Apraglutide for Short Bowel Syndrome

(STARS Trial)

No longer recruiting at 88 trial locations

Overseen By Fritze

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: VectivBio AG

Must not be taking: Growth factors

Disqualifiers: Pregnancy, Cancer, Heart failure, others

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: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if apraglutide, administered as a weekly injection, can reduce the need for parenteral support (nutrition delivered directly into the bloodstream) in individuals with Short Bowel Syndrome (SBS). Participants will receive either apraglutide or a placebo to assess the treatment's effectiveness. The trial seeks individuals with SBS due to surgery who rely on parenteral support at least three days a week and do not plan further surgery to alter their support needs. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, any previous use of growth factors like growth hormone or GLP-2 analogues should be discussed with the investigator.

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

Research has shown that apraglutide is generally safe for people with short bowel syndrome. Studies indicate it has a good safety record and can help reduce the need for intravenous nutrient support. Few side effects occur, such as reactions at the injection site. No new safety issues have emerged, and most people taking apraglutide tolerate it well. Overall, current data suggest that apraglutide is well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Apraglutide is unique because it is a peptide analogue of GLP-2, a hormone that helps manage nutrient absorption in the gut. Unlike the standard treatments for Short Bowel Syndrome, which often include dietary changes and medications to reduce diarrhea, Apraglutide directly stimulates the growth and function of the intestinal lining, potentially improving nutrient absorption. This targeted mechanism of action is why researchers are excited, as it offers hope for more effective management of symptoms and improved quality of life for patients with this 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. In studies, patients taking apraglutide needed significantly less IV nutrition, with an average 52% reduction in weekly requirements after one year. Many patients also absorbed more nutrients from their food, allowing their bodies to benefit more from their diet. Overall, apraglutide consistently proved effective and safe. These findings suggest apraglutide could be a promising option for managing short bowel syndrome. Participants in this trial will receive either apraglutide or a placebo to further evaluate its effectiveness and safety. ^{1 2 3 4 6}

Who Is on the Research Team?

Tomasz Masior

Principal Investigator

VectivBio AG

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Short Bowel Syndrome-Intestinal Failure who need parenteral support at least 3 days a week and are stable. They shouldn't plan any restorative gut surgery during the trial, have had recent major abdominal surgery, inflammatory GI conditions, severe organ impairment, or cancer within the last 5 years.

Inclusion Criteria

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.

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

Exclusion Criteria

You have had a flare up of inflammatory bowel disease or other gastrointestinal conditions in the past 6 months.

If you have ever used growth hormones or similar medications before, you will need to talk with the researcher before joining the study.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly subcutaneous injections of apraglutide or placebo for 48 weeks

48 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Apraglutide

Trial Overview The trial tests apraglutide's effectiveness in reducing dependency on parenteral support (PS) among patients with SBS-IF. Participants will receive weekly subcutaneous injections of apraglutide to see if it can help reduce their need for PS.

How Is the Trial Designed?

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

Peptide analogue of GLP-2

Group II: Placebo Placebo Group 1 Intervention

Placebo for apraglutide, SC injection once weekly

Who Is Running the Clinical Trial?

VectivBio AG

Lead Sponsor

Trials

11

Recruited

490+

Citations

1. 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.

2. 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 ...

3. 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.

4. 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 ...

5. journals.lww.com journals.lww.com/10.14309/01.ajg.0001139660.79793.4f

S3050 Apraglutide for Short Bowel Syndrome: A Systematic... in 9 adults with SBS showed that apraglutide yielded a mean 52% reduction in weekly PS volume at 52 weeks (−4702 mL/week). Seven of 9 patients (78%) achieved ≥1 ...

6. 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- ... Apraglutide has a safety profile consistent with previous APRA studies, with no new safety concerns. The low incidences of injection site reactions and AEs ...