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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Short Bowel Syndrome
• Intervention / Treatment: Drug: Apraglutide

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 Type: Interventional
• Enrollment (Actual): 158
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1093AAS
    • University Hospital Fundacion Favaloro
• Belgium
  • Brussel, Belgium, B-1090
    • University Hospital Brussels
  • Leuven, Belgium, 3000
    • UZ Leuven
• Czechia
  • Brno, Czechia, 62500
    • University Hospital Brno
  • Hradec Králové, Czechia, 500 05
    • University hospital Hradec Králové
  • Nový Jičín, Czechia, 741 01
    • Hospital Novy Jicin
  • Pilsen, Czechia, 30460
    • University Hospital Plzen
  • Prague, Czechia, 12800
    • General University Hospital in Prague
  • Praha, Czechia, 10034
    • University Hospital Královské Vinohrady
• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet - University Hospital Copenhagen, Department of Intestinal Failure and Liver Diseases
• France
  • Clichy, France, 92110
    • Beaujon Hospital
  • Lyon, France, 69495
    • South Lyon Hospital Center
  • Nantes, France, 44093
    • Nantes University Hospital Center - Hotel Dieu Hospital
  • Nice, France, 06200
    • Nice University Hospital Center - Archet 1 Hospital
  • Pessac, France, 33604
    • Hôpital Haut-Lévêque
  • Vandœuvre-lès-Nancy, France, 54500
    • Brabois Adults Hospital
• Germany
  • Berlin, Germany, 10117
    • Charite - University Hospital Berlin
  • Bonn, Germany, 53127
    • University Hospital Bonn
  • Hamburg, Germany, 20099
    • Asklepios Clinic St. Georg
  • Heidelberg, Germany, 69120
    • University Hospital Heidelberg
  • Münster, Germany, 48149
    • University hospital Muenster
• Hungary
  • Budapest, Hungary, 1115
    • Szent Imre University Teaching Hospital, Department of Gastroenterology
  • Budapest, Hungary, H-1062
    • Central Hospital of Northern Pest - Military Hospital
  • Budapest, Hungary, H-1062
    • Semmelweis University
  • Szeged, Hungary, 6725
    • University of Szeged
• Israel
  • Haifa, Israel, 31096
    • Rambam Health Care Campus, Institute of Gastroenterology
  • Tel HaShomer, Israel, 5262000
    • Chaim Sheba Medical Center
• Italy
  • Bologna, Italy, 40138
    • Polyclinic S. Orsola-Malpighi
  • Rome, Italy, 00168
    • University Polyclinic Foundation "Agostino Gemelli" - IRCCS
  • Turin, Italy, 10126
    • City of Health and Science of Turin
• Japan
  • Kanagawa, Japan, 232-0024
    • Yokohama City University Medical Center
  • Kanagawa, Japan, 232-0024
    • Yokohama Municipal Citizen's Hospital
  • Osaka, Japan, 565-0871
    • Osaka University Hospital
  • Sendai, Japan, 980-0872
    • Tohoku University Hospital
  • Tokyo, Japan, 169-0073
    • Jcho Tokyo Yamate Medical Center
• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of, 063351
    • Samsung Medical Center
• Norway
  • Ålesund, Norway, 6017
    • More og Romsdal Hospital Trust - Alesund Hospital
• Poland
  • Bydgoszcz, Poland, 85-391
    • Stadmedica, Non-Public Healthcare Facility
  • Gdańsk, Poland, 80-152
    • COPERNICUS Limited Liability Company, Nutrition Outpatient Clinic for Adults
  • Lublin, Poland, 20-582
    • Gastromed Poland Sp. z o.o.
  • Skawina, Poland, 32-050
    • Stanley Dudrick Multispecialty Hospital
  • Łódź, Poland, 90-531
    • M. Pirogow Provincial Specialized Hospital
• Spain
  • Madrid, Spain, 28041
    • University Hospital 12 de Octubre
  • Madrid, Spain, 28007
    • University General Hospital Gregorio Maranon
  • Sevilla, Spain, 41013
    • University Hospital Virgen del Rocio (HUVR)
• Sweden
  • Gothenburg, Sweden, 413 45
    • Sahlgrenska University Hospital, Sahlgrenska Intestinal Failure and Transplant Centre
• Taiwan
  • New Taipei City, Taiwan, 220
    • Far Eastern Memorial Hospital
• United Kingdom
  • Harrow, United Kingdom, HA1 3UJ
    • St Mark's Hospital
  • London, United Kingdom, E1 1BB
    • Royal London Hospital
  • London, United Kingdom, NW1 2BU
    • University College Hospital
  • Salford, United Kingdom, M6 8HD
    • Northern Care Alliance NHS Foundation Trust
• United States
  • California
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
  • Florida
    • Naples, Florida, United States, 34102
      • Gastroenterology Group Of Naples
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University - Chicago
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • University of Nebraska Medical Center
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3039
      • Cincinnati Children's Hospital Medical Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apraglutide subcutaneous (SC) injections, once weekly; Peptide analogue of Glucagon-like Peptide 2 (GLP-2)	Drug: Apraglutide; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemostasis	Hemostasis INR will be examined for clinically significant changes.	From baseline to week 104
Adverse events (AE)	System organ class, frequency and severity	From baseline to week 208
Clinical chemistry	Clinical Chemistry panel of analytes will be examined for clinically significant changes.	From baseline to week 208
Hematology	Hematology panel of analytes will be examined for clinically significant changes.	From baseline to week 208
Urinalysis	Urinanalysis panel of analytes will be examined for clinically significant changes.	From baseline to week 208
Occurrence of clinically relevant changes in vital signs	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.	From baseline to week 208
Occurrence of clinically relevant changes in electrocardiogram	ECG; intervals and rhythm	From baseline to week 208

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects reaching enteral autonomy		From baseline to week 104
Change from baseline in body weight	Units: kg	From baseline to week 104
Change from baseline on the Patient Global Impression of Severity (PGIS)		From baseline to week 104
Change from baseline in PS volume		From baseline to week 208
Change from baseline in PS frequency	Change in PS days/week from baseline to week 104	From baseline to week 208
Clinically significant changes in PS total energy	Units: kcal	From baseline to week 208
Change from baseline in PS infusion time		From baseline to week 208
Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI)		From baseline to week 208
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 Satisfaction with Parenteral Support (PGI-SPS)		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

Collaborators and Investigators

• Sponsor: VectivBio AG
• Investigators: Study Director: Tomasz Masior, VectivBio AG

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2021
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Short Bowel Syndrome; SBS; Intestinal Failure; SBS-IF
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Intestinal Diseases; Disease; Digestive System Diseases; Gastrointestinal Diseases; Malabsorption Syndromes; Syndrome; Short Bowel Syndrome
• Other Study ID Numbers: TA799-012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No