Simplicity

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EPI due to CF

≥7 years old

N=16

Week 1: Safety, Stool Frequency GI Symptoms/Malabsorption

Powder for oral solution

Powder for oral solution

Week 7: Primary Endpoint Coefficient of fat absorption (CFA)

Safety Extension

Week 24: Long-term endpoints Weight, Height, BMI

EPI due to CF

28 days up to 7 years

on stable PERT

N=30

The SIMPLICITY study will evaluate the safety and efficacy of Sollpura powder for oral solution, supplied in sachets. This study will be conducted in 2 parts based on age.

The purpose of Part A of the SIMPLICITY trial is to evaluate the safety of Sollpura powder for oral solution in subjects ≥ 7 years of age with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).

The purpose of Part B is to evaluate the safety and efficacy of Sollpura powder for oral solution in pediatric subjects 28 days up to 7 years of age with EPI due to CF based on observed coefficient of fat absorption measured after 7 weeks of open-label treatment with Sollpura. Subjects who were on a stable PERT dosing regimen prior to enrollment will be administered Sollpura at a dose equivalent to their prerandomization PERT dose based on the number of lipase units per meal.

STATUS: Enrolling

For latest updates, please go to clinicaltrials.gov

Learn more about Sollpura.

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