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

Phase 3

Completed

• Conditions: Short Bowel Syndrome
• Interventions: Drug: apraglutide

• Registration Number: NCT04627025
• Lead Sponsor: VectivBio AG

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.

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 Timeline

• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-11-08
• Study First Posted: 2020-11-13
• Study Start: 2021-01-26
• Primary Completion: 2024-01-02
• Study Completion: 2024-02-22
• Disposition First Posted: 2024-10-26
• Status Verified: 2024-11
• Disposition First Submitted: 2024-11-22
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apraglutide SC injections, once weekly	apraglutide	Peptide analogue of GLP-2
Placebo	apraglutide	Placebo for apraglutide, SC injection once weekly

Primary Outcome Measures

Name	Time	Method
Relative change from baseline in actual weekly PS volume at Week 24.	At week 24 of treatment

Secondary Outcome Measures

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

Trial Locations

Locations (68)

Ronald Reagan UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Gastroenterology Group of Naples; 🇺🇸 Naples, Florida, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Henry Ford Medical Center - Columbus; 🇺🇸 Novi, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

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