Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.

NCT05018286 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: TA799-012
• Study Type: interventional
• Target: 158
• Locations: 18 countries
• Sites: 66

Brief Summary

The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.

Conditions

Short Bowel Syndrome

Keywords

Short Bowel Syndrome; SBS; Intestinal Failure; SBS-IF

Outcome Measures

Primary Outcomes (7)

• Adverse events (AE)

  System organ class, frequency and severity

  From baseline to week 208

• Clinical chemistry

  Clinical Chemistry panel of analytes will be examined for clinically significant changes.

  From baseline to week 208

• Hematology

  Hematology panel of analytes will be examined for clinically significant changes.

  From baseline to week 208

• Hemostasis

  Hemostasis INR will be examined for clinically significant changes.

  From baseline to week 104

• Urinalysis

  Urinanalysis panel of analytes will be examined for clinically significant changes.

  From baseline to week 208

• Occurrence of clinically relevant changes in vital signs

  * Systolic and diastolic blood pressure in mmHg will be examined for clinically significant changes. * Heart rate in Beats per Minute (BPM) will be examined for clinically significant changes.

  From baseline to week 208

• Occurrence of clinically relevant changes in electrocardiogram

  ECG; intervals and rhythm

  From baseline to week 208

Secondary Outcomes (14)

• Change from baseline in PS volume

  From baseline to week 208

• Change from baseline in PS frequency

  From baseline to week 208

• Clinically significant changes in PS total energy

  From baseline to week 208

• Change from baseline in PS infusion time

  From baseline to week 208

• Percentage of subjects reaching enteral autonomy

  From baseline to week 104

Study Arms (1)

Apraglutide subcutaneous (SC) injections, once weekly

EXPERIMENTAL

Peptide analogue of Glucagon-like Peptide 2 (GLP-2)

Drug: Apraglutide

Interventions

Apraglutide DRUG

Apraglutide is a synthetic peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2

Apraglutide subcutaneous (SC) injections, once weekly

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females with a diagnosis of SBS-IF secondary to surgical resection of the small intestine, with Colon-in-Continuity (CIC) or stoma, who were trial subjects of parent trials TA799-007 or TA799-013
• Able to give informed consent and agree to follow the details of participation as outlined in the protocol.

You may not qualify if:

• Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.
• Any other reason judged not eligible by the Investigator.
• Pregnancy or lactation

Sponsors & Collaborators

• VectivBio AG: lead

Study Sites (66)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Gastroenterology Group of Naples

Naples, Florida, 34102, United States

Location

Northwestern University - Chicago

Chicago, Illinois, 60611, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68105, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

University Hospital Fundacion Favaloro

Buenos Aires, C1093AAS, Argentina

Location

University Hospital Brussels

Brussels, B-1090, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

University Hospital Brno

Brno, 62500, Czechia

Location

University Hospital Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Hospital Novy Jicin

Nový Jičín, 741 01, Czechia

Location

University Hospital Plzen

Pilsen, 30460, Czechia

Location

University Hospital Kralovske Vinohrady

Prague, 10034, Czechia

Location

General University Hospital in Prague

Prague, 12800, Czechia

Location

Rigshospitalet - University Hospital Copenhagen, Department of Intestinal Failure and Liver Diseases

Copenhagen, 2100, Denmark

Location

Beaujon Hospital

Clichy, 92110, France

Location

South Lyon Hospital Center

Lyon, 69495, France

Location

Nantes University Hospital Center - Hotel Dieu Hospital

Nantes, 44093, France

Location

Nice University Hospital Center - Archet 1 Hospital

Nice, 06200, France

Location

Hôpital Haut-Lévèque

Pessac, 33604, France

Location

Brabois Adults Hospital

Vandœuvre-lès-Nancy, 54500, France

Location

Charite - University Hospital Berlin

Berlin, 10117, Germany

Location

University Hospital Bonn

Bonn, 53127, Germany

Location

Asklepios Clinic St. Georg

Hamburg, 20099, Germany

Location

University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

University Hospital Muenster

Münster, 48149, Germany

Location

Szent Imre University Teaching Hospital, Department of Gastroenterology

Budapest, 1115, Hungary

Location

Central Hospital of Northern Pest - Military Hospital

Budapest, H-1062, Hungary

Location

Semmelweis University

Budapest, H-1062, Hungary

Location

University of Szeged

Szeged, 6725, Hungary

Location

Rambam Health Care Campus, Institute of Gastroenterology

Haifa, 31096, Israel

Location

Chaim Sheba Medical Center

Tel Litwinsky, 5262000, Israel

Location

Polyclinic S. Orsola-Malpighi

Bologna, 40138, Italy

Location

University Polyclinic Foundation "Agostino Gemelli" - IRCCS

Rome, 00168, Italy

Location

City of Health and Science of Turin

Turin, 10126, Italy

Location

Yokohama City University Medical Center

Kanagawa, 232-0024, Japan

Location

Yokohama Municipal Citizen's Hospital

Kanagawa, 232-0024, Japan

Location

Osaka University Hospital

Osaka, 565-0871, Japan

Location

Tohoku University Hospital

Sendai, 980-0872, Japan

Location

JCHO Tokyo Yamate Medical Center

Tokyo, 169-0073, Japan

Location

More og Romsdal Hospital Trust - Alesund Hospital

Ålesund, 6017, Norway

Location

Stadmedica, Non-Public Healthcare Facility

Bydgoszcz, 85-391, Poland

Location

COPERNICUS Limited Liability Company, Nutrition Outpatient Clinic for Adults

Gdansk, 80-152, Poland

Location

M. Pirogow Provincial Specialized Hospital

Lodz, 90-531, Poland

Location

Gastromed Poland Sp. z o.o.

Lublin, 20-582, Poland

Location

Stanley Dudrick Multispecialty Hospital

Skawina, 32-050, Poland

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 063351, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

University General Hospital Gregorio Maranon

Madrid, 28007, Spain

Location

University Hospital 12 de Octubre

Madrid, 28041, Spain

Location

University Hospital Virgen del Rocio (HUVR)

Seville, 41013, Spain

Location

Sahlgrenska University Hospital, Sahlgrenska Intestinal Failure and Transplant Centre

Gothenburg, 413 45, Sweden

Location

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

St Mark's Hospital

Harrow, HA1 3UJ, United Kingdom

Location

Royal London Hospital

London, E1 1BB, United Kingdom

Location

University College Hospital

London, NW1 2BU, United Kingdom

Location

Northern Care Alliance NHS Foundation Trust

Salford, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Short Bowel Syndrome; Intestinal Failure

Interventions

apraglutide

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tomasz Masior

  VectivBio AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: August 24, 2021
• Study Start: July 13, 2021
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: July 2, 2025

Record last verified: 2025-07

Locations

KR (3); PL (5); ES (3); TW (1); US (13); JP (5); CZ (6); SE (1); NO (1); DE (5); BE (2); FR (6); DK (1); GB (4); AR (1); HU (4); IL (2); IT (3)