Status:
TERMINATED
Proof-of-concept Trial of Apraglutide in Acute Graft Versus Host Disease (aGVHD)
Lead Sponsor:
VectivBio AG
Conditions:
GVHD
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
The aim of this trial is to assess safety and efficacy of apraglutide in subjects with steroid refractory gastrointestinal aGVHD.
Detailed Description
This is an international, multicenter, randomized proof-of-concept trial to evaluate safety, tolerability, efficacy, durability of response, and clinical outcomes of apraglutide administration to subj...
Eligibility Criteria
Inclusion
- Able to give informed consent and agree to follow the details of participation as outlined in the protocol
- 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) prior to randomization
- Have undergone alloSCT from any donor source, any conditioning regimen
- Treated with SS plus RUX (RUX starts concomitantly to apraglutide or a maximum of 72 hours before apraglutide initiation)
- Women of childbearing potential (WOCBP): highly effective method of contraception and refrain from donating eggs during the trial and for 4 weeks after the End of Trial (EOT) visit
- Male subjects with partner WOCBP: contraception and abstention from sperm donation during the trial and for 2 weeks after the EOT visit
Exclusion
- Treatment with any systemic GVHD therapy other than SS and RUX including methotrexate and mycophenolate mofetil at the time of randomization / Day 0
- Concomitant treatment with Janus kinase inhibitor other than RUX at the time of randomization
- Failed alloSCT due to relapse of underlying malignant disease
- Presence of SR GI-aGVHD occurring after donor lymphocyte infusion for pre-emptive treatment of malignancy recurrence
- Any use of enteral glutamine or GLP analogs or known ADA, within 6 months prior to randomization / Day 0
- Significant organ system failures (respiratory renal hepatic and cardiac)
- Presence of relapsed primary malignancy or treatment for relapse after alloHSCT
- Presence or history of GI tumors (including the hepatobiliary system and pancreas) within the last five years before randomization
- Presence of colonic polyps not removed
- Active clinically uncontrolled infection or active tuberculosis
- Known chronic GVHD
- Known active GI inflammation not related to GI-aGVHD
- Major abdominal surgery in the last 6-months prior to randomization or history of clinically significant intestinal adhesions
- Abnormal liver function tests
Key Trial Info
Start Date :
May 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2024
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05415410
Start Date
May 25 2022
End Date
December 17 2024
Last Update
October 20 2025
Active Locations (13)
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1
Stanford Cancer Center
Stanford, California, United States, 94305
2
University of Iowa
Iowa City, Iowa, United States, 52242
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
The Ohio State University
Columbus, Ohio, United States, 43210