NCT05018286 (STARS extend) is a Phase 3 clinical trial of Apraglutide in Short Bowel Syndrome, sponsored by VectivBio AG.

Who is sponsoring NCT05018286?

NCT05018286 is sponsored by VectivBio AG.

What drugs are being tested in NCT05018286?

Interventions in NCT05018286: Apraglutide.

What condition does NCT05018286 study?

NCT05018286 studies Short Bowel Syndrome.

Is NCT05018286 still recruiting?

NCT05018286 is currently active, enrolled. Last updated 2 July 2025.

Last reviewed 2025-07-02 · How we verify

NCT05018286: STARS extend

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 3 Last updated 2 July 2025

What this trial tests

Phase 3 trial testing Apraglutide in Short Bowel Syndrome in 158 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

13 July 2021

Primary endpoint
30 October 2027

30 October 2027

Quick facts

Lead sponsor	VectivBio AG
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	158
Start date	13 July 2021
Primary completion	30 October 2027
Estimated completion	30 October 2027
Sites	66 locations across Denmark, France, Italy, Japan, Belgium, Sweden, Taiwan, United Kingdom

Drugs / interventions tested

Apraglutide — full drug profile →

Conditions studied

Short Bowel Syndrome — all drugs for Short Bowel Syndrome →

Sponsor

VectivBio AG — full company profile →

Who can join

18 and older, any sex, with Short Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Advance in peptide-based drug development: delivery platforms, therapeutics and vaccines.
Xiao W, Jiang W, Chen Z, Huang Y, et al · · 2025 · cited 144× · PMID 40038239 · DOI 10.1038/s41392-024-02107-5
A Gut-Restricted Liver X Receptor Agonist Ameliorates Liver Injury in Experimental Short Bowel Syndrome.
Kim A, Alligood DM, Maram L, Phelps HM, et al · · 2026 · cited 1× · PMID 41790074 · DOI 10.1053/j.gastro.2025.12.015
Pharmacokinetics and Safety of Single-Dose Apraglutide in Individuals with Normal and Impaired Hepatic Function: A Phase 1, Open-Label Trial.
Greig G, Hay J, Valencia P, Boules M, et al · · 2026 · PMID 41545784 · DOI 10.1002/cpdd.70006

Verify or expand the search:

Other trials of Apraglutide

Trials testing the same drug.

NCT06002555 — Relative Bioavailability of a New Presentation of Apraglutide Versus the Reference Formulation · Phase 1 · completed
NCT05995704 — Evaluation of Apraglutide on Gastric Emptying · Phase 1 · completed
NCT05706623 — A Phase 1 Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Norm · Phase 1 · completed
NCT05415410 — Proof-of-concept Trial of Apraglutide in Acute Graft Versus Host Disease (aGVHD) · Phase 2 · terminated
NCT04964986 — Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-C · Phase 2 · completed

Other recruiting trials for Short Bowel Syndrome

Currently open trials in the same condition.

NCT07197944 — Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS · Phase 3 · recruiting
NCT05535361 — A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in A · NA · recruiting
NCT06973304 — A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome · Phase 3 · recruiting
NCT06326645 — Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome · EARLY_PHASE1 · recruiting
NCT06771505 — SBS DISK- Creation of a Quality of Life Tool for Short Bowel Patients Compared With a Validated Quality of Life Question · recruiting

Other VectivBio AG trials

Trials by the same sponsor.

NCT06002555 — Relative Bioavailability of a New Presentation of Apraglutide Versus the Reference Formulation · Phase 1 · completed
NCT05995704 — Evaluation of Apraglutide on Gastric Emptying · Phase 1 · completed
NCT05706623 — A Phase 1 Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Norm · Phase 1 · completed
NCT05415410 — Proof-of-concept Trial of Apraglutide in Acute Graft Versus Host Disease (aGVHD) · Phase 2 · terminated
NCT04964986 — Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-C · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05018286 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VectivBio AG
Last refreshed: 2 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05018286.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing