Apraglutide for GVHD

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Hospital Clinico Universitario de Valencia, Valencia, Spain
GVHD+1 More
Apraglutide - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

The aim of this trial is to assess safety and efficacy of apraglutide in subjects with steroid refractory gastrointestinal acute graft versus host disease (aGVHD).

Eligible Conditions

  • GVHD

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 10 Secondary · Reporting Duration: Baseline to 2 years

Day 14
Lower gastrointestinal-aGVHD response
Day 14
Overall response
Baseline to 2 years
Failure free survival post-first dose of apraglutide
Graft failure post-first dose of apraglutide
Lower Gastrointestinal-GVHD relapse following complete GI response
Malignancy relapse/progression post-first dose of apraglutide
Overall survival post-first dose of apraglutide
Day 56
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
Week 104
Adverse events (AE)
Occurrence and titer anti-drug antibodies (ADA)
Occurrence of clinically relevant changes in electrocardiogram
Occurrence of clinically relevant changes in vital signs

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Apraglutide Low Dose
1 of 3
Apraglutide High Dose
1 of 3
Apraglutide open label
1 of 3
Experimental Treatment

34 Total Participants · 3 Treatment Groups

Primary Treatment: Apraglutide · No Placebo Group · Phase 2

Apraglutide Low Dose
Drug
Experimental Group · 1 Intervention: Apraglutide · Intervention Types: Drug
Apraglutide High Dose
Drug
Experimental Group · 1 Intervention: Apraglutide · Intervention Types: Drug
Apraglutide open label
Drug
Experimental Group · 1 Intervention: Apraglutide · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apraglutide
2020
Completed Phase 1
~20

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 2 years
Closest Location: South Austin Medical Center · Austin, TX
Photo of Austin 1Photo of Austin 2Photo of Austin 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching GVHD
0 CompletedClinical Trials

Who is running the clinical trial?

VectivBio AGLead Sponsor
7 Previous Clinical Trials
324 Total Patients Enrolled
AdelmannStudy DirectorVectivBio AG

Eligibility Criteria

Age Any Age · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are at least 12 years of age and weigh at least 40 kg.
You are able to give informed consent and agree to follow the details of participation as outlined in the protocol.
You are a woman of childbearing potential (WOCBP).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.