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Phase 2 Study to Assess the Safety and Efficacy of ANG003

RecruitingPhase 2Ages 12 Years - anyAllAnagram Therapeutics, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Male and female subjects aged โ‰ฅ12 years from the date of informed consent in the US and aged โ‰ฅ18 years in the EU 2. Confirmed and documented diagnosis of CF 3. Diagnosed with severe EPI as defined by a fecal elastase โ‰ค50 ฮผg/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 โ‰ฅ25th percentile for children aged 12-17 years 2. BMI โ‰ฅ18.5 kg/m2 for โ‰ฅ18 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.
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What it tests

  • ANG003 Dose A
  • ANG003 Dose B
  • Creon
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Where

27 sites
Long Beach Memorial Medical Center
Long Beach, United States
Center for Cystic Fibrosis at Keck Medical Center of USC
Los Angeles, United States
National Jewish Health
Denver, United States
University of Florida
Gainesville, United States
Central Florida Pulmonary Group
Orlando, United States
The Cystic Fibrosis Institute
Glenview, United States
University of Iowa
Iowa City, United States
University of Kansas Medical Center
Kansas City, United States

โ€ฆand 19 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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