Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic… (NCT07679893) | Clinical Trial Compass
RecruitingPhase 2
Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis
Canada210 participantsStarted 2026-06-30
Plain-language 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.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Efficacy
Timeframe: From enrollment to the end of randomized treatment at 12 weeks
2
Events of clinical bronchospasm
Timeframe: From enrollment to the end of open-label treatment at 36 weeks
3
FEV1 change
Timeframe: From enrollment to the end of open-label treatment at 36 weeks
4
Spirometry Change
Timeframe: enrollment to end of open label at 36 weeks
5
Study Drug Discontinuation
Timeframe: From enrollment to the end of open-label treatment at 36 weeks
6
Study Drug Dose Reductions
Timeframe: From enrollment to the end of open-label treatment at 36 weeks
7
Adverse Events
Timeframe: From enrollment to the end of open-label treatment at 36 weeks