OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis

Completed · Phase 2

Conditions studied: Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)

In brief

The primary objectives of this study are to assess the safety and efficacy of MS1819 in enteric capsules vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). The exploratory objective of the extension phase (EP) is to find a dose of MS1819 in immediate release capsules that is safe and results in CFA values in a therapeutic range.

Key facts

Study ID

NCT04375878

Run by

Entero Therapeutics

People needed

27

Starts

2020-07-20

Expected to finish

2021-04-08

Last updated by the study team

2022-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cystic fibrosis, based on 2 clinical features consistent with CF, plus either a new/historic sweat chloride ≥60 mmol/L (measured while not on a CFTR modulator) or genotype.
• Under stable dose of porcine PERT
• A fair or better nutritional status
• Fecal elastase <100 µg/g
• Standard-of-care medications including CFTR modulators are allowed

You may not qualify if…

• History or diagnosis of fibrosing colonopathy
• Any chronic diarrheal illness unrelated to pancreatic insufficiency
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥5 ×upper limit of normal (ULN), or total bilirubin level ≥1.5 ×ULN at the Screening visit
• Feeding via an enteral tube during 6 months before screening
• Forced expiratory volume ≤30% at the Screening visit

Where it is running

• Investigator Site 105 — Long Beach, California, United States
• Investigator Site 102 — Altamonte Springs, Florida, United States
• Investigator Site 107 — Miami, Florida, United States
• Investigator Site 101 — Glenview, Illinois, United States
• Investigator Site 111 — Wichita, Kansas, United States
• Investigator Site 108 — Portland, Maine, United States
• Investigator Site 103 — Las Vegas, Nevada, United States
• Investigator Site 110 — Cleveland, Ohio, United States
• Investigator Site 104 — Toledo, Ohio, United States
• Investigator Site 106 — Hershey, Pennsylvania, United States
• Investigator Site 205 — Bialystok, Poland
• Investigator Site 203 — Karpacz, Poland
• Investigator Site 206 — Katowice, Poland
• Investigator Site 202 — Rabka-Zdrój, Poland
• Investigator Site 204 — Sopot, Poland

Full record on ClinicalTrials.gov

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