Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF
- Registration Number
- NCT04627025
- Lead Sponsor
- VectivBio AG
- Brief Summary
The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.
- Detailed Description
This is an international, multicenter, double-blind, randomized, placebo-controlled, trial to evaluate the efficacy and safety of weekly SC injections of apraglutide in adult subjects with SBS-IF. The active pharmaceutical ingredient is apraglutide, a GLP-2 analogue.
The trial consists of a screening phase, a treatment phase of 48 weeks, and a safety follow-up phase. Trial participants will receive, after successful screening, once weekly apraglutide.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 164
Not provided
- Pregnancy or lactation.
- Major abdominal surgery in the last 6 months prior to screening.
- History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer.
- Evidence of active inflammatory GI conditions in the previous 6 months.
- Evidence of decompensated heart failure.
- Evidence of severe renal or hepatic impairment.
- Any previous use of growth factors such as growth hormone (GH), native GLP-2, GLP-1, or GLP-2 or GLP-1 analogues should be discussed with the Investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Apraglutide SC injections, once weekly apraglutide Peptide analogue of GLP-2 Placebo apraglutide Placebo for apraglutide, SC injection once weekly
- Primary Outcome Measures
Name Time Method Relative change from baseline in actual weekly PS volume at Week 24. At week 24 of treatment
- Secondary Outcome Measures
Name Time Method Apparent volume of distribution (Vz/F) of apraglutide through population PK data analysis Weeks 0 / 24 of treatment Subjects who achieve a reduction of at least 1 day per week of PS at Weeks 24 / 48 (CIC only). Weeks 24 and 48 of treatment At least 40% reduction of PS volume at Weeks 20 and 24 (Stoma only) Weeks 20 / 24 of treatment Trough plasma concentrations (Ctrough) at every other visit during the prolonged dosing period (CIC only) Weeks 24 / 48 of treatment Relative change from baseline in actual weekly PS volume at Weeks 12 / 24 / 48 (CIC only). Weeks 12 / 24 / 48 of treatment Subjects reaching enteral autonomy at Weeks 24 / 48 (CIC only). Weeks 24 / 48 of treatment At least 20% reduction of PS volume from baseline at Weeks 20 / 24. Weeks 20 / 24 of treatment Calorie reduction in the PN at Weeks 24. Weeks 24 of treatment Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI) at Weeks 24 / 48 (CIC only) Weeks 24 / 48 of treatment Change from baseline on the Patient Global Impression of Change (PGIC) at Weeks 24 / 48 (CIC only) Weeks 24 / 48 of treatment. Change from baseline on the Patient Global Impression of Treatment Satisfaction (PGI-TS) at week 24 and 48 (CIC only). Weeks 24 / 48 of treatment Change from baseline on the Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS) at Week 24 and 48 (CIC only). Weeks 24 / 48 of treatment Change from baseline on the Patient Global Impression of Parenteral Support Impact (PGI-PSI) at Week 24 and 48 (CIC only). Weeks 24 / 48 of treatment Absorption rate constant (ka) of apraglutide through population PK data analysis Weeks 0 / 24 of treatment Apparent clearance (CL/F) of apraglutide through population PK data analysis Weeks 0 / 24 of treatment
Trial Locations
- Locations (68)
University of Szeged
🇭🇺Szeged, Hungary
Duke University Hospital
🇺🇸Durham, North Carolina, United States
Rigshospitalet - University Hospital Copenhagen
🇩🇰Copenhagen, Denmark
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Henry Ford Medical Center - Columbus
🇺🇸Novi, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Vanderbilt University Medical Center, Center for Human Nutrition
🇺🇸Nashville, Tennessee, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
University Hospital Foundation Favaloro
🇦🇷Buenos Aires, Argentina
University Hospital Brno
🇨🇿Brno, Czechia
University Hospital Brussels
🇧🇪Brussels, Belgium
University Hospital Hradec Kralove
🇨🇿Hradec Králové, Czechia
Universitair Ziekenhuis Leuven - Gasthuisberg
🇧🇪Leuven, Vlaams Brabant, Belgium
University Hospital Plzen
🇨🇿Pilsen, Czechia
Hospital Novy Jicin
🇨🇿Nový Jičín, Czechia
University Hospital Kralovske Vinohrady, 2nd Internal Clinic
🇨🇿Prague, Czechia
General University Hospital in Prague
🇨🇿Prague, Czechia
Hôpital Beaujon
🇫🇷Clichy, France
CHU Hôtel Dieu
🇫🇷Nantes, France
Hôpital ARCHET II
🇫🇷Nice, France
University Hospital Heidelberg
🇩🇪Heidelberg, Germany
Hôpital Haut-Lévèque
🇫🇷Pessac, France
Hospices Civils de Lyon
🇫🇷Pierre Benite, France
Brabois Adults Hospital
🇫🇷Vandœuvre-lès-Nancy, France
Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
University Hospital Bonn
🇩🇪Bonn, Germany
University Hospital Muenster
🇩🇪Münster, Germany
Medical Centre, Hungarian Defence Forces
🇭🇺Budapest, Hungary
University Polyclinic Foundation "Agostino Gemelli" - IRCCS
🇮🇹Rome, Italy
Rambam Health Care Campus
🇮🇱Haifa, Israel
Rabin Medical Center
🇮🇱Petah-Tikva, Israel
Semmelweis University
🇭🇺Budapest, Hungary
St. Imre University Teaching Hospital Budapest
🇭🇺Budapest, Hungary
Polyclinic S. Orsola-Malpighi
🇮🇹Bologna, Italy
Sheba Medical Center
🇮🇱Tel HaShomer, Israel
Citta della salute e della Scienza di Torino Hospital
🇮🇹Torino, Italy
Yokohama Municipal Citizen's Hospital
🇯🇵Kanagawa, Japan
Yokohama City University Medical Center
🇯🇵Kanagawa, Japan
National University Corportation Tohoku University Tohoku University Hospital
🇯🇵Miyagi, Japan
JCHO Tokyo Yamate Medical Center
🇯🇵Tokyo, Japan
Osaka University Hospital
🇯🇵Osaka, Japan
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Soeul, Korea, Republic of
Alesund Hospital
🇳🇴Ålesund, Norway
Stadmedica, Non-Public Healthcare Facility
🇵🇱Bydgoszcz, Poland
Samsung Medical Center
🇰🇷Soeul, Korea, Republic of
COPERNICUS Limited Liability Company
🇵🇱Gdansk, Poland
M. Pirogow Provincial Specialized Hospital
🇵🇱Łódź, Poland
Gastromed Poland Sp. z o.o.
🇵🇱Lublin, Poland
Stanley Dudrick Multispecialty Hospital
🇵🇱Skawina, Poland
University General Hospital Gregorio Maranon
🇪🇸Madrid, Spain
University Hospital 12 de Octubre
🇪🇸Madrid, Spain
University Hospital Virgen del Rocio
🇪🇸Sevilla, Spain
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Sahlgrenska University Hospital
🇸🇪Göteborg, Sweden
Far Eastern Memorial Hospital
🇨🇳New Taipei City, Taiwan
St Mark's Hospital
🇬🇧Harrow, United Kingdom
Royal London Hospital
🇬🇧London, United Kingdom
University College Hospital
🇬🇧London, United Kingdom
Salford Royal Hospital
🇬🇧Salford, United Kingdom
Gastroenterology Group of Naples
🇺🇸Naples, Florida, United States