Short Bowel SyndromePhase 3STARS extendNCT05018286
Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.
A Phase 3 study testing Apraglutide in people with Short Bowel Syndrome, run by VectivBio AG at 66 sites in 18 countries.
Trial summary
The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- Apraglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 66 sitesin 18 countries
- Study dates
- 13 Jul 2021to 30 Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Able to give informed consent and agree to follow the details of participation as outlined in the protocol.
Who cannot join
- Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.
- Any other reason judged not eligible by the Investigator.
- Pregnancy or lactation
Trial locations and contacts
66 sites in 18 countries.
66 sites in 18 countries
United States13 sites
Northwestern University - Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Henry Ford Health System
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Gastroenterology Group of Naples
Naples, Florida, 34102
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Mount Sinai Medical Center
New York, New York, 10029
University of Nebraska Medical Center
Omaha, Nebraska, 68105
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
University of Washington Medical Center
Seattle, Washington, 98195
Czechia6 sites
University Hospital Brno
Brno, 62500
University Hospital Hradec Kralove
Hradec Králové, 500 05
Hospital Novy Jicin
Nový Jičín, 741 01
University Hospital Plzen
Pilsen, 30460
University Hospital Kralovske Vinohrady
Prague, 10034
General University Hospital in Prague
Prague, 12800
France6 sites
Beaujon Hospital
Clichy, 92110
South Lyon Hospital Center
Lyon, 69495
Nantes University Hospital Center - Hotel Dieu Hospital
Nantes, 44093
Nice University Hospital Center - Archet 1 Hospital
Nice, 06200
Hôpital Haut-Lévèque
Pessac, 33604
Brabois Adults Hospital
Vandœuvre-lès-Nancy, 54500
Germany5 sites
Charite - University Hospital Berlin
Berlin, 10117
University Hospital Bonn
Bonn, 53127
Asklepios Clinic St. Georg
Hamburg, 20099
University Hospital Heidelberg
Heidelberg, 69120
University Hospital Muenster
Münster, 48149
Japan5 sites
Yokohama City University Medical Center
Kanagawa, 232-0024
Yokohama Municipal Citizen's Hospital
Kanagawa, 232-0024
Osaka University Hospital
Osaka, 565-0871
Tohoku University Hospital
Sendai, 980-0872
JCHO Tokyo Yamate Medical Center
Tokyo, 169-0073
Poland5 sites
Stadmedica, Non-Public Healthcare Facility
Bydgoszcz, 85-391
COPERNICUS Limited Liability Company, Nutrition Outpatient Clinic for Adults
Gdansk, 80-152
M. Pirogow Provincial Specialized Hospital
Lodz, 90-531
Gastromed Poland Sp. z o.o.
Lublin, 20-582
Stanley Dudrick Multispecialty Hospital
Skawina, 32-050
Hungary4 sites
Szent Imre University Teaching Hospital, Department of Gastroenterology
Budapest, 1115
Central Hospital of Northern Pest - Military Hospital
Budapest, H-1062
Semmelweis University
Budapest, H-1062
University of Szeged
Szeged, 6725
United Kingdom4 sites
St Mark's Hospital
Harrow, HA1 3UJ
Royal London Hospital
London, E1 1BB
University College Hospital
London, NW1 2BU
Northern Care Alliance NHS Foundation Trust
Salford, M6 8HD
Italy3 sites
Polyclinic S. Orsola-Malpighi
Bologna, 40138
University Polyclinic Foundation "Agostino Gemelli" - IRCCS
Rome, 00168
City of Health and Science of Turin
Turin, 10126
South Korea3 sites
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 063351
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Spain3 sites
University General Hospital Gregorio Maranon
Madrid, 28007
University Hospital 12 de Octubre
Madrid, 28041
University Hospital Virgen del Rocio (HUVR)
Seville, 41013
Belgium2 sites
University Hospital Brussels
Brussels, B-1090
UZ Leuven
Leuven, 3000
Israel2 sites
Rambam Health Care Campus, Institute of Gastroenterology
Haifa, 31096
Chaim Sheba Medical Center
Tel HaShomer, 5262000
Argentina1 site
University Hospital Fundacion Favaloro
Buenos Aires, C1093AAS
Denmark1 site
Rigshospitalet - University Hospital Copenhagen, Department of Intestinal Failure and Liver Diseases
Copenhagen, 2100
Sweden1 site
Sahlgrenska University Hospital, Sahlgrenska Intestinal Failure and Transplant Centre
Gothenburg, 413 45
About this study
Official title: 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.
Read the 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.
- Conditions
- Short Bowel Syndrome
- Being tested
- Apraglutide
- Keywords
- Short Bowel Syndrome, SBS, Intestinal Failure, SBS-IF
- Medical subject headings
- Short Bowel Syndrome, Intestinal Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApraglutideDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Apraglutide subcutaneous (SC) injections, once weekly | Experimental | Peptide analogue of Glucagon-like Peptide 2 (GLP-2) Receives: Drug: Apraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AE)
System organ class, frequency and severity
Measured: From baseline to week 208
Clinical chemistry
Clinical Chemistry panel of analytes will be examined for clinically significant changes.
Measured: From baseline to week 208
Hematology
Hematology panel of analytes will be examined for clinically significant changes.
Measured: From baseline to week 208
Hemostasis
Hemostasis INR will be examined for clinically significant changes.
Measured: From baseline to week 104
Urinalysis
Urinanalysis panel of analytes will be examined for clinically significant changes.
Measured: 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.
Measured: From baseline to week 208
Occurrence of clinically relevant changes in electrocardiogram
ECG; intervals and rhythm
Measured: From baseline to week 208
Secondary outcomes (14)
Change from baseline in PS volume
Measured: From baseline to week 208
Change from baseline in PS frequency
Change in PS days/week from baseline to week 104
Measured: From baseline to week 208
Clinically significant changes in PS total energy
Units: kcal
Measured: From baseline to week 208
Change from baseline in PS infusion time
Measured: From baseline to week 208
Percentage of subjects reaching enteral autonomy
Measured: From baseline to week 104
Change from baseline in body weight
Units: kg
Measured: From baseline to week 104
Change from baseline on the Patient Global Impression of Severity (PGIS)
Measured: From baseline to week 104
Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI)
Measured: From baseline to week 208
Change from baseline on the Patient Global Impression of Change (PGIC)
Measured: From baseline to week 208
Changes from baseline on Patient Global Impression of Treatment Satisfaction (PGI-TS)
Measured: From baseline to week 208
Changes from baseline on Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS)
Measured: From baseline to week 208
Changes from baseline on Patient Global Impression of Parenteral Support Impact (PGI-PSI)
Measured: From baseline to week 208
Change from baseline on the Short Form (36) Health Survey (SF-36)
Measured: From baseline to week 208
Change from baseline on the EuroQoL-5 dimension -5 level survey (EQ-5D-5L)
Measured: From baseline to week 208
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start13 Jul 2021
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- VectivBio AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomasz Masior, Study director, VectivBio AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018286
- Sponsor's protocol ID
- TA799-012
- Acronym
- STARS extend
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2021
- Last updated
- 2 Jul 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.
- ClinicalTrials.gov ID
- NCT05018286
- Acronym / sponsor ID
- STARS extend / TA799-012
- Conditions
- Short Bowel Syndrome
- Keywords
- Short Bowel Syndrome, SBS, Intestinal Failure, SBS-IF
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 158 participants (actual)
- Lead sponsor
- VectivBio AGIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apraglutide subcutaneous (SC) injections, once weekly | Experimental | Drug: ApraglutidePeptide analogue of Glucagon-like Peptide 2 (GLP-2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
- Able to give informed consent and agree to follow the details of participation as outlined in the protocol.
Key exclusion criteria (3 listed)
- Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.
- Any other reason judged not eligible by the Investigator.
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApraglutideApraglutide 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 | Drug | Apraglutide subcutaneous (SC) injections, once weekly |
Primary outcome
Adverse events (AE)
Time frame: From baseline to week 208
System organ class, frequency and severity
Clinical chemistry
Time frame: From baseline to week 208
Clinical Chemistry panel of analytes will be examined for clinically significant changes.
Hematology
Time frame: From baseline to week 208
Hematology panel of analytes will be examined for clinically significant changes.
Hemostasis
Time frame: From baseline to week 104
Hemostasis INR will be examined for clinically significant changes.
Urinalysis
Time frame: From baseline to week 208
Urinanalysis panel of analytes will be examined for clinically significant changes.
Occurrence of clinically relevant changes in vital signs
Time frame: 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
Time frame: From baseline to week 208
ECG; intervals and rhythm
14 secondary outcomes
Change from baseline in PS volume
Time frame: From baseline to week 208
Change from baseline in PS frequency
Time frame: From baseline to week 208
Clinically significant changes in PS total energy
Time frame: From baseline to week 208
Change from baseline in PS infusion time
Time frame: From baseline to week 208
Percentage of subjects reaching enteral autonomy
Time frame: From baseline to week 104
Change from baseline in body weight
Time frame: From baseline to week 104
Change from baseline on the Patient Global Impression of Severity (PGIS)
Time frame: From baseline to week 104
Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI)
Time frame: From baseline to week 208
Change from baseline on the Patient Global Impression of Change (PGIC)
Time frame: From baseline to week 208
Changes from baseline on Patient Global Impression of Treatment Satisfaction (PGI-TS)
Time frame: From baseline to week 208
Changes from baseline on Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS)
Time frame: From baseline to week 208
Changes from baseline on Patient Global Impression of Parenteral Support Impact (PGI-PSI)
Time frame: From baseline to week 208
Change from baseline on the Short Form (36) Health Survey (SF-36)
Time frame: From baseline to week 208
Change from baseline on the EuroQoL-5 dimension -5 level survey (EQ-5D-5L)
Time frame: From baseline to week 208
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Masior study director
VectivBio AG
66 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apraglutide in people with Short Bowel Syndrome, run by VectivBio AG at 66 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, Czechia, France, Germany, Japan and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AE) (time frame: From baseline to week 208). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.