Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF

NCT04627025 | Completed Phase 3 FDA Drug

• 2 other identifiers: TA799-0072020-001202-32
• Study Type: interventional
• Target: 164
• Locations: 18 countries
• Sites: 68

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.

Conditions

Short Bowel Syndrome

Keywords

Short Bowel Syndrome; Intestinal Failure; SBS; SBS-IF; GLP-2; Short Bowel Syndrome Intestinal Failure

Outcome Measures

Primary Outcomes (1)

• Relative change from baseline in actual weekly PS volume at Week 24.

  At week 24 of treatment

Secondary Outcomes (15)

• 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

• 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

Study Arms (2)

Apraglutide SC injections, once weekly

EXPERIMENTAL

Peptide analogue of GLP-2

Drug: apraglutide

Placebo

PLACEBO COMPARATOR

Placebo for apraglutide, SC injection once weekly

Drug: apraglutide

Interventions

apraglutide DRUG

Apraglutide is a 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 SC injections, once weekly; Placebo

Eligibility Criteria

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

You may qualify if:

• Signed informed consent for this trial prior to any trial specific assessment.
• Male and female subjects with SBS-IF, receiving parenteral support (PS), secondary to surgical resection of the small intestine with either stoma or colon-in-continuity (CIC).
• Subject must require PS at least 3 days per work and be considered stable.
• No restorative surgery intended to change PS requirements in the trial period.
• Age ≥18 years at screening.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VectivBio AG: lead

Study Sites (68)

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, Illinois, 60611, United States

Location

Henry Ford Medical Center - Columbus

Novi, Michigan, 48377, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Duke University Hospital

Durham, North Carolina, 27705, 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, Center for Human Nutrition

Nashville, Tennessee, 37212, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

University Hospital Foundation Favaloro

Buenos Aires, Argentina

Location

Universitair Ziekenhuis Leuven - Gasthuisberg

Leuven, Vlaams Brabant, 3000, Belgium

Location

University Hospital Brussels

Brussels, 1090, Belgium

Location

University Hospital Brno

Brno, 62500, Czechia

Location

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location

Hospital Novy Jicin

Nový Jičín, 741 01, Czechia

Location

University Hospital Plzen

Pilsen, 30460, Czechia

Location

University Hospital Kralovske Vinohrady, 2nd Internal Clinic

Prague, 10034, Czechia

Location

General University Hospital in Prague

Prague, 12800, Czechia

Location

Rigshospitalet - University Hospital Copenhagen

Copenhagen, 2100, Denmark

Location

Hôpital Beaujon

Clichy, 92110, France

Location

CHU Hôtel Dieu

Nantes, 44093, France

Location

Hôpital ARCHET II

Nice, 6202, France

Location

Hôpital Haut-Lévèque

Pessac, 33604, France

Location

Hospices Civils de Lyon

Pierre-Bénite, 69495, France

Location

Brabois Adults Hospital

Vandœuvre-lès-Nancy, 54500, France

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

University Hospital Bonn

Bonn, 53127, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

University Hospital Muenster

Münster, 48149, Germany

Location

Medical Centre, Hungarian Defence Forces

Budapest, 1062, Hungary

Location

Semmelweis University

Budapest, 1082, Hungary

Location

St. Imre University Teaching Hospital Budapest

Budapest, H-1115, Hungary

Location

University of Szeged

Szeged, 6725, Hungary

Location

Rambam Health Care Campus

Haifa, 31096, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

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

Citta della salute e della Scienza di Torino Hospital

Torino, 10126, Italy

Location

Yokohama Municipal Citizen's Hospital

Kanagawa, 05505, Japan

Location

Yokohama City University Medical Center

Kanagawa, 232-0024, Japan

Location

National University Corportation Tohoku University Tohoku University Hospital

Miyagi, 980-8574, Japan

Location

Osaka University Hospital

Osaka, 565-0871, Japan

Location

JCHO Tokyo Yamate Medical Center

Tokyo, 169-0073, Japan

Location

Alesund Hospital

Ålesund, 6017, Norway

Location

Stadmedica, Non-Public Healthcare Facility

Bydgoszcz, 85-391, Poland

Location

COPERNICUS Limited Liability Company

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

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

Seoul, 06591, South Korea

Location

Asan Medical Center

Soeul, 05505, South Korea

Location

Samsung Medical Center

Soeul, 06351, 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

Seville, 41013, Spain

Location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2TH, United Kingdom

Location

St Mark's Hospital

Harrow, HA1 3UJ, United Kingdom

Location

Royal London Hospital

London, E1 1BB, United Kingdom

Location

University College Hospital

London, United Kingdom

Location

Salford Royal Hospital

Salford, 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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 13, 2020
• Study Start: January 26, 2021
• Primary Completion: January 2, 2024
• Study Completion: February 22, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

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