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Trial record 2 of 4 for:    MS1819

A Phase IIa Study With Escalating Dose of MS1819-SD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03481803
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
AzurRx SAS

Tracking Information
First Submitted Date  ICMJE March 6, 2018
First Posted Date  ICMJE March 29, 2018
Last Update Posted Date September 28, 2018
Actual Study Start Date  ICMJE January 27, 2017
Actual Primary Completion Date June 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase IIa Study With Escalating Dose of MS1819-SD
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
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)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Pancreatitis
  • Distal Pancreatectomy
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2018)
11
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2018)
12
Actual Study Completion Date  ICMJE June 29, 2018
Actual Primary Completion Date June 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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),
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   France,   New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03481803
Other Study ID Numbers  ICMJE MS1819/16/01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party AzurRx SAS
Study Sponsor  ICMJE AzurRx SAS
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AzurRx SAS
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP