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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07679893
- Acronym / sponsor ID
- INFLO-2 / MKC-NI-003
- Keywords
- inhalable treatments, lung scarring, Pulmonary fibrosis, fibrosis, pulmonary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 May 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 12 weeks parallel treatment followed by 24 weeks open label treatment of nintedanib.
| Arm | Type | Receives |
|---|---|---|
| Nintedanib DPI 2X day 1st dose | Experimental | Drug: Nintedanib Dry Powder InhalationInhalable |
| Placebo 2X day 1st dose | Placebo comparator | Drug: PlaceboInhalable |
| Nintedanib DPI 2X day 2nd dose | Experimental | Drug: Nintedanib Dry Powder Inhalation2nd dose |
| Placebo 2X day 2nd dose | Placebo comparator | Drug: Placebo2nd dose |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nintedanib Dry Powder InhalationNintedanib DPI is a dry powder nintedanib formulation for oral inhalation. | Drug | Nintedanib DPI 2X day 1st dose, Nintedanib DPI 2X day 2nd dose |
| PlaceboPlacebo oral inhalation powder | Drug | Placebo 2X day 1st dose, Placebo 2X day 2nd dose |
Primary outcome
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)
1 secondary outcome
Efficacy of Nintedanib DPI
Time frame: From enrollment to the end of randomized treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wassim Fares, MD, SVP, Therapeutic Area Head, Orphan Lung Disease, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wassim Fares, MD, SVP, Therapeutic Area Head, Orphan Lung Disease, MD (203-796-3407, wfares@mannkindcorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Efficacy (time frame: From enrollment to the end of randomized treatment at 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.