Long-Term Safety of Apraglutide for Short Bowel Syndrome

(STARS extend Trial)

Not currently recruiting at 77 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the long-term safety of apraglutide for individuals with Short Bowel Syndrome with Intestinal Failure (SBS-IF). SBS-IF occurs when the body cannot absorb enough nutrients due to a missing part of the small intestine. The trial includes weekly injections of apraglutide, designed to enhance nutrient absorption. Individuals with SBS-IF from previous surgery who have participated in related studies might be suitable candidates for this trial. As a Phase 3 trial, it represents the final step before FDA approval, giving participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that apraglutide is likely to be safe for humans?

Research has shown that apraglutide, a treatment for short bowel syndrome with intestinal failure (SBS-IF), is generally safe. In earlier studies, patients using apraglutide required less parenteral support (PS), which is extra nutrition given through a vein, and their bodies absorbed nutrients more effectively. Most participants handled the treatment well, with over 98% continuing with their treatment plans. These results suggest that apraglutide is usually well-tolerated by patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Short Bowel Syndrome, which often involve complex nutritional support and existing GLP-2 analogues, apraglutide stands out due to its once-weekly subcutaneous injection protocol. This makes it potentially more convenient for patients than therapies requiring more frequent administration. Apraglutide is a peptide analogue of Glucagon-like Peptide 2 (GLP-2), and researchers are excited because it could improve intestinal absorption and nutritional status more effectively, offering a promising new approach to managing this challenging condition.

What evidence suggests that apraglutide might be an effective treatment for short bowel syndrome?

Research has shown that apraglutide can greatly help people with Short Bowel Syndrome with Intestinal Failure (SBS-IF). In studies, patients using apraglutide required less parenteral support—nutrition given directly into the bloodstream—and experienced more days without needing this support. It also improved nutrient absorption in their intestines. The treatment was well-tolerated and provided consistent benefits across different patients. Overall, these findings suggest that apraglutide effectively manages SBS-IF by enhancing intestinal function and reducing the need for external nutrition. ^{1 2 3 6 7}

Who Is on the Research Team?

Tomasz Masior

Principal Investigator

VectivBio AG

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39461299/

Efficacy and safety of apraglutide in short bowel syndrome ... Apraglutide had an acceptable safety profile and was associated with significant reductions in PS needs and days off PS, improvements in intestinal absorption.

2. clinicalnutritionjournal.com clinicalnutritionjournal.com/article/S0261-5614(24)00369-8/fulltext

Efficacy and safety of apraglutide in short bowel syndrome ... Apraglutide had an acceptable safety profile and was associated with significant reductions in PS needs and days off PS, improvements in ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0261561424003698

Efficacy and safety of apraglutide in short bowel syndrome ... Apraglutide had an acceptable safety profile and was associated with significant reductions in PS needs and days off PS, improvements in intestinal absorption.

4. investor.ironwoodpharma.com investor.ironwoodpharma.com/press-releases/press-release-details/2024/Once-Weekly-Apraglutide-Showed-Consistent-Treatment-Effect-Across-Baseline-Demographics-and-Disease-Characteristics-in-Adults-with-Short-Bowel-Syndrome-with-Intestinal-Failure-SBS-IF-According-to-New-STARS-Phase-III-Data-from-Ironwood-at-ACG-2024/default.aspx

Once-Weekly Apraglutide Showed Consistent Treatment ... Once-Weekly Apraglutide Showed Consistent Treatment Effect Across Baseline Demographics and Disease Characteristics in Adults with Short Bowel ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9545924/

Apraglutide, a novel once‐weekly glucagon‐like peptide‐2 ... Once‐weekly 5 mg apraglutide was well tolerated in patients with SBS‐II and SBS‐IF and significantly improved the absorption of fluids, electrolytes, and energy ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05018286

Study Details | NCT05018286 | Open-label Extension Trial ... The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF. Detailed Description. This is an ...

7. journals.lww.com journals.lww.com/ajg/fulltext/2024/10001/s2213_safety_and_tolerability_of_once_weekly.2214.aspx

S2213 Safety and Tolerability of Once-Weekly Glucagon ... More than 98% of patients had ≥80% treatment compliance in both treatment arms. Most patients entered the long-term, open-label STARS Extend trial at the end of ...