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Glucagon-Like Peptide-2 (GLP-2) Analog

Apraglutide for Graft-versus-Host Disease

Phase 2
Waitlist Available
Research Sponsored by VectivBio AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects aged 12 years or above at the time of consent and who weigh a minimum of 40 kg. Only subjects aged 18 years and above will be included in Germany.
Clinically confirmed steroid refractory lower GI-aGVHD (MAGIC stage 1-4)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 2 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new drug to see if it is safe and effective in treating aGVHD in people who haven't responded to steroids.

Who is the study for?
This trial is for individuals aged 12 and above, weighing at least 40 kg, who have steroid refractory gastrointestinal acute graft versus host disease after a stem cell transplant. Participants must use effective contraception if of childbearing potential and can't be on certain other GVHD therapies or have significant organ failures.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of Apraglutide in treating lower GI-aGVHD that hasn’t responded to steroids. Patients will also receive standard treatment with SS plus RUX starting up to five days before or within 72 hours of beginning Apraglutide.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions to new medications such as digestive issues, allergic responses, fatigue, or complications related to immune system changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are male or female, aged between 12 and 65 years, and weigh between 40 and 100 kg.
Select...
You have undergone alloSCT from any donor source, any conditioning regimen.
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You took SS plus RUX (at the recommended dose) twice a day starting no more than 5 days before Day 0.
Select...
You have received a stem cell transplant from any kind of donor and any type of preparation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events (AE)
Occurrence and titer anti-drug antibodies (ADA)
Occurrence of clinically relevant changes in electrocardiogram
+1 more
Secondary outcome measures
Absorption rate constant (ka) of apraglutide through population PK data analysis
Apparent clearance (CL/F) of apraglutide through population PK data analysis
Apparent volume of distribution (Vz/F) of apraglutide through population PK data analysis
+7 more

Side effects data

From 2021 Phase 1 trial • 16 Patients • NCT04699032
13%
Blood creatinine increased
13%
Chest pain
13%
Injection site hemorrhage
13%
Injection site papule
13%
Nausea
13%
Vomiting
13%
Alanine aminotransferase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Severely Impaired Renal Function
Normal Renal Function

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Apraglutide Standard DoseExperimental Treatment1 Intervention
Apraglutide SC injections, once weekly, for subjects with body weight between 40.0 kg to 49.9 kg.
Group II: Apraglutide Low DoseExperimental Treatment1 Intervention
Apraglutide SC injections, once weekly, for subjects with body weight of more than 50.0 kg.
Group III: Apraglutide High DoseExperimental Treatment1 Intervention
Apraglutide SC injections, once weekly, for subjects with body weight of more than 50.0 kg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apraglutide
2023
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

VectivBio AGLead Sponsor
10 Previous Clinical Trials
455 Total Patients Enrolled
AdelmannStudy DirectorVectivBio AG

Media Library

Apraglutide (Glucagon-Like Peptide-2 (GLP-2) Analog) Clinical Trial Eligibility Overview. Trial Name: NCT05415410 — Phase 2
Graft-versus-Host Disease Research Study Groups: Apraglutide Low Dose, Apraglutide High Dose, Apraglutide Standard Dose
Graft-versus-Host Disease Clinical Trial 2023: Apraglutide Highlights & Side Effects. Trial Name: NCT05415410 — Phase 2
Apraglutide (Glucagon-Like Peptide-2 (GLP-2) Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05415410 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What kind of safety measures are in place to protect individuals taking Apraglutide?

"Due to the nature of a Phase 2 trial, where there is pre-existing evidence for safety but not efficacy, Apraglutide earned a score of 2."

Answered by AI

What is the size of this research cohort?

"This trial requires 34 participants that fulfill the inclusion criteria. Those looking to enroll can choose between The Winship Cancer Institute Emory University in Atlanta, Georgia or Stanford Cancer Center in Stanford, California."

Answered by AI

Is recruitment for this research study still available?

"Clinicaltrials.gov lists the trial as currently enrolling participants, which was initiated on May 25th 2022 and last modified in November of that same year."

Answered by AI

In what locations is the trial being conducted?

"Currently, 7 medical centres are accepting patients for this trial. Locations include Atlanta, Stanford and Iowa City among other nearby cities to reduce the travel burden of participating in the study."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
What portion of applicants met pre-screening criteria?
Did not meet criteria
~14 spots leftby Aug 2025