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A Study to Investigate the Efficacy and Safety of Apraglutide Compared With Placebo in Adult Participants With Short Bowel Syndrome Associated With Intestinal Failure (SBS-IF) (STARS-2)

3. August 2026 aktualisiert von: VectivBio AG

A Parallel-group Treatment, Phase 3, Double-blind, Randomized, 2-arm Study to Investigate the Efficacy and Safety of Apraglutide Compared With Placebo in Adult Participants With Short Bowel Syndrome Associated With Intestinal Failure (SBS-IF)

This Phase 3 placebo-controlled study is planned to further investigate the efficacy, safety, and tolerability of apraglutide in the overall SBS-IF (short bowel syndrome associated with intestinal failure) population during 24 weeks of study treatment. It is expected that approximately 124 participants will be randomized worldwide to either apraglutide or placebo in a 1:1 ratio in this trial.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to investigate the efficacy, safety, and tolerability of apraglutide compared with placebo in adults with SBS-IF. The study population will be representative of the SBS-IF general population and will include adult participants (≥18 years of age) who are dependent on, and who are receiving, PS at least 3 days per week. Eligible participants will be randomized 1:1 to receive SC apraglutide or placebo once weekly for 24 weeks stratified by anatomy (i.e., colon-in-continuity [CIC] or stoma) and baseline parenteral support (PS) volume (i.e., <12 L/week or ≥12 L/week). The number of randomized participants in CIC and stoma will be monitored to ensure approximately equal numbers of CIC and stoma participants are randomized.

The study will consist of 4 periods: a Screening Period prior to randomization (including optimization and stabilization phases), a Treatment Period starting at randomization, a Safety Follow-up (SFU) Period after the last dose of IMP is completed, and an Anti-Drug Antibody (ADA) Follow-up Period beginning after the last dose of IMP.

All participants who complete the IMP treatment will be offered participation in an open label single arm apraglutide long-term extension (LTE) study. Participants who do not wish to continue onto the LTE study will be requested to complete an SFU Visit, which will occur 4 weeks (±1 week) after the last dose of IMP, after which they will transition into ADA Follow-Up period.

Studientyp

Interventionell

Einschreibung (Geschätzt)

124

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Argentinien
      • Buenos Aires, Argentinien, C1199ABB
        • Noch keine Rekrutierung
        • Buenos Aires Italian Hospital
      • Córdoba, Argentinien, X5000JHQ
        • Noch keine Rekrutierung
        • Allende Sanatorium
      • La Plata, Argentinien, B1904CFU
        • Noch keine Rekrutierung
        • San Martin General La Plata Acute General Regional Hospital
      • Luján, Argentinien, M5505
        • Noch keine Rekrutierung
        • CDC Medical Center
  • Australien
      • Fitzroy, Australien, VIC 3065
        • Noch keine Rekrutierung
        • St Vincent's Hospital (Melbourne) Ltd
      • Heidelberg, Australien, VIC 3084
        • Noch keine Rekrutierung
        • Austin Hospital
      • Herston, Australien, QLD 4029
        • Noch keine Rekrutierung
        • Royal Brisbane and Women's Hospital, Gastroenterology and Hepatology
      • Perth, Australien, WA 6150
        • Noch keine Rekrutierung
        • Fiona Stanley Hospital, Harry Perkins Medical Research Institute
  • Belgien
      • Edegem, Belgien, 2650
        • Noch keine Rekrutierung
        • University Hospital Antwerp (UZA), Department of Gastroenterology and Hepatology
      • Leuven, Belgien, 3000
        • Noch keine Rekrutierung
        • University Hospitals Leuven, Campus Gasthuisberg, Department of Gastroenterology
  • Brasilien
    • Piauí
      • Teresina, Piauí, Brasilien, 64001-280
        • Noch keine Rekrutierung
        • Hospital Sao Marcos
    • Rio Grande do Sul
      • Caxias do Sul, Rio Grande do Sul, Brasilien, 95070-560
        • Noch keine Rekrutierung
        • Caxias Do Sul University / Clinical Research For Multicenter Studies Institute
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90035-903
        • Noch keine Rekrutierung
        • Porto Alegre Clinical Hospital (HCPA)
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90610-000
        • Noch keine Rekrutierung
        • Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital
    • São Paulo
      • São José do Rio Preto, São Paulo, Brasilien, 15090-000
        • Noch keine Rekrutierung
        • Regional Medical School Foundation (CIP HB/FAMERP)
      • São Paulo, São Paulo, Brasilien, 01233-000
        • Noch keine Rekrutierung
        • QualiVida Higienopolis - Hapvida NotreDame
      • São Paulo, São Paulo, Brasilien, 05403-000
        • Noch keine Rekrutierung
        • University of São Paulo Faculty of Medicine Clinics Hospital
  • Deutschland
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Deutschland, 69120
        • Noch keine Rekrutierung
        • University Hospital Heidelberg, Department of Endocrinology and Metabolism
    • Bavaria
      • Erlangen, Bavaria, Deutschland, 91054
        • Noch keine Rekrutierung
        • University Hospital Erlangen
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Deutschland, 20099
        • Noch keine Rekrutierung
        • Asklepios Clinic St. Georg
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Deutschland, 53127
        • Noch keine Rekrutierung
        • University Hospital Bonn
      • Essen, North Rhine-Westphalia, Deutschland, 45147
        • Noch keine Rekrutierung
        • University Duisburg-Essen, University Hospital Essen
      • Münster, North Rhine-Westphalia, Deutschland, 48149
        • Noch keine Rekrutierung
        • University Hospital Muenster
    • Rhine-Westphalia
      • Aachen, Rhine-Westphalia, Deutschland, 52074
        • Noch keine Rekrutierung
        • University Hospital Aachen AoeR
    • State of Berlin
      • Berlin, State of Berlin, Deutschland, 10117
        • Noch keine Rekrutierung
        • Charite - University Hospital Berlin
  • Dänemark
      • Copenhagen, Dänemark, DK-2100
        • Noch keine Rekrutierung
        • Rigshospitalet - University Hospital Copenhagen
  • Frankreich
      • Clichy, Frankreich, 92110
        • Noch keine Rekrutierung
        • Beaujon Hospital - APHP
      • Lyon, Frankreich, 69310
        • Noch keine Rekrutierung
        • Hospices Civils de Lyon - Lyon Sud
      • Nantes, Frankreich, 44000
        • Noch keine Rekrutierung
        • Nantes University Hospital Center - Hotel Dieu Hospital
      • Pessac, Frankreich, 33600
        • Noch keine Rekrutierung
        • Bordeaux University Hospital Center - Haut-Leveque Hospital, Haut-Leveque Hospital
      • Vandœuvre-lès-Nancy, Frankreich, 54500
        • Noch keine Rekrutierung
        • Nancy Regional University Hospital Center - Brabois Hospital
  • Israel
      • Haifa, Israel, 3109601
        • Noch keine Rekrutierung
        • Rambam Health Care Campus, Institute of Gastroenterology, Nutrition Clinic
      • Jerusalem, Israel, 9103102
        • Noch keine Rekrutierung
        • Shaare Zedek Medical Center, Digestive Diseases Institute, Nutrition Clinic
      • Kfar Saba, Israel, 4428164
        • Noch keine Rekrutierung
        • Meir Medical Center, Institute of Gastroenterology and Liver Diseases
      • Tel Aviv, Israel, 64239
        • Noch keine Rekrutierung
        • The Tel Aviv Sourasky Medical Center, Institute of Gastrointestinal and Liver Diseases, Nutrition Clinic
      • Tel Litwinsky, Israel, 5262000
        • Noch keine Rekrutierung
        • Chaim Sheba Medical Center, Institute of Gastrointestinal Diseases, Nutrition Unit
  • Italien
      • Bologna, Italien, 40138
        • Noch keine Rekrutierung
        • IRCCS University Hospital of Bologna, Polyclinic S. Orsola-Malpighi
      • Florence, Italien, 50134
        • Noch keine Rekrutierung
        • Careggi University Hospital
      • Milan, Italien, 20122
        • Noch keine Rekrutierung
        • Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
      • Torino, Italien, 10126
        • Noch keine Rekrutierung
        • University Hospital City of Health and Science of Turin - Hospital Molinette
    • Lombardy
      • Pavia, Lombardy, Italien, 27100
        • Noch keine Rekrutierung
        • Polyclinic San Matteo, IRCCS
    • Veneto
      • Padova, Veneto, Italien, 35128
        • Noch keine Rekrutierung
        • University Hospital Of Padova
  • Japan
      • Kagawa, Japan, 761-0793
        • Noch keine Rekrutierung
        • Kagawa University Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 221-0855
        • Noch keine Rekrutierung
        • Yokohama Municipal Citizen's Hospital
    • Saga-ken
      • Saga, Saga-ken, Japan, 840-8571
        • Noch keine Rekrutierung
        • Saga-Ken Medical Centre Koseikan
  • Kanada
    • British Columbia
      • Vancouver, British Columbia, Kanada, V6Z 2K5
        • Noch keine Rekrutierung
        • Pacific Gastroenterology Associates
    • Quebec
      • Montreal, Quebec, Kanada, H2X 3E4
        • Noch keine Rekrutierung
        • CHUM - University of Montreal Hospital Centre
  • Niederlande
      • Nijmegen, Niederlande, 6525GA
        • Noch keine Rekrutierung
        • Radboud University Medical Center (Radboudumc)
  • Polen
      • Bydgoszcz, Polen, 85-391
        • Noch keine Rekrutierung
        • Non-Public Healthcare Facility Stadmedica, Ambulatory Specialist Care
      • Lublin, Polen, 20-582
        • Noch keine Rekrutierung
        • Medrise Sp. z o.o. (LLC)
      • Wroclaw, Polen, 51-149
        • Noch keine Rekrutierung
        • Jerzy Gromkowski Provincial Specialist Hospital
  • Spanien
    • Andalusia
      • Seville, Andalusia, Spanien, 41013
        • Noch keine Rekrutierung
        • University Hospital Virgen del Rocio (HUVR)
  • Südkorea
      • Seoul, Südkorea, 05505
        • Noch keine Rekrutierung
        • Asan Medical Center
      • Seoul, Südkorea, 06351
        • Noch keine Rekrutierung
        • Samsung Medical Center
      • Seoul, Südkorea, 06591
        • Noch keine Rekrutierung
        • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Taiwan
      • Kaohsiung City, Taiwan, 807377
        • Noch keine Rekrutierung
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • New Taipei City, Taiwan, 220
        • Noch keine Rekrutierung
        • Far Eastern Memorial Hospital
      • Taichung, Taiwan, 407219
        • Noch keine Rekrutierung
        • Taichung Veterans General Hospital
  • Thailand
      • Bangkok, Thailand, 10330
        • Noch keine Rekrutierung
        • King Chulalongkorn Memorial Hospital
      • Bangkok, Thailand, 10700
        • Noch keine Rekrutierung
        • Siriraj Hospital
      • Bangkok, Thailand, 10400
        • Noch keine Rekrutierung
        • Ramathibodi Hospital
      • Bangkok, Thailand, 10400
        • Noch keine Rekrutierung
        • Phramongkutklao Hospital
      • Hat Yai, Thailand, 90110
        • Noch keine Rekrutierung
        • Songklanagarind Hospital
      • Nakhon Ratchasima, Thailand, 30000
        • Noch keine Rekrutierung
        • Maharat Nakhon Ratchasima Hospital
  • Tschechien
      • Brno, Tschechien, 625 00
        • Noch keine Rekrutierung
        • University Hospital Brno, Clinic of Internal Medicine - Gastroenterology
      • Hradec Králové, Tschechien, 500 05
        • Noch keine Rekrutierung
        • University Hospital Hradec Kralove, 3rd Internal Clinic of Geronto-Metabolic
      • Prague, Tschechien, 100 00
        • Noch keine Rekrutierung
        • University Hospital Kralovske Vinohrady, Internal Clinic
      • Prague, Tschechien, 128 08
        • Noch keine Rekrutierung
        • General University Hospital in Prague
  • Ungarn
      • Budapest, Ungarn, H-1082
        • Noch keine Rekrutierung
        • Semmelweis University, Department of Surgery, Transplantation and Gastroenterology
      • Szeged, Ungarn, H-6725
        • Noch keine Rekrutierung
        • University of Szeged, Department of Internal Medicine- Western Site
  • Vereinigte Staaten
    • California
      • Los Angeles, California, Vereinigte Staaten, 90095
        • Noch keine Rekrutierung
        • Ronald Reagan UCLA Medical Center, Center for the Health Sciences
    • Colorado
      • Denver, Colorado, Vereinigte Staaten, 80204
        • Noch keine Rekrutierung
        • Denver Health Medical Center
    • District of Columbia
      • Washington D.C., District of Columbia, Vereinigte Staaten, 20007
        • Noch keine Rekrutierung
        • MedStar Georgetown University Hospital
    • Florida
      • Gainesville, Florida, Vereinigte Staaten, 32610
        • Noch keine Rekrutierung
        • University of Florida Health (UF Health)
      • Naples, Florida, Vereinigte Staaten, 34102
        • Rekrutierung
        • GI Pros
      • Weston, Florida, Vereinigte Staaten, 33331
        • Noch keine Rekrutierung
        • Cleveland Clinic Florida
    • Illinois
      • Maywood, Illinois, Vereinigte Staaten, 60153
        • Noch keine Rekrutierung
        • Loyola University Medical Center
    • Kentucky
      • Louisville, Kentucky, Vereinigte Staaten, 40202
        • Noch keine Rekrutierung
        • UofL Physicians - Colon & Rectal Surgery
    • Michigan
      • Novi, Michigan, Vereinigte Staaten, 48377
        • Noch keine Rekrutierung
        • Henry Ford Medical Center - Columbus
    • New York
      • Albany, New York, Vereinigte Staaten, 12208
        • Noch keine Rekrutierung
        • Albany Medical Center
      • New York, New York, Vereinigte Staaten, 10029
        • Noch keine Rekrutierung
        • Mount Sinai Medical Center, RMTI - Intestinal Transplantation & Rehabilitation
    • North Carolina
      • Durham, North Carolina, Vereinigte Staaten, 27710
        • Noch keine Rekrutierung
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, Vereinigte Staaten, 45219
        • Noch keine Rekrutierung
        • Gastro Health - Clifton
      • Cleveland, Ohio, Vereinigte Staaten, 44195
        • Noch keine Rekrutierung
        • Cleveland Clinic - Cleveland
      • Columbus, Ohio, Vereinigte Staaten, 43210
        • Noch keine Rekrutierung
        • OSU Wexner Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • Noch keine Rekrutierung
        • Hospital of the University of Pennsylvania
    • Tennessee
      • Nashville, Tennessee, Vereinigte Staaten, 37232
        • Noch keine Rekrutierung
        • Vanderbilt University Medical Center
  • Vereinigtes Königreich
      • Birmingham, Vereinigtes Königreich, B15 2TH
        • Noch keine Rekrutierung
        • University Hospitals Birmingham NHS Foundation Trust
      • London, Vereinigtes Königreich, E1 1FR
        • Noch keine Rekrutierung
        • Royal London Hospital
      • Salford, Vereinigtes Königreich, M6 8HD
        • Noch keine Rekrutierung
        • Northern Care Alliance NHS Foundation Trust, Intestinal Failure Unit
    • Middlesex
      • London, Middlesex, Vereinigtes Königreich, HA1 3UJ
        • Noch keine Rekrutierung
        • St Mark's Hospital
    • Scotland
      • Aberdeen, Scotland, Vereinigtes Königreich, AB25 2ZN
        • Noch keine Rekrutierung
        • Aberdeen Royal Infirmary
  • Österreich
      • Graz, Österreich, 8010
        • Noch keine Rekrutierung
        • University Hospital Graz
    • Upper Austria
      • Linz, Upper Austria, Österreich, 4010
        • Noch keine Rekrutierung
        • Order Hospital Linz Ltd. - Hospital of Sisters of Mercy, Department of Surgery

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Participant must be ≥18 years of age, at the time of signing the informed consent.
  • Male and female participants with SBS-IF, receiving PS secondary to surgical resection of the small intestine with residual length ≥10 cm to <200 cm from duodeno-jejunal flexure, based on available clinical and/or medical/surgical records, and with either: (a.) CIC remaining and neither jejunostomy nor ileostomy with the latest intestinal resection resulting in SBS-IF being at least 12 months prior to Screening OR (b.) Jejunostomy or ileostomy with the latest intestinal resection resulting in SBS-IF being at least 6 months prior to Screening.
  • BMI of ≥18.5 to <30 kg/m2 at randomization.
  • Individuals of any gender identity, assigned male or female at birth are eligible to participate. Male participants: Male participants with a female partner of childbearing potential must commit to practice highly effective methods of contraception (eg, condom, vasectomy) and abstain from sperm donation during the study and for 2 weeks after the EOT/Early Discontinuation (ED) Visit. Female participants: Women of childbearing potential must agree to practice effective contraception and to use a highly effective method of contraception during the study and for 4 weeks after the EOT/ED Visit. To be considered sterilized or infertile, female participants must have undergone surgical sterilization (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) or be postmenopausal (defined as at least 12 months amenorrhea without an alternative medical cause; a follicle-stimulating hormone [FSH] test [with or without estradiol] is required to confirm if there is doubt). Women who do not engage in heterosexual intercourse will be allowed to join the study without contraception following a thorough discussion with the investigator to determine if this is feasible for the participant. The following are not considered acceptable methods of contraception: calendar, ovulation, symptothermal, postovulation methods, withdrawal (coitus interruptus), spermicides only, and the lactational amenorrhea method.
  • Signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
  • PS requirement of at least 3 days per week as assessed before Screening, at the end of optimization, and at the time of randomization.
  • Participant is considered optimized (average drinking volume is ≥1.0 L and ≤3.5 L per day and the average urinary volume is ≥0.8 L and ≤2.5 L per day) at study Visit 2a, 2b, or 2c.
  • Participant is considered stable with regard to PS volume requirement, drinking volume, and urinary output at last Stabilization Phase Visit and Visit 4 when the actual PS usage matches prescribed PS (±10% deviation in volume from the last optimization visit), average urine volume at the last stabilization visit and randomization visit match (±25% deviation from last optimization visit is acceptable), while the average drinking volume is constant (the 48-hour oral intake differs from the last optimization visit by less than 10% and minimum 1.0 and maximum 3.5 L per day) and average urine volume is ≥0.8 L and ≤2.5 L per day.
  • Willingness to adhere to an individual predefined drinking menu and urine measurements during the 48-hour fluid balance periods.
  • No planned restorative surgery or major intestinal surgery (more than 10% intestinal resection or surgery that changes anatomy group, ie, CIC or stoma) from the signing of informed consent through completion of the SFU visit.
  • Willingness to undergo either a colonoscopy or CT/MRI colonography (if anatomically feasible and medically appropriate) and have any identified polyps removed.

Exclusion Criteria:

  • Pregnancy and/or lactation and/or plans to become pregnant or to breastfeed.
  • Major abdominal surgery (more than 10% intestinal resection or surgery that changes anatomy group) in the last 6 months prior to Screening Visit. Surgery for feeding tube placement and cholecystectomy allowed, after discussion with medical monitor and appropriate documentation. Any planned surgical procedures during the study duration must be discussed with the medical monitor prior to enrollment, with appropriate documentation of approval of eligibility, if applicable.
  • Ultra-short gut (residual length <10 cm from duodeno-jejunal flexure).
  • A history of clinically significant intestinal adhesions increasing the risk of GI obstruction and/or GI contrast study(ies) of remaining small bowel suggesting subacute intestinal obstruction or mild stricture within 6 months prior to Screening.
  • Constipation that is not adequately managed by dietary recommendations, laxatives, or cathartic medications.
  • Active or untreated enterocutaneous fistula.
  • History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer.
  • Diagnosis of any variant of familial adenomatous polyposis or comparable polyposis syndrome.
  • Active inflammatory bowel disease or any other acute or chronic related underlying medical condition that, in the opinion of the investigator, would limit the participant's ability to complete or participate in the study, or confound study results. Discussion with the medical monitor is required.
  • Sepsis experienced within the previous 2 months prior to or during Screening; or a central venous catheter infection requiring the use of systemic antibiotics within 30 days prior to or during Screening, with the exception of systemic antibiotics administered for <72 hours while awaiting the results of pending blood culture(s) that turn out negative (ie, <72 hours empiric systemic antibiotics while ruling out a central venous catheter infection is allowed as long as the culture turns out negative).
  • Decompensated heart failure (New York Heart Association class III-IV) and/or known coronary heart disease defined as unstable angina pectoris and/or myocardial infarction within the previous 6 months prior to Screening.
  • Radiation enteritis, scleroderma, or residual evidence of intestinal dysmotility, including pseudo-obstruction and Hirschsprung's disease, coeliac disease, refractory or tropical sprue.
  • History of alcohol or drug abuse within the previous 12 months prior to Screening that, in the opinion of the investigator, could interfere with study participation, compliance, and safety of participants.
  • Child-Pugh scale Class C for liver disease.
  • Evidence of chronic renal disease as demonstrated by inadequate renal function, which is defined as estimated glomerular filtration rate <20 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology formula).
  • Positive results for HIV, hepatitis A, B, and/or C tests at the Screening Visit. Note: Participants recovered from hepatitis B or C can be enrolled, ie, they have markers of the infection, but the viral load is undetectable. Participants with evidence of an acute or chronically active hepatitis B or C infection should be excluded. If a participant has a positive hepatitis A immunoglobulin M test, this would indicate an acute infection and the participant is ineligible, but they may be eligible for rescreening after recovery. Participants with positive HIV test results and undetectable viral loads may be rescreened (in case the initial test was a false positive).
  • Clinically significant concurrent illness (eg, uncontrolled hypertension, pancreatic or gallbladder disease) or finding on physical examination or clinical laboratory test after signing the ICF but before receiving the first dose of IMP. Note: The investigator will determine if a finding is clinically significant. The investigator will consider whether the finding 1) could prevent the participant from performing any study procedure or assessment, 2) represents a condition that would be exclusionary, 3) could represent a safety concern if the participant participated in the study, or 4) could confound any study assessment.
  • Elevated liver enzymes during the screening period: (a.) ALT or AST >5 × upper limit of normal (ULN); (b.) ALT or AST >3 × ULN and total bilirubin (TBL) >2 × ULN or international normalized ratio (INR) >1.5 for a person not using anticoagulant drug and INR >3 for a person on anticoagulant therapy such as warfarin; (c.) ALT or AST >3 × ULN and clinical signs of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia; (d.) Participants with serum conjugated bilirubin >34 μmol/L during 2 consecutive measurements.
  • Use of diuretics, anti-diarrheals, and other common concomitant medications used in SBS-IF if dosing is not stable within 14 days prior to randomization.
  • New drug treatment other than biologic therapies, or a change to the dose or dosing interval of an existing drug treatment other than a biologic, within 1 month prior to randomization. In cases of weight loss or weight gain, dose adjustments that enable the same drug unit/kg dosing (eg, mg/kg) for weight-based dosing are permitted within 1 month prior to randomization after discussion with the medical monitor and proper documentation.
  • New biologic therapy or changes to dose or dosing interval of existing biologic therapy within 3 months prior to Screening, unless the dose adjustment was due to a change in weight and maintained the same drug-unit/kg (eg, mg/kg) weight-based dosing. Switching from a reference biologic product to a biosimilar, while maintaining the same dose and dosing interval, is permitted outside the 3 months prior to the screening window and/or during the study.
  • Use of dipeptidyl peptidase-4 inhibitors within 3 months prior to Screening.
  • At least 2 weeks of treatment with growth factors, such as growth hormone, glutamine, native GLP-2, GLP-1, short acting GLP-2 analogs (eg, teduglutide) or GLP-1 analogs within 3 months before Screening; or treatment with longer acting experimental GLP-2 analogs in the previous 6 months before Screening. Note: Prior discontinuation of GLP-2 analog treatment due to safety concerns or lack of efficacy is an exclusion criterion regardless of wash-out period. For prior discontinuation due to intolerance, the patient may be eligible based on discussion with the medical monitor. The nature of the intolerance must be clearly documented and discussed with the medical monitor.
  • Citrulline supplements within less than 30 days prior to Screening.
  • Prior use of apraglutide, or prior randomization in this study. Note: Randomization to placebo in a prior study of apraglutide is not an exclusion criterion.
  • Known or suspected hypersensitivity to GLP-1 or GLP-2 analogs or any apraglutide excipients.
  • Known antidrug antibodies (ADAs) against GLP-1 or GLP-2 analogs.
  • Participation in another interventional clinical study in the last 3 months before screening and during this study (studies with catheter locks or observational studies, which are not a burden on the participant and do not interfere with the participation in this study, are allowed after discussion with the medical monitor).
  • Incapable of understanding or unwilling to adhere to the study visit schedules and/or other protocol requirements.
  • Inability to prepare and/or administer the dose of the study intervention or inability to have the dose prepared and/or administered by an appropriately trained care provider.
  • Any condition, underlying disease, or circumstance, including psychosocial or environmental that, in the opinion of the investigator, could reduce the participant's adherence with the study visit schedule, dosing regimen, or other study requirements.
  • Participant is directly or indirectly involved in the conduct and administration of this study as an investigator, subinvestigator, study coordinator, study staff member, or employee of the sponsor; or the participant is a direct relative of an individual involved in the study.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Active
Apraglutide subcutaneous (SC) injections, once weekly
Arzneimittel: Apraglutide

Apraglutide is a synthetic peptide analogue of glucagon-like peptide-2 (GLP-2), which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2.

Participants will be administered or will self-administer a weekly SC injection of apraglutide.
Placebo-Komparator: Placebo
Placebo SC injections, once weekly
Arzneimittel: Placebo
Participants will be administered or will self-administer a weekly single SC injection of placebo in the matching injection volumes.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Relative change from baseline in actual weekly PS volume at Week 24.
Zeitfenster: At Week 24
At Week 24

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Participants who achieve clinical response in actual weekly PS volume (at least 20% reduction from baseline) at both Week 20 and Week 24.
Zeitfenster: At both Week 20 and Week 24
At both Week 20 and Week 24
Participants who achieve a reduction of PS days per week (categorical) from baseline at Week 24.
Zeitfenster: At Week 24
Categorical reduction includes 4 ordered categories: 0 days; 1 day; 2 days; ≥3 days.
At Week 24
Participants who achieve a reduction of at least 1 PS day per week from baseline at Week 24.
Zeitfenster: At Week 24
At Week 24
Participants reaching enteral autonomy at Week 24.
Zeitfenster: At Week 24
At Week 24
Absolute change from baseline in actual weekly PS volume at Week 24.
Zeitfenster: At Week 24
At Week 24
Participants who achieve clinical response (categorical) in actual weekly PS volume reduction from baseline at both Week 20 and Week 24.
Zeitfenster: At both Week 20 and Week 24
Categorical response includes 4 ordered categories of response: <20%; 20% to <40%; 40% to <99%; ≥99%.
At both Week 20 and Week 24
Participants who achieve a reduction of at least 2 PS days per week from baseline at Week 24.
Zeitfenster: At Week 24
At Week 24
Participants who achieve a reduction of at least 3 PS days per week from baseline at Week 24.
Zeitfenster: At Week 24
At Week 24
Relative change from baseline in actual weekly PS volume at Week 12.
Zeitfenster: At Week 12
At Week 12
Relative change from baseline in parenteral nutrition (PN) calories at Week 24.
Zeitfenster: At Week 24
At Week 24
Improvement on Patient Global Impression of Change Version 2 (PGICv2) at Week 24.
Zeitfenster: At Week 24
Improvement defined as reporting "a little better" or "much better" on a 5-point scale.
At Week 24
Incidence of Treatment-Emergent Adverse Events
Zeitfenster: From first dose through 28 days after last dose
From first dose through 28 days after last dose

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

VectivBio AG

Mitarbeiter

PSI CRO

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2028

Studienabschluss (Geschätzt)

1. Oktober 2029

Studienanmeldedaten

Zuerst eingereicht

12. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Juli 2026

Zuerst gepostet (Tatsächlich)

3. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • TA799-025
  • 2026-526274-16-00 (Ctis)

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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