Phase 2
N=41
OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Exocrine Pancreatic Insufficiency (EPI) · Cystic Fibrosis (CF)
Bottom Line
View on ClinicalTrials.gov: NCT03746483 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Efficacy of MS1819-SD: Coefficient of Fat Absorption (CFA) — 55.6; 86.2 % CFA
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MS1819 (Drug); Porcine PERT (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Entero Therapeutics
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of MS1819-SD: Coefficient of Fat Absorption (CFA) |
55.6; 86.2 | — |
| PRIMARY Safety of MS1819-SD by Number of Participants Reporting 1 or More Adverse Events (AE) |
13; 6; 2; 0 | — |
| PRIMARY Safety of MS1819-SD by Number of Treatment Emergent Adverse Events (TEAEs) |
19; 8; 0; 0 | — |
| SECONDARY Stool Weights |
1394.0; 727.3 | — |
| SECONDARY Signs and Symptoms of Malabsorption |
15; 32; 12; 3; 6; 1 | — |
| SECONDARY Coefficient of Nitrogen Absorption (CNA) |
93.0; 97.2 | — |
Summary
The primary objectives of this study are to assess the safety and efficacy of MS1819-SD vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).
Eligibility Criteria
Inclusion Criteria
- Cystic fibrosis, based on 2 clinical features consistent with CF, plus initial diagnostic sweat chloride ≥ 60 mmol/L
- Under stable dose of porcine PERT
- A fair or better nutritional status
- Fecal elastase <100 µg/g
- Standard-of-care medications including Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulators are allowed
Exclusion Criteria
- History or diagnosis of fibrosing colonopathy
- Any chronic diarrheal illness unrelated to pancreatic insufficiency
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥5 ×upper limit of normal (ULN), or total bilirubin level ≥1.5 ×ULN at the Screening visit
- Feeding via an enteral tube during 6 months before screening
- Forced expiratory volume ≤30% at the Screening visit
Data sourced from ClinicalTrials.gov (NCT03746483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.