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Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF (STARS)

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ClinicalTrials.gov Identifier: NCT04627025
Recruitment Status : Completed
First Posted : November 13, 2020
Last Update Posted : May 3, 2024
Sponsor:
Information provided by (Responsible Party):
VectivBio AG

Study Description
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Brief Summary:
The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.

Condition or disease Intervention/treatment Phase
Short Bowel Syndrome Drug: apraglutide Phase 3

Detailed Description:

This is an international, multicenter, double-blind, randomized, placebo-controlled, trial to evaluate the efficacy and safety of weekly SC injections of apraglutide in adult subjects with SBS-IF. The active pharmaceutical ingredient is apraglutide, a GLP-2 analogue.

The trial consists of a screening phase, a treatment phase of 48 weeks, and a safety follow-up phase. Trial participants will receive, after successful screening, once weekly apraglutide.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : January 26, 2021
Actual Primary Completion Date : January 2, 2024
Actual Study Completion Date : February 22, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Apraglutide SC injections, once weekly
Peptide analogue of GLP-2
 Drug: apraglutide
Apraglutide is a peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2.
Placebo Comparator: Placebo
Placebo for apraglutide, SC injection once weekly
 Drug: apraglutide
Apraglutide is a peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2.


Outcome Measures
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Primary Outcome Measures :
  1. Relative change from baseline in actual weekly PS volume at Week 24. [ Time Frame: At week 24 of treatment ]

Secondary Outcome Measures :
  1. Subjects who achieve a reduction of at least 1 day per week of PS at Weeks 24 / 48 (CIC only). [ Time Frame: Weeks 24 and 48 of treatment ]
  2. Relative change from baseline in actual weekly PS volume at Weeks 12 / 24 / 48 (CIC only). [ Time Frame: Weeks 12 / 24 / 48 of treatment ]
  3. Subjects reaching enteral autonomy at Weeks 24 / 48 (CIC only). [ Time Frame: Weeks 24 / 48 of treatment ]
  4. At least 20% reduction of PS volume from baseline at Weeks 20 / 24. [ Time Frame: Weeks 20 / 24 of treatment ]
  5. Calorie reduction in the PN at Weeks 24. [ Time Frame: Weeks 24 of treatment ]
  6. Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI) at Weeks 24 / 48 (CIC only) [ Time Frame: Weeks 24 / 48 of treatment ]
  7. Change from baseline on the Patient Global Impression of Change (PGIC) at Weeks 24 / 48 (CIC only) [ Time Frame: Weeks 24 / 48 of treatment. ]
  8. Change from baseline on the Patient Global Impression of Treatment Satisfaction (PGI-TS) at week 24 and 48 (CIC only). [ Time Frame: Weeks 24 / 48 of treatment ]
  9. Change from baseline on the Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS) at Week 24 and 48 (CIC only). [ Time Frame: Weeks 24 / 48 of treatment ]
  10. Change from baseline on the Patient Global Impression of Parenteral Support Impact (PGI-PSI) at Week 24 and 48 (CIC only). [ Time Frame: Weeks 24 / 48 of treatment ]
  11. Absorption rate constant (ka) of apraglutide through population PK data analysis [ Time Frame: Weeks 0 / 24 of treatment ]
  12. Apparent clearance (CL/F) of apraglutide through population PK data analysis [ Time Frame: Weeks 0 / 24 of treatment ]
  13. Apparent volume of distribution (Vz/F) of apraglutide through population PK data analysis [ Time Frame: Weeks 0 / 24 of treatment ]
  14. At least 40% reduction of PS volume at Weeks 20 and 24 (Stoma only) [ Time Frame: Weeks 20 / 24 of treatment ]
  15. Trough plasma concentrations (Ctrough) at every other visit during the prolonged dosing period (CIC only) [ Time Frame: Weeks 24 / 48 of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Signed informed consent for this trial prior to any trial specific assessment.
  2. Male and female subjects with SBS-IF, receiving parenteral support (PS), secondary to surgical resection of the small intestine with either stoma or colon-in-continuity (CIC).
  3. Subject must require PS at least 3 days per work and be considered stable.
  4. No restorative surgery intended to change PS requirements in the trial period.
  5. Age ≥18 years at screening.

Exclusion Criteria:

  1. Pregnancy or lactation.
  2. Major abdominal surgery in the last 6 months prior to screening.
  3. History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer.
  4. Evidence of active inflammatory GI conditions in the previous 6 months.
  5. Evidence of decompensated heart failure.
  6. Evidence of severe renal or hepatic impairment.
  7. Any previous use of growth factors such as growth hormone (GH), native GLP-2, GLP-1, or GLP-2 or GLP-1 analogues should be discussed with the Investigator.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04627025


Locations
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Sponsors and Collaborators
VectivBio AG
Investigators
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Study Director: Bolognani VectivBio AG
More Information
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Additional Information:

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Responsible Party: VectivBio AG
ClinicalTrials.gov Identifier: NCT04627025    
Other Study ID Numbers: TA799-007
2020-001202-32 ( EudraCT Number )
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: May 3, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VectivBio AG:
Short Bowel Syndrome
Intestinal Failure
SBS
 SBS-IF
GLP-2
Short Bowel Syndrome Intestinal Failure
Additional relevant MeSH terms:
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Short Bowel Syndrome
Intestinal Failure
Syndrome
Disease
Pathologic Processes
 Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications