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 sierpnia 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Status
Rekrutacyjny
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Typ studiów
Interwencyjne
Zapisy (Szacowany)
Zapisy
124
Faza
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Emie Liu, MD
- Numer telefonu: +41 61 551 30 30
- E-mail: clinicaltrialenquiries@ironwoodpharma.com
Lokalizacje studiów
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Buenos Aires, Argentyna, C1199ABB
- Jeszcze nie rekrutacja
- Buenos Aires Italian Hospital
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Córdoba, Argentyna, X5000JHQ
- Jeszcze nie rekrutacja
- Allende Sanatorium
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La Plata, Argentyna, B1904CFU
- Jeszcze nie rekrutacja
- San Martin General La Plata Acute General Regional Hospital
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Luján, Argentyna, M5505
- Jeszcze nie rekrutacja
- CDC Medical Center
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Fitzroy, Australia, VIC 3065
- Jeszcze nie rekrutacja
- St Vincent's Hospital (Melbourne) Ltd
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Heidelberg, Australia, VIC 3084
- Jeszcze nie rekrutacja
- Austin Hospital
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Herston, Australia, QLD 4029
- Jeszcze nie rekrutacja
- Royal Brisbane and Women's Hospital, Gastroenterology and Hepatology
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Perth, Australia, WA 6150
- Jeszcze nie rekrutacja
- Fiona Stanley Hospital, Harry Perkins Medical Research Institute
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Graz, Austria, 8010
- Jeszcze nie rekrutacja
- University Hospital Graz
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Upper Austria
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Linz, Upper Austria, Austria, 4010
- Jeszcze nie rekrutacja
- Order Hospital Linz Ltd. - Hospital of Sisters of Mercy, Department of Surgery
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Edegem, Belgia, 2650
- Jeszcze nie rekrutacja
- University Hospital Antwerp (UZA), Department of Gastroenterology and Hepatology
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Leuven, Belgia, 3000
- Jeszcze nie rekrutacja
- University Hospitals Leuven, Campus Gasthuisberg, Department of Gastroenterology
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Piauí
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Teresina, Piauí, Brazylia, 64001-280
- Jeszcze nie rekrutacja
- Hospital Sao Marcos
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Rio Grande do Sul
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Caxias do Sul, Rio Grande do Sul, Brazylia, 95070-560
- Jeszcze nie rekrutacja
- Caxias Do Sul University / Clinical Research For Multicenter Studies Institute
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Porto Alegre, Rio Grande do Sul, Brazylia, 90035-903
- Jeszcze nie rekrutacja
- Porto Alegre Clinical Hospital (HCPA)
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Porto Alegre, Rio Grande do Sul, Brazylia, 90610-000
- Jeszcze nie rekrutacja
- Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital
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São Paulo
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São José do Rio Preto, São Paulo, Brazylia, 15090-000
- Jeszcze nie rekrutacja
- Regional Medical School Foundation (CIP HB/FAMERP)
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São Paulo, São Paulo, Brazylia, 01233-000
- Jeszcze nie rekrutacja
- QualiVida Higienopolis - Hapvida NotreDame
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São Paulo, São Paulo, Brazylia, 05403-000
- Jeszcze nie rekrutacja
- University of São Paulo Faculty of Medicine Clinics Hospital
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Brno, Czechy, 625 00
- Jeszcze nie rekrutacja
- University Hospital Brno, Clinic of Internal Medicine - Gastroenterology
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Hradec Králové, Czechy, 500 05
- Jeszcze nie rekrutacja
- University Hospital Hradec Kralove, 3rd Internal Clinic of Geronto-Metabolic
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Prague, Czechy, 100 00
- Jeszcze nie rekrutacja
- University Hospital Kralovske Vinohrady, Internal Clinic
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Prague, Czechy, 128 08
- Jeszcze nie rekrutacja
- General University Hospital in Prague
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Copenhagen, Dania, DK-2100
- Jeszcze nie rekrutacja
- Rigshospitalet - University Hospital Copenhagen
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Clichy, Francja, 92110
- Jeszcze nie rekrutacja
- Beaujon Hospital - APHP
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Lyon, Francja, 69310
- Jeszcze nie rekrutacja
- Hospices Civils de Lyon - Lyon Sud
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Nantes, Francja, 44000
- Jeszcze nie rekrutacja
- Nantes University Hospital Center - Hotel Dieu Hospital
