
FEV1 change
Time frame: From enrollment to the end of open-label treatment at 36 weeks
Change in forced expiratory volume in 1 second (FEV1) (mL)
Spirometry Change
Time frame: enrollment to end of open label at 36 weeks
Change in FEV1/forced vital capacity (FVC) ratio
Study Drug Discontinuation
Time frame: From enrollment to the end of open-label treatment at 36 weeks
Rate of study drug discontinuations
Study Drug Dose Reductions
Time frame: From enrollment to the end of open-label treatment at 36 weeks
Rate of study drug dose reductions
Adverse Events
Time frame: From enrollment to the end of open-label treatment at 36 weeks
Rate of TEAEs
Related Adverse Events
Time frame: From enrollment to the end of open-label treatment at 36 weeks
Rate of treatment-related adverse events (TRAEs)
Serious Adverse Events
Time frame: From enrollment to the end of open-label treatment at 36 weeks
Rate of serious adverse events (SAEs)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Danbury, Connecticut
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations