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New treatment option for Autoimmune Pulmonary Alveolar Proteinosis
Official title Inhaled Molgramostim in Pediatric Participants With Autoimmune Pulmonary Alveolar Proteinosis (aPAP).
ClinicalTrials.gov ID: NCT06431776
What this study is testing
What is Molgramostim?
Molgramostim is an investigational medicine, given as an once-daily inhaled treatment, being studied as a potential treatment for autoimmune pulmonary alveolar proteinosis.
Also referred to as Recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF)..
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this open-label study is to study molgramostim as a treatment for autoimmune pulmonary alveolar proteinosis (aPAP) in pediatric patients between age 6 and 18. The main questions it aims to answer are: The effect of molgramostim on breathing tests and activity in pediatric patients with aPAP and the safety of molgramostim in pediatric patients with aPAP.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 18
You may be able to join if
- Be ≥6 and \<18 years of age, at the time of signing the informed consent and informed assent (if applicable).
- Have a history of pulmonary alveolar proteinosis, based on examination of a lung biopsy, bronchoalveolar lavage cytology, or a high-resolution...
- Have a positive serum anti-GM-CSF autoantibody test result confirming aPAP.
- Have a hemoglobin (Hb)-adjusted diffusing capacity of the lung for carbon monoxide (DLCO) ≤70% predicted at Screening.
You likely can't join if
- Have a diagnosis of hereditary (congenital) or secondary PAP, or a metabolic disorder of surfactant production.
- Have undergone treatment with Lung Lavage (WLL) within 1 month of Baseline
The study team makes the final eligibility decision.
Where it's taking place
- München, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include München, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.