Efficacy and Safety of apraglutide in SBS-IF
Research type
Research Study
Full 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)
IRAS ID
281704
Contact name
Farooq Rahman
Contact email
Sponsor organisation
VectivBio AG
Eudract number
2020-001202-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 22 days
Research summary
Plain Language Summary of the STARS Study (TA799-007)\n\nStudy Overview\n•\tStudy Title: STudy to evaluate efficacy and safety of ApRaglutide in Short bowel syndrome with intestinal failure (STARS)\n•\tSponsor: VectivBio AG (subsidiary of Ironwood Pharmaceuticals)\n•\tTreatment: Apraglutide (investigational GLP-2 analog given once weekly by injection)\n•\tStudy Period: 03 December 2020 to 22 February 2024\n•\tDesign: A study at many centers where participants were assigned by chance to receive apraglutide or placebo (a treatment that looked like apraglutide without active medicine). Neither participants nor study staff knew which treatment was assigned.\n•\tShort bowel syndrome: Rare condition in which large parts of the intestine are removed by surgery. In people with short bowel syndrome with intestinal failure (SBS-IF), remaining intestine cannot absorb enough nutrients/fluids from eating and drinking to sustain their health\n•\tParticipants: 163 adults with SBS-IF who needed stable amount of nutrition and/or fluids to be given through vein (intravenous [IV] support). Participants with stoma were treated for up to 24 weeks and those with preserved colon were treated for up to 48 weeks. After completing STARS study, participants could choose to join ongoing long-term study STARS Extend (TA799-012) where participants receive apraglutide. \n•\tCountries: 18 countries, 68 study sites\nThank you\nThank you for participating in STARS study (TA799-007) of apraglutide\nThis is a short plain language summary of study results. Please note, apraglutide has not been approved for use outside of clinical studies in any country\nIf you took part in this study and have questions about the results, please speak with a doctor or staff at your study site\nPurpose\nThe study evaluated whether apraglutide could improve intestinal absorption, reduce need for IV nutrition and/or fluids, and improve quality of life in adults with SBS-IF. It also assessed side effects\n Key Results\nPrimary Efficacy Outcome\nAfter 24 weeks \n•\tParticipants receiving apraglutide had about 26% reduction in weekly IV nutrition/fluid requirements compared to before treatment\n•\tParticipants receiving placebo had about 13% reduction. Difference between these groups was statistically significant, meaning it was unlikely due to chance\nParticipants with a Stoma\nAfter 24 weeks\n•\tParticipants receiving apraglutide had about 26% reduction in IV support volume compared with before treatment\n•\tParticipants receiving placebo had about 8% reduction\n•\tDifference between these groups was statistically significant\nReduction of IV Support by at least 1 Day per Week\nAfter 24 weeks \n•\t42% participants receiving apraglutide reduced IV support by at least 1 day per week\n•\t26% participants receiving placebo achieved the same result\n•\tDifference between these groups was statistically significant\nStopping IV Support Completely \nParticipants with a preserved colon after 48 weeks:\n•\tAbout 13% participants receiving apraglutide discontinued IV nutrition/fluids completely\n•\tAbout 7% participants receiving placebo achieved the same\n•\tDifference between these groups was not statistically significant, meaning it may have been due to chance\n How Participants Rated their Experience with IV Support\nAfter 24 weeks, the Patient Global Impression of Change (PGIC) Survey:\n•\t64% participants receiving apraglutide reported improvement\n•\t43% participants receiving placebo reported improvement\n•\tDifference between these groups was statistically significant\n•\tOther quality-of-life measures showed either small or no meaningful improvements.\nSafety Results\nOverall Safety\n•\tNo new or unexpected safety concerns were identified\n•\tSide effects were consistent with previous apraglutide studies\n•\tThree participants receiving apraglutide and one receiving placebo stopped treatment due to side effects\n•\tOne participant receiving apraglutide died of sudden cardiac death, considered not related to treatment\n•\tNo side effects led to participant withdrawal from study\nSerious Side Effects Considered Related to Study Treatment\n•\tApraglutide: 3% of participants\n•\tPlacebo: 6% of participants\nSerious side effects considered related to apraglutide included one report each of:\n•\tDuodenal ulcer\n•\tEnterocolonic fistula\n•\tHydrocholecystis (gallbladder swelling)\n•\tDiverticulitis\nCommon Side Effects Considered Related to Apraglutide seen in ≥5% participants\n•\tInjection-site redness: about 6%\n•\tAbdominal pain: about 5%\n•\tAbdominal distension (bloating): about 5%\nGastrointestinal Polyps\n•\tPolyps in the stomach or intestines seen in about 4% of participants across groups\n•\tAll polyps were non-cancerous and removed.\nConclusion\nThe STARS study showed once-weekly apraglutide reduced the need for IV nutrition and/or fluids in adults with SBS-IF more than placebo. More participants receiving apraglutide reported improvement in how they felt overall than those taking placebo. The treatment with apraglutide had acceptable safety profile and no new or important safety concerns were seen.\n
REC name
East of Scotland Research Ethics Service REC 2
REC reference
21/ES/0018
Date of REC Opinion
10 Mar 2021
REC opinion
Further Information Favourable Opinion