Recruiting
Phase 2

Nintedanib

Sponsor:

Mannkind Corporation

Code:

NCT07679893

Conditions

Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis (IPF)

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Nintedanib Dry Powder Inhalation

Placebo

Study Details

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.

Conditions

Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis (IPF)

Study ID

NCT07679893

Start date

Jun 30, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jan 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nintedanib DPI 4X day

Inhalable

placebo comparator: Placebo 4X day

Inhalable

experimental: Nintedanib 2X day

Inhalable

placebo comparator: Placebo 2X day

Inhalable

Interventions

Nintedanib Dry Powder Inhalation

Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation.

Placebo

Placebo oral inhalation powder

Primary outcome measure

  • Safety and Efficacy [ Time Frame: From enrollment to the end of randomized treatment at 12 weeks ]
  • Events of clinical bronchospasm [ Time Frame: From enrollment to the end of open-label treatment at 36 weeks ]
  • FEV1 change [ Time Frame: From enrollment to the end of open-label treatment at 36 weeks ]
  • Spirometry Change [ Time Frame: enrollment to end of open label at 36 weeks ]
  • Study Drug Discontinuation [ Time Frame: From enrollment to the end of open-label treatment at 36 weeks ]
  • Study Drug Dose Reductions [ Time Frame: From enrollment to the end of open-label treatment at 36 weeks ]
  • Adverse Events [ Time Frame: From enrollment to the end of open-label treatment at 36 weeks ]
  • Related Adverse Events [ Time Frame: From enrollment to the end of open-label treatment at 36 weeks ]
  • Serious Adverse Events [ Time Frame: From enrollment to the end of open-label treatment at 36 weeks ]

Central Contacts and Locations

Central contacts

Wassim Fares, MD, SVP, Therapeutic Area Head, Orphan Lung Disease, MD

203-796-3407wfares@mannkindcorp.com

Locations

Trial Management Group Inc

Recruiting

Windsor, Ontario, Canada, N8X1T3

Contacts

Syed Anees

416-929-7717aneesresearch@yahoo.com

More Information

Sponsor

Mannkind Corporation

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • inhalable treatments
  • lung scarring
  • Pulmonary fibrosis
  • fibrosis
  • pulmonary

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mannkind Corporation on 2026-07-24.