Long-Term Safety of Apraglutide for Short Bowel Syndrome

(STARS extend Trial)

Recruiting at 68 trial locations

Overseen By Ahn

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: VectivBio AG

Disqualifiers: Pregnancy, Lactation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 208 weeks

158 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Tomasz Masior

Principal Investigator

VectivBio AG

Eligibility Criteria

This trial is for men and women with Short Bowel Syndrome (SBS) due to surgery, who were previously in trials TA799-007 or TA799-013. Participants must be able to consent and follow the study plan. Those unable to understand the requirements, unwilling to adhere to visit schedules, pregnant or lactating individuals are excluded.

Inclusion Criteria

I was part of previous trials TA799-007 or TA799-013 and have SBS-IF due to surgery on my small intestine.

Able to give informed consent and agree to follow the details of participation as outlined in the protocol.

Exclusion Criteria

Any other reason judged not eligible by the Investigator

Pregnancy or lactation

I understand and agree to follow the trial's schedule and requirements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive apraglutide subcutaneous injections once weekly

208 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants continue to receive apraglutide until it is commercially available in their country

Up to 208 weeks

Treatment Details

Interventions

• Apraglutide

Trial Overview The trial is testing Apraglutide's long-term safety for people with SBS. It's an open-label extension which means everyone knows they're getting Apraglutide and there’s no placebo group involved.

Participant Groups

Group I: Apraglutide subcutaneous (SC) injections, once weekly Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

VectivBio AG

Lead Sponsor

Trials

11

Recruited

490+