此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

124

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Active
Apraglutide subcutaneous (SC) injections, once weekly
药品：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.
安慰剂比较：Placebo
Placebo SC injections, once weekly
药品：Placebo
Participants will be administered or will self-administer a weekly single SC injection of placebo in the matching injection volumes.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Relative change from baseline in actual weekly PS volume at Week 24.
大体时间：At Week 24
At Week 24

次要结果测量

结果测量
措施说明
大体时间
Participants who achieve clinical response in actual weekly PS volume (at least 20% reduction from baseline) at both Week 20 and Week 24.
大体时间：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.
大体时间：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.
大体时间：At Week 24
At Week 24
Participants reaching enteral autonomy at Week 24.
大体时间：At Week 24
At Week 24
Absolute change from baseline in actual weekly PS volume at Week 24.
大体时间：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.
大体时间：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.
大体时间：At Week 24
At Week 24
Participants who achieve a reduction of at least 3 PS days per week from baseline at Week 24.
大体时间：At Week 24
At Week 24
Relative change from baseline in actual weekly PS volume at Week 12.
大体时间：At Week 12
At Week 12
Relative change from baseline in parenteral nutrition (PN) calories at Week 24.
大体时间：At Week 24
At Week 24
Improvement on Patient Global Impression of Change Version 2 (PGICv2) at Week 24.
大体时间：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
大体时间：From first dose through 28 days after last dose
From first dose through 28 days after last dose

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

VectivBio AG

合作者

PSI CRO

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2028年10月1日

研究完成 (估计的)

2029年10月1日

研究注册日期

首次提交

2026年7月12日

首先提交符合 QC 标准的

2026年7月28日

首次发布 (实际的)

2026年8月3日

研究记录更新

最后更新发布 (实际的)

2026年8月4日

上次提交的符合 QC 标准的更新

2026年8月3日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • TA799-025
  • 2026-526274-16-00 (克蒂斯)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