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Phase 2 Study to Assess the Safety and Efficacy of ANG003
Sponsor: Anagram Therapeutics, Inc.
Summary
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.
Official title: A Phase 2, Multicenter, Randomized, Active-controlled Study to Assess the Safety and Efficacy of ANG003 at Two Different Dose Levels in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
113
Start Date
2026-04-24
Completion Date
2027-07
Last Updated
2026-05-08
Healthy Volunteers
No
Interventions
ANG003 Dose A
160,000 u\* lipase, 105,000 u\* protease, and 11,600 u\* amylase per dose (\*units are comparable to United States Pharmacopeiea \[USP\])
ANG003 Dose B
240,000 u\* lipase, 105,000 u\* protease, and 11,600 u\* amylase per dose (\*units are comparable to United States Pharmacopeiea \[USP\])
Creon
The commercially available pPERT Creon will be the active comparator in the study. Subjects will be instructed to take Creon according to the package insert and PI direction.
Locations (26)
Long Beach Memorial Medical Center
Long Beach, California, United States
Center for Cystic Fibrosis at Keck Medical Center of USC
Los Angeles, California, United States
National Jewish Health
Denver, Colorado, United States
University of Florida
Gainesville, Florida, United States
Central Florida Pulmonary Group
Orlando, Florida, United States
The Cystic Fibrosis Institute
Glenview, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
MaineHealth Pediatric Specialty Care
Portland, Maine, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Children's Hospita
Boston, Massachusetts, United States
University of Michigan, Michigan Medicine
Ann Arbor, Michigan, United States
Wayne State University Harper University Hospital
Detroit, Michigan, United States
Rutgers - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
New York Medical College at Westchester Medical Center
Valhalla, New York, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Nationwide Children's Hospital, Columbus
Columbus, Ohio, United States
Toledo Children's Hospital
Toledo, Ohio, United States
Hershey Medical Center Pennsylvania State University
Hershey, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern / Children's Health
Dallas, Texas, United States
Adult Cystic Fibrosis Center at the University of Utah
Salt Lake City, Utah, United States
University of Wisconsin
Madison, Wisconsin, United States
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, United States