Phase 2 Study to Assess the Safety and Efficacy of ANG003
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorAnagram Therapeutics, Inc.
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, an approved PERT.
Eligibility criteria
Qualifiers
Male and female subjects 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.
Disqualifiers
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. Subjects 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 duration, Clostridioides difficile infection within 6 months prior to Screening, or severe constipation defined as <1 bowel movement/week.
Trial design
Treatments tested in this trial
- ANG003 Dose A
- ANG003 Dose B
- Creon
Treatment groups
113 Participants
are divided into 5 treatment groupsLocations
26California
Long Beach Memorial Medical Center90806, Long Beach United States
Center for Cystic Fibrosis at Keck Medical Center of USC90033, Los Angeles United States
Colorado
National Jewish Health80206, Denver United States
Florida
University of Florida32610, Gainesville United States
Sponsors and collaborators
Anagram Therapeutics, Inc.
Lead sponsor
Source ClinicalTrials.gov