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

Primary Purpose

Short Bowel Syndrome

Status
Active
Phase
Phase 3
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 Short Bowel Syndrome, Intestinal Failure, SBS, SBS-IF, GLP-2, Short Bowel Syndrome Intestinal Failure

Eligibility Criteria

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

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.

Sites / Locations

  • Ronald Reagan UCLA Medical Center
  • Gastroenterology Group of Naples
  • Northwestern University
  • Henry Ford Medical Center - Columbus
  • Mayo Clinic
  • University of Nebraska Medical Center
  • Mount Sinai Medical Center
  • Duke University Hospital
  • Cincinnati Children's Hospital Medical Center
  • Cleveland Clinic Foundation
  • Hospital of the University of Pennsylvania
  • Vanderbilt University Medical Center, Center for Human Nutrition
  • University of Washington Medical Center
  • University Hospital Foundation Favaloro
  • Universitair Ziekenhuis Leuven - Gasthuisberg
  • University Hospital Brussels
  • University Hospital Brno
  • University Hospital Hradec Kralove
  • Hospital Novy Jicin
  • University Hospital Plzen
  • University Hospital Kralovske Vinohrady, 2nd Internal Clinic
  • General University Hospital in Prague
  • Rigshospitalet - University Hospital Copenhagen
  • Hôpital Beaujon
  • CHU Hôtel Dieu
  • Hôpital ARCHET II
  • Hôpital Haut-Lévèque
  • Hospices Civils de Lyon
  • Brabois Adults Hospital
  • Charité - Universitätsmedizin Berlin
  • University Hospital Bonn
  • Asklepios Klinik St. Georg
  • University Hospital Heidelberg
  • University Hospital Muenster
  • Medical Centre, Hungarian Defence Forces
  • Semmelweis University
  • St. Imre University Teaching Hospital Budapest
  • University of Szeged
  • Rambam Health Care Campus
  • Rabin Medical Center
  • Sheba Medical Center
  • Polyclinic S. Orsola-Malpighi
  • University Polyclinic Foundation "Agostino Gemelli" - IRCCS
  • Citta della salute e della Scienza di Torino Hospital
  • Yokohama Municipal Citizen's Hospital
  • Yokohama City University Medical Center
  • National University Corportation Tohoku University Tohoku University Hospital
  • Osaka University Hospital
  • JCHO Tokyo Yamate Medical Center
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Alesund Hospital
  • Stadmedica, Non-Public Healthcare Facility
  • COPERNICUS Limited Liability Company
  • Gastromed Poland Sp. z o.o.
  • Stanley Dudrick Multispecialty Hospital
  • M. Pirogow Provincial Specialized Hospital
  • University General Hospital Gregorio Maranon
  • University Hospital 12 de Octubre
  • University Hospital Virgen del Rocio
  • Sahlgrenska University Hospital
  • Far Eastern Memorial Hospital
  • University Hospitals Birmingham NHS Foundation Trust
  • St Mark's Hospital
  • Royal London Hospital
  • University College Hospital
  • Salford Royal Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Apraglutide SC injections, once weekly

Placebo

Arm Description

Peptide analogue of GLP-2

Placebo for apraglutide, SC injection once weekly

Outcomes

Primary Outcome Measures

Relative change from baseline in actual weekly PS volume at Week 24.

Secondary Outcome Measures

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

Full Information

First Posted
October 22, 2020
Last Updated
August 15, 2023
Sponsor
VectivBio AG
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1. Study Identification

Unique Protocol Identification Number
NCT04627025
Brief Title
Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF
Acronym
STARS
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 26, 2021 (Actual)
Primary Completion Date
January 4, 2024 (Anticipated)
Study Completion Date
January 4, 2024 (Anticipated)

