Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Protei… (NCT04544293) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
United States164 participantsStarted 2021-05-19
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject must be ≥18 years of age, at the time of signing the informed consent (≥20 in Japan).
✓. A serum anti-GM-CSF autoantibody test result confirming autoimmune PAP.
✓. History of PAP, based on examination of a lung biopsy, bronchoalveolar lavage (BAL) cytology, or a high-resolution computed tomogram (HRCT) of the chest.
✓. A diffusing capacity for carbon monoxide of 70% predicted or lower adjusted for hemoglobin (%DLCOadj) at the screening and baseline visits.
✓. Change in %DLCO adj of \<15% points during the screening period.
✓. Demonstrated functional impairment in the treadmill exercise test (defined as a peak metabolic equivalent (MET) ≤8).
✓. Willing and able to come off supplemental oxygen use prior to and during the treadmill exercise test, the DLCO assessment, and the arterial blood gas sampling.
✓. Resting oxygen saturation (SpO2) \>85% during 15 minutes without use of supplemental oxygen at the screening visits.
Exclusion criteria
✕. Diagnosis of hereditary or secondary PAP, or a metabolic disorder of surfactant production.
✕. Whole lung lavage (WLL) performed within 3 months prior to baseline.
✕. Requirement for WLL at screening or baseline.
✕
What they're measuring
1
Change From Baseline in Percent (%) Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Adjusted for Hemoglobin Concentration to Week 24