MS1819-SD phase IIa clinical trial for patients with exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis (CP) and/or distal pancreatectomy.
A multicentre open-label phase IIa study with escalating dose of MS1819-SD, to investigate the efficacy and safety of a Yarrowia lipolytica lipase preparation for the compensation of exocrine pancreatic insufficiency caused by chronic pancreatitis and/or distal pancreatectomy.
INC Research Australia Pty Ltd
13 participants
Jan 27, 2017
Interventional
Conditions
Summary
This is a Phase IIa study, testing a new medication for chronic pancreatitis. The new medication is called MS1819-SD which is a modified version of a naturally occurring enzyme made in the pancreas. The primary purpose of this study is to investigate the safety of escalating doses of study drug MS1819-SD in people with chronic pancreatitis. This enzyme has demonstrated an appropriate profile to compensate the pancreatic lipase (enzyme) deficiency that is common with CP patients. The deficiency in this enzyme can be responsible of greasy diarrhea, fecal urge and weight loss. The design of the study is open-label, meaning that all eligible participants will receive the study drug MS1819-SD. The MS1819-SD dose will increase throughout the study during dose escalation visits in each treatment period; study includes a total of four treatment periods that ranges from low, medium, to higher doses. The total duration of the MS1819-SD treatment phase is of 48-60 days, Participants will be required to complete five day stool collections following high fat meals at the end of the washout period and at the end of each treatment phase. The total duration of patient participation in the study is of 74-93 days. Safety will be assessed at throughout the study that will include physical examinations and pathology testing to determine immunoallergic effects, Digestive symptoms will also be assessed and evaluated throughout the study. This study is being sponsored by AzurRx (the Sponsor). The Sponsor will fund researchers who conduct this research for the use of their facilities and to conduct this study.
Eligibility
Inclusion Criteria9
- Signed and dated informed consent form,
- Age 18 years and older,
- Male or female,
- Body weight within the range [50-100 Kg] for males or [40-90 Kg] for females,
- Distal pancreatectomy for any disorder (e.g. acute pancreatitis or its complications, CP or its complications, pancreatic endocrine or exocrine cancer, or others) and/or CP of any etiology (e.g. alcohol, genetics, hypercalcemia, or others) of grade 2 or higher (Cambridge classification),
- Faecal pancreatic elastase-1 less than 100 micro g/g at screening or within one month of the screening visit,
- CFA measurement less than or equal to 75% at washout,
- Female patients must be post-menopausal (defined as at least 12 months post cessation of menses), surgically sterile or, if of childbearing potential, using a reliable method of contraception during the study.
- Being considered as reliable and capable of adhering to the protocol, according to the judgment of the investigator.
Exclusion Criteria10
- Cystic fibrosis,
- Total or partial gastrectomy,
- Cephalic or total duodenopancreatectomy,
- Documented fibrosing colonopathy,
- Any small bowel disease possibly responsible for malabsorption, including small intestinal bacterial overgrowth, celiac disease, small bowel resection greater than or equal to 1 meter length, etc.,
- Acute pancreatitis or exacerbation of CP less than or equal to 3 months,
- Pancreatectomy for exocrine or endocrine cancer less than or equal to 1 year,
- Metastatic or locally recurrent exocrine pancreatic cancer,
- Known hypersensitivity or other severe reaction to any ingredient of the investigational medicinal product,
- Lactation or known pregnancy or positive pregnancy test at both screening and baseline for women of childbearing potential,
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Interventions
This is a Phase IIa study, testing a new medication for the compensation of exocrine pancreatic insufficiency caused by chronic pacreatitis and/or distal pancreatectomy. The new medication is called MS1819-SD which is a lipase produced by the LIP2 gene of Yarrowia lipolytica using recombinant DNA technology. The primary purpose of this study is to investigate the safety of escalating doses of study drug MS1819-SD in people with chronic pancreatitis. This enzyme has demonstrated an appropriate profile to compensate the pancreatic lipase (enzyme) deficiency that is common with CP patients. The deficiency in this enzyme can be responsible of greasy diarrhea, fecal urge and weight loss. The design of the study is open-label, meaning that all eligible participants will receive the study drug MS1819-SD. The MS1819-SD dose will increase throughout the study during dose escalation visits in each treatment period; study includes a total of four treatment periods. The total duration of the MS1819-SD treatment phase is of 48-60 days, The total duration of patient participation in the study is of 74-93 days. Patient will receive increasing doses from the lowest dose of MS1819-SD to a maximum dose of MS1819-SD. The total treatment phase will range from 48 days to 60 days.
Locations(6)
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ACTRN12616000962437