OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:January 10, 2019
End Date:August 31, 2019
Contact:Monica Gangal
Email:mgangal@azurrx.com
Phone:6466997855

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A Phase 2, Open-Label, Multicenter, 2x2 Crossover Trial to Assess the Safety and Efficacy of MS1819-SD in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

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).

This is a Phase 2, open-label, multi-center, 2x2 crossover study assessing the safety and
efficacy of MS1819-SD vs porcine PERT given at the same dose that was being administered
during the pre-study period.

MS1819-SD will be assessed in a 2x2 crossover including at least 30 patients completing both
periods.

Inclusion Criteria:

1. Cystic fibrosis, based on 2 clinical features consistent with CF, plus initial
diagnostic sweat chloride ≥ 60 mmol/L

2. Under stable dose of porcine PERT

3. A fair or better nutritional status

4. Fecal elastase <100 µg/g

5. Standard-of-care medications including CFTR modulators are allowed

Exclusion Criteria:

1. History or diagnosis of fibrosing colonopathy

2. Any chronic diarrheal illness unrelated to pancreatic insufficiency

3. 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

4. Feeding via an enteral tube during 6 months before screening

5. Forced expiratory volume ≤30% at the Screening visit
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