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Phase 2 Study to Assess the Safety and Efficacy of ANG003

RecruitingPhase 2

Sponsor: Anagram Therapeutics, Inc.

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

Interventions: ANG003 Dose A, ANG003 Dose B, Creon

Countries: United States

In this study, ANG003, a pancreatic enzyme replacement therapy (PERT; commonly called "enzymes"), is being investigated as a potential treatment for exocrine pancreatic insufficiency (EPI). People with EPI due to Cystic Fibrosis (CF) may be eligible to participate in this study. The primary objective of this study is to evaluate the safety of ANG003 and see if it works as well compared to Creon, an approved PERT.

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

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

1. BMI ≥25th percentile for children aged 12-17 years
2. BMI ≥18.5 kg/m2 for ≥18 years of age

Exclusion Criteria:

1. History of fibrosing colonopathy or recurring distal intestinal obstructive syndrome within 6 months of Screening.
2. 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.
3. Known hypersensitivity or other severe reaction to any ingredient of the investigational product (IP), Creon, or the stool marker (FD\&C Blue #2).
4. 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.

Locations (26)

Long Beach, California, United States
Los Angeles, California, United States
Denver, Colorado, United States
Gainesville, Florida, United States
Orlando, Florida, United States
Glenview, Illinois, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Lexington, Kentucky, United States
Portland, Maine, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
New Brunswick, New Jersey, United States
Valhalla, New York, United States
Akron, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Hershey, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States