Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis
Recruiting
Phase 2
Interventional Study
Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 40 – 80
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 210 (estimated)
- Sponsor
- Mannkind Corporation · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
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 (8…
Contacts
Wassim Fares, MD, SVP, Therapeutic Area Head, Orphan Lung Disease, MD
203-796-3407
CONTACT