Proof-of-concept Trial of Apraglutide in Acute Graft Versus Host Disease (aGVHD)
NCT ID: NCT05415410
Last Updated: 2025-10-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
31 participants
INTERVENTIONAL
2022-05-25
2024-12-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Apraglutide Low Dose
Low-dose, weight-based apraglutide subcutaneous (SC) injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
Apraglutide
Apraglutide is a new, synthetic glucagon-like peptide 2 (GLP-2) receptor agonist which acts as a gut targeted regenerative approach that is intestinotrophic with a mode of action that improves absorption and enhances gut barrier function.
Apraglutide High Dose
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
Apraglutide
Apraglutide is a new, synthetic glucagon-like peptide 2 (GLP-2) receptor agonist which acts as a gut targeted regenerative approach that is intestinotrophic with a mode of action that improves absorption and enhances gut barrier function.
Apraglutide Standard Dose
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
Apraglutide
Apraglutide is a new, synthetic glucagon-like peptide 2 (GLP-2) receptor agonist which acts as a gut targeted regenerative approach that is intestinotrophic with a mode of action that improves absorption and enhances gut barrier function.
Interventions
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Apraglutide
Apraglutide is a new, synthetic glucagon-like peptide 2 (GLP-2) receptor agonist which acts as a gut targeted regenerative approach that is intestinotrophic with a mode of action that improves absorption and enhances gut barrier function.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
12 Years
ALL
No
Sponsors
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VectivBio AG
INDUSTRY
Responsible Party
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Principal Investigators
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Tomasz Masior
Role: STUDY_DIRECTOR
VectivBio AG
Locations
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Stanford Cancer Center
Stanford, California, United States
University of Iowa
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
The Ohio State University
Columbus, Ohio, United States
South Austin Medical Center
Austin, Texas, United States
Universitätsklinikum Köln (AoeR)
Cologne, , Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Martin Luther Universität Halle-Wittenberg
Halle, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitätsmedizin der Johannes Gutenberg - Universität Mainz
Mainz, , Germany
Instituto Portugues de Oncologia do Porto Francisco Gentil
Porto, , Portugal
Hospital Universitario Virgen del Rocio
Seville, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TA799-101
Identifier Type: -
Identifier Source: org_study_id
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