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Metabolic Balance Study of Apraglutide in Patients With SBS-IF and Colon-in-Continuity (STARSnutrition)

Primary Purpose

Short Bowel Syndrome

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Apraglutide
Sponsored by
VectivBio AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Short Bowel Syndrome focused on measuring Intestinal Failure, SBS, SBS-IF, CIC, Colon-in-Continuity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent for this trial prior to any trial specific assessment.
  • Male and female subjects with SBS-IF and CIC, receiving parenteral support (PS), secondary to surgical resection of the small intestine with <200 cm from duodenojejunal flexure.
  • Subject must require PS at least 2 days per week and be considered stable.
  • No restorative surgery intended to change PS requirements in the trial period.
  • Age ≥18 years at screening.

Exclusion Criteria:

  • Pregnancy or lactation.
  • Body mass index equal or higher than 30 kg/m2 at the time of screening.
  • Major abdominal surgery in the last 6 months prior to screening.

Sites / Locations

  • UZ Leuven
  • Beaujon Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apraglutide SC injections, once weekly

Arm Description

Peptide analogue of GLP-2

Outcomes

Primary Outcome Measures

To evaluate the safety and tolerability of apraglutide
Assessed by: Adverse events (AEs; system organ class, frequency and severity) Adverse events of special interest (AESIs): Injection site reaction Gastrointestinal obstruction Gallbladder, biliary and pancreatic disease Fluid overload Colorectal polyps Malignancies Clinical chemistry, hematology, hemostasis, anti-drug antibodies (ADA), and urine analysis

Secondary Outcome Measures

Relative change from baseline in actual weekly PS volume
Absolute change from baseline in actual weekly PS volume
Subjects who achieve a reduction of at least 1 day per week of PS
Clinical responders (20% reduction of PS volume from baseline)
Subjects reaching enteral autonomy as assessed by the need or reduction of parenteral support requirements.
Energy reduction in the Parenteral Nutrition as assessed by parenteral support calorie content
Units: Cal/week
Change in absolute energy absorption assessed by the difference between oral intake and excretion
Assessed by bomb calorimetry Units: Cal/gr
Relative change in absorption of energy derived as the difference between oral intake and excretion.
Assessed by bomb calorimetry
Relative change in absorption of carbohydrate derived as the difference between oral intake and excretion
Assessed by Englyst's method
Relative change in absorption of nitrogen derived as the difference between oral intake and excretion
Assessed by Kjeldahl's method
Relative change in absorption of lipid derived as the difference between oral intake and excretion
Assessed by modified Van de Kamer titration technique
Change in absolute absorption of energy over metabolic balance periods to assess changes in nutrient absorption of intestinal output
Assessed by bomb calorimetry Units: Cal/day
Change in absolute absorption of carbohydrate, over metabolic balance periods
Assessed by Englyst's method Units: kJ/day
Change in absolute absorption of nitrogen, over metabolic balance periods
Assessed by Kjeldahl's method Units: kJ/day
Change in absolute absorption of lipid, over metabolic balance periods
Assessed by modified Van de Kamer titration technique Units: kJ/day
Changes in urine output over metabolic balance periods.
Units: L/day
Changes in urinary sodium as assessed by flame photometry
Units: mmol/day
Changes in urinary potassium as assessed by flame photometry
Units: mmol/day
Changes in urinary calcium as assessed by atomic absorption spectrometry
Units: mmol/day
Changes in urinary magnesium as assessed by atomic absorption spectrometry
Units: mmol/day

Full Information

First Posted
May 27, 2021
Last Updated
August 15, 2023
Sponsor
VectivBio AG
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1. Study Identification

