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

9 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

153

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

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

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Nintedanib DPI 2X day 1st dose
Inhalable
Médicament: Nintedanib Dry Powder Inhalation
Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation.
Comparateur placebo: Placebo 2X day 1st dose
Inhalable
Médicament: Placebo
Placebo oral inhalation powder
Expérimental: Nintedanib DPI 2X day 2nd dose
2nd dose
Médicament: Nintedanib Dry Powder Inhalation
Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation.
Comparateur placebo: Placebo 2X day 2nd dose
2nd dose
Médicament: Placebo
Placebo oral inhalation powder

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Safety and Efficacy
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Efficacy of Nintedanib DPI
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Mannkind Corporation

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 mai 2026

Achèvement primaire (Estimé)

30 décembre 2027

Achèvement de l'étude (Estimé)

1 juin 2028

Dates d'inscription aux études

Première soumission

18 juin 2026

Première soumission répondant aux critères de contrôle qualité

25 juin 2026

Première publication (Réel)

1 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • MKC-NI-003

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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