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

Sponsor
Mannkind Corporation
Study ID
NCT07679893
Phase
PHASE2
Status
Recruiting
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Conditions

  • Idiopathic Pulmonary Fibrosis
  • Idiopathic Pulmonary Fibrosis (IPF)

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Nintedanib Dry Powder Inhalation — DRUG
    Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation.
  • Placebo — DRUG
    Placebo oral inhalation powder

Study Details

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.

Key Dates

First listed
Jul 1, 2026
Start date
Jun 30, 2026
Status verified
Jul 2026
Primary completion
Jan 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nintedanib DPI 4X day
    Inhalable
  • Placebo Comparator: Placebo 4X day
    Inhalable
  • Experimental: Nintedanib 2X day
    Inhalable
  • Placebo Comparator: Placebo 2X day
    Inhalable

Primary Outcome Measure

Safety and Efficacy [ Time Frame: From enrollment to the end of randomized treatment at 12 weeks ]

Central Contacts

  • Wassim Fares, MD, SVP, Therapeutic Area Head, Orphan Lung Disease, MD
    203-796-3407
    [email protected]

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