Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.

Phase 3

Active, not recruiting

• Conditions: Short Bowel Syndrome
• Interventions: Drug: Apraglutide

• Registration Number: NCT05018286
• Lead Sponsor: VectivBio AG

Brief Summary

The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.

Detailed Description

This is an international, multicenter, open label extension trial to collect further safety, tolerability, efficacy, durability, and clinical outcomes of apraglutide once weekly adminstration, for up to 208 weeks or until apraglutide is commercially available in the country, whichever comes first. Eligible subjects would be those who were trial subjects of TA799-007 or TA799-013 trials.

Study Timeline

• Study First Submitted: 2021-07-06
• Study Start: 2021-07-13
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-24
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-02
• Primary Completion: 2027-10-30
• Study Completion: 2027-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

1. Males and females with a diagnosis of SBS-IF secondary to surgical resection of the small intestine, with Colon-in-Continuity (CIC) or stoma, who were trial subjects of parent trials TA799-007 or TA799-013
2. Able to give informed consent and agree to follow the details of participation as outlined in the protocol.

Exclusion Criteria

1. Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.
2. Any other reason judged not eligible by the Investigator.
3. Pregnancy or lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apraglutide subcutaneous (SC) injections, once weekly	Apraglutide	Peptide analogue of Glucagon-like Peptide 2 (GLP-2)

Primary Outcome Measures

Name	Time	Method
Clinical chemistry	From baseline to week 208	Clinical Chemistry panel of analytes will be examined for clinically significant changes.
Adverse events (AE)	From baseline to week 208	System organ class, frequency and severity
Hemostasis	From baseline to week 104	Hemostasis INR will be examined for clinically significant changes.
Urinalysis	From baseline to week 208	Urinanalysis panel of analytes will be examined for clinically significant changes.
Hematology	From baseline to week 208	Hematology panel of analytes will be examined for clinically significant changes.
Occurrence of clinically relevant changes in vital signs	From baseline to week 208	* Systolic and diastolic blood pressure in mmHg will be examined for clinically significant changes.; * Heart rate in Beats per Minute (BPM) will be examined for clinically significant changes.
Occurrence of clinically relevant changes in electrocardiogram	From baseline to week 208	ECG; intervals and rhythm

Secondary Outcome Measures

Name	Time	Method
Change from baseline in PS volume	From baseline to week 208
Change from baseline in PS frequency	From baseline to week 208	Change in PS days/week from baseline to week 104
Clinically significant changes in PS total energy	From baseline to week 208	Units: kcal
Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI)	From baseline to week 208
Changes from baseline on Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS)	From baseline to week 208
Change from baseline in PS infusion time	From baseline to week 208
Percentage of subjects reaching enteral autonomy	From baseline to week 104
Change from baseline in body weight	From baseline to week 104	Units: kg
Change from baseline on the Patient Global Impression of Severity (PGIS)	From baseline to week 104
Change from baseline on the Patient Global Impression of Change (PGIC)	From baseline to week 208
Changes from baseline on Patient Global Impression of Treatment Satisfaction (PGI-TS)	From baseline to week 208
Changes from baseline on Patient Global Impression of Parenteral Support Impact (PGI-PSI)	From baseline to week 208
Change from baseline on the Short Form (36) Health Survey (SF-36)	From baseline to week 208
Change from baseline on the EuroQoL-5 dimension -5 level survey (EQ-5D-5L)	From baseline to week 208

Trial Locations

Locations (66)

Yokohama Municipal Citizen's Hospital; 🇯🇵 Kanagawa, Japan

Ronald Reagan UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Gastroenterology Group of Naples; 🇺🇸 Naples, Florida, United States

Northwestern University - Chicago; 🇺🇸 Chicago, Illinois, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Mayo Clinic - Rochester; 🇺🇸 Rochester, Minnesota, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Scroll for more (56 remaining)