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Pessac, Francja, 33600
- Jeszcze nie rekrutacja
- Bordeaux University Hospital Center - Haut-Leveque Hospital, Haut-Leveque Hospital
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Vandœuvre-lès-Nancy, Francja, 54500
- Jeszcze nie rekrutacja
- Nancy Regional University Hospital Center - Brabois Hospital
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Andalusia
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Seville, Andalusia, Hiszpania, 41013
- Jeszcze nie rekrutacja
- University Hospital Virgen del Rocio (HUVR)
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Nijmegen, Holandia, 6525GA
- Jeszcze nie rekrutacja
- Radboud University Medical Center (Radboudumc)
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Haifa, Izrael, 3109601
- Jeszcze nie rekrutacja
- Rambam Health Care Campus, Institute of Gastroenterology, Nutrition Clinic
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Jerusalem, Izrael, 9103102
- Jeszcze nie rekrutacja
- Shaare Zedek Medical Center, Digestive Diseases Institute, Nutrition Clinic
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Kfar Saba, Izrael, 4428164
- Jeszcze nie rekrutacja
- Meir Medical Center, Institute of Gastroenterology and Liver Diseases
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Tel Aviv, Izrael, 64239
- Jeszcze nie rekrutacja
- The Tel Aviv Sourasky Medical Center, Institute of Gastrointestinal and Liver Diseases, Nutrition Clinic
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Tel Litwinsky, Izrael, 5262000
- Jeszcze nie rekrutacja
- Chaim Sheba Medical Center, Institute of Gastrointestinal Diseases, Nutrition Unit
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Kagawa, Japonia, 761-0793
- Jeszcze nie rekrutacja
- Kagawa University Hospital
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Kanagawa
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Yokohama, Kanagawa, Japonia, 221-0855
- Jeszcze nie rekrutacja
- Yokohama Municipal Citizen's Hospital
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Saga-ken
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Saga, Saga-ken, Japonia, 840-8571
- Jeszcze nie rekrutacja
- Saga-Ken Medical Centre Koseikan
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British Columbia
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Vancouver, British Columbia, Kanada, V6Z 2K5
- Jeszcze nie rekrutacja
- Pacific Gastroenterology Associates
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Quebec
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Montreal, Quebec, Kanada, H2X 3E4
- Jeszcze nie rekrutacja
- CHUM - University of Montreal Hospital Centre
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Seoul, Korea Południowa, 05505
- Jeszcze nie rekrutacja
- Asan Medical Center
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Seoul, Korea Południowa, 06351
- Jeszcze nie rekrutacja
- Samsung Medical Center
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Seoul, Korea Południowa, 06591
- Jeszcze nie rekrutacja
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Baden-Wurttemberg
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Heidelberg, Baden-Wurttemberg, Niemcy, 69120
- Jeszcze nie rekrutacja
- University Hospital Heidelberg, Department of Endocrinology and Metabolism
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Bavaria
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Erlangen, Bavaria, Niemcy, 91054
- Jeszcze nie rekrutacja
- University Hospital Erlangen
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Free and Hanseatic City of Hamburg
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Hamburg, Free and Hanseatic City of Hamburg, Niemcy, 20099
- Jeszcze nie rekrutacja
- Asklepios Clinic St. Georg
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Niemcy, 53127
- Jeszcze nie rekrutacja
- University Hospital Bonn
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Essen, North Rhine-Westphalia, Niemcy, 45147
- Jeszcze nie rekrutacja
- University Duisburg-Essen, University Hospital Essen
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Münster, North Rhine-Westphalia, Niemcy, 48149
- Jeszcze nie rekrutacja
- University Hospital Muenster
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Rhine-Westphalia
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Aachen, Rhine-Westphalia, Niemcy, 52074
- Jeszcze nie rekrutacja
- University Hospital Aachen AoeR
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State of Berlin
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Berlin, State of Berlin, Niemcy, 10117
- Jeszcze nie rekrutacja
- Charite - University Hospital Berlin
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Bydgoszcz, Polska, 85-391
- Jeszcze nie rekrutacja
- Non-Public Healthcare Facility Stadmedica, Ambulatory Specialist Care
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Lublin, Polska, 20-582
- Jeszcze nie rekrutacja
- Medrise Sp. z o.o. (LLC)
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Wroclaw, Polska, 51-149
