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Tests treatment safety and results for Exocrine Pancreatic Insufficiency (EPI)
Official title Phase 2 Study to Assess the Safety and Efficacy of ANG003
ClinicalTrials.gov ID: NCT07450547
What this study is testing
What is ANG003 Dose A?
ANG003 Dose A is an investigational medicine, being studied as a potential treatment for exocrine pancreatic insufficiency (epi).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Male and female people 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:
You likely can't join if
- 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. people with a history of...
- 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...
See the full eligibility criteria
- Male and female people 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
- 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. people with a history of resection that does not result in short bowel syndrome are eligible.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- 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
- 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
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.