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

Short Bowel Syndrome Clinical Trial

— STARS  

Official title:

A Multicenter, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Apraglutide in Adult Subjects With Short Bowel Syndrome and Intestinal Failure (SBS-IF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04627025
• Other study ID #: TA799-007
• Secondary ID: 2020-001202-32
• Status: Completed
• Phase: Phase 3
• Start date: January 26, 2021
• Est. completion date: February 22, 2024

Study information

• Verified date: March 2024
• Source: VectivBio AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: February 22, 2024
• Est. primary completion date: January 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Signed informed consent for this trial prior to any trial specific assessment.

2. 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).

3. Subject must require PS at least 3 days per work and be considered stable.

4. No restorative surgery intended to change PS requirements in the trial period.

5. Age =18 years at screening.

Exclusion Criteria:

1. Pregnancy or lactation.

2. Major abdominal surgery in the last 6 months prior to screening.

3. History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within =5 years, except for adequately treated basal cell skin cancer.

4. Evidence of active inflammatory GI conditions in the previous 6 months.

5. Evidence of decompensated heart failure.

6. Evidence of severe renal or hepatic impairment.

7. 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.

Related Conditions & MeSH terms

• Intestinal Failure
• Short Bowel Syndrome
• Syndrome

Intervention

Drug:
• apraglutide
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.

Locations

Country	Name	City	State
Argentina	University Hospital Foundation Favaloro	Buenos Aires
Belgium	University Hospital Brussels	Brussels
Belgium	Universitair Ziekenhuis Leuven - Gasthuisberg	Leuven	Vlaams Brabant
Czechia	University Hospital Brno	Brno
Czechia	University Hospital Hradec Kralove	Hradec Králové
Czechia	Hospital Novy Jicin	Nový Jicín
Czechia	University Hospital Plzen	Pilsen
Czechia	General University Hospital in Prague	Prague
Czechia	University Hospital Kralovske Vinohrady, 2nd Internal Clinic	Prague
Denmark	Rigshospitalet - University Hospital Copenhagen	Copenhagen
France	Hôpital Beaujon	Clichy
France	CHU Hôtel Dieu	Nantes
France	Hôpital ARCHET II	Nice
France	Hôpital Haut-Lévèque	Pessac
France	Hospices Civils de Lyon	Pierre Benite
France	Brabois Adults Hospital	Vandœuvre-lès-Nancy
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	University Hospital Bonn	Bonn
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	University Hospital Heidelberg	Heidelberg
Germany	University Hospital Muenster	Münster
Hungary	Medical Centre, Hungarian Defence Forces	Budapest
Hungary	Semmelweis University	Budapest
Hungary	St. Imre University Teaching Hospital Budapest	Budapest
Hungary	University of Szeged	Szeged
Israel	Rambam Health Care Campus	Haifa
Israel	Rabin Medical Center	Petah-Tikva
Israel	Sheba Medical Center	Tel HaShomer
Italy	Polyclinic S. Orsola-Malpighi	Bologna
Italy	University Polyclinic Foundation "Agostino Gemelli" - IRCCS	Rome
Italy	Citta della salute e della Scienza di Torino Hospital	Torino
Japan	Yokohama City University Medical Center	Kanagawa
Japan	Yokohama Municipal Citizen's Hospital	Kanagawa
Japan	National University Corportation Tohoku University Tohoku University Hospital	Miyagi
Japan	Osaka University Hospital	Osaka
Japan	JCHO Tokyo Yamate Medical Center	Tokyo
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Asan Medical Center	Soeul
Korea, Republic of	Samsung Medical Center	Soeul
Norway	Alesund Hospital	Ålesund
Poland	Stadmedica, Non-Public Healthcare Facility	Bydgoszcz
Poland	COPERNICUS Limited Liability Company	Gdansk
Poland	M. Pirogow Provincial Specialized Hospital	Lódz
Poland	Gastromed Poland Sp. z o.o.	Lublin
Poland	Stanley Dudrick Multispecialty Hospital	Skawina
Spain	University General Hospital Gregorio Maranon	Madrid
Spain	University Hospital 12 de Octubre	Madrid
Spain	University Hospital Virgen del Rocio	Sevilla
Sweden	Sahlgrenska University Hospital	Göteborg
Taiwan	Far Eastern Memorial Hospital	New Taipei City
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	St Mark's Hospital	Harrow
United Kingdom	Royal London Hospital	London
United Kingdom	University College Hospital	London
United Kingdom	Salford Royal Hospital	Salford
United States	Northwestern University	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Duke University Hospital	Durham	North Carolina
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	Gastroenterology Group of Naples	Naples	Florida
United States	Vanderbilt University Medical Center, Center for Human Nutrition	Nashville	Tennessee
United States	Mount Sinai Medical Center	New York	New York
United States	Henry Ford Medical Center - Columbus	Novi	Michigan
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VectivBio AG

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Czechia,  Denmark,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Norway,  Poland,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative change from baseline in actual weekly PS volume at Week 24.		At week 24 of treatment
Secondary	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
Secondary	Relative change from baseline in actual weekly PS volume at Weeks 12 / 24 / 48 (CIC only).		Weeks 12 / 24 / 48 of treatment
Secondary	Subjects reaching enteral autonomy at Weeks 24 / 48 (CIC only).		Weeks 24 / 48 of treatment
Secondary	At least 20% reduction of PS volume from baseline at Weeks 20 / 24.		Weeks 20 / 24 of treatment
Secondary	Calorie reduction in the PN at Weeks 24.		Weeks 24 of treatment
Secondary	Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI) at Weeks 24 / 48 (CIC only)		Weeks 24 / 48 of treatment
Secondary	Change from baseline on the Patient Global Impression of Change (PGIC) at Weeks 24 / 48 (CIC only)		Weeks 24 / 48 of treatment.
Secondary	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
Secondary	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
Secondary	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
Secondary	Absorption rate constant (ka) of apraglutide through population PK data analysis		Weeks 0 / 24 of treatment
Secondary	Apparent clearance (CL/F) of apraglutide through population PK data analysis		Weeks 0 / 24 of treatment
Secondary	Apparent volume of distribution (Vz/F) of apraglutide through population PK data analysis		Weeks 0 / 24 of treatment
Secondary	At least 40% reduction of PS volume at Weeks 20 and 24 (Stoma only)		Weeks 20 / 24 of treatment
Secondary	Trough plasma concentrations (Ctrough) at every other visit during the prolonged dosing period (CIC only)		Weeks 24 / 48 of treatment

External Links

•   If you are in the United States and want to learn more about the STARS study, click HERE (https://app.patientwing.com/campaign/sbsifctgov)