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Clinical trialNCT04544293Active, not recruitingPhase 3Interventional

Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

SponsorSavara Inc.Enrollment164Autoimmune Pulmonary Alveolar Proteinosis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

160 subjects with autoimmune pulmonary alveolar proteinosis (aPAP) will be randomized to receive once daily treatment with inhaled molgramostim (MOL) or placebo (PBO) for 48 weeks. Subjects completing the 48-week placebo-controlled period will receive open-label treatment with once daily inhaled molgramostim for 96 weeks.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

54 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, Australia

  • Westmead Hospital

    Westmead, New South Wales, Australia

Belgium
  • Hôpital Erasme

    Brussels, Brussels Capital, Belgium

  • Uz Leuven - Campus Gasthuisberg - Pneumologie

    Leuven, Vlaams Brabant, Belgium

Canada
  • University of Calgary

    Calgary, Alberta, Canada

  • St Joseph'S Healthcare Hamilton Research

    Hamilton, Ontario, Canada

  • University Institute of Cardiology and Respirology of Quebec

    Québec, Canada

France
  • Hôpital Louis Pradel

    Bron, Auvergne-Rhône-Alpes, France

  • Chu Pontchaillou

    Rennes, Brittany Region, France

Germany
  • Thoraxklinik Heidelberg Ggmbh Am Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, Germany

  • Asklepios Fachkliniken Muenchen-Gauting

    Muenchen-Gauting, Bavaria, Germany

  • Ruhrlandklinik Westdeutsches Lungenzentrum

    Essen, North Rhine-Westphalia, Germany

Greece
  • Attikon University Hospital

    Athens, Greece

Ireland
  • St. Vincent'S University Hospital

    Dublin, Ireland

Italy
  • Fondazione Irccs Policlinico San Matteo

    Pavia, Lombardy, Italy

Japan
  • Hokkaido University Hospital

    Sapporo, Hokkaidô, Japan

  • Kanagawa Cardiovascular and Respiratory Center

    Yokohama, Kanagawa, Japan

  • Tohoku University Hospital - Respiratory Tract Medicine

    Sendai, Miyagi, Japan

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Sakai, Osaka, Japan

  • Kyorin University Hospital

    Mitaka, Tokyo, Japan

  • Chiba University Hospital - Respiratory Medicine

    Chiba, Japan

  • Kumamoto University Hospital

    Kumamoto, Japan

  • Aichi Medical University Hospital

    Nagakute, Japan

  • Saitama Red Cross Hospital

    Saitama, Japan

Netherlands
  • St Antonius Hospital

    Nieuwegein, Utrecht, Netherlands

Poland
  • Instytut Gruzlicy I Chorob Pluc

    Warsaw, Masovian Voivodeship, Poland

Portugal
  • Hospital Pulido Valente

    Lisbon, Portugal

  • Hospital São João

    Porto, Portugal

Romania
  • Institutul de Pneumoftiziologie "marius Nasta"

    Bucharest, Romania

South Korea
  • Asan Medical Center

    Seoul, South Korea

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Severance Hospital - Yonsei University Health System - Pulmonary

    Seoul, South Korea

Spain
  • Hospital Universitario de Bellvitge

    Barcelona, Catalonia, Spain

Turkey (Türkiye)
  • Ege University Hospital - Department of Pulmonology

    Bornova, İzmir, Turkey (Türkiye)

  • Health Sciences University Gulhane Training and Research Hospital

    Ankara, Turkey (Türkiye)

  • Yedikule Chest Disease and Surgery Training and Research Hospital

    Istanbul, Turkey (Türkiye)

United Kingdom
  • Royal Brompton and Harefield Nhs Foundation Trust

    London, United Kingdom

United States
  • University of Arkansas for Medical Services

    Little Rock, Arkansas, United States

  • Ucla David Geffen School of Medicine

    Los Angeles, California, United States

14 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

MolgramostimMolgramostim Open-labelPlacebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
19 May 2021
Primary completion
30 Nov 2023
Completion
30 May 2027
Last update posted
7 Aug 2025
Registered enrollment
164
Registry id
NCT04544293

Cross-registrations

EU-CTR / CTIS (EudraCT)2020-001263-85

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.