Unique Protocol Identification Number
NCT04964986
Brief Title
Metabolic Balance Study of Apraglutide in Patients With SBS-IF and Colon-in-Continuity
Acronym
STARSnutrition
Official Title
A Multicenter, Open-label, Metabolic Balance Study to Evaluate the Effects of Apraglutide on Intestinal Absorption in Adult Subjects With Short Bowel Syndrome, Intestinal Failure (SBS-IF), and Colon-in-Continuity (CIC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
June 6, 2023 (Actual)
Study Completion Date
June 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VectivBio AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The primary objective of the trial is to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC.
Detailed Description
This is an international, multicenter trial to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC. The active pharmaceutical ingredient is apraglutide, an investigational GLP-2 analogue. The trial consists of an evaluation period of 52 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome
Keywords
Intestinal Failure, SBS, SBS-IF, CIC, Colon-in-Continuity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apraglutide SC injections, once weekly
Arm Type
Experimental
Arm Description
Peptide analogue of GLP-2
Intervention Type
Drug
Intervention Name(s)
Apraglutide
Intervention Description
Apraglutide is a synthetic peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2.
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of apraglutide
Description
Assessed by: Adverse events (AEs; system organ class, frequency and severity) Adverse events of special interest (AESIs): Injection site reaction Gastrointestinal obstruction Gallbladder, biliary and pancreatic disease Fluid overload Colorectal polyps Malignancies Clinical chemistry, hematology, hemostasis, anti-drug antibodies (ADA), and urine analysis
Time Frame
From baseline to week 48
Secondary Outcome Measure Information:
Title
Relative change from baseline in actual weekly PS volume
Time Frame
Weeks 24 and 52
Title
Absolute change from baseline in actual weekly PS volume
Time Frame
Weeks 24 and 52
Title
Subjects who achieve a reduction of at least 1 day per week of PS
Time Frame
From Baseline at weeks 24 and 52
Title
Clinical responders (20% reduction of PS volume from baseline)
Time Frame
Weeks 24 and 52
Title
Subjects reaching enteral autonomy as assessed by the need or reduction of parenteral support requirements.
Time Frame
Weeks 24 and 52
Title
Energy reduction in the Parenteral Nutrition as assessed by parenteral support calorie content
Description
Units: Cal/week
Time Frame
From Baseline at weeks 24 and 52
Title
Change in absolute energy absorption assessed by the difference between oral intake and excretion
Description
Assessed by bomb calorimetry Units: Cal/gr
Time Frame
From Baseline to week 48
Title
Relative change in absorption of energy derived as the difference between oral intake and excretion.
Description
Assessed by bomb calorimetry
Time Frame
From Baseline at week 4 and at week 48
Title
Relative change in absorption of carbohydrate derived as the difference between oral intake and excretion
Description
Assessed by Englyst's method
Time Frame
From Baseline at week 4 and at week 48
Title
Relative change in absorption of nitrogen derived as the difference between oral intake and excretion
Description
Assessed by Kjeldahl's method
Time Frame
From Baseline at week 4 and at week 48
Title
Relative change in absorption of lipid derived as the difference between oral intake and excretion
Description
Assessed by modified Van de Kamer titration technique
Time Frame
From Baseline at week 4 and at week 48
Title
Change in absolute absorption of energy over metabolic balance periods to assess changes in nutrient absorption of intestinal output
Description
Assessed by bomb calorimetry Units: Cal/day
Time Frame
From Baseline at week 4 and at week 48
Title
Change in absolute absorption of carbohydrate, over metabolic balance periods
Description
Assessed by Englyst's method Units: kJ/day
Time Frame
From Baseline at week 4 and at week 48
Title
Change in absolute absorption of nitrogen, over metabolic balance periods
Description
Assessed by Kjeldahl's method Units: kJ/day
Time Frame
From Baseline at week 4 and at week 48
Title
Change in absolute absorption of lipid, over metabolic balance periods
Description
Assessed by modified Van de Kamer titration technique Units: kJ/day
Time Frame
From Baseline at week 4 and at week 48
Title
Changes in urine output over metabolic balance periods.
Description
Units: L/day
Time Frame
From Baseline at weeks 4 and 48
Title
Changes in urinary sodium as assessed by flame photometry
Description
Units: mmol/day
Time Frame
From Baseline at weeks 4 and 48
Title
Changes in urinary potassium as assessed by flame photometry
Description
Units: mmol/day
Time Frame
From Baseline at weeks 4 and 48
Title
Changes in urinary calcium as assessed by atomic absorption spectrometry
Description
Units: mmol/day
Time Frame
From Baseline at weeks 4 and 48
Title
Changes in urinary magnesium as assessed by atomic absorption spectrometry
Description
Units: mmol/day
Time Frame
From Baseline at weeks 4 and 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent for this trial prior to any trial specific assessment. Male and female subjects with SBS-IF and CIC, receiving parenteral support (PS), secondary to surgical resection of the small intestine with <200 cm from duodenojejunal flexure. Subject must require PS at least 2 days per week and be considered stable. No restorative surgery intended to change PS requirements in the trial period. Age ≥18 years at screening. Exclusion Criteria: Pregnancy or lactation. Body mass index equal or higher than 30 kg/m2 at the time of screening. Major abdominal surgery in the last 6 months prior to screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bolognani
Organizational Affiliation
VectivBio AG
Official's Role
Study Director
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Beaujon Hospital
City
Clichy
ZIP/Postal Code
92110
Country
France

12. IPD Sharing Statement

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Metabolic Balance Study of Apraglutide in Patients With SBS-IF and Colon-in-Continuity

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