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NOT YET RECRUITING
NCT07679893
PHASE2

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

Sponsor: Mannkind Corporation

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2026-06-30

Completion Date

2028-12

Last Updated

2026-07-01

Healthy Volunteers

No

Interventions

DRUG

Nintedanib Dry Powder Inhalation

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

DRUG

Placebo

Placebo oral inhalation powder

Locations (1)

Mannkind Corporation

Danbury, Connecticut, United States