Phase 2 Study to Assess the Safety and Efficacy of ANG003
Recruiting
Phase 2
Interventional Study
Exocrine Pancreatic Insufficiency (EPI)
Cystic Fibrosis (CF)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 113 (estimated)
- Sponsor
- Anagram Therapeutics, Inc. · Industry
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About This Trial
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, a…
Trial Locations
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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 laborator…
Contacts