NCT07679893 Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis
| NCT ID | NCT07679893 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mannkind Corporation |
| Condition | Idiopathic Pulmonary Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2026-06-30 |
| Primary Completion | 2028-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 210 participants in total. It began in 2026-06-30 with a primary completion date of 2028-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Senior Vice President, Therapeutic Area Head, Orphan Lung Dise, MD
✉ wfares@mannkindcorp.com📞 203-796-3407
Frequently Asked Questions
Who can join the NCT07679893 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Idiopathic Pulmonary Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07679893 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07679893 currently recruiting?
Yes, NCT07679893 is actively recruiting participants. Contact the research team at wfares@mannkindcorp.com for enrollment information.
Where is the NCT07679893 trial being conducted?
This trial is being conducted at Danbury, United States, Windsor, Canada.
Who is sponsoring the NCT07679893 clinical trial?
NCT07679893 is sponsored by Mannkind Corporation. The trial plans to enroll 210 participants.