Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF (STARS)

A Multicenter, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Apraglutide in Adult Subjects With Short Bowel Syndrome and Intestinal Failure (SBS-IF)

The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.

Study Overview

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

Detailed Description

This is an international, multicenter, double-blind, randomized, placebo-controlled, trial to evaluate the efficacy and safety of weekly SC injections of apraglutide in adult subjects with SBS-IF. The active pharmaceutical ingredient is apraglutide, a GLP-2 analogue.

The trial consists of a screening phase, a treatment phase of 48 weeks, and a safety follow-up phase. Trial participants will receive, after successful screening, once weekly apraglutide.

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Fritze; Phone Number: +41615513030; Email: clinicaltrials@vectivbio.com

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • University Hospital Foundation Favaloro
• Belgium
  • Brussels, Belgium, 1090
    • University Hospital Brussels
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • Universitair Ziekenhuis Leuven - Gasthuisberg
• Czechia
  • Brno, Czechia, 62500
    • University Hospital Brno
  • Hradec Králové, Czechia, 50005
    • University hospital Hradec Králové
  • Nový Jičín, Czechia, 741 01
    • Hospital Novy Jicin
  • Pilsen, Czechia, 30460
    • University Hospital Plzen
  • Prague, Czechia, 10034
    • University Hospital Kralovske Vinohrady, 2nd Internal Clinic
  • Prague, Czechia, 12800
    • General University Hospital in Prague
• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet - University Hospital Copenhagen
• France
  • Clichy, France, 92110
    • Hopital Beaujon
  • Nantes, France, 44093
    • Chu Hotel Dieu
  • Nice, France, 6202
    • Hôpital ARCHET II
  • Pessac, France, 33604
    • Hôpital Haut-Lévèque
  • Pierre Benite, France, 69495
    • Hospices Civils de Lyon
  • Vandœuvre-lès-Nancy, France, 54500
    • Brabois Adults Hospital
• Germany
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin
  • Bonn, Germany, 53127
    • University Hospital Bonn
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg
  • Heidelberg, Germany, 69120
    • University Hospital Heidelberg
  • Münster, Germany, 48149
    • University Hospital Muenster
• Hungary
  • Budapest, Hungary, 1082
    • Semmelweis University
  • Budapest, Hungary, 1062
    • Medical Centre, Hungarian Defence Forces
  • Budapest, Hungary, H-1115
    • St. Imre University Teaching Hospital Budapest
  • Szeged, Hungary, 6725
    • University of Szeged
• Israel
  • Haifa, Israel, 31096
    • Rambam Health Care Campus
  • Petah-Tikva, Israel, 49100
    • Rabin Medical Center
  • Tel HaShomer, Israel, 5262000
    • Sheba Medical Center
• Italy
  • Bologna, Italy, 40138
    • Polyclinic S. Orsola-Malpighi
  • Rome, Italy, 00168
    • University Polyclinic Foundation "Agostino Gemelli" - IRCCS
  • Torino, Italy, 10126
    • Citta della salute e della Scienza di Torino Hospital
• Japan
  • Kanagawa, Japan, 232-0024
    • Yokohama City University Medical Center
  • Kanagawa, Japan, 05505
    • Yokohama Municipal Citizen's Hospital
  • Miyagi, Japan, 980-8574
    • National University Corportation Tohoku University Tohoku University Hospital
  • Osaka, Japan, 565-0871
    • Osaka University Hospital
  • Tokyo, Japan, 169-0073
    • JCHO Tokyo Yamate Medical Center
• Korea, Republic of
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Soeul, Korea, Republic of, 05505
    • Asan Medical Center
  • Soeul, Korea, Republic of, 06351
    • Samsung Medical Center
• Norway
  • Ålesund, Norway, 6017
    • Alesund Hospital
• Poland
  • Bydgoszcz, Poland, 85-391
    • Stadmedica, Non-Public Healthcare Facility
  • Gdansk, Poland, 80-152
    • COPERNICUS Limited Liability Company
  • 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
• Sweden
  • Göteborg, Sweden, 41345
    • Sahlgrenska University Hospital
• Taiwan
  • New Taipei City, Taiwan, 220
    • Far Eastern Memorial Hospital
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • University Hospitals Birmingham NHS Foundation Trust
  • Harrow, United Kingdom, HA1 3UJ
    • St Mark's Hospital
  • London, United Kingdom, E1 1BB
    • Royal London Hospital
  • London, United Kingdom
    • University College Hospital
  • Salford, United Kingdom
    • Salford Royal Hospital
• 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
  • Michigan
    • Novi, Michigan, United States, 48377
      • Henry Ford Medical Center - Columbus
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • 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, 27705
      • Duke University Hospital
  • 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, 37212
      • Vanderbilt University Medical Center, Center for Human Nutrition
  • 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. Signed informed consent for this trial prior to any trial specific assessment.
2. Male and female subjects with SBS-IF, receiving parenteral support (PS), secondary to surgical resection of the small intestine with either stoma or colon-in-continuity (CIC).
3. Subject must require PS at least 3 days per work and be considered stable.
4. No restorative surgery intended to change PS requirements in the trial period.
5. Age ≥18 years at screening.

