ANG003 for pancreatic enzyme replacement in cystic fibrosis–related exocrine pancreatic insufficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study compares two dose levels of ANG003 to an approved pancreatic enzyme replacement, Creon, in people with cystic fibrosis and severe exocrine pancreatic insufficiency. Eligible participants must have confirmed CF, fecal elastase ≤50 μg/g, be on a stable PERT dose for at least 90 days, and meet age and BMI requirements. The primary objective is to evaluate the safety of ANG003 and see if it works as well as Creon. The study is sponsored by Anagram Therapeutics with sites in California and Colorado.

Why it matters

Who can join: the full rules

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.

Where it's running

• Long Beach Memorial Medical Center
  Long Beach, California, United States Recruiting
• Center for Cystic Fibrosis at Keck Medical Center of USC
  Los Angeles, California, United States Recruiting
• National Jewish Health
  Denver, Colorado, United States Recruiting
• Emory-Children's Healthcare of Atlanta Cystic Fibrosis Center
  Atlanta, Georgia, United States Recruiting
• The Cystic Fibrosis Institute
  Glenview, Illinois, United States Recruiting
• University of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting

Study contacts

• Study coordinator: Evan Bailey, MD
• Email: medical@anagramtx.com
• Phone: 617-466-3111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.