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Trial from ClinicalTrials.gov

A Phase IIa Study With Escalating Dose of MS1819-SD

  • Recruitment status at the time of last update
    Completed
  • Has the trial been updated in the last 24 months?
    Up to date
    (Last updated: 27/9/2018)
Key trial Information

Trial ID

NCT03481803

Date registered

22 March 2018

Recruitment status

Completed

Anticipated date of first participant enrolment

n/a

Brief summary

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.

Eligibility

Key inclusion criteria



1. Signed and dated informed consent form,

2. Age >18 years,

3. Male or female,

4. Body weight within the range [50-100 Kg] for males or [40-90 Kg] for females,

5. 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),

6. Faecal pancreatic elastase-1 <100 µg/g of stools at screening or within one month of
the screening visit,

7. CFA measurement = 75% at washout

8. 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.

9. Being considered as reliable and capable of adhering to the protocol, according to the
judgment of the investigator.

Minimum age

18 Years

Maximum age

No limit

Gender

Both males and females

Key exclusion criteria



1. Cystic fibrosis,

2. Total or partial gastrectomy,

3. Cephalic or total duodenopancreatectomy,

4. Documented fibrosing colonopathy,

5. Any small bowel disease possibly responsible for malabsorption, including small
intestinal bacterial overgrowth, celiac disease, small bowel resection =1 meter
length, etc.,

6. Acute pancreatitis or exacerbation of CP =3 months,

7. Pancreatectomy for exocrine or endocrine cancer =1 year,

8. Metastatic or locally recurrent exocrine pancreatic cancer,

9. Known hypersensitivity or other severe reaction to any ingredient of the
investigational medicinal product,

10. Bilirubin >3 times ULN (upper limit normal),



Trial from ANZCTR

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.

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 26/2/2018)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12616000962437

Date registered

21 July 2016

Health condition

Exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis (CP) , Exocrine pancreatic insufficiency (EPI) caused by distal pancreatectomy.

Recruitment countries

Australia, New Zealand, New Zealand, France

Recruitment site location(s) (State)

South Australia, Western Australia

Recruitment status

Recruiting

Anticipated date of first participant enrolment

28 November 2016

Ethics application status

Approved

Brief 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

Key inclusion criteria

1. Signed and dated informed consent form,
2. Age 18 years and older,
3. Male or female,
4. Body weight within the range [50-100 Kg] for males or [40-90 Kg] for females,
5. 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),
6. Faecal pancreatic elastase-1 less than 100 micro g/g at screening or within one month of the screening visit,
7. CFA measurement less than or equal to 75% at washout,
8. 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.
9. Being considered as reliable and capable of adhering to the protocol, according to the judgment of the investigator.

Minimum age

18 Years

Maximum age

No limit

Gender

Both males and females

Key exclusion criteria

1. Cystic fibrosis,
2. Total or partial gastrectomy,
3. Cephalic or total duodenopancreatectomy,
4. Documented fibrosing colonopathy,
5. 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.,
6. Acute pancreatitis or exacerbation of CP less than or equal to 3 months,
7. Pancreatectomy for exocrine or endocrine cancer less than or equal to 1 year,
8. Metastatic or locally recurrent exocrine pancreatic cancer,
9. Known hypersensitivity or other severe reaction to any ingredient of the investigational medicinal product,
10. Lactation or known pregnancy or positive pregnancy test at both screening and baseline for women of childbearing potential,

Contact details and further information

Primary Sponsor

Type: Commercial sector/Industry
Name: INC Research Australia Pty Ltd
Address: 159 Port Road Hindmarsh
South Australia 5007
Australia
Country: Australia

Contact person for information and recruitment

Mr Pawel Waszka
Crown Square Building Przyokopowa 31, 9th floor, Warsaw
Poland
+48222564220
pawel.waszka@syneoshealth.com