- Jeszcze nie rekrutacja
- Jerzy Gromkowski Provincial Specialist Hospital
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California
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Los Angeles, California, Stany Zjednoczone, 90095
- Jeszcze nie rekrutacja
- Ronald Reagan UCLA Medical Center, Center for the Health Sciences
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Colorado
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Denver, Colorado, Stany Zjednoczone, 80204
- Jeszcze nie rekrutacja
- Denver Health Medical Center
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District of Columbia
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Washington D.C., District of Columbia, Stany Zjednoczone, 20007
- Jeszcze nie rekrutacja
- MedStar Georgetown University Hospital
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Florida
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Gainesville, Florida, Stany Zjednoczone, 32610
- Jeszcze nie rekrutacja
- University of Florida Health (UF Health)
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Naples, Florida, Stany Zjednoczone, 34102
- Rekrutacyjny
- GI Pros
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Weston, Florida, Stany Zjednoczone, 33331
- Jeszcze nie rekrutacja
- Cleveland Clinic Florida
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Illinois
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Maywood, Illinois, Stany Zjednoczone, 60153
- Jeszcze nie rekrutacja
- Loyola University Medical Center
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Kentucky
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Louisville, Kentucky, Stany Zjednoczone, 40202
- Jeszcze nie rekrutacja
- UofL Physicians - Colon & Rectal Surgery
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Michigan
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Novi, Michigan, Stany Zjednoczone, 48377
- Jeszcze nie rekrutacja
- Henry Ford Medical Center - Columbus
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New York
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Albany, New York, Stany Zjednoczone, 12208
- Jeszcze nie rekrutacja
- Albany Medical Center
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New York, New York, Stany Zjednoczone, 10029
- Jeszcze nie rekrutacja
- Mount Sinai Medical Center, RMTI - Intestinal Transplantation & Rehabilitation
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North Carolina
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Durham, North Carolina, Stany Zjednoczone, 27710
- Jeszcze nie rekrutacja
- Duke University Medical Center
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Ohio
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Cincinnati, Ohio, Stany Zjednoczone, 45219
- Jeszcze nie rekrutacja
- Gastro Health - Clifton
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Cleveland, Ohio, Stany Zjednoczone, 44195
- Jeszcze nie rekrutacja
- Cleveland Clinic - Cleveland
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Columbus, Ohio, Stany Zjednoczone, 43210
- Jeszcze nie rekrutacja
- OSU Wexner Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- Jeszcze nie rekrutacja
- Hospital of the University of Pennsylvania
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Tennessee
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Nashville, Tennessee, Stany Zjednoczone, 37232
- Jeszcze nie rekrutacja
- Vanderbilt University Medical Center
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Bangkok, Tajlandia, 10330
- Jeszcze nie rekrutacja
- King Chulalongkorn Memorial Hospital
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Bangkok, Tajlandia, 10700
- Jeszcze nie rekrutacja
- Siriraj Hospital
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Bangkok, Tajlandia, 10400
- Jeszcze nie rekrutacja
- Ramathibodi Hospital
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Bangkok, Tajlandia, 10400
- Jeszcze nie rekrutacja
- Phramongkutklao Hospital
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Hat Yai, Tajlandia, 90110
- Jeszcze nie rekrutacja
- Songklanagarind Hospital
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Nakhon Ratchasima, Tajlandia, 30000
- Jeszcze nie rekrutacja
- Maharat Nakhon Ratchasima Hospital
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Kaohsiung City, Tajwan, 807377
- Jeszcze nie rekrutacja
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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New Taipei City, Tajwan, 220
- Jeszcze nie rekrutacja
- Far Eastern Memorial Hospital
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Taichung, Tajwan, 407219
- Jeszcze nie rekrutacja
- Taichung Veterans General Hospital
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Budapest, Węgry, H-1082
- Jeszcze nie rekrutacja
- Semmelweis University, Department of Surgery, Transplantation and Gastroenterology
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Szeged, Węgry, H-6725
- Jeszcze nie rekrutacja
- University of Szeged, Department of Internal Medicine- Western Site
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Bologna, Włochy, 40138
- Jeszcze nie rekrutacja
- IRCCS University Hospital of Bologna, Polyclinic S. Orsola-Malpighi
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Florence, Włochy, 50134
- Jeszcze nie rekrutacja
- Careggi University Hospital
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Milan, Włochy, 20122
- Jeszcze nie rekrutacja
- Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
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Torino, Włochy, 10126
- Jeszcze nie rekrutacja
- University Hospital City of Health and Science of Turin - Hospital Molinette
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Lombardy
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Pavia, Lombardy, Włochy, 27100
- Jeszcze nie rekrutacja
- Polyclinic San Matteo, IRCCS
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Veneto
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Padova, Veneto, Włochy, 35128
- Jeszcze nie rekrutacja
- University Hospital Of Padova
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Birmingham, Zjednoczone Królestwo, B15 2TH
- Jeszcze nie rekrutacja
- University Hospitals Birmingham NHS Foundation Trust
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London, Zjednoczone Królestwo, E1 1FR
- Jeszcze nie rekrutacja
- Royal London Hospital
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Salford, Zjednoczone Królestwo, M6 8HD
- Jeszcze nie rekrutacja
- Northern Care Alliance NHS Foundation Trust, Intestinal Failure Unit
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Middlesex
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London, Middlesex, Zjednoczone Królestwo, HA1 3UJ
- Jeszcze nie rekrutacja
- St Mark's Hospital
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Scotland
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Aberdeen, Scotland, Zjednoczone Królestwo, AB25 2ZN
- Jeszcze nie rekrutacja
- Aberdeen Royal Infirmary
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Liczba ramion
2
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
|
Eksperymentalny: Active
Apraglutide subcutaneous (SC) injections, once weekly
|
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. |
|
Komparator placebo: Placebo
Placebo SC injections, once weekly
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Participants will be administered or will self-administer a weekly single SC injection of placebo in the matching injection volumes.
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
Relative change from baseline in actual weekly PS volume at Week 24.
Ramy czasowe: At Week 24
|
At Week 24
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Participants who achieve clinical response in actual weekly PS volume (at least 20% reduction from baseline) at both Week 20 and Week 24.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: At Week 24
|
At Week 24
|
|
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Participants reaching enteral autonomy at Week 24.
Ramy czasowe: At Week 24
|
At Week 24
|
|
|
Absolute change from baseline in actual weekly PS volume at Week 24.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: At Week 24
|
At Week 24
|
|
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Participants who achieve a reduction of at least 3 PS days per week from baseline at Week 24.
Ramy czasowe: At Week 24
|
At Week 24
|
|
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Relative change from baseline in actual weekly PS volume at Week 12.
Ramy czasowe: At Week 12
|
At Week 12
|
|
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Relative change from baseline in parenteral nutrition (PN) calories at Week 24.
Ramy czasowe: At Week 24
|
At Week 24
|
|
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Improvement on Patient Global Impression of Change Version 2 (PGICv2) at Week 24.
Ramy czasowe: At Week 24
|
Improvement defined as reporting "a little better" or "much better" on a 5-point scale.
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At Week 24
|
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Incidence of Treatment-Emergent Adverse Events
Ramy czasowe: From first dose through 28 days after last dose
|
From first dose through 28 days after last dose
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
1 sierpnia 2026
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
1 października 2028
Ukończenie studiów (Szacowany)
Ukończenie studiów
1 października 2029
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
12 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
28 lipca 2026
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
3 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
4 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
3 sierpnia 2026
Ostatnia weryfikacja
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- TA799-025
- 2026-526274-16-00 (Ctis)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Tak
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .