Clinical Trials in the USA / NCT07450547
Recruiting
Phase 2
Phase 2 Study to Assess the Safety and Efficacy of ANG003
NCT07450547 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Exocrine Pancreatic Insufficiency (EPI)Cystic Fibrosis (CF)
Investigational drug(s) / intervention(s)
ANG003 Dose AANG003 Dose BCreon
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.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Adverse events (AEs); Treatment-emergent AEs; Serious AEs; Discontinuation due to AEs; Clinical laboratory values — From Visit 1 to Visit 5, anticipated average 80 days
Adverse events (AEs); Treatment-emergent AEs; Serious AEs; Discontinuation due to AEs; Clinical laboratory values - Coefficient of Fat Absorption (CFA) — Period A (baseline) and Period B 72 hour CFA collection
Mean change from baseline CFA (i.e., Period B CFA minus Period A CFA) assessed for ANG003 Dose A, ANG003 Dose B, and Creon amongst subjects with baseline CFA ≥80%.
Trial sites (28)
| Facility | City | Region | Status |
|---|---|---|---|
| Long Beach Memorial Medical Center | Long Beach | California | Recruiting |
| Center for Cystic Fibrosis at Keck Medical Center of USC | Los Angeles | California | Recruiting |
| National Jewish Health | Denver | Colorado | Recruiting |
| University of Florida | Gainesville | Florida | Not Yet Recruiting |
| Central Florida Pulmonary Group | Orlando | Florida | Not Yet Recruiting |
| Emory-Children's Healthcare of Atlanta Cystic Fibrosis Center | Atlanta | Georgia | Recruiting |
| The Cystic Fibrosis Institute | Glenview | Illinois | Recruiting |
| University of Iowa | Iowa City | Iowa | Not Yet Recruiting |
| University of Kansas Medical Center | Kansas City | Kansas | Recruiting |
| University of Kentucky | Lexington | Kentucky | Recruiting |
| MaineHealth Pediatric Specialty Care | Portland | Maine | Not Yet Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Boston Children's Hospita | Boston | Massachusetts | Recruiting |
| University of Michigan, Michigan Medicine | Ann Arbor | Michigan | Recruiting |
| Wayne State University Harper University Hospital | Detroit | Michigan | Recruiting |
| University of Minnesota | Minneapolis | Minnesota | Recruiting |
| Rutgers - Robert Wood Johnson Medical School | New Brunswick | New Jersey | Recruiting |
| New York Medical College at Westchester Medical Center | Valhalla | New York | Not Yet Recruiting |
| Children's Hospital Medical Center of Akron | Akron | Ohio | Recruiting |
| Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center | Cleveland | Ohio | Recruiting |
| Nationwide Children's Hospital, Columbus | Columbus | Ohio | Recruiting |
| Toledo Children's Hospital | Toledo | Ohio | Recruiting |
| Hershey Medical Center Pennsylvania State University | Hershey | Pennsylvania | Recruiting |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | Not Yet Recruiting |
| University of Texas Southwestern / Children's Health | Dallas | Texas | Recruiting |
| Adult Cystic Fibrosis Center at the University of Utah | Salt Lake City | Utah | Recruiting |
| University of Wisconsin | Madison | Wisconsin | Recruiting |
| Froedtert & Medical College of Wisconsin | Milwaukee | Wisconsin | Not Yet Recruiting |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07450547 on ClinicalTrials.gov ↗ ← All trials in the USA