Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis

Inclusion Criteria: * aPAP diagnosed by computed tomography, or by biopsy, or by Broncho Alveolar Lavage (BAL), and by increased GM-CSF autoantibodies in serum. * Stable or progressive aPAP during a minimum period of 2 months prior to the Baseline visit. * Arterial oxygen tension (PaO2) \<75 mmHg/\<10 kilo Pascal (kPa) at rest, OR desaturation of \>4 percentage points on the 6MWT * An alveolar-arterial oxygen difference \[(A-a)DO2\] of minimum 25 mmHg/3.33 kPa * Female or male ≥18 years of age * Females who have been post-menopausal for \>1 year or females of childbearing potential after a confirmed menstrual period using a highly efficient method of contraception (i.e. a method with \<1% failure rate such as combined hormonal contraception, progesterone-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence), during and until 30 days after last dose of double-blind trial treatment. Females of childbearing potential must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at dosing at Baseline (Visit 2) and must not be lactating * Males agreeing to use condoms during and until 30 days after last dose of double-blind medication, or males having a female partner who is using adequate contraception as described above * Willing and able to provide signed informed consent * Willing and able to comply with scheduled visits, treatment plan…