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Recruiting NCT07450547

Phase 2 Study to Assess the Safety and Efficacy of ANG003

Phase II Interventional Exocrine Pancreatic Insufficiency (EPI) Cystic Fibrosis (CF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ANG003 Dose A, ANG003 Dose B, Creon.
Who it may be relevant to
Registry conditions: Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF). Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2, Multicenter, Randomized, Active-controlled Study to Assess the Safety and Efficacy of ANG003 at Two Different Dose Levels in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

Overview

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.

Interventions

  • Drug 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 \[USP\])
  • Drug 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 \[USP\])
  • Drug 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.

Primary outcome measures

  • Adverse events (AEs); Treatment-emergent AEs; Serious AEs; Discontinuation due to AEs; Clinical laboratory values [Time frame: From Visit 1 to Visit 5, anticipated average 80 days]
  • Coefficient of Fat Absorption (CFA) [Time frame: Period A (baseline) and Period B 72 hour CFA collection]
Secondary outcome measures (5)
  • Plasma docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) (ug/mL) [Time frame: Period A (baseline) and Period B time 0, 1, 2, 4, 6, 8, 10 and 24 hour collections]
  • Coefficient of Nitrogen Absorption (CNA) [Time frame: Period A (baseline) and Period B 72 hour CNA collection]
  • % of subjects with GI symptoms [Time frame: From Visit 2 to Visit 5, anticipated average 59 days]
  • Cumulative stool weight [Time frame: Period A (baseline) and Period B 72 hour collection]
  • Number of Stools per Day [Time frame: Period A (baseline) and Period B 72 hour collection]

Eligibility criteria

Inclusion criteria

  • 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.
  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 26 centers
  • Long Beach Memorial Medical Center — Long Beach
  • Center for Cystic Fibrosis at Keck Medical Center of USC — Los Angeles
  • National Jewish Health — Denver
  • University of Florida — Gainesville
  • Central Florida Pulmonary Group — Orlando
  • The Cystic Fibrosis Institute — Glenview
  • University of Iowa — Iowa City
  • University of Kansas Medical Center — Kansas City
  • … and 18 more centers

Identifiers

NCT: NCT07450547 · ANG003-25-201 · 2025-524569-25-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