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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)

2026年8月3日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

124

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Active
Apraglutide subcutaneous (SC) injections, once weekly
薬：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.
プラセボコンパレーター：Placebo
Placebo SC injections, once weekly
薬：Placebo
Participants will be administered or will self-administer a weekly single SC injection of placebo in the matching injection volumes.

この研究は何を測定していますか？

主要な結果の測定

結果測定
時間枠
Relative change from baseline in actual weekly PS volume at Week 24.
時間枠：At Week 24
At Week 24

二次結果の測定

結果測定
メジャーの説明
時間枠
Participants who achieve clinical response in actual weekly PS volume (at least 20% reduction from baseline) at both Week 20 and Week 24.
時間枠：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.
時間枠：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.
時間枠：At Week 24
At Week 24
Participants reaching enteral autonomy at Week 24.
時間枠：At Week 24
At Week 24
Absolute change from baseline in actual weekly PS volume at Week 24.
時間枠：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.
時間枠：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.
時間枠：At Week 24
At Week 24
Participants who achieve a reduction of at least 3 PS days per week from baseline at Week 24.
時間枠：At Week 24
At Week 24
Relative change from baseline in actual weekly PS volume at Week 12.
時間枠：At Week 12
At Week 12
Relative change from baseline in parenteral nutrition (PN) calories at Week 24.
時間枠：At Week 24
At Week 24
Improvement on Patient Global Impression of Change Version 2 (PGICv2) at Week 24.
時間枠：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
時間枠：From first dose through 28 days after last dose
From first dose through 28 days after last dose

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

VectivBio AG

協力者

PSI CRO

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2028年10月1日

研究の完了 (推定)

2029年10月1日

試験登録日

最初に提出

2026年7月12日

QC基準を満たした最初の提出物

2026年7月28日

最初の投稿 (実際)

2026年8月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月4日

QC基準を満たした最後の更新が送信されました

2026年8月3日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

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

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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