Phase 2 Study to Assess the Safety and Efficacy of ANG003

Korábbi kezelés

• Known hypersensitivity or other severe reaction to any ingredient of the investigational product (IP), Creon, or the stool marker (FD\&C Blue #2).
• Any chronic diarrheal illness unrelated to pancreatic insufficiency, actively being treated for small intestinal bacterial overgrowth, requiring use of naso-gastric, J-tube, G-tube, and/or enteral feeding for the study duration, Clostridioides difficile infection within 6 months prior to Screening, or severe constipation defined as <1 bowel movement/week.

Más betegség

• History of fibrosing colonopathy or recurring distal intestinal obstructive syndrome within 6 months of Screening.
• History of lung or liver transplant, listing for organ transplant or significant bowel resection within the last 6 months. Subjects with a history of resection that does not result in short bowel syndrome are eligible.

• Male and female subjects aged ≥12 years from the date of informed consent in the US and aged ≥18 years in the EU
• Confirmed and documented diagnosis of CF
• Diagnosed with severe EPI as defined by a fecal elastase ≤50 μg/g stool measured at Screening by a central laboratory.
• Subject has controlled EPI and taking a stable dose of pancreatic enzyme replacement therapy (PERT) for 90 days prior to Screening.
• Adequate nutritional status measured by body mass index (BMI) defined by:
  • BMI ≥25th percentile for children aged 12-17 years
  • BMI ≥18.5 kg/m2 for ≥18 years of age