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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
Clinically confirmed steroid refractory lower GI-aGVHD (MAGIC stage 1-4) prior to randomization
Male or female subjects aged 12 years or above at the time of consent and who weigh a minimum of 40 kg (subjects aged 18 years and above in Germany)
Must not have
Presence of SR GI-aGVHD occurring after donor lymphocyte infusion for pre-emptive treatment of malignancy recurrence
Active clinically uncontrolled infection or active tuberculosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 2 years
Awards & highlights
No Placebo-Only Group

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.
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.
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
Select...
My lower GI acute graft-versus-host disease hasn't improved with steroids.
Select...
I am 12 years or older and weigh at least 40 kg.
Select...
I have had a stem cell transplant from a donor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have GI issues after a treatment to prevent cancer return.
Select...
I do not have an active, uncontrolled infection or tuberculosis.
Select...
I am not taking any Janus kinase inhibitors except for RUX currently.
Select...
I have chronic graft-versus-host disease.
Select...
I haven't had major belly surgery or serious gut issues in the last 6 months.
Select...
My liver tests are not normal.
Select...
I have polyps in my colon that have not been removed.
Select...
I have active inflammation in my digestive system not caused by graft-versus-host disease.
Select...
My major organs like heart, lungs, liver, and kidneys are functioning well.
Select...
My cancer returned after a stem cell transplant.
Select...
I am not on any GVHD treatment except for SS and RUX.
Select...
My cancer returned after a stem cell transplant.
Select...
I haven't taken glutamine, GLP analogs, or ADA in the last 6 months.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events (AE)
Occurrence and titer anti-drug antibodies (ADA)
Occurrence of clinically relevant changes in electrocardiogram
+1 more
Secondary study objectives
Failure free survival post-first dose of apraglutide
Graft failure post-first dose of apraglutide
Lower Gastrointestinal-GVHD relapse following complete GI response
+3 more

Side effects data

From 2021 Phase 1 trial • 16 Patients • NCT04699032
13%
Chest pain
13%
Blood creatinine increased
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
Holger AdelmannStudy DirectorVectivBio AG
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
~6 spots leftby Aug 2025
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