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

9 september 2026 bijgewerkt door: Mannkind Corporation

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

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 BID, 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

153

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Wassim Fares, MD, SVP, Therapeutic Area Head, Orphan Lung Disease, MD
  • Telefoonnummer: 203-796-3407
  • E-mail: wfares@mannkindcorp.com

Studie Locaties

  • Canada
    • Ontario
      • Windsor, Ontario, Canada, N8X1T3
        • Werving
        • Trial Management Group Inc
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Nintedanib DPI 2X day 1st dose
Inhalable
Geneesmiddel: Nintedanib Dry Powder Inhalation
Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation.
Placebo-vergelijker: Placebo 2X day 1st dose
Inhalable
Geneesmiddel: Placebo
Placebo oral inhalation powder
Experimenteel: Nintedanib DPI 2X day 2nd dose
2nd dose
Geneesmiddel: Nintedanib Dry Powder Inhalation
Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation.
Placebo-vergelijker: Placebo 2X day 2nd dose
2nd dose
Geneesmiddel: Placebo
Placebo oral inhalation powder

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Safety and Efficacy
Tijdsspanne: From enrollment to the end of randomized treatment at 12 weeks
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
Tijdsspanne: From enrollment to the end of open-label treatment at 36 weeks
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
Tijdsspanne: From enrollment to the end of open-label treatment at 36 weeks
Change in forced expiratory volume in 1 second (FEV1) (mL)
From enrollment to the end of open-label treatment at 36 weeks
Spirometry Change
Tijdsspanne: enrollment to end of open label at 36 weeks
Change in FEV1/forced vital capacity (FVC) ratio
enrollment to end of open label at 36 weeks
Study Drug Discontinuation
Tijdsspanne: From enrollment to the end of open-label treatment at 36 weeks
Rate of study drug discontinuations
From enrollment to the end of open-label treatment at 36 weeks
Study Drug Dose Reductions
Tijdsspanne: From enrollment to the end of open-label treatment at 36 weeks
Rate of study drug dose reductions
From enrollment to the end of open-label treatment at 36 weeks
Adverse Events
Tijdsspanne: From enrollment to the end of open-label treatment at 36 weeks
Rate of TEAEs
From enrollment to the end of open-label treatment at 36 weeks
Related Adverse Events
Tijdsspanne: From enrollment to the end of open-label treatment at 36 weeks
Rate of treatment-related adverse events (TRAEs)
From enrollment to the end of open-label treatment at 36 weeks
Serious Adverse Events
Tijdsspanne: From enrollment to the end of open-label treatment at 36 weeks
Rate of serious adverse events (SAEs)
From enrollment to the end of open-label treatment at 36 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Efficacy of Nintedanib DPI
Tijdsspanne: From enrollment to the end of randomized treatment at 12 weeks
To assess a potential efficacy signal of different doses of Nintedanib DPI over 12 weeks in patients with IPF.
From enrollment to the end of randomized treatment at 12 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Mannkind Corporation

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 mei 2026

Primaire voltooiing (Geschat)

30 december 2027

Studie voltooiing (Geschat)

1 juni 2028

Studieregistratiedata

Eerst ingediend

18 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

25 juni 2026

Eerst geplaatst (Werkelijk)

1 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 september 2026

Laatste update ingediend die voldeed aan QC-criteria

9 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MKC-NI-003

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Ja

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