Idiopathic Pulmonary FibrosisPhase 2INFLO-2NCT07679893
Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis
A Phase 2 study testing Nintedanib Dry Powder Inhalation in people with Idiopathic Pulmonary Fibrosis and Idiopathic Pulmonary Fibrosis (IPF), run by Mannkind Corporation at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- Nintedanib Dry Powder Inhalation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2026to Jun 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wassim Fares, MD, SVP, Therapeutic Area Head, Orphan Lung Disease, MD contact
Canada1 site, 1 recruiting
- Recruiting
Trial Management Group Inc
Windsor, Ontario, N8X1T3
Syed Anees, 416-929-7717, aneesresearch@yahoo.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial of the Efficacy and Safety of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis Followed by an Open-Label Extension
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.
- Being tested
- Nintedanib Dry Powder Inhalation, Placebo
- Keywords
- inhalable treatments, lung scarring, Pulmonary fibrosis, fibrosis, pulmonary
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintedanib Dry Powder InhalationDrug
Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation.
PlaceboDrug
Placebo oral inhalation powder
| Study group | Role | What they receive |
|---|---|---|
| Nintedanib DPI 2X day 1st dose | Experimental | Inhalable Receives: Drug: Nintedanib Dry Powder Inhalation |
| Placebo 2X day 1st dose | Placebo comparator | Inhalable Receives: Drug: Placebo |
| Nintedanib DPI 2X day 2nd dose | Experimental | 2nd dose Receives: Drug: Nintedanib Dry Powder Inhalation |
| Placebo 2X day 2nd dose | Placebo comparator | 2nd dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Efficacy
Safety and tolerability of different doses and to confirm an optimal dose of Nintedanib Dry Powder Inhalation (DPI)
Measured: From enrollment to the end of randomized treatment at 12 weeks
Events of clinical bronchospasm
Events of clinical bronchospasm (e.g., treatment-emergent adverse event [TEAE] of wheezing or chest tightness immediately after inhalation)
Measured: From enrollment to the end of open-label treatment at 36 weeks
FEV1 change
Change in forced expiratory volume in 1 second (FEV1) (mL)
Measured: From enrollment to the end of open-label treatment at 36 weeks
Spirometry Change
Change in FEV1/forced vital capacity (FVC) ratio
Measured: enrollment to end of open label at 36 weeks
Study Drug Discontinuation
Rate of study drug discontinuations
Measured: From enrollment to the end of open-label treatment at 36 weeks
Study Drug Dose Reductions
Rate of study drug dose reductions
Measured: From enrollment to the end of open-label treatment at 36 weeks
Adverse Events
Rate of TEAEs
Measured: From enrollment to the end of open-label treatment at 36 weeks
Related Adverse Events
Rate of treatment-related adverse events (TRAEs)
Measured: From enrollment to the end of open-label treatment at 36 weeks
Serious Adverse Events
Rate of serious adverse events (SAEs)
Measured: From enrollment to the end of open-label treatment at 36 weeks
Secondary 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.
Measured: From enrollment to the end of randomized treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start15 May 2026
- Primary completion30 Dec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 12 weeks parallel treatment followed by 24 weeks open label treatment of nintedanib.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679893
- Sponsor's protocol ID
- MKC-NI-003
- Acronym
- INFLO-2
- Status last verified
- Sep 2026
- First submitted
- 18 Jun 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No