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 the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome
Keywords
Short Bowel Syndrome, Intestinal Failure, SBS, SBS-IF, GLP-2, Short Bowel Syndrome Intestinal Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apraglutide SC injections, once weekly
Arm Type
Experimental
Arm Description
Peptide analogue of GLP-2
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for apraglutide, SC injection once weekly
Intervention Type
Drug
Intervention Name(s)
apraglutide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Relative change from baseline in actual weekly PS volume at Week 24.
Time Frame
At week 24 of treatment
Secondary Outcome Measure Information:
Title
Subjects who achieve a reduction of at least 1 day per week of PS at Weeks 24 / 48 (CIC only).
Time Frame
Weeks 24 and 48 of treatment
Title
Relative change from baseline in actual weekly PS volume at Weeks 12 / 24 / 48 (CIC only).
Time Frame
Weeks 12 / 24 / 48 of treatment
Title
Subjects reaching enteral autonomy at Weeks 24 / 48 (CIC only).
Time Frame
Weeks 24 / 48 of treatment
Title
At least 20% reduction of PS volume from baseline at Weeks 20 / 24.
Time Frame
Weeks 20 / 24 of treatment
Title
Calorie reduction in the PN at Weeks 24.
Time Frame
Weeks 24 of treatment
Title
Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI) at Weeks 24 / 48 (CIC only)
Time Frame
Weeks 24 / 48 of treatment
Title
Change from baseline on the Patient Global Impression of Change (PGIC) at Weeks 24 / 48 (CIC only)
Time Frame
Weeks 24 / 48 of treatment.
Title
Change from baseline on the Patient Global Impression of Treatment Satisfaction (PGI-TS) at week 24 and 48 (CIC only).
Time Frame
Weeks 24 / 48 of treatment
Title
Change from baseline on the Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS) at Week 24 and 48 (CIC only).
Time Frame
Weeks 24 / 48 of treatment
Title
Change from baseline on the Patient Global Impression of Parenteral Support Impact (PGI-PSI) at Week 24 and 48 (CIC only).
Time Frame
Weeks 24 / 48 of treatment
Title
Absorption rate constant (ka) of apraglutide through population PK data analysis
Time Frame
Weeks 0 / 24 of treatment
Title
Apparent clearance (CL/F) of apraglutide through population PK data analysis
Time Frame
Weeks 0 / 24 of treatment
Title
Apparent volume of distribution (Vz/F) of apraglutide through population PK data analysis
Time Frame
Weeks 0 / 24 of treatment
Title
At least 40% reduction of PS volume at Weeks 20 and 24 (Stoma only)
Time Frame
Weeks 20 / 24 of treatment
Title
Trough plasma concentrations (Ctrough) at every other visit during the prolonged dosing period (CIC only)
Time Frame
Weeks 24 / 48 of treatment

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, receiving parenteral support (PS), secondary to surgical resection of the small intestine with either stoma or colon-in-continuity (CIC). Subject must require PS at least 3 days per work 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. Major abdominal surgery in the last 6 months prior to screening. History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer. Evidence of active inflammatory GI conditions in the previous 6 months. Evidence of decompensated heart failure. Evidence of severe renal or hepatic impairment. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bolognani
Organizational Affiliation
VectivBio AG
Official's Role
Study Director
Facility Information:
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Henry Ford Medical Center - Columbus
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt University Medical Center, Center for Human Nutrition
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University Hospital Foundation Favaloro
City
Buenos Aires
Country
Argentina
Facility Name
Universitair Ziekenhuis Leuven - Gasthuisberg
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University Hospital Brussels
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
University Hospital Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
University Hospital Hradec Kralove
City
Hradec Králové
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Hospital Novy Jicin
City
Nový Jičín
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
University Hospital Plzen
City
Pilsen
ZIP/Postal Code
30460
Country
Czechia
Facility Name
University Hospital Kralovske Vinohrady, 2nd Internal Clinic
City
Prague
ZIP/Postal Code
10034
Country
Czechia
Facility Name
General University Hospital in Prague
City
Prague
ZIP/Postal Code
12800
Country
Czechia
Facility Name
Rigshospitalet - University Hospital Copenhagen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
CHU Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital ARCHET II
City
Nice
ZIP/Postal Code
6202
Country
France
Facility Name
Hôpital Haut-Lévèque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Hospices Civils de Lyon
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Brabois Adults Hospital
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
University Hospital Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
University Hospital Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
University Hospital Muenster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Medical Centre, Hungarian Defence Forces
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Facility Name
St. Imre University Teaching Hospital Budapest
City
Budapest
ZIP/Postal Code
H-1115
Country
Hungary
Facility Name
University of Szeged
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Rabin Medical Center
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sheba Medical Center
City
Tel HaShomer
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Polyclinic S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
University Polyclinic Foundation "Agostino Gemelli" - IRCCS
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Citta della salute e della Scienza di Torino Hospital
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Yokohama Municipal Citizen's Hospital
City
Kanagawa
ZIP/Postal Code
05505
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
National University Corportation Tohoku University Tohoku University Hospital
City
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
JCHO Tokyo Yamate Medical Center
City
Tokyo
ZIP/Postal Code
169-0073
Country
Japan
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Soeul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Soeul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Alesund Hospital
City
Ålesund
ZIP/Postal Code
6017
Country
Norway
Facility Name
Stadmedica, Non-Public Healthcare Facility
City
Bydgoszcz
ZIP/Postal Code
85-391
Country
Poland
Facility Name
COPERNICUS Limited Liability Company
City
Gdansk
ZIP/Postal Code
80-152
Country
Poland
Facility Name
Gastromed Poland Sp. z o.o.
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Facility Name
Stanley Dudrick Multispecialty Hospital
City
Skawina
ZIP/Postal Code
32-050
Country
Poland
Facility Name
M. Pirogow Provincial Specialized Hospital
City
Łódź
ZIP/Postal Code
90-531
Country
Poland
Facility Name
University General Hospital Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
University Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
University Hospital Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Sahlgrenska University Hospital
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
St Mark's Hospital
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
University College Hospital
City
London
Country
United Kingdom
Facility Name
Salford Royal Hospital
City
Salford
Country
United Kingdom

12. IPD Sharing Statement

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

Learn more about this trial

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

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