A Phase IIa Study With Escalating Dose of MS1819-SD
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|ClinicalTrials.gov Identifier: NCT03481803|
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : September 28, 2018
This is a Phase IIa study sponsored by AzurRx SAS and Syneos Health is a local representative sponsor and involves testing of a new medication for the compensation of exocrine pancreatic insufficiency (EPI) caused by chronic pacreatitis (CP) and/or distal pancreatectomy. The new medication is called MS1819 Spray Dried (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.
Approximately twelve patients will be enrolled in this study.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pancreatitis Distal Pancreatectomy||Drug: MS1819-SD||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Sequential Assignment Eligible patients will be receiving increased doses from lower, middle to upper range of study medication MS1819-SD|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||January 27, 2017|
|Actual Primary Completion Date :||June 29, 2018|
|Actual Study Completion Date :||June 29, 2018|
- Drug: MS1819-SD
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.
- Investigate safety of escalating doses of MS1819-SD as measured by number of participants with adverse events including clinical or laboratory abnormalities [ Time Frame: 60 days ]Safety variables will be monitored by physical examination with particular attention paid to immunoallergic events and digestive symptomatology. In addition, laboratory tests will include haematology and biochemistry.
- Investigate the efficacy of MS1819-SD in patients by the Coefficient of Fat Absorption change from baseline [ Time Frame: 60 days ]The primary efficacy endpoint is the Coefficient Fat Absorption (CFA) change from baseline.The secondary efficacy endpoints are the number of daily evacuations per day, the consistency of stools assessed by the Bristol scale (from Type 1 to Type 7) and the weight of stools during the stool collection period.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481803
|Mackay Institute of Research and Innovation|
|Mackay, Queensland, Australia, 4740|
|Australia, South Australia|
|Adelaide, South Australia, Australia, 5000|
|Australia, Western Australia|
|Perth, Western Australia, Australia, 6009|
|Hôpital Timone Adulte (CIC-CPCET)|
|Marseille, France, 13385|
|Christchurch Clinical Studies Trust|
|Christchurch, New Zealand, 8011|
|Wellington, New Zealand, 6242|