Clinical trial NCT04964986: Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC)
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Short Bowel Syndrome
Keywords: Intestinal Failure
SBS
SBS-IF
CIC
Colon-in-Continuity
Lead sponsor: VectivBio AG
Sponsor class: INDUSTRY
First posted: 2021-07-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 participants with SBS-IF and CIC. The active pharmaceutical ingredient is apraglutide, an investigational glucagon-like peptide-2 (GLP-2) analogue. The trial consists of an evaluation period of 52 weeks.

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 parenteral support (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/m\^2 at the time of screening.
* Major abdominal surgery in the last 6 months prior to screening.

Primary outcomes:
measure: Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE)
timeFrame: Day 1 up to approximately 55 weeks
measure: Absolute Change in Absorption of Energy Over Metabolic Balance (MB) Periods From Baseline at Week 48
timeFrame: Baseline and Week 48
Secondary outcomes:
measure: Relative Change From Baseline in Actual Weekly Parenteral Support (PS) Volume at Weeks 4, 24, and 52
timeFrame: Baseline, Week 4, Week 24, and Week 52
measure: Absolute Change From Baseline in Actual Weekly PS Volume at Weeks 24 and 52
timeFrame: Baseline, Week 24 and Week 52
measure: Number of Participants Who Achieved a Reduction of at Least 1 Day Per Week of PS From Baseline at Weeks 24 and 52
timeFrame: Baseline, Week 24 and Week 52
measure: Number of Participants Considered Clinical Responders at Weeks 24 and 52
timeFrame: Baseline, Week 24 and 52
measure: Number of Participants Who Achieved Enteral Autonomy at Weeks 24 and 52
timeFrame: Weeks 24 and 52
measure: Absolute Change in Total Energy in PN From Baseline at Weeks 24 and 52
timeFrame: Baseline, Week 24 and Week 52
measure: Relative Change in Absorption of Energy Over MB Periods From Baseline at Week 48
timeFrame: Baseline and Week 48
measure: Absolute Change in Absorption of Macronutrients Over MB Periods From Baseline at Weeks 4 and 48
timeFrame: Baseline, Week 4 and Week 48
measure: Absolute Change in Urine Volume Over MB Periods From Baseline at Week 4 and Week 48
timeFrame: Baseline, Week 4 and Week 48
measure: Absolute Change in Absorption of Energy Over MB Periods From Baseline at Week 4
timeFrame: Baseline and Week 4
measure: Absolute Change in Urinary Electrolytes Over MB Periods From Baseline at Week 4 and Week 48
timeFrame: Baseline, Week 4 and Week 48
measure: Change From Baseline in Pittsburgh Sleep Quality Inventory (PSQI) Total Score at Week 24 and Week 52
timeFrame: Baseline, Week 24 and Week 52
measure: Change From Baseline in Patient Global Impression of Change (PGIC) at Week 24 and Week 52
timeFrame: Baseline, Week 24 and Week 52
measure: Secondary: Patient Global Impression of Treatment Satisfaction (PGI-TS) at Week 24 and Week 52
timeFrame: Week 24 and Week 52
measure: Change From Baseline in Patient Global Impression of Satisfaction With Parenteral Support (PGI-SPS) at Week 24 and Week 52
timeFrame: Baseline, Week 24 and Week 52
measure: Change From Baseline in Patient Global Impression of Parenteral Support Impact (PGI-PSI) at Week 24 and Week 52
timeFrame: Baseline, Week 24 and Week 52
measure: Trough Apraglutide Plasma Concentration (Ctrough)
timeFrame: Pre-dose on Weeks 2, 4, 12, 24, 32, 40, 48, and 52
measure: Mean Plasma Citrulline Level
timeFrame: Baseline and Weeks 2, 4, 12, 24, 32, 40, 48, and 52
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: Clichy
country: France
facility: Beaujon Hospital
Study officials:
affiliation: VectivBio AG
name: Tomasz Masior
role: STUDY_DIRECTOR
References: