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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)

2026년 8월 3일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

124

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

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아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Active
Apraglutide subcutaneous (SC) injections, once weekly
의약품: 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.
위약 비교기: Placebo
Placebo SC injections, once weekly
의약품: Placebo
Participants will be administered or will self-administer a weekly single SC injection of placebo in the matching injection volumes.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Relative change from baseline in actual weekly PS volume at Week 24.
기간: At Week 24
At Week 24

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

VectivBio AG

협력자

PSI CRO

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2028년 10월 1일

연구 완료 (추정된)

2029년 10월 1일

연구 등록 날짜

최초 제출

2026년 7월 12일

QC 기준을 충족하는 최초 제출

2026년 7월 28일

처음 게시됨 (실제)

2026년 8월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 3일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다