Exclusion Criteria:

1. Pregnancy or lactation.
2. Major abdominal surgery in the last 6 months prior to screening.
3. History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer.
4. Evidence of active inflammatory GI conditions in the previous 6 months.
5. Evidence of decompensated heart failure.
6. Evidence of severe renal or hepatic impairment.
7. Any previous use of growth factors such as growth hormone (GH), native GLP-2, GLP-1, or GLP-2 or GLP-1 analogues should be discussed with the Investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apraglutide SC injections, once weekly; Peptide analogue of GLP-2	Drug: apraglutide; Apraglutide is a 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.
Placebo Comparator: Placebo; Placebo for apraglutide, SC injection once weekly	Drug: apraglutide; Apraglutide is a 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	Time Frame
Relative change from baseline in actual weekly PS volume at Week 24.	At week 24 of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Subjects who achieve a reduction of at least 1 day per week of PS at Weeks 24 / 48 (CIC only).	Weeks 24 and 48 of treatment
Relative change from baseline in actual weekly PS volume at Weeks 12 / 24 / 48 (CIC only).	Weeks 12 / 24 / 48 of treatment
Subjects reaching enteral autonomy at Weeks 24 / 48 (CIC only).	Weeks 24 / 48 of treatment
At least 20% reduction of PS volume from baseline at Weeks 20 / 24.	Weeks 20 / 24 of treatment
Calorie reduction in the PN at Weeks 24.	Weeks 24 of treatment
Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI) at Weeks 24 / 48 (CIC only)	Weeks 24 / 48 of treatment
Change from baseline on the Patient Global Impression of Change (PGIC) at Weeks 24 / 48 (CIC only)	Weeks 24 / 48 of treatment.
Change from baseline on the Patient Global Impression of Treatment Satisfaction (PGI-TS) at week 24 and 48 (CIC only).	Weeks 24 / 48 of treatment
Change from baseline on the Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS) at Week 24 and 48 (CIC only).	Weeks 24 / 48 of treatment
Change from baseline on the Patient Global Impression of Parenteral Support Impact (PGI-PSI) at Week 24 and 48 (CIC only).	Weeks 24 / 48 of treatment
Absorption rate constant (ka) of apraglutide through population PK data analysis	Weeks 0 / 24 of treatment
Apparent clearance (CL/F) of apraglutide through population PK data analysis	Weeks 0 / 24 of treatment
Apparent volume of distribution (Vz/F) of apraglutide through population PK data analysis	Weeks 0 / 24 of treatment
At least 40% reduction of PS volume at Weeks 20 and 24 (Stoma only)	Weeks 20 / 24 of treatment
Trough plasma concentrations (Ctrough) at every other visit during the prolonged dosing period (CIC only)	Weeks 24 / 48 of treatment

Collaborators and Investigators

• Sponsor: VectivBio AG
• Investigators: Study Director: Bolognani, VectivBio AG

Publications and helpful links

Helpful Links

• If you are in the United States and want to learn more about the STARS study, click HERE (https://app.patientwing.com/campaign/sbsifctgov)

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Estimated): January 4, 2024
• Study Completion (Estimated): January 4, 2024

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: November 8, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Short Bowel Syndrome; SBS; GLP-2; Intestinal Failure; SBS-IF; Short Bowel Syndrome Intestinal Failure
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Syndrome; Short Bowel Syndrome; Intestinal Failure
• Other Study ID Numbers: TA799-007; 2020-001202-32 (EudraCT Number)

Drug and device information, study documents

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