Chronic PancreatitisPhase 2NCT03481803
A Phase IIa Study With Escalating Dose of MS1819-SD
A Phase 2 study testing MS1819-SD in people with Chronic Pancreatitis and Distal Pancreatectomy, run by AzurRx SAS at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis, Distal Pancreatectomy
- What is being tested?
- MS1819-SD
- How many people
- 11 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 27 Jan 2017to 29 Jun 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent form,
- Age >18 years,
- 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 <100 μg/g of stools at screening or within one month of the screening visit,
Show all 9Show fewer
- CFA measurement ≤ 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.
Who cannot join
- 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 ≥1 meter length, etc.,
- Acute pancreatitis or exacerbation of CP ≤3 months,
Show all 10Show fewer
- Pancreatectomy for exocrine or endocrine cancer ≤1 year,
- Metastatic or locally recurrent exocrine pancreatic cancer,
- Known hypersensitivity or other severe reaction to any ingredient of the investigational medicinal product,
- Bilirubin >3 times ULN (upper limit normal),
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Australia3 sites
CMAX
Adelaide, South Australia, 5000
Mackay Institute of Research and Innovation
Mackay, Queensland, 4740
Linear Research
Perth, Western Australia, 6009
New Zealand2 sites
Christchurch Clinical Studies Trust
Christchurch, 8011
P3 Research
Wellington, 6242
About this study
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
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.
Read more
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.
- Conditions
- Chronic Pancreatitis, Distal Pancreatectomy
- Being tested
- MS1819-SD
- Keywords
- Exocrine Pancreatic Insufficiency
- Medical subject headings
- Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MS1819-SDDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate safety of escalating doses of MS1819-SD as measured by number of participants with adverse events including clinical or laboratory abnormalities
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.
Measured: 60 days
Secondary outcomes (1)
Investigate the efficacy of MS1819-SD in patients by the Coefficient of Fat Absorption change from baseline
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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start27 Jan 2017
- Primary completion29 Jun 2018
- Study completion29 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- AzurRx SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481803
- Sponsor's protocol ID
- MS1819/16/01
- Status last verified
- Sep 2018
- First submitted
- 6 Mar 2018
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03481803
- Acronym / sponsor ID
- MS1819/16/01
- Conditions
- Chronic Pancreatitis, Distal Pancreatectomy
- Keywords
- Exocrine Pancreatic Insufficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- AzurRx SASIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2017 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Model description
- Sequential Assignment Eligible patients will be receiving increased doses from lower, middle to upper range of study medication MS1819-SD
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed and dated informed consent form,
- Age >18 years,
- 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),
Key exclusion criteria (10 listed)
- 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 ≥1 meter length, etc.,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MS1819-SDPatient 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. | Drug | – |
Primary outcome
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.
1 secondary outcome
Investigate the efficacy of MS1819-SD in patients by the Coefficient of Fat Absorption change from baseline
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Pancreatitis
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
RecruitingPhase 1/2
Soy Tomato Juice to Improve Outcomes in Pancreatitis
Recurrent Acute Pancreatitis, Chronic Pancreatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MS1819-SD in people with Chronic Pancreatitis and Distal Pancreatectomy, run by AzurRx SAS at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, New Zealand, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.