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

NCT07679893 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MKC-NI-003
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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)

Keywords

inhalable treatments; lung scarring; Pulmonary fibrosis; fibrosis; pulmonary

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (1)

• Efficacy of Nintedanib DPI

  From enrollment to the end of randomized treatment at 12 weeks

Study Arms (4)

Nintedanib DPI 4X day

EXPERIMENTAL

Inhalable

Drug: Nintedanib Dry Powder Inhalation

Placebo 4X day

PLACEBO COMPARATOR

Inhalable

Drug: Placebo

Nintedanib 2X day

EXPERIMENTAL

Inhalable

Drug: Nintedanib Dry Powder Inhalation

Placebo 2X day

PLACEBO COMPARATOR

Inhalable

Drug: Placebo

Interventions

Nintedanib Dry Powder Inhalation DRUG

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

Nintedanib 2X day; Nintedanib DPI 4X day

Placebo DRUG

Placebo oral inhalation powder

Placebo 2X day; Placebo 4X day

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (1)

Trial Management Group Inc

Windsor, Ontario, N8X1T3, Canada

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

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

CONTACT

203-796-3407; wfares@mannkindcorp.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 12 weeks parallel treatment followed by 24 weeks open label treatment of nintedanib.

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 1, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)