Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis (INFLO-2)

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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis (IPF)
• Intervention / Treatment: Drug: Nintedanib Dry Powder Inhalation; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Senior Vice President, Therapeutic Area Head, Orphan Lung Dise, MD; Phone Number: 203-796-3407; Email: wfares@mannkindcorp.com

Study Locations

• United States
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Mannkind Corporation
      • Contact: Senior Vice President, Therapeutic Area Head, Orphan Lung Dise, MD; Phone Number: 203-796-3407; Email: wfares@mannkindcorp.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nintedanib DPI 4X day; Inhalable	Drug: Nintedanib Dry Powder Inhalation; Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation.
Placebo Comparator: Placebo 4X day; Inhalable	Drug: Placebo; Placebo oral inhalation powder
Experimental: Nintedanib 2X day; Inhalable	Drug: Nintedanib Dry Powder Inhalation; Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation.
Placebo Comparator: Placebo 2X day; Inhalable	Drug: Placebo; Placebo oral inhalation powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Efficacy	Safety and tolerability of different doses and to confirm an optimal dose of Nintedanib Dry Powder Inhalation (DPI)	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)	From enrollment to the end of open-label treatment at 36 weeks
FEV1 change	Change in forced expiratory volume in 1 second (FEV1) (mL)	From enrollment to the end of open-label treatment at 36 weeks
Spirometry Change	Change in FEV1/forced vital capacity (FVC) ratio	enrollment to end of open label at 36 weeks
Study Drug Discontinuation	Rate of study drug discontinuations	From enrollment to the end of open-label treatment at 36 weeks
Study Drug Dose Reductions	Rate of study drug dose reductions	From enrollment to the end of open-label treatment at 36 weeks
Adverse Events	Rate of TEAEs	From enrollment to the end of open-label treatment at 36 weeks
Related Adverse Events	Rate of treatment-related adverse events (TRAEs)	From enrollment to the end of open-label treatment at 36 weeks
Serious Adverse Events	Rate of serious adverse events (SAEs)	From enrollment to the end of open-label treatment at 36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Nintedanib DPI	To assess a potential efficacy signal of different doses of Nintedanib DPI over 12 weeks in patients with IPF.	From enrollment to the end of randomized treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Mannkind Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: fibrosis; Pulmonary fibrosis; pulmonary; lung scarring; inhalable treatments
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pathological Conditions, Signs and Symptoms; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
• Other Study ID Numbers: MKC-NI-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No