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

Purpose

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)

Eligibility

Eligible Ages
Between 40 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
12 weeks parallel treatment followed by 24 weeks open label treatment of nintedanib.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

More Details

Status
Recruiting
Sponsor
Mannkind Corporation

Study Contact

Senior Vice President, Therapeutic Area Head, Orphan Lung Dise, MD
203-796-3407
wfares@mannkindcorp.com