Short Bowel SyndromePhase 3STARSNCT04627025
Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF
A Phase 3 study testing apraglutide in people with Short Bowel Syndrome, run by VectivBio AG at 68 sites in 18 countries.
Trial 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. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 68 sitesin 18 countries
- Study dates
- 26 Jan 2021to 22 Feb 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
68 sites in 18 countries.
68 sites in 18 countries
United States13 sites
Northwestern University
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Duke University Hospital
Durham, North Carolina, 27705
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Gastroenterology Group of Naples
Naples, Florida, 34102
Vanderbilt University Medical Center, Center for Human Nutrition
Nashville, Tennessee, 37212
Mount Sinai Medical Center
New York, New York, 10029
Henry Ford Medical Center - Columbus
Novi, Michigan, 48377
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
University of Washington Medical Center
Seattle, Washington, 98195
Czechia6 sites
University Hospital Brno
Brno, 62500
University Hospital Hradec Kralove
Hradec Králové, 50005
Hospital Novy Jicin
Nový Jičín, 741 01
University Hospital Plzen
Pilsen, 30460
University Hospital Kralovske Vinohrady, 2nd Internal Clinic
Prague, 10034
General University Hospital in Prague
Prague, 12800
France6 sites
Hôpital Beaujon
Clichy, 92110
CHU Hôtel Dieu
Nantes, 44093
Hôpital ARCHET II
Nice, 6202
Hôpital Haut-Lévèque
Pessac, 33604
Hospices Civils de Lyon
Pierre-Bénite, 69495
Brabois Adults Hospital
Vandœuvre-lès-Nancy, 54500
Germany5 sites
Charité - Universitätsmedizin Berlin
Berlin, 10117
University Hospital Bonn
Bonn, 53127
Asklepios Klinik St. Georg
Hamburg, 20099
University Hospital Heidelberg
Heidelberg, 69120
University Hospital Muenster
Münster, 48149
Japan5 sites
Yokohama Municipal Citizen's Hospital
Kanagawa, 05505
Yokohama City University Medical Center
Kanagawa, 232-0024
National University Corportation Tohoku University Tohoku University Hospital
Miyagi, 980-8574
Osaka University Hospital
Osaka, 565-0871
JCHO Tokyo Yamate Medical Center
Tokyo, 169-0073
Poland5 sites
Stadmedica, Non-Public Healthcare Facility
Bydgoszcz, 85-391
COPERNICUS Limited Liability Company
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
United Kingdom5 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
St Mark's Hospital
Harrow, HA1 3UJ
Royal London Hospital
London, E1 1BB
University College Hospital
London
Salford Royal Hospital
Salford
Hungary4 sites
Medical Centre, Hungarian Defence Forces
Budapest, 1062
Semmelweis University
Budapest, 1082
St. Imre University Teaching Hospital Budapest
Budapest, H-1115
University of Szeged
Szeged, 6725
Israel3 sites
Rambam Health Care Campus
Haifa, 31096
Rabin Medical Center
Petah Tikva, 49100
Sheba Medical Center
Tel HaShomer, 5262000
Italy3 sites
Polyclinic S. Orsola-Malpighi
Bologna, 40138
University Polyclinic Foundation "Agostino Gemelli" - IRCCS
Rome, 00168
Citta della salute e della Scienza di Torino Hospital
Torino, 10126
South Korea3 sites
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Asan Medical Center
Soeul, 05505
Samsung Medical Center
Soeul, 06351
Spain3 sites
University General Hospital Gregorio Maranon
Madrid, 28007
University Hospital 12 de Octubre
Madrid, 28041
University Hospital Virgen del Rocio
Seville, 41013
Belgium2 sites
University Hospital Brussels
Brussels, 1090
Universitair Ziekenhuis Leuven - Gasthuisberg
Leuven, Vlaams Brabant, 3000
Denmark1 site
Rigshospitalet - University Hospital Copenhagen
Copenhagen, 2100
About this study
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)
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.
Read the 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.
- Conditions
- Short Bowel Syndrome
- Being tested
- apraglutide
- Keywords
- Short Bowel Syndrome, Intestinal Failure, SBS, SBS-IF, GLP-2, Short Bowel Syndrome Intestinal Failure
- 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 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 SC injections, once weekly | Experimental | Peptide analogue of GLP-2 Receives: Drug: apraglutide |
| Placebo | Placebo comparator | Placebo for apraglutide, SC injection once weekly Receives: Drug: apraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change from baseline in actual weekly PS volume at Week 24.
Measured: At week 24 of treatment
Secondary outcomes (15)
Subjects who achieve a reduction of at least 1 day per week of PS at Weeks 24 / 48 (CIC only).
Measured: Weeks 24 and 48 of treatment
Relative change from baseline in actual weekly PS volume at Weeks 12 / 24 / 48 (CIC only).
Measured: Weeks 12 / 24 / 48 of treatment
Subjects reaching enteral autonomy at Weeks 24 / 48 (CIC only).
Measured: Weeks 24 / 48 of treatment
At least 20% reduction of PS volume from baseline at Weeks 20 / 24.
Measured: Weeks 20 / 24 of treatment
Calorie reduction in the PN at Weeks 24.
Measured: Weeks 24 of treatment
Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI) at Weeks 24 / 48 (CIC only)
Measured: Weeks 24 / 48 of treatment
Change from baseline on the Patient Global Impression of Change (PGIC) at Weeks 24 / 48 (CIC only)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Weeks 24 / 48 of treatment
Absorption rate constant (ka) of apraglutide through population PK data analysis
Measured: Weeks 0 / 24 of treatment
Apparent clearance (CL/F) of apraglutide through population PK data analysis
Measured: Weeks 0 / 24 of treatment
Apparent volume of distribution (Vz/F) of apraglutide through population PK data analysis
Measured: Weeks 0 / 24 of treatment
At least 40% reduction of PS volume at Weeks 20 and 24 (Stoma only)
Measured: Weeks 20 / 24 of treatment
Trough plasma concentrations (Ctrough) at every other visit during the prolonged dosing period (CIC only)
Measured: Weeks 24 / 48 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start26 Jan 2021
- Primary completion2 Jan 2024
- Study completion22 Feb 2024
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 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
- NCT04627025
- Sponsor's protocol ID
- TA799-007
- Other IDs
- 2020-001202-32
- Acronym
- STARS
- Status last verified
- Nov 2024
- First submitted
- 22 Oct 2020
- Last updated
- 27 Nov 2024
- 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 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04627025
- Acronym / sponsor ID
- STARS / TA799-007
- Conditions
- Short Bowel Syndrome
- Keywords
- Short Bowel Syndrome, Intestinal Failure, SBS, SBS-IF, GLP-2, Short Bowel Syndrome Intestinal Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- VectivBio AGIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 13 Nov 2020 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apraglutide SC injections, once weekly | Experimental | Drug: apraglutidePeptide analogue of GLP-2 |
| Placebo | Placebo comparator | Drug: apraglutidePlacebo for apraglutide, SC injection once weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 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 SC injections, once weekly, Placebo |
Primary outcome
Relative change from baseline in actual weekly PS volume at Week 24.
Time frame: At week 24 of treatment
15 secondary outcomes
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
Relative change from baseline in actual weekly PS volume at Weeks 12 / 24 / 48 (CIC only).
Time frame: Weeks 12 / 24 / 48 of treatment
Subjects reaching enteral autonomy at Weeks 24 / 48 (CIC only).
Time frame: Weeks 24 / 48 of treatment
At least 20% reduction of PS volume from baseline at Weeks 20 / 24.
Time frame: Weeks 20 / 24 of treatment
Calorie reduction in the PN at Weeks 24.
Time frame: Weeks 24 of treatment
Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI) at Weeks 24 / 48 (CIC only)
Time frame: Weeks 24 / 48 of treatment
Change from baseline on the Patient Global Impression of Change (PGIC) at Weeks 24 / 48 (CIC only)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Weeks 24 / 48 of treatment
Absorption rate constant (ka) of apraglutide through population PK data analysis
Time frame: Weeks 0 / 24 of treatment
Apparent clearance (CL/F) of apraglutide through population PK data analysis
Time frame: Weeks 0 / 24 of treatment
Apparent volume of distribution (Vz/F) of apraglutide through population PK data analysis
Time frame: Weeks 0 / 24 of treatment
At least 40% reduction of PS volume at Weeks 20 and 24 (Stoma only)
Time frame: Weeks 20 / 24 of treatment
Trough plasma concentrations (Ctrough) at every other visit during the prolonged dosing period (CIC only)
Time frame: Weeks 24 / 48 of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
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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
68 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 68 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relative change from baseline in actual weekly PS volume at Week 24. (time frame: At week 24 of treatment). 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 27 Nov 2024.