Phase 2 Combination Study With Escalating Doses of MS1819-SD on Top of a Stable Dose of PPEs

  • STATUS
    Recruiting
  • participants needed
    24
  • sponsor
    AzurRx SAS
Updated on 23 September 2021
antibiotic therapy
antibiotics
hysterectomy
lipase
respiratory symptom
oxygen supplementation
fibrosis
pilocarpine
pancreatic insufficiency
sweat test

Summary

This is a Phase 2 study sponsored by AzurRx SAS and involves testing of a new medication for the compensation of exocrine pancreatic insufficiency (EPI) caused by cystic fibrosis (CF). The new medication is called MS1819 spray dried (MS1819-SD) which is a lipase produced by the Lip2 gene of Yarrowia lipolytica using recombinant DNA technology.

The primary purpose of this study is to investigate the efficacy and safety of escalating doses of study drug on top of a stable dose of PPEs in CF patients who are not fully compensated by PPEs only.

This enzyme has demonstrated an appropriate profile to compensate the pancreatic lipase (enzyme) deficiency that is common in CP (chronic pancreatitis) and CF patients.

The design of the study is open-label, meaning that all eligible patients will receive the study drug MS1819-SD. The study drug dose will increase throughout the study during dose escalation visits in each treatment period; study includes a total of three treatment periods.

The total duration of the MS1819-SD treatment phase is of 39-51 days. The total duration of patient participation in the study is of 69-81 days. Approximately 24 patients will be enrolled in this study.

Details
Condition Pulmonary Disease, Cystic Fibrosis, Pancreatic disorder, Pancreatic Disorders, Lung Disease, Cystic Fibrosis Gastrointestinal Disease
Treatment MS1819-SD
Clinical Study IdentifierNCT04302662
SponsorAzurRx SAS
Last Modified on23 September 2021

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