NL-OMON46238
Completed
Phase 2
A Randomised, Double-Blind, Placebo-Controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary AlveoLAr Proteinosis Patients - IMPALA
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Savara ApS
- Enrollment
- 9
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- aPAP diagnosed by CT, or by biopsy, or by Broncho Alveolar Lavage (BAL), and by increased GM\-CSF autoantibodies in serum.;\- Stable or progressive aPAP (i.e. absolute VC not improved by more than 5% and/or DLCO not improved by more than 10% \- assessed from medical records) during a minimum period of two months prior to the Baseline visit. ;\- PaO2 \<75 mmHg/\<10 kPa at rest, OR desaturation of \>4 percentage points on the 6 Minute Walk Test (6MWT) ;\- An (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, laboratory tests, and other trial procedures specified in the protocol as judged by the investigator
Exclusion Criteria
- •\- Diagnosis of hereditary or secondary pulmonary alveolar proteinosis (PAP);\- WLL within two months of Baseline ;\- Treatment with GM\-CSF within three months of Baseline;\- Treatment with rituximab within six months of Baseline;\- Treatment with plasmapheresis within three months of Baseline;\- Treatment with any investigational medicinal product within four weeks of Screening;\- Concomitant use of sputum modifying drugs such as carbocystein or ambroxol;\- History of allergic reactions to GM\-CSF;\- Connective tissue disease, inflammatory bowel disease or other autoimmune disorder requiring treatment associated with significant immunosuppression, e.g. more than 10 mg/kg systemic prednisolone.;\- Previous experience of severe and unexplained side\-effects during aerosol delivery of any kind of medicinal product;\- History of, or present, myeloproliferative disease or leukaemia;\- Known active infection (viral, bacterial, fungal or mycobacterial);\- Apparent pre\-existing concurrent pulmonary fibrosis;\- Any other serious medical condition which in the opinion of the investigator would make the subject unsuitable for the trial
Outcomes
Primary Outcomes
Not specified
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