NCT03746483

OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

A Phase 2, Open-Label, Multicenter, 2x2 Crossover Trial to Assess the Safety and Efficacy of MS1819-SD in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Entero Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to assess the safety and efficacy of MS1819-SD vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).

Detailed description

This is a Phase 2, open-label, multi-center, 2x2 crossover study assessing the safety and efficacy of MS1819-SD (spray dried) vs porcine PERT given at the same dose that was being administered during the pre-study period. MS1819-SD will be assessed in a 2x2 crossover including at least 30 patients completing both periods.

Conditions

• Exocrine Pancreatic Insufficiency (EPI)
• Cystic Fibrosis (CF)

Interventions

Type	Name	Description
DRUG	MS1819	MS1819, an oral, non-systemic, that is non-enterically-coated. It is a yeast-derived (non-porcine) lipase pancreatic enzyme replacement.
DRUG	Porcine PERT	Porcine PERT is being used as a comparator to MS1819 as a second drug/intervention

Timeline

• Start date: 2019-01-10
• Primary completion: 2019-07-13
• Completion: 2019-07-27
• First posted: 2018-11-19
• Last updated: 2022-06-06
• Results posted: 2022-06-06

Locations

14 sites across 2 countries: United States, Poland

Regulatory

• FDA-regulated